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Monday, March 05, 2012
Survey - Cure Magazine/Extra - Do you think environmental factors contributed to your cancer?
This poll is not conducted scientifically and represents the opinions of site visitors. (to answer yes or no click on the survey below)
Survey
ACP Calls for Colon Cancer Screening at 50 - in Primary Care, Preventive Care from MedPage Today
Action Points
- Explain that colorectal cancer screening should begin at age 50 for all average-risk individuals, according to a new clinical guideline from the American College of Physicians (ACP), and options include fecal occult blood testing (FOBT), flexible sigmoidoscopy, and colonoscopy.
- Point out that high-risk patients should begin screening at 40 (or 10 years younger than the age when the youngest affected relative was diagnosed), and colonoscopy is the recommended screening modality.
A Heart Helper May Come at a Price for the Brain - NYTimes.com
"Statins are the most prescribed drugs in the world, and there is no doubt that for people at high risk of cardiovascular problems, the drugs lower not only cholesterol but also the risk of heart attack and stroke. But for years doctors have been fielding reports from patients that the drugs leave them feeling “fuzzy,” and unable to remember small and big things, like where they left the car, a favorite poem or a recently memorized presentation. Last week, the Food and Drug Administration finally acknowledged what many patients and doctors have believed for a long time: Statin drugs carry a risk of cognitive side effects. The agency also warned users about diabetes risk and muscle pain...........
March 6, 2012 - Screening for Colorectal Cancer: A Guidance Statement From the American College of Physicians (pdf) including high risk
Blogger's Note: if searching for Lynch Syndrome, the older term 'HNPCC' will need to be used
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Genetic or clinical diagnosis of hereditary nonpolyposis colorectal cancer (HNPCC): colonoscopy every one to two years beginning at age 20 to 25 years or 10 years before the age of the youngest case in the immediate family."
For Doctors, Luck Can Explain What They Themselves Cannot - NYTimes.com
"The hospital I work at has no 13th floor.
The absence can be a bit awkward to explain to people. I mean, here sits
a building at the center of the modern evidence-based scientific
empire. Yet as soon as we set foot in the elevator, it is clear that we
have decided to hedge our bets a little, and play the dark side too.....
abstract: Knowledge engineering for health: A new discipline required to bridge the ‘ICT Gap’ between research and healthcare
Knowledge engineering for health: A new discipline required to bridge the ‘ICT Gap’ between research and healthcare:
Abstract
Despite vast amounts of money and research being channelled towards biomedical research, relatively little impact has been made on routine clinical practice.
At the heart of this failure is the information and communication technology (ICT) 'chasm' that exists between research and healthcare. A new domain of 'knowledge engineering for health' is needed to facilitate knowledge transmission across the research-healthcare gap. This discipline is required to engineer the bi-directional flow of data: research data and knowledge processed to identify clinically relevant advances and delivered into healthcare use; conversely, outcomes from the practice of medicine made suitably available for use by the research community. This system will be able to self-optimise, in that outcomes for patients treated by decisions that were based on the latest research knowledge will be fed back to the research world. A series of meetings, culminating in the 'I-Health 2011' workshop, have brought together interdisciplinary experts to map the challenges and requirements for such as system. Here we describe the main conclusions from these meetings.
An 'I4Health' interdisciplinary network of experts now exists to promote the key aims and objectives, namely “integrating and interpreting information for individualised healthcare”, by developing the 'knowledge engineering for health' domain.
At the heart of this failure is the information and communication technology (ICT) 'chasm' that exists between research and healthcare. A new domain of 'knowledge engineering for health' is needed to facilitate knowledge transmission across the research-healthcare gap. This discipline is required to engineer the bi-directional flow of data: research data and knowledge processed to identify clinically relevant advances and delivered into healthcare use; conversely, outcomes from the practice of medicine made suitably available for use by the research community. This system will be able to self-optimise, in that outcomes for patients treated by decisions that were based on the latest research knowledge will be fed back to the research world. A series of meetings, culminating in the 'I-Health 2011' workshop, have brought together interdisciplinary experts to map the challenges and requirements for such as system. Here we describe the main conclusions from these meetings.
An 'I4Health' interdisciplinary network of experts now exists to promote the key aims and objectives, namely “integrating and interpreting information for individualised healthcare”, by developing the 'knowledge engineering for health' domain.
news: FDA clears UELS contactless breast cancer imaging tool
Fallopian Tube Removal as a Method of Ovarian Cancer Prevention: A Descriptive Study - Full Text View - ClinicalTrials.gov
Fallopian Tube Removal as a Method of Ovarian Cancer Prevention: A Descriptive Study
This study is currently recruiting participants.
Verified February 2012 by University of Washington
First Received on February 28, 2012. Last Updated on March 2, 2012 History of Changes
Purpose
Purpose
The purpose of this study is to better understand why women choose to have their fallopian tubes removed as a method for ovarian cancer prevention. This will be done through a paper questionnaire and phone interviews. The investigators hope to gain information that will allow us to better counsel women about ovarian cancer prevention.
| Sponsor: | University of Washington |
|---|---|
| Information provided by (Responsible Party): | Elizabeth Swisher, University of Washington |
| ClinicalTrials.gov Identifier: | NCT01544049 |
phase 11 - Trial of Adjuvant FANG™ Vaccine for High Risk Stage IIIc Ovarian Cancer - Full Text View - ClinicalTrials.gov
Primary Outcome Measures:
- To determine and compare time to recurrence (TTR) [ Time Frame: Participants will be followed for life. ] [ Designated as safety issue: No ]• To determine and compare time to recurrence (TTR) following the administration of bi-shRNAfurin and GMCSF autologous tumor cell (FANG™) vaccine in high risk patients with stage IIIc ovarian cancer NED following tumor debulking surgery and chemotherapy to standard of care post treatment observation.
Secondary Outcome Measures:
- Immune Function [ Time Frame: Blood will be collected at baseline, Months 2, 4, 6, 9, 12, 18 and EOT ] [ Designated as safety issue: Yes ]
- To identify and determine the effect of FANG™ autologous tumor cell vaccine on immune surrogate markers in this group of patients.
- To enlarge the safety database of FANG™ autologous tumor cell vaccine in patients with minimal disease.
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
abstract: Alternative and complementary therapies for the menopause
Alternative and complementary therapies for the menopause:
"Despite a re-evaluation of risks in recent years, hormone replacement therapy is still surrounded by controversy. Almost 30% of women in a recent survey sought a natural approach to combat climacteric symptoms. Nevertheless, a large proportion of patients felt that they wanted a good safety profile and strong evidence base for treatment. This article seeks to review the evidence supporting non-hormonal approaches to treatment. There is only conflicting evidence at best to support alpha-2 agonists, e.g. clonidine and limited evidence for dihydroepiandrosterone and natural progesterones. There is limited randomized controlled trial data for gabapentin, selective norepinephrine re-uptake inhibitors (SNRIs) and selective serotonin re-uptake inhibitors (SSRIs), many of these studies being related to breast cancer patients. Of the herbal medicinal products, the largest evidence base rests with phytoestrogens. A Cochrane Database review looking at all types of phytoestrogens, e.g. red clover extracts, dietary soya and soya extracts concluded that there was no evidence to support improvement in climacteric symptoms and the meta-analysis of a 178 studies on soy products was inconsistent. Nevertheless, other studies disagree. Mammographic density is not affected by soy or phytoestrogen products and recent in vitro work shows only a weakly proliferative effect of soy isoflavone on breast cancer cells and evidence that soy isoflavone blocks the proliferative effect of estradiol on these cells. There are no studies looking at clinical outcome measures for cardiovascular disease but a number of studies looking at biochemical markers including arterial wall stiffness and apolipo protein B. Recent studies have also looked at the effects of red clover isoflavone on mood and depression, using specific depression rating scales. Finally, it is important to note that herbal medicinal products should not be used without caution. Some may produce quite marked side-effects in high doses and others can interact with pre-existing medication. A strategy for which patients are suitable for herbal medicinal products is reviewed."
Understanding Evidence-based Healthcare: A Foundation for Action | US Cochrane Center - 6 modules
Course Description:
In these six modules, we will illustrate key concepts with compelling real-world examples, covering the following topics and issues. Run times do not take into account interruptions or a second review of selected slides.
- Module 1. INTRO: What is evidence-based healthcare and why is it important? (45 minutes)
- Module 2. ASK: The importance of research questions in evidence based healthcare. (40 minutes)
- Module 3. ALIGN: Research design, bias and levels of evidence. (1 hour)
- Module 4. ACQUIRE: Searching for healthcare information. Assessing harms and benefits. (1 hour 10 minutes)
- Module 5. APPRAISE: Behind the numbers: Understanding healthcare statistics. Science, speed and the search for best evidence. (1 hour 20 minutes)
- Module 6: APPLY: Critical appraisal and making better decisions for evidence-based healthcare, Determining causality. (1 hour)
The Power of Observational Studies (critical commentaries)
We tend to forget that medicine and most of its discoveries have been observational. .......
I think both Gooznews and Healthnewsreview have been invaluable resources in pointing out the various calamities of health journalism.
I think both Gooznews and Healthnewsreview have been invaluable resources in pointing out the various calamities of health journalism.
Saturday, March 03, 2012
abstract - EvidenceUpdates: Cochrane Review: Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy (including professional commentaries)
| Abstract |
|---|
| BACKGROUND: Venous thromboembolism (VTE) often complicates the clinical course of cancer disease. The risk is further increased by chemotherapy but the safety and efficacy of primary thromboprophylaxis in cancer patients treated with chemotherapy is uncertain. OBJECTIVES: To assess the efficacy and safety of primary thromboprophylaxis in ambulatory cancer patients receiving chemotherapy. AUTHORS' CONCLUSIONS: Primary thromboprophylaxis with LMWH significantly reduced the incidence of symptomatic VTE in ambulatory cancer patients treated with chemotherapy. However, the lack of power hampers definite conclusions on the effects on major safety outcomes, which mandates additional studies to determine the risk to benefit ratio of LMWH in this setting. |
| Comments from Clinical Raters |
|---|
| Oncology - Breast |
UK media: Charity calls for ovarian cancer awareness campaign (one percent aware of ovarian cancer symptoms)
"ONLY one per cent of women in the East of England are very confident in noticing symptoms of ovarian cancer, and a leading charity says symptom awareness could prevent needless deaths.....".
"The Target Ovarian Cancer Pathfinder Study 2012 did find the number of women who recognised bloating as a major sympton has nearly doubled from nine per cent to 17 per cent, but in the East of England this was 13 per cent.
The charity said this still compares poorly to other cancers with 76 per cent of women knowing a breast lump is a sign of breast cancer.
Ms Jones said: “The evidence is piling up. Women are being let down by the failure to act in the UK. We need a national awareness campaign now to end needless deaths from this disease......"
Polymorphisms in MSH2 gene and risk of gastric cancer, and interactions with lifestyle factors in a Chinese population ( IVS10+12G>A and IVS12−6T>C )
Polymorphisms inMSH2gene and risk of gastric cancer, and interactions with lifestyle factors in a Chinese population
Background:
Although polymorphisms in DNA mismatch repair (MMR) gene MSH2 have been associated with risks of many cancers, little is known about their etiology role in gastric cancer (GC) and the potential interacting role with lifestyle factors known to damage DNA.
Conclusion:
The IVS10+12G>A and IVS12−6T>C polymorphisms in MSH2 gene appear to be associated with risk of GC in this Chinese population. Risk for GC, stratified by related genotypes, was further modified by drinking, high pickled food or fried food intake. Larger prospective studies are needed to confirm these findings.
Friday, March 02, 2012
FDA U.S. Drug Shortages - Paclitaxel (Taxol)
Paclitaxel Injection (updated 3/2/2012)
| Company/Products | Reason | Related Information |
|---|---|---|
| Sandoz: 1-800-525-8747 6 mg/mL injection 30 mg/5 mL vial (NDC 66578-0043-01) 100 mg/16.7 mL vial (NDC 66578-0043-02) 300 mg/50 mL vial (NDC 66578-0043-03) | Manufacturing delays | Sandoz is currently on backorder. |
| APP 1-888-386-1300 6 mg/mL injection 30 mg/5 mL vial (NDC 63323-0763-05) 100 mg/16.7 mL vial (NDC 63323-0763-16) 300 mg/50 mL vial (NDC 63323-0763-50) | Increase in demand | APP is on intermittent back order and is releasing product as it becomes available. |
| Hospira Inc. Customer Service: 1-877-946-7747 300 mg/50 mL vial (NDC 0409-0342-50) 30 mg/5 mL vial (NDC 0409-0342-09) 100 mg/16.7 mL vial (NDC 0409-0342-22) | Higher than anticipated market demand. |
Product 30 mg/5 mL vial (NDC 0409-0342-09): ample levels of inventory to support market demand.
Product 300 mg/50 mL vial (NDC 0409-0342-50): next delivery March. Product 100 mg/16.7 mL vial (NDC 0409-0342-22): next delivery April. Please check with your wholesaler for available inventory. |
| Bedford Laboratories 1-800-562-4797 6 mg/mL injection 30 mg/5 mL vial (NDC 55390-0114-05) 100 mg/16.7 mL vial (NDC 55390-0114-20) 300 mg/50 mL vial (NDC 55390-0114-50) | Manufacturing delays | Bedford has all paclitaxel presentations on backorder and the company cannot estimate a release date. |
| Teva 1-800-545-8800 6 mg/mL injection 30 mg/5 mL vial (NDC 00703-4764-01) 100 mg/16.7 mL vial (NDC 00703-4766-01) 150 mg/25 mL vial (NDC 00703-4767-01) 300 mg/50 mL vial (NDC 00703-4768-01) | Manufacturing delays | Teva continues to release Paclitaxel 30mg/5mL vial (NDC 00703-4764-01), Paclitaxel 100mg/16.7mL vial (NDC 00703-4766-01), Paclitaxel 150mg/25mL (NDC 00703-4767-01) and Paclitaxel 300mg/50mL (NDC 00703-4768-01) as it becomes available |
| Sagent Pharmaceticals 1-866-625-1618 30mg/5mL NDC 25021-213-05 100mg/16.7mL NDC 25021-213-17 300mg/50mL NDC 25021-213-50 | Sagent has the 5mL and 16.7mL on allocation and the 50mL product is available. |
The silent minority - unpublished data on cancer care - Impact Factor - Isseus 46 - Articles - Cancer World
The silent minority - unpublished data on cancer care
From 1989 to 2003, 709 phase III trials evaluating systemic cancer treatment were presented at ASCO meetings. Tam and collaborators have now reported that 9% of these trials were never published, and 13% were published after a five-year delay. More than half of these studies would have had clinical impact if published promptly.
» Daniel F. Hayes
Two key elements of the scientific method are methodology transparency and reproducibility of results by others. Traditionally, these elements have been facilitated by the well-entrenched system of peer-review publication. This concept has had almost universal acceptance among the scientific community, although in the past few years there have been calls for open publication of all scientific results without the peer-review process. Some experts have advocated the creation of a type of ‘free-for-all’ post-publication peer review, with the view that classic, pre-publication peer review is usually selective (based on whom the editor knows and on who actually agrees to referee the article) and arbitrary (based on the respective biases of the reviewers).[1]........
FDA: The Quality Problems Causing The Drug Shortage Were Not News To Those Making The Medicines - blog
Dr Len's Cancer Blog:
"Sometimes you have the opportunity to be educated, or to learn a bit more about a topic of importance. Yesterday was one of those opportunities.
Attending a meeting (as an observer) of the National Cancer Institute Director's Consumer Liaison Group on the issue of cancer drug shortages, there were some messages delivered that provided a bit more clarity surrounding a very complex problem. And there were messages delivered that had even me sit up and take notice, and frame the seriousness and depth of the problems that confront patients, their families and those who treat them. The observations were--to say the least--very unsettling.
Try this one, for example:......
[Comment] Offline: Is CDC a science-based organisation? The Lancet
[Comment] Offline: Is CDC a science-based organisation?:
"When we published our first report describing discontent about the work of the Center for Global Health (CGH) at the US Centers for Disease Control and Prevention, CDC immediately contacted us to ask for an opportunity to reply. We agreed and await their response. Meanwhile, two further letters have arrived. They again signal severe concerns about the way in which CDC organises its global health work. Both correspondents are well informed about the details of the CDC's work in global health. Their allegations are serious." (subscription required $$$)
media: Benefits of Bevacizumab in Ovarian Cancer Clarified - Michael J. Birrer, MD, PhD
"Bevacizumab (Avastin) has failed to demonstrate statistically significant improvements in overall survival (OS) for women with recurrent ovarian cancer in 2 recent clinical trials, but those results may be affected by factors not related to the drug’s efficacy, according to Michael J. Birrer, MD, PhD......
[Lancet Oncology News] US firm corners exclusive license for RAD51C cancer gene
[News] US firm corners exclusive license for RAD51C cancer gene:
"Already facing a legal challenge to its BRCA1 and BRCA2 patents, Myriad Genetics (Salt Lake City, UT, USA) has secured an exclusive licence for another breast and ovarian cancer-associated gene, RAD51C, under agreement with the German Consortium for Hereditary Breast and Ovarian Cancers, which will share exclusivity in Germany. RAD51C will be used to test patients' hereditary breast and ovarian cancer risks."
High-Risk Ovarian Cancer Based on 126-Gene Expression Signature Is Uniquely Characterized by Downregulation of Antigen Presentation Pathway - Japan
Abstract
Purpose:
High-grade serous ovarian cancers are heterogeneous not only in terms of clinical outcome but also at the molecular level. Our aim was to establish a novel risk classification system based on a gene expression signature for predicting overall survival, leading to suggesting novel therapeutic strategies for high-risk patients.
Experimental Design:
In this large-scale cross-platform study of six microarray data sets consisting of 1,054 ovarian cancer patients, we developed a gene expression signature for predicting overall survival by applying elastic net and 10-fold cross-validation to a Japanese data set A (n = 260) and evaluated the signature in five other data sets. Subsequently, we investigated differences in the biological characteristics between high- and low-risk ovarian cancer groups.
Results:
An elastic net analysis identified a 126-gene expression signature for predicting overall survival in patients with ovarian cancer using the Japanese data set A (multivariate analysis, P = 4 × 10−20).. ........ Through gene ontology and pathway analyses, we identified a significant reduction in expression of immune-response–related genes, especially on the antigen presentation pathway, in high-risk ovarian cancer patients.
Conclusions:
This risk classification based on the 126-gene expression signature is an accurate predictor of clinical outcome in patients with advanced stage high-grade serous ovarian cancer and has the potential to develop new therapeutic strategies for high-grade serous ovarian cancer patients.
Phase I Study of the Vascular-Disrupting Agent OXi4503
Phase I Study of the Vascular-Disrupting Agent OXi4503:
Purpose:
Preclinical studies show that OXi4503 (combretastatin A1 diphosphate, CA1P) is more potent than other clinically evaluated vascular-disrupting agents.
Experimental Design:
Escalating doses of OXi4503 were given intravenously over 10 minutes on days 1, 8, and 15 every 28 days to patients with advanced solid tumors.
Results:
Doses were escalated in single-patient cohorts from 0.06 to 1.92 mg/m2, then expanded cohorts to 15.4 mg/m2 in 43 patients. Common adverse drug reactions were hypertension, tumor pain, anemia, lymphopenia, and easily controllable nausea/vomiting and fatigue. Five patients experienced different drug-related dose-limiting toxicities, atrial fibrillation, increased troponin, blurred vision, diplopia, and tumor lysis. Prophylactic amlodipine failed to prevent adverse events. Pharmacokinetics showed dose-dependent linear increases in peak plasma concentrations and area under the curve value of OXi4503. One partial response was seen in a heavily pretreated patient with ovarian cancer. Dynamic contrast-enhanced MRI confirmed a dose effect and showed significant antivascular effects in 10 of 13 patients treated at doses of 11 mg/m2 or higher.
Conclusions:
The maximum tolerated dose was 8.5 mg/m2 but escalation to 14 mg/m2 was possible with only temporary reversible cerebrovascular toxicity by excluding hypertensive patients. As a tumor response was seen at 14 mg/m2 and maximum tumor perfusion reductions were seen at doses of 11 mg/m2 or higher, the recommended phase II dose is from 11 to 14 mg/m2. Clin Cancer Res; 18(5); 1415–25. ©2012 AACR.
www.nlm.nih.gov
| Amlodipine is used alone or in combination with other medications to treat high blood pressure and chest pain (angina). Amlodipine is in a class of medications called calcium channel blockers. It lowers blood pressure by relaxing the blood vessels so the heart does not have to pump as hard. It controls chest pain ... | |
| Side effects - How to take - Precautions - Dietary Instructions - Missed a dose | |
abstract: Histology-specific long-term trends in the incidence of ovarian cancer and borderline tumor in Japanese females: A population-based study from 1983 to 2007
Blogger's Views:
there are a number of interesting subjects here - Japan appears historically to have a higher rate of clear cell than other nations; Japan has also studied clear cell ovarian cancer more extensively than elsewhere (for obvious reasons); increasing incidence rates observed in the Japanese population seems to be contrary to other nation's research (eg. stable/declining incidence rates) however the key is in the data compliation (eg. exclusion of LMP; peritoneal cancers), it can be noted however that there has been reported in the North America's that ovarian cancer rates have been increasing but for some unknown (or unpopular?) reason less is known about the reasons for these discrepancies; past blogs have been posted about increasing incident rates; it is unfortunate that this paper is not open access
~~~~~~~~~~~~~~~~~~~~
Histology-specific long-term trends in the incidence of ovarian cancer and borderline tumor in Japanese females: A population-based study from 1983 to 2007 in Niigata:
Abstract
Aim:
The histology-specific long-term trends in the incidence of ovarian cancer and borderline tumors in Japanese women were examined, based on data from the population-based cancer registry in Niigata, Japan.
The histology-specific long-term trends in the incidence of ovarian cancer and borderline tumors in Japanese women were examined, based on data from the population-based cancer registry in Niigata, Japan.
Material and Methods:
Data were obtained from the Niigata Gynecological Cancer Registry, which covered the entire female population in Niigata prefecture, Japan, during the period from 1983 to 2007.
Data were obtained from the Niigata Gynecological Cancer Registry, which covered the entire female population in Niigata prefecture, Japan, during the period from 1983 to 2007.
Results:
A total of 3134 females with epithelial ovarian cancer, including borderline tumor cases, were diagnosed between 1983 and 2007. The age-standardized rates (ASRs) of both ovarian cancer and borderline tumors have steadily increased, with significant changes in ovarian cancer in all age groups, and borderline ovarian tumors in subjects aged <50. The ASRs of endometrioid adenocarcinoma showed a steady increasing trend, and those of clear cell and mucinous adenocarcinomas showed significant increasing trends in the total population. The ASRs of clear cell, mucinous, and endometrioid adenocarcinomas in the 50+ age group were significantly increased, especially the incidence of clear cell adenocarcinoma, which strikingly increased by approximately threefold from 1.2 (1983–1989) to 3.5 (2000–2007) per 100 000 females.
A total of 3134 females with epithelial ovarian cancer, including borderline tumor cases, were diagnosed between 1983 and 2007. The age-standardized rates (ASRs) of both ovarian cancer and borderline tumors have steadily increased, with significant changes in ovarian cancer in all age groups, and borderline ovarian tumors in subjects aged <50. The ASRs of endometrioid adenocarcinoma showed a steady increasing trend, and those of clear cell and mucinous adenocarcinomas showed significant increasing trends in the total population. The ASRs of clear cell, mucinous, and endometrioid adenocarcinomas in the 50+ age group were significantly increased, especially the incidence of clear cell adenocarcinoma, which strikingly increased by approximately threefold from 1.2 (1983–1989) to 3.5 (2000–2007) per 100 000 females.
Conclusion:
This prefecture-wide study showed the practical trends in ovarian cancer and borderline tumors in Japanese females. The incidence of ovarian cancer has steadily increased, with significant increases in the incidence of clear cell and mucinous adenocarcinomas in the total population during the past two decades. Because of the poor response rate of these histological subtypes to platinum-based regimens, novel treatment approaches should be adopted to improve the prognostic outcome in patients with ovarian cancer in Japan.
This prefecture-wide study showed the practical trends in ovarian cancer and borderline tumors in Japanese females. The incidence of ovarian cancer has steadily increased, with significant increases in the incidence of clear cell and mucinous adenocarcinomas in the total population during the past two decades. Because of the poor response rate of these histological subtypes to platinum-based regimens, novel treatment approaches should be adopted to improve the prognostic outcome in patients with ovarian cancer in Japan.
Bioinformatics and epigenetics - computer-aided cancer diagnosis - medical press
The relatively young research field of epigenetics is the talk of the town. Many scientists expect the research on biochemical modifications beyond the actual DNA strand to lead to huge progress in the understanding of the regulation of gene activity in the years to come. Just how promising the results of epigenetic research are in terms of concrete medical applications is demonstrated by the work of Thomas Lengauer and Christoph Bock from the Max Planck Institute for Informatics in Saarbrücken. With the help of computers, they trawl through the genomes of cancer patients in search for suspect structures, and develop fast and simple new tools for improving cancer diagnosis in hospitals.
"Although Thomas Lengauer regards epigenome analysis as playing a crucial role in the attainment of rapid progress in cancer diagnosis in the near future, he plays down expectations with regard to the development of new drugs. “Many scientists point to the potential of future drugs that can repair defects in the epigenome of diseased cells. I tend to be more cautious in this regard. Such targeted interventions involve significant risks, not least because little or nothing is currently known about the highly-complex gene regulation mechanisms being manipulated here.”"
Thursday, March 01, 2012
abstract: Serum HE4 as a diagnostic and prognostic marker for lung cancer (study included ovarian cancer patients)
Abstract
We evaluated the diagnostic and prognostic efficacy of human epididymis protein 4 (HE4) for lung cancer patients by using our novel enzyme-linked immunosorbent assay (ELISA) system. We measured serum HE4 levels of cancer patients including 49 lung cancer and 18 ovarian cancer patients. Furthermore, we evaluated the relationship between serum HE4 levels and overall survival after chemotherapy of 24 lung cancer patients. Serum HE4 levels were significantly higher for non-small, small cell lung cancer and ovarian cancer patients than for healthy controls. The area under the receiver operating characteristic curve (AUC) was calculated for differentiation of lung cancer patients and healthy controls. AUC for serum HE4 was 0.988 for differentiating lung cancer patients from healthy controls, with a cutoff value of 6.56 ng/ml (sensitivity = 89.8%, specificity = 100%).
Serum HE4 levels were elevated in 36/40 (90.0%) non-small cell lung cancer patients, 8/9 (88.9%) small cell lung cancer patients and 8/18 (44.4%) ovarian cancer patients. High levels of serum HE4 (>15 ng/ml) after chemotherapy were significantly correlated with worse overall survival after the treatment. These findings suggest that serum HE4 is a potential diagnostic and prognostic marker for lung cancer patients.
Serum HE4 levels were elevated in 36/40 (90.0%) non-small cell lung cancer patients, 8/9 (88.9%) small cell lung cancer patients and 8/18 (44.4%) ovarian cancer patients. High levels of serum HE4 (>15 ng/ml) after chemotherapy were significantly correlated with worse overall survival after the treatment. These findings suggest that serum HE4 is a potential diagnostic and prognostic marker for lung cancer patients.
abstract: Role of Neoadjuvant Chemotherapy in the Management of Stage IIIC-IV Ovarian Cancer: Survey Results from the Members of the European Society of Gynecological Oncology
Int J Gynecol Cancer. 2012 Mar;22(3):407-16.
Abstract
OBJECTIVE:
The aim of this study is to evaluate the current opinion of the members of the European Society of Gynecological Oncology (ESGO) on the use of neoadjuvant chemotherapy (NACT) in stage IIIC and IV ovarian cancer.METHODS:
A link to a 21-item questionnaire, with questions about the management of patients with stage IIIC and IV ovarian cancer, was sent 3 times to the ESGO members (N = 1177).abstract: Unopposed estrogen and estrogen plus progestin menopausal hormone therapy and lung cancer risk in the NIH-AARP Diet and Health Study Cohort
Abstract
PURPOSE:
Previous studies have reported that lung cancer risk may be decreased, increased, or unaffected by prior use of menopausal hormone therapy (MHT).CONCLUSIONS:
Our results failed to support any substantial alterations in lung cancer risk associated with use of either unopposed estrogen or estrogen plus progestin MHT, even when detailed exposure measures and other risk predictors were considered.Cancer misdiagnosis claim refuted (From The Oxford Times)
"HOSPITAL bosses have disputed claims that three ‘serious’ cases were misdiagnosed by gynaecological departments in Oxford.
The claim was made by an anonymous GP in a survey by a doctors’ magazine.
He told GP journal Pulse he knew of three ‘serious’ cases which had been misdiagnosed by the gynaecological department at the John Radcliffe Hospital – including one of a patient with ovarian cancer.
He said: “We wrote a letter. All we wanted was something back saying ‘let’s look at this’. Instead we got a five-sentence reply saying ‘under Nice guidelines we did nothing negligent’.”.......
still recruiting: A (phase 11) Study of MK-1775 in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone for Participants With Platinum-Sensitive Ovarian Tumors With the P53 Gene Mutation (MK-1775-004) - Full Text View - ClinicalTrials.gov
Official Title:
A Randomized, Phase II Study Evaluating MK-1775 in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone in Adult Patients With Platinum Sensitive p53 Mutant Ovarian Cancer
Criteria
Inclusion Criteria:
- Histologically confirmed non-low grade, non-borderline (low malignant potential) ovarian cancer which has progressed after paclitaxel / carboplatin therapy.
- Platinum-sensitive disease. The earliest evidence of progression must have occurred at least 6 months following the completion of the most recent platinum-based treatment.
- Measurable disease.
- Available tumor sample(s).
- Performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Adequate organ function.
Comment on Keeping Up With Science : InTech Publishes 49 New Books For You To Get Hold Of Right Now by sandipniauskas
Comment on Keeping Up With Science : InTech Publishes 49 New Books For You To Get Hold Of Right Now by sandipniauskas:
Thanks on behalf of our ovarian cancer communities, families and friends for your book on Ovarian Cancer and in particular the section by Dr Yi Pan (neuropathy). Yi is a favourite and does so very much for many patients.
PCORI Paddles the Potomac (healthcare systems/dysfunction....)
By Merrill Goozner
Merrill Goozner has been writing about economics and health care for many years. The former chief economics correspondent for the Chicago Tribune, Merrill has written for a long list of publications including the New York Times, The American Prospect, The Washington Post and The Fiscal Times. You can read more pieces by him at GoozNews.
PCORI Paddles the Potomac:
Cynics say Washington is the city where good ideas go to die. A promising strategy for holding down health care costs in the Obama administration’s reform bill – providing patients and doctors with authoritative information on what works best in health care – should provide a classic test of that proposition, assuming the law survives the next election.
Experts estimate anywhere from 10 to 30 percent of the health care that Americans receive is wasted. It is either ineffective or does more harm than good. To put that in perspective, waste costs anywhere from $250 billion and $750 billion a year, or as much as three-fourths of the annual federal deficit.
Yet every effort to curb wasteful spending (health care fraud, though pervasive, is estimated at less than a quarter of the total) has come up short.
Correspondence: Emergency Hospitalizations for Adverse Drug Events — NEJM
To the Editor:
"We commend Budnitz and colleagues (Nov. 24 issue)1 for their contribution to our understanding of emergency hospitalizations caused by adverse drug events. However, as a result of detection bias, it is likely that the relative contribution of bleeding and hypoglycemic manifestations of adverse drug events have been overestimated and that the overall burden of disease has been underestimated. This is because the case-finding methods at institutions participating in the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance (NEISS-CADES) project rely on coders who use a short list of symptoms that include “bleeding” and “hypoglycemia” to identify adverse drug events.2 Other commonly found manifestations of adverse drug events, such as neuropsychiatric, gastrointestinal, and cardiovascular symptoms, are not listed as triggers and therefore are less likely to be identified.3
In addition, emergency physicians frequently do not attribute emergency department presentations to adverse drug events, which leads to a lack of documentation in hospital records.4 Validation of the triggers in the NEISS-CADES project against a prospective criterion standard would enable a better estimate of the sensitivity of such measures. Prospective case-finding methods may yield more accurate data on the frequency and causes of adverse drug events and on the relative contribution of various adverse drug events to the overall disease burden."
In addition, emergency physicians frequently do not attribute emergency department presentations to adverse drug events, which leads to a lack of documentation in hospital records.4 Validation of the triggers in the NEISS-CADES project against a prospective criterion standard would enable a better estimate of the sensitivity of such measures. Prospective case-finding methods may yield more accurate data on the frequency and causes of adverse drug events and on the relative contribution of various adverse drug events to the overall disease burden."
open access - 4 articles: Shared Decision Making — The Pinnacle of Patient-Centered Care NEJM
Perspective
D.B. Reuben and M.E. Tinetti
- Free Full Text
- Comments
M.J. Barry and S. Edgman-Levitan
- Free Full Text
- Audio Interview
- Comments
open access: Shared Decision Making — The Pinnacle of Patient-Centered Care — NEJM
"Caring and compassion were once often the only “treatment” available to clinicians. Over time, advances in medical science have provided new options that, although often improving outcomes, have inadvertently distanced physicians from their patients. The result is a health care environment in which patients and their families are often excluded from important discussions and left feeling in the dark about how their problems are being managed and how to navigate the overwhelming array of diagnostic and treatment options available to them..........If we can view the health care experience through the patient's eyes, we will become more responsive to patients' needs and, thereby, better clinicians. Recognition of shared decision making as the pinnacle of patient-centered care is overdue. We will have succeeded in building a truly patient-centered health care system when an informed woman can decide whether to have a screening mammogram and an informed man can consider whether to have a screening prostate-specific–antigen test without their clinicians labeling the decision “wrong” on the basis of different values and preferences.Nothing about me without me.— Valerie Billingham, Through the Patient's Eyes, Salzburg Seminar Session 356, 1998
open access: Goal-Oriented Patient Care — An Alternative Health Outcomes Paradigm — NEJM
"Ultimately, good medicine is about doing right for the patient. For patients with multiple chronic diseases, severe disability, or limited life expectancy, any accounting of how well we're succeeding in providing care must above all consider patients' preferred outcomes."
A phase II trial (AGO 2.11) in platinum-resistant ovarian cancer: a randomized multicenter trial with sunitinib (SU11248) to evaluate dosage, schedule, tolerability, toxicity and effectiveness of a multitargeted receptor tyrosine kinase inhibitor monotherapy
A phase II trial (AGO 2.11) in platinum-resistant ovarian cancer: a randomized multicenter trial with sunitinib (SU11248) to evaluate dosage, schedule, tolerability, toxicity and effectiveness of a multitargeted receptor tyrosine kinase inhibitor monotherapy:
Background:
.....This phase II study was conducted to evaluate sunitinib, an oral antiangiogenic multitargeted tyrosin kinase inhibitor, in this setting.
Material and methods:
The primary end point of this randomized phase II trial was the objective response rate according to RECIST criteria and/or Gynecologic Cancer InterGroup CA125 response criteria to sunitinib in patients with recurrent platinum-resistant ovarian cancer who were pretreated with up to three chemotherapies. A selection design was employed to compare two schedules of sunitinib (arm 1: 50 mg sunitinib daily orally for 28 days followed by 14 days off drug; and arm 2: 37.5 mg sunitinib administered daily continuously).
Results:
Of 73 patients enrolled, 36 patients were randomly allocated to the noncontinuous treatment arm (arm 1) and 37 patients were randomly allocated to the continuous treatment arm (arm 2). The mean age was 58.8 and 58.5 years, respectively. We observed six responders (complete response + partial response) in arm 1 (16.7%) and 2 responders in arm 2 (5.4%). The median progression-free survival (arm 1: 4.8 [2.9–8.1] months; arm 2: 2.9 [2.9–5.1] months) and the median overall survival (arm 1: 13.6 [7.0–23.2] months; arm 2: 13.7 [8.4–25.6] months) revealed no significant difference. Adverse events included fatigue as well as cardiovascular, gastrointestinal and abdominal symptoms, hematologic and hepatic laboratory abnormalities. Pattern and frequency of adverse events revealed no substantial differences between both treatment groups.
Conclusions:
Sunitinib treatment is feasible and moderately active in relapsed platinum-resistant ovarian cancer. The noncontinuous treatment schedule should be chosen for further studies in ovarian cancer.
Risk of serious toxicity in 1181 patients treated in phase I clinical trials of predominantly targeted anticancer drugs: the M. D. Anderson Cancer Center experience
Risk of serious toxicity in 1181 patients treated in phase I clinical trials of predominantly targeted anticancer drugs: the M. D. Anderson Cancer Center experience:
Background:
This study assessed toxicity in advanced cancer patients treated in a phase I clinic that focuses on targeted agents.
Patients and methods:An analysis of database records of 1181 consecutive patients with advanced cancer who were treated in the phase I program starting 1 January 2006 was carried out.
Results:All patients were treated on at least 1 of the 82 phase I clinical trials. Overall, 56 trials (68.3%) had only targeted agents, 13 (15.9%) only cytotoxics, and 13 (15.9%) targeted and cytotoxic agents. Rates of grade 3 and 4 toxicity that were at least possibly drug related were 7.1% and 3.2%, respectively, and 5 of the 1181 patients (0.4%) died from toxicity that was at least possibly drug related. The most common grade 3 or more toxic effects were neutropenia, thrombocytopenia, anemia, dehydration, infection, altered mental status, bleeding, vomiting, nausea, and diarrhea. Eastern Cooperative Oncology Group (ECOG) performance status greater than zero and use of a cytotoxic agent were selected as independent factors associated with serious toxicity.
Conclusion:Phase I trials of primarily targeted agents showed low rates of toxicity, with 10.3% of patients experiencing grade 3 or 4 toxicity and a 0.4% rate of death, at least possibly drug related.
Grants.gov - Opportunity Synopsis - OCRP Ovarian Cancer Academy
The synopsis for this grant opportunity is detailed below, following this paragraph. This synopsis contains all of the updates to this document that have been posted as of 02/27/2012 . If updates have been made to the opportunity synopsis, update information is provided below the synopsis.
If you would like to receive notifications of changes to the grant opportunity click send me change notification emails . The only thing you need to provide for this service is your email address. No other information is requested.
Any inconsistency between the original printed document and the disk or electronic document shall be resolved by giving precedence to the printed document.
Document Type: Grants Notice Funding Opportunity Number: W81XWH-12-OCRP-OCA Opportunity Category: Discretionary Posted Date: Feb 27, 2012 Creation Date: Feb 27, 2012 Original Closing Date for Applications: Jul 18, 2012 Current Closing Date for Applications: Jul 18, 2012 Archive Date: Aug 17, 2012 Funding Instrument Type: Cooperative Agreement
GrantCategory of Funding Activity: Science and Technology and other Research and Development Category Explanation: Expected Number of Awards: 2 Estimated Total Program Funding: $2,400,000 Award Ceiling: Award Floor: CFDA Number(s): 12.420 -- Military Medical Research and Development Cost Sharing or Matching Requirement: No
Eligible Applicants
- Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility" Additional Information on Eligibility:
Agency Name
- Dept. of the Army -- USAMRAA
Description
- The OCRP Ovarian Cancer Academy, which was initially created in FY09, is intended to be a unique, interactive virtual academy providing intensive mentoring, national networking, and a peer group for junior faculty. The overarching goal of the Ovarian Cancer Academy is to develop successful, highly productive ovarian cancer researchers in a collaborative research training environment. The current Ovarian Cancer Academy is a virtual career development and research training platform consisting of seven Early-Career Investigator/Designated Mentor pairs from different institutions and one Academy Dean. The Academy Dean serves as a resource for the Early-Career Investigators and Mentors, assesses the progress of the Early-Career Investigators, and facilitates communication and collaboration among all of the Early-Career Investigators and Mentors.
Link to Full Announcement
Wednesday, February 29, 2012
American Institute for Cancer Research (AICR): 2012 Research Conference on Food, Nutrition, Physical Activity and Cancer
2012 AICR Annual Research Conference
on Food, Nutrition, Physical Activity and Cancer
November 1-2 / Washington, DCon Food, Nutrition, Physical Activity and Cancer
About the Conference:
This conference is a unique forum that brings together researchers and clinicians for a two-day program that is dedicated to increasing knowledge, stimulating research and promoting prevention and treatment of cancer through nutrition, physical activity and weight management.Who Should Attend:
Basic scientists, clinical investigators, epidemiologists, dietitians, nutritionists, policy makers and other health professionals interested in food, nutrition, physical activity and weight management in relation to cancer.Clinical Oncology News - Study Details Risks for Contralateral Cancer in BRCA1/2
"For years, researchers have known that the risk that a woman will develop CBC is higher than an average woman’s risk for developing a first cancer and that this risk is even greater if the woman carries the BRCA1/2 mutation."
Table. 10-year Risk for Contralateral Breast Cancer: Key Stats
"Dr. Van Poznak said the information in the study would help doctors counsel patients. “The analysis performed in this large database of European women under the age of 50 suggests that risks for contralateral breast cancer within 10 years may be estimated based on age and BRCA1/2 status,” she said.
Ms. van den Broek said that if the results are confirmed in other studies, age criteria and receptor status of the first breast cancers might be included in guidelines for prophylactic measures and screening in the follow-up of BRCA1/2 mutations carriers."
Clinical Oncology News - Applying Clinical Trial Results to ‘Real-World’ Care - Markman/Editorial
"A far less frequently discussed aspect of transitioning trial results into routine care is the realistic potential that when the strategy in question is undertaken by individuals without the same level of clinical expertise, the actual outcome may not be as favorable as the one demonstrated in the investigative setting."
"Finally, it should be noted that the scenario presented is simply one of many that could have been provided as a word of caution in this important and complex discussion, that has relevance for both individual patients and society at large."
The POWER Study (Project for an Ontario Women's Health Evidence-based Report) Social Determinants of Health and Populations at Risk chapter
The POWER Study (Project for an Ontario Women's Health Evidence-based Report) Social Determinants of Health and Populations at Risk chapter is now available for download. Using a community-engaged research model and integrated KT approach, the POWER Study has examined a comprehensive set of evidence-based indicators bridging population health and health system performance. The Women's Health Equity Report is serving as an evidence-based tool for policy makers, providers and consumers in their efforts to improve health and reduce health inequities in Ontario. POWER has examined gender differences in access to care, as well as quality and outcomes of care for the leading causes of morbidity and mortality in the province and how they differ by gender, socioeconomic status, ethnicity, and geography. The Social Determinants of Health and Populations at Risk chapter examines the social determinants of health among Ontario's women and men including: low income, low education, indicators of employment, lone-parent families, and food insecurity. We also summarize the POWER Study indicators across all chapters as they relate to low-income populations, providing a synthesis of health functional status, risk factors and prevention, access to health care services, clinical management, and health outcomes of lower-income adults. The final section re-examines and synthesizes the POWER Study findings in relation to immigrant and minority populations, as well as reporting three indicators of immigrant women's health that have not previously been reported in the POWER Study. Based on our analyses, identified opportunities to improve health and health care and reduce inequities, together with broad community consultation and dialogue, we developed the POWER Health Equity Road Map. The aim of the Road Map is to help move us forward to the goal of achieving health equity in Ontario. The time to move forward is now. What is needed is the will and commitment. To download a copy of the full chapter or the highlights document (which outlines the chapter's key findings and messages): http://powerstudy.ca/the-power-report/the-power-report-volume-2/social-determinants-of-health-and-populations-at-risk The French translation of the Social Determinants of Health and Populations at Risk Highlights document will be available on our website soon. Also available for download from www.powerstudy.ca: Introduction to the POWER Study (Ch 1); The POWER Study Framework (Ch 2); Burden of Illness (Ch 3); Cancer (Ch 4); Depression (Ch 5), Cardiovascular Disease (Ch 6), Access to Health Care Services (Ch 7), Musculoskeletal Conditions (Ch 8), Diabetes (Ch 9), Reproductive and Gynaecological Health (Ch 10), HIV Infection (Ch 11), Older Women's Health Report. The POWER Study's concluding chapter 'Achieving Health Equity in Ontario: Opportunities for Intervention and Improvement' is forthcoming and will be available on our website soon. Arlene S. Bierman, MD, MS Echo's Ontario Women's Health Council Chair in Women's Health Lawrence S. Bloomberg Faculty of Nursing, University of Toronto and Keenan Research Centre in the Li Ka Shing Knowledge Institute, St. Michael's Hospital 30 Bond Street (209 Victoria Street, Room 219) Toronto, ON M5B 1W8 Phone: (416) 864-3041 Fax: (416) 864-5641 Web: www.powerstudy.ca The POWER Study is funded by Echo: Improving Women's Health in Ontario, an agency of the Ministry of Health and Long-Term Care. This report does not necessarily reflect the views of Echo or the Ministry. _______________________________________________
Canadian Scientists Develops World’s Most Advanced Drug to Protect the Brain After a Stroke (PSD95 inhibitor)
“There is hope that this new drug could be used in conjunction with other treatments, such as thrombolytic agents or other means to restore blood flow to the brain, in order to further reduce the impact of stroke on patients,” said Dr. Tymianski. “These findings are extremely exciting and our next step is to confirm these results in a clinical trial.”
abstract: Borderline ovarian tumour: pathological diagnostic dilemma and risk factors for invasive or lethal recurrence : The Lancet Oncology
The Lancet Oncology, Volume 13, Issue 3, Pages e103 - e115, March 2012
doi:10.1016/S1470-2045(11)70288-1
Borderline ovarian tumour: pathological diagnostic dilemma and risk factors for invasive or lethal recurrence
Summary
By comparison with ovarian carcinomas, borderline ovarian tumours are characterised clinically by superior overall survival, even in women with peritoneal spread.
In this Review, we aimed to clarify the histological and clinical factors potentially defining a high-risk group in whom disease is likely to evolve to invasive disease. Invasive peritoneal implants (in serous borderline ovarian tumours) and residual disease after surgery were the two factors clearly identified.
Other factors are controversial owing to increased risk of invasive recurrence: micropapillary patterns in serous borderline ovarian tumour, intraepithelial carcinoma in mucinous lesions, stromal microinvasion in serous lesions, and use of cystectomy in mucinous borderline ovarian tumours.
The pathologist has a pivotal role in assessment of the borderline nature of ovarian tumours and in identification of high-risk criteria, most of which are histological. But, reproducibility of the histological interpretation of some of these potential criteria—eg, classification of peritoneal implants (particularly in desmoplastic subtype), stromal microinvasion, micropapillary patterns, and intraepithelial carcinoma in mucinous borderline ovarian tumours—remains unclear, and should be investigated.
In this Review, we aimed to clarify the histological and clinical factors potentially defining a high-risk group in whom disease is likely to evolve to invasive disease. Invasive peritoneal implants (in serous borderline ovarian tumours) and residual disease after surgery were the two factors clearly identified.
Other factors are controversial owing to increased risk of invasive recurrence: micropapillary patterns in serous borderline ovarian tumour, intraepithelial carcinoma in mucinous lesions, stromal microinvasion in serous lesions, and use of cystectomy in mucinous borderline ovarian tumours.
The pathologist has a pivotal role in assessment of the borderline nature of ovarian tumours and in identification of high-risk criteria, most of which are histological. But, reproducibility of the histological interpretation of some of these potential criteria—eg, classification of peritoneal implants (particularly in desmoplastic subtype), stromal microinvasion, micropapillary patterns, and intraepithelial carcinoma in mucinous borderline ovarian tumours—remains unclear, and should be investigated.
abstract: Inflammatory Pseudotumor: The Great Mimicker
Abstract:
OBJECTIVE. The purpose of this review is to describe the pathophysiologic findings, differential diagnosis, imaging features, and management of inflammatory pseudotumor in various locations throughout the body.
CONCLUSION. Inflammatory pseudotumor is a rare benign process mimicking malignant processes and has been found in almost every organ system. Radiologists should be familiar with this entity as a diagnostic consideration to avoid unnecessary surgery.
( Italy) Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) in Ovarian Cancer Recurrence - Full Text View - ClinicalTrials.gov
Official Title:
Surgery Plus Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) Versus Surgery Alone in Patients With Platinum-sensitive First
Recurrence of Ovarian Cancer: a Prospective Randomized Multicenter Trial
Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) in Ovarian Cancer Recurrence (HORSE)
Purpose
Surgery Plus Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) Versus Surgery Alone in Patients With Platinum-sensitive First
Recurrence of Ovarian Cancer: a Prospective Randomized Multicenter Trial
Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) in Ovarian Cancer Recurrence (HORSE)
Purpose
The purpose of this study is to determine the role of surgery followed by hyperthermic intra-peritoneal chemotherapy (HIPEC) versus surgery
alone in patients with platinum-sensitive first recurrence of ovarian cancer. Moreover it is a prospective randomized multicenter trial, aimed
to investigate the prognostic role of surgery plus HIPEC versus surgery alone in terms of progression free interval, overall survival, morbidity
and mortality, second recurrence pattern, quality of life with EORTC QLQ-C30 and QLQ OV28 questionnaires.
This study is currently recruiting participants.
Verified February 2012 by Catholic University of the Sacred Heart
First Received on February 20, 2012. Last Updated on February 28, 2012 History of Changes
| Sponsor: | Catholic University of the Sacred Heart |
|---|---|
| Information provided by (Responsible Party): | Prof. Giovanni Scambia, Catholic University of the Sacred Heart |
| ClinicalTrials.gov Identifier: | NCT01539785 |
not yet recruiting: phase 11/BRCA - Veliparib in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer - Full Text View - ClinicalTrials.gov
Condition:
brca1 Mutation Carrier
brca2 Mutation Carrier
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Veliparib in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
brca1 Mutation Carrier
brca2 Mutation Carrier
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Criteria
DISEASE CHARACTERISTICS:
- Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma AND carry a germline mutation in BRCA1 or BRCA2 (confirmation required via Myriad test report); histologic documentation of the original primary tumor is required via the pathology report........
Veliparib in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This study is not yet open for participant recruitment.
Verified February 2012 by National Cancer Institute (NCI)
First Received on February 22, 2012. No Changes Posted
| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: | National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01540565 |
Confused by genetic tests? NIH's new online tool may help, February 29, 2012 News Release - National Institutes of Health (NIH)
Confused by genetic tests? NIH’s new online tool may help
An online tool launched today by the National Institutes of Health will make it easier to navigate the rapidly changing landscape of genetic tests. The free resource, called the Genetic Testing Registry (GTR), is available at http://www.ncbi.nlm.nih.gov/gtr/Stopping menopausal hormone therapy: If breast cancer really decreased, why did colorectal cancer not increase? Maturitas "Alternative explanations must be found."
Abstract
Objective
The Women's Health Initiative (WHI) study of postmenopausal hormone therapy (HT) found that estrogen plus progestogen therapy (EPT) decreased colorectal cancer risk.
Thus, the decline in EPT use from 2002 to 2003 should have precipitated an increase in the incidence of colorectal cancer. We tested this prediction using the SEER 9 epidemiologic database.
Methods
We analyzed WHI data concerning the effects of EPT and estrogen therapy (ET) on colorectal cancer risks. We also examined HT prescription sales data, as well as SEER 9 colorectal cancer incidences from 2001 to 2004.
Results
In the WHI study, the incidence of colorectal cancer was comparable in EPT placebo-users, ET users, and ET placebo-users, but significantly lower in EPT users. Assuming that 30% of eligible women used HT in 2001, the decline in EPT sales from 2002 to 2003 of 63% should have increased the incidence of colorectal cancer by 2.8% in the overall population at risk. However, the SEER 9 colorectal cancer incidence fell by 5.9% in this population, which is comparable to the 6.7% decrease observed for invasive breast cancer from 2002 to 2003.
Conclusions
Declining EPT use from 2002 to 2003 should have precipitated an increase in the incidence of colorectal cancer, but the opposite trend was seen in the SEER 9 database during this time. The incidences of invasive breast cancer and colorectal cancer both declined by a similar amount from 2002 to 2003, despite the results of the WHI study predicting opposing trends for the two different types of cancer. Thus, the SEER 9 findings are fundamentally incompatible with expectations from the WHI findings. This implies that reductions in HT use from 2002 to 2003 cannot account for the contemporaneous changes in invasive breast cancer and colorectal cancer incidences.
Alternative explanations must be found.
abstract : Hazard ratios in cancer clinical trials - a primer : Nature Reviews Clinical Oncology
Perspectives
Nature Reviews Clinical Oncology 9, 178-183 (March 2012) | doi:10.1038/nrclinonc.2011.217
Hazard ratios in cancer clinical trials—a primer
Abstract
The increase and diversity of clinical trial data has resulted in a greater reliance on statistical analyses to discern value. Assessing differences between two similar survival curves can pose a challenge for those without formal training in statistical interpretation; therefore, there has been an increased reliance on hazard ratios often to the exclusion of more-traditional survival measures.
However, because a hazard ratio lacks dimensions it can only inform the reader about the reliability and uniformity of the data. It does not provide practitioners with quantitative values they can use, nor does it provide information they can discuss with patients.
Motivated by a non-scientific poll of oncologists in training and those with board certification that suggested only a limited understanding of the derivation of hazard ratios we undertook this presentation of hazard ratios: a measure of treatment efficacy that is increasingly used and often misused.
open access: PLoS ONE: Standard Colonic Lavage Alters the Natural State of Mucosal-Associated Microbiota in the Human Colon
Background & Aims
Past studies of the human intestinal microbiota are potentially confounded by the common practice of using bowel-cleansing preparations. We examined if colonic lavage changes the natural state of enteric mucosal-adherent microbes in healthy human subjects.
Conclusion
Standard bowel cleansing preparation altered the mucosal-adherent microbiota in all of our subjects, although the degree of change was variable. These findings underscore the importance of considering the confounding effects of bowel preparation when designing experiments exploring the gut microbiota.
"We recommend that future investigations of the human enteric microbiota include un-prepped subjects in whom the natural state of the colonic microbiota can be preserved and observed. Acquisition of left sided colon samples should not be a major problem, but obtaining right side colonic samples will be more technically demanding; potentially requiring conscious sedation and increasing risk and duration of colonoscopic procedures. Nonetheless, in the hands of an experienced endoscopist, full colonoscopy in un-prepped individuals is feasible. Our group has an 80% success rate reaching the cecum in un-prepped patients.
In summary, we report that the routine practice of colonic lavage may significantly alter the mucosa-associated microbiota of the distal human colon. While the effects are obvious in some individuals, the effects of colonic lavage can be unpredictable. Given that colonic lavage has the potential to distort the enteric microbiota, we recommend that future studies of the human enteric microbiota be performed on the un-prepped colon where the natural state of both luminal and mucosa-associated microbiota is most likely to be retained.
abstract: Priorities for cancer prevention: lifestyle choices versus unavoidable exposures
Priorities for cancer prevention: lifestyle choices versus unavoidable exposures:
Source: The Lancet Oncology
"Although cancer prevention in the USA and other developed countries focuses on disease attributable to lifestyle factors such as smoking, alcohol intake, sun exposure, and obesity, cancer caused by involuntary exposures is a concern. The term environmental is ambiguously used to distinguish between lifestyle and unavoidable exposures. The general community is said to be vulnerable to carcinogens encountered in pollution, contaminated food, and consumer products. In view of these concerns, assessments of the carcinogenicity of particular chemicals are of little assistance in prevention of cancer. Appraisal of cancer attributable to widespread and localised pollution, pesticides, endocrine disrupting chemicals, and consumer products yields diverse outcomes, from established causation to absence of harm. The precautionary principle is not a practicable approach for unknown carcinogenic risks. Procedures for individuals to reduce exposure to recognised or suspect carcinogens in consumer products are not effective measures for cancer prevention. Anxiety concerning insidious cancer causation could divert attention from proven means of cancer prevention."
abstract: Radiation Oncology Quality: Aggressiveness of Cancer Care Near the End of Life
Radiation Oncology Quality: Aggressiveness of Cancer Care Near the End of Life
Purpose
Quality in cancer care is an issue that has come to the forefront over the past decade. Although the American Society of Clinical Oncology has developed extensive quality metrics and goals, such as limiting chemotherapy being provided within the last 14 days of a patient's life, there are no similar quality metrics, and few data, in the field of radiation oncology.
Methods
In this study, morbidity and mortality records from 2008 to 2011 were reviewed for patients at Indiana University who received radiation therapy (RT) within 30 days of death; 63 patients met those criteria.
Results
Analysis showed that 22.2% of patients had Karnofsky Performance Status Scale scores >80, whereas 66.7% of patients had scores < 60. Just over half of patients (52%) were still on treatment at death, and more than half of patients (54%) had completed less than half of their original RT plans. Six patients had their final treatments on the days of their deaths, and another 43 patients had their last treatments within 10 days of death. Forty-eight percent of patients received RT for less than one-fifth of their final month of life and 21% for more than half of their last month alive.
Conclusions
These data are valuable in ongoing discussions of RT use at the end of life, especially as related to hospice underutilization.
abstManagement-changing errors in the recall of radiologic results — A pilot study Clinical Radiology
Management-changing errors in the recall of radiologic results — A pilot study
Aim
To evaluate the occurrence of alterations to diagnostic information from radiological studies, which are altered by person-to-person communication and/or faulty recall, and whether they affect patient management
Materials and methods
A structured telephone survey was conducted at a large tertiary care medical centre of house staff managing inpatients who had undergone chest, abdominal, or pelvic computed tomography (CT) or magnetic resonance imaging (MRI) and remained in the hospital at least 2 days later.
Fifty-six physicians were surveyed regarding 98 patient cases. Each physician was asked how he or she first became aware of the results of the study. Each was then asked to recall the substance of radiological interpretation and to compare it with the radiology report. Each was then asked to assess the level of difference between the interpretations and whether management was affected. Results were correlated with the route by which interviewees became aware of the report, the report length, and whether the managing service was medical or surgical.
Results
In nearly 15% (14/98) of cases, differences between the recalled and official results were such that patient management could have been (11.2%) or had already been affected (3.1%). There was no significant correlation between errors and either the route of report communication or the report length.
Conclusion
There was a substantial rate of error in the recall and/or transmission of diagnostic radiological information, which was sufficiently severe to affect patient management.
Neoadjuvant chemotherapy, interval debulking surgery or primary surgery in ovarian carcinoma FIGO stage IV? 10.1016/j.ejca.2012.01.031 : European Journal of Cancer
Abstract
Objectives
The aim of this study was to investigate the impact of surgical approach, the extent of surgery and chemotherapy on overall survival in patients with ovarian carcinoma (OC) stage IV.
Methods
We retrospectively collected population-based data from the Norwegian Radium Hospital code registry on the diagnosis and surgery of 238 patients diagnosed with OC stage IV from 1996–2005. All patients received platinum-based chemotherapy. Surgical approach was registered as primary debulking surgery (PDS), interval debulking surgery (IDS) and delayed primary surgery (DPS). Surgery level was classified as radical surgery (RS), standard surgery (SS) or suboptimal surgery (SUBS). Univariate and multivariate analyses identified prognostic factors in PDS, IDS and DPS groups and subgroups.
Results
There were no differences in overall survival between the PDS, IDS and DPS groups. Surgery level was significantly associated with overall survival in the whole cohort (p < 0.001), the PDS and IDS groups, but not in the DPS group. More patients with RS achieved no residual tumour (RT), but overall survival was not superior compared to no RT in the SS group. In 66 patients with no RT there were no differences in overall survival between those who underwent PDS, IDS and DPS. Chemotherapy with platinum/paclitaxel tended to improve survival. RT, World Health Organisation (WHO) performance status and histology were prognostic factors for overall survival in the whole cohort.
Conclusion
No RT remains the objective, whether PDS, IDS or DPS is performed, and no differences in overall survival were found in the three treatment groups.
Tuesday, February 28, 2012
abstract: (negative trial) Phase II trial of imatinib mesylate in patients with recurrent platinum- and taxane-resistant low-grade serous carcinoma of the ovary, peritoneum, or fallopian tube
Phase II trial of imatinib mesylate in patients with recurrent platinum- and taxane-resistant low-grade serous carcinoma of the ovary, peritoneum, or fallopian tube:
Objective
To evaluate the efficacy and tolerability of imatinib mesylate in patients with recurrent low-grade serous carcinoma (LGSC) of the ovary, peritoneum, or fallopian tube.
Methods
This open-label, single-institution phase II trial enrolled patients with platinum-resistant LGSC who had measurable disease, had received up to 4 platinum- and/or taxane-containing chemotherapy regimens, and had been previously screened for at least one imatinib targeted biomarker (c-kit, platelet-derived growth factor receptor [PDGFR]-β, or bcr-abl). Imatinib (600 mg) was administered daily for one 6-week course and continued in the absence of toxicity and disease progression.
Results
Thirteen patients were enrolled; 12 were evaluable for toxicity, and 11 were evaluable for response. A total of 17 courses were administered (median, 1 course; range, 1–5 courses). Complete or partial responses were not observed. One patient had stable disease for 7.3 months.
c-Kit, bcr-abl, or PDGFR-β were present in 48%, 77%, and 100% of patients, respectively. No correlation between best response (stable disease) and the presence of imatinib-targeted biomarkers was observed.
Adverse events included grade 3 skin rash in one patient leading to discontinuation of the drug, and grade 3 febrile neutropenia and grade 2 weight gain in two patients leading to dose reductions. The most common grade 1 or 2 toxicities were fatigue (66%), nausea/ vomiting (66%), and diarrhea (41%); grade 3 toxicities included skin rash and granulocytopenia events. No grade 4 or 5 toxicities were observed. The median progression-free survival time was 1.3 months (95% CI, 1.27, 1.40 months), and the median overall survival time was 14.9 months (95% CI, 11.0, 18.9 months).
Conclusion
Imatinib is well-tolerated but has no activity in patients with platinum- and taxane-resistant LGSC or the ovary, peritoneum, or fallopian tube.
Highlights
► Low-grade serous carcinoma of the ovary or peritoneum is a unique entity.► There is a need to develop new therapeutic agents for this rare subtype.
► Imatinib mesylate appears to have no activity in patients with recurrent low-grade serous carcinoma.
open access: BMC Cancer | Abstract | Monitoring physical and psychosocial symptom trajectories in ovarian cancer patients receiving chemotherapy (severe symptoms/loss of QOL/persist beyond treatments....)
Monitoring physical and psychosocial symptom trajectories in ovarian cancer patients receiving chemotherapy
The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.
Published: 28 February 2012
Abstract (provisional)
Background
Diagnosis and treatment of ovarian cancer (OC) entail severe symptom burden and a significant loss of quality of life (QOL). Somatic and psychological impairments may persist well beyond active therapy. Although essential for optimal symptom management as well as for the interpretation of treatment outcomes, knowledge on the course of QOL-related issues is scarce. This study aimed at assessing the course of depressive symptoms, anxiety, fatigue and QOL in patients with OC over the course of chemotherapy until early aftercare.
Methods
23 patients were assessed longitudinally (eight time points) with regard to symptom burden (depression, anxiety, fatigue, and QOL) by means of patient-reported outcome instruments (HADS, MFI-20, EORTC QLQ-C30/ -OV28) and clinician ratings (HAMA/D) at each chemotherapy cycle and at the first two aftercare visits.
Results
Statistically significant decrease over time was found for depressive symptoms and anxiety as well as for all fatigue scales. With regard to QOL, results indicated significant increase for 11 of 15 QOL scales, best for Social (effect size = 1.95; p<0.001), Emotional (e.s. = 1.62; p<0.001) and Physical Functioning (e.s. = 1.47; p<0.001). Abdominal Symptoms (e.s. = 1.01; p=0.009) decreased, Attitudes towards Disease and Treatment (e.s. = 1.80; p<0.001) improved significantly over time. Analysis of Sexual Functioning was not possible due to a high percentage of missing responses (61.9%).
Conclusions
The present study underlines the importance of longitudinal assessment of QOL in order to facilitate the identification of symptom burden in OC patients. We found that patients show high levels of fatigue, anxiety and depressive symptoms and severely impaired QOL post-surgery (i.e. at start of chemotherapy) but their condition improves considerably throughout chemotherapy reaching nearly general population symptom levels until aftercare.(Blogger's Note: small study which may or may not apply to our general ovarian cancer women's population)
The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.
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