Friday, June 11, 2010
Note: "The prospective study of 3,238 postmenopausal women aged 50 to 74 with no significant family history of breast or ovarian cancer, enrolled over a course of nine years."
CHICAGO—In the continuing quest for an effective screening method to detect ovarian cancer at an early stage, a new approach using an algorithm has shown promise in early testing as reported here at the ASCO Annual Meeting and featured beforehand in a teleconference by the society.
What Do You Wish You Had Known?
Most cancer survivors in the U.S. don’t have a cancer treatment plan, treatment summary, or follow-up survivorship care plan. So it’s no surprise, they and their doctors don’t always know what signs and symptoms of long-term and late-term effects to look for or how choices they made at the beginning of treatment might affect their well-being down the road.
What was your experience? Did you have to go back to your doctor again and again to demand a chest x-ray for a cough that was dismissed as allergies? Did your doctor tell you that you’d need bone density scans ahead of time to ward off chemo-related bone loss? Did you sail through treatment only to be hit by a wave of depression after the fact?
Please help us to collect stories from everyone – survivors, caregivers, and providers – across all 50 states, to illustrate what surviving cancer looks like today. Please share a short note about how knowing what to expect ahead of time – or not knowing at all – has affected your health and well-being.
"As a psychiatrist who has cancer, I have developed a deep understanding of the ways in which our training can help us help patients who find themselves forced to deal with the complicated emotional aspects that accompany this disease. My hope is that my insights will help psychiatrists as they wrestle with the problems that plague their patients who are coping with this difficult disease....."
The drug, Patupilone, failed to show improvements over existing drugs in 829 patients with advanced ovarian cancer.
An update of controlled physical activity trials in cancer survivors: a systematic review and meta-analysis
Current evidence suggests many health benefits from physical activity during and post cancer treatments. Additional studies are needed in cancer diagnoses other than breast and with a focus on survivors in greatest need of improvements for the health outcomes of interest.
Note: the p53 gene has been studied extensively for decades including p53 vaccines, hopefully new research will move research on p53 quickly as its implications in cancer will have a great impact
2010 Institute for Continuing Healthcare Education - Ovarian Cancer Screening and Management to Improve Patient Survival
Ovarian cancer is the leading cause of death from gynecologic malignancy and the fifth leading cause of cancer‐related death among women in the United States. The high mortality rate associated with ovarian cancer is due in part to the lack of effective screening strategies to detect the disease in early stages (I or II) when the cancer is confined to the ovary. Since symptoms associated with ovarian cancer are typically nonspecific, a clinical diagnosis is difficult to make until the disease has advanced. The Institute for Continuing Healthcare Education has identified a number of areas related to the screening, diagnosis, and treatment of ovarian cancer where education is vital in order to address the need for improvement in professional care.
In this Webcast, the faculty members will present up-to-date, relevant information on screening guidelines, referral procedures, and therapies for ovarian cancer. As a learning reinforcement, individuals who complete this activity will be able to request a certified monograph with two case studies pertaining to the treatment strategies discussed within the Webcast.
INSTRUCTIONS FOR OBTAINING CME/CE CREDIT
There are no fees or prerequisites for participating in and receiving CME/CE credit for this online educational activity.
Thursday, June 10, 2010
Continuous Docetaxel Chemotherapy Improves Therapeutic Efficacy in Murine Models of Ovarian Cancer — Mol Cancer Therapy
Note: in research
Compassion Fatigue: What Is It? Why Does It Matter? Recognizing the Symptoms, Acknowledging the Impact (healthcare professionals)
Compassion Fatigue: What Is It? Why Does It Matter? Recognizing the Symptoms, Acknowledging the Impact, Developing the Tools to Prevent Compassion Fatigue, and Strengthen the Professional Already Suffering From the Effects
Cancer Symptom Clusters: Old Concept But New Data -- American Journal of Hospice and Palliative Medicine
Note: there are other blog postings regarding symptom clusters (ie; certain symptoms go together eg depression, fatigue etc...) "Symptom clusters may help in cancer diagnosis, symptom management, and prognostication. However, the cluster method, reliability, and validity need to be established before assessment or treatment guidelines are established. Symptom clusters require further research before becoming part of routine medical symptom assessment and management."
Note: one very good caution when undergoing investigational drugs
"Treatment with the chemotherapeutic agent bevacizumab, a humanized mAb that neutralizes vascular endothelial growth factor, can lead to proteinuria and renal damage. The risk factors and clinical outcomes of renal adverse events are not well understood.
We performed a systematic review and meta-analysis of published randomized, controlled trials to assess the overall risk for severe proteinuria with bevacizumab.
We analyzed data from 16 studies comprising 12,268 patients with a variety of tumors. The incidence of high-grade (grade 3 or 4) proteinuria with bevacizumab was 2.2% (95% confidence interval [CI] 1.2 to 4.3%). Compared with chemotherapy alone, bevacizumab combined with chemotherapy significantly increased the risk for high-grade proteinuria (relative risk 4.79; 95% CI 2.71 to 8.46) and nephrotic syndrome (relative risk 7.78; 95% CI 1.80 to 33.62); higher dosages of bevacizumab associated with increased risk for proteinuria.
Regarding tumor type, renal cell carcinoma associated with the highest risk (cumulative incidence 10.2%).
We did not detect a significant difference between platinum- and non–platinum-based concurrent chemotherapy with regard to risk for high-grade proteinuria (P = 0.39).
In conclusion, the addition of bevacizumab to chemotherapy significantly increases the risk for high-grade proteinuria and nephrotic syndrome."
IU-OSU center gets $9 million more for cancer epigenetics: IU News Room: Indiana University (includes ovarian cancer)
"Over the next five years, Nephew said the OSU/IU-led team will study epigenetic changes in prostate, breast, and ovarian cancer cells that cause resistance to hormonal therapy or traditional chemotherapy. Nephew said a major objective is to identify a panel of epigenetic biomarkers for predicting responsiveness to anti-hormone treatments and chemotherapies in cancer patients."
Note: recap of pertinent ovarian cancer topics from ASCO
Search by topic:
"The phase II clinical trial evaluated responses in 44 ovarian cancer patients in their first relapse period, who received either farletuzumab as a single agent or in combination with carboplatin and a taxane..."cont'd
"Chemotherapy resulted in an overall response rate of 42% in this heavily pretreated patient population, including a 55% response rate for carboplatin and/or a taxane," said Ang. "If these results are confirmed in a larger patient population, they could remain an option for these patients, even if they have demonstrated prior resistance."
The Gastrointestinal Phenotype of Germline Biallelic Mismatch Repair Gene Mutations (Lynch Syndrome)
OBJECTIVES:A novel cancer syndrome associated with biallelic mismatch repair (MMR) mutations has been described recently. Patients presenting with childhood-onset gastrointestinal (GI) cancers may carry biallelic MMR mutations and have a distinct phenotype from classic Lynch syndrome. The aim of this study was to characterize patients with GI small bowel and/or colorectal cancers (CRCs) who have germline biallelic MMR mutations.
METHODS:A search of a Canadian GI cancer registry and literature review to identify patients with biallelic MMR was conducted.
RESULTS:The database identified 237 patients with intestinal cancer diagnosed before the age of 35 years. Five (2.1%) patients had biallelic MMR mutations. Overall, 32 individuals, from 29 families, with biallelic MMR gene mutations and GI cancers were identified by the registry and literature review. Among the 29 patients with CRCs, the mean age of first cancer diagnosis was 16.4 years (range: 5-28).
Note: this issue is important as early-age diagnoses in Lynch Syndrome is common
"Approximately one quarter of women diagnosed with Lynch syndrome-associated CRC (colorectal cancer) developed EC within 10 years. This supports the sentinel cancer concept and suggests that active and early management is important for these women."
Note: abstract is in English/full free pdf file is in chinese
OBJECTIVE: To investigate neuroendocrine differentiation and its mechanism in ovarian epithelial tumors.
BACKGROUND: Mucinous ovarian cancer raises problems of differential diagnoses because it is often difficult to distinguish the primary from the metastatic form. Most metastatic ovarian tumors originate from the gastrointestinal tract, mainly colorectal, gastric, pancreatic; the gallbladder is a very rare source of ovarian metastases.
CASE: We report a case of ovarian metastases from a gallbladder cancer, incidentally diagnosed more than 2.5 years earlier during a laparoscopic intervention for biliary lithiasis.
CONCLUSION: The interest of this case lies in the long progression-free survival, the venous thromboembolism syndrome that preceded by a few months the diagnosis of the ovarian mass and the discrepancy between the radiologic and the laparoscopic stage assessment.
PURPOSE OF REVIEW: Ovarian borderline tumours are relatively uncommon, but not rare, neoplasms. Pathologists and oncologists often struggle with various aspects of borderline tumours which are sometimes controversial and poorly understood.
Note: in research
Wednesday, June 09, 2010
Genetic and Clinical Predictors for Breast Cancer Risk Assessment and Stratification Among Chinese Women
CONTEXT AND CAVEATS
Most of the genetic variants identified in genome-wide association studies of breast cancer conducted primarily among women of European ancestry have not been validated in Asian women. Consequently, no risk assessment model that incorporates both genetic and clinical predictors is currently available to predict breast cancer risk in this population.
Case–control study evaluating associations between the 12 single-nucleotide polymorphisms identified as risk variants and the risk of breast cancer among Chinese women participating in the Shanghai Breast Cancer Study as well as the cumulative risk of breast cancer associated with combinations of these risk variants. A risk assessment model that incorporates both newly identified genetic variants and traditional risk factors was developed, and its performance in risk prediction was evaluated.
Eight of the 12 single-nucleotide polymorphisms were also associated with the risk of breast cancer among Chinese women. An aggregate measure of the combined effect of multiple genetic risk variants had moderate discriminatory accuracy by itself but in combination with established risk factors for breast cancer showed promise for stratifying women into high- vs low-risk groups.
A risk assessment model that includes both genetic markers and clinical predictors may be useful to classify Asian women into relevant risk groups for cost-efficient screening and other prevention programs.
The moderate discriminatory accuracy provided by the full risk assessment model established in this study is inadequate for cancer diagnosis and screening. The absolute risk estimates provided by the model would be applicable only to populations with rates comparable to those of Shanghai.
Note: this website requires registration/free
"Women with biochemically recurrent ovarian cancer who take tamoxifen can gain an additional month of progression-free survival and have fewer side effects than women taking thalidomide, according to a study presented at the recent Society for Gynecologic Oncology’s annual meeting (abstract 2)"
“This is a very well-tolerated, very inexpensive drug, and now we have a randomized controlled, Phase III trial conducted by a cooperative group showing that it actually improves the time to subsequent disease progression,” said Maurie Markman, MD, vice president for clinical research at the University of Texas M.D. Anderson Cancer Center in Houston, who was not involved with the study...."cont'd
Late-stage ovarian cancer therapy shows promise in phase I trial: IU News Room: Indiana University Decitabine/Carboplatin
Note: reference to carbo reaction
* CIPROFLOXACIN INJECTION - Voluntary Recall
o Notice to Hospitals [2010-06-09]
per Wiki: "Ciprofloxacin is marketed worldwide with over three hundred different brand names. In the United States, Canada and the UK, it is marketed as Baycip, Ciloxan, Ciflox, Cipro, Cipro XR, Cipro XL, Ciproxin and most recently, Proquin. Additionally, ciprofloxacin is available as a generic drug under a variety of different brand names and is also available for limited use in veterinary medicine."
Oncology Videos - Consider Your Heart During Cancer Treatment (heart failure during/associated with cancer therapy)
Survival benefit from ovarian metastatectomy in colorectal cancer patients with ovarian metastasis: a retrospective analysis
PURPOSE: A recent study demonstrated that colorectal cancer (CRC) with ovarian metastases was less responsive to chemotherapy compared with extraovarian metastases. Hence, the ovary may actually represent a "sanctuary" for metastatic cells from CRC. The aim of the study was to investigate the impact of ovarian metastatectomy on survival of CRC patients with ovarian metastasis.
Oncology Videos - ASCO 2010 Highlights (American Society of Clinical Oncology) Dr. Bradley Monk MD of the University of California Irvine talks about gynecological oncology, GOG 218, ovarian cancer, and angiogenesis
Note: Ascites/Avastin as single agent and or chemo GOG 218
Oncology Videos ASCO 2009: Rustin trial UK: Treatment based on rising CA125 blood levels does not improve survival for ovarian cancer
Hereditary Cancer in Clinical Practice | Full text | Cancer risk in MLH1, MSH2 and MSH6 mutation carriers; different risk profiles may influence clinical management
"The aim of the present study was to calculate the cumulative risk
of LS related cancers in proven MLH1, MSH2 and MSH6 mutation carriers."
"Furthermore, some studies have suggested that extracolonic cancers are more often observed in MSH2 mutation families compared to MLH1 mutation families."
Note: Transducin-like enhancer protein 3 is a protein that in humans is encoded by the TLE3 gene
"Clarient, Inc., a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced that the United Kingdom Patent Office has granted a U.K. patent on the Company's TLE3 biomarker, a marker which may be used to predict which cancer patients will respond favorably to taxane therapy. In addition, the Company has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a U.S. patent on the TLE3 biomarker. Other patents for the TLE3 biomarker are pending in the U.S., Canada, Japan, China, India and elsewhere in Europe.
The U.S. patent will cover uses of the TLE3 biomarker in breast cancer. The U.K. patent covers uses of TLE3 in breast, lung and ovarian cancers.
Taxanes are important cancer therapeutics which, in combination with other cancer therapies, can markedly improve a patient's response rate to therapy. However, taxanes also carry with them a significant incidence of severe side effects, making it important to identify which patients will most likely benefit from the therapy.
"Given the frequent prescription of taxanes in the U.S., the U.K. and elsewhere in Europe and the world, we are very excited about the granting of these patents and the protection they provide our taxane sensitivity marker," said Clarient Vice Chairman and CEO Ron Andrews."
Note: see prior posting regarding 'Monk Debates'
Note: see prior posting regarding criticisms of WHO (June 2010)
"Financial ties to the pharmaceutical industry did not play a role in the declaration and handling of the H1N1 influenza pandemic, said Margaret Chan, MD, MPH, secretary-general of the World Health Organization.
"At no time, not for one second, did commercial interests enter my decision-making," she wrote in a letter to the editors of the BMJ, which published a report last week detailing undisclosed conflicts of interest among researchers advising the WHO.
The implication of the report was that these ties to industry may have influenced some of the guidance the advisers were giving to the WHO.
"Without question, the BMJ feature and editorial will leave many readers with the impression that WHO's decision to declare a pandemic was at least partially influenced by a desire to boost the profits of the pharmaceutical industry," Chan wrote. "The bottom line, however, is that decisions to raise the level of pandemic alert were based on clearly defined virological and epidemiological criteria. It is hard to bend these criteria, no matter what the motive."
Although Chan disagreed with any implication of untoward influence from industry, she agreed that difficult questions about conflicts of interest are warranted...."
Repeat posting: Controversies in Targeted Therapy: Management of Recurrent Ovarian Cancer—Practical Case-Based Discussions CME (3)
1 Controversies in Targeted Therapy: Management of Recurrent Ovarian Cancer—Webcast (Activity OCPS01)1942 (MARCH 2010)
2 Using Targeted Therapies in a Real-World Setting—Podcast Series (Activity OCPS02)1943.01 (APRIL 2010)
3 Personalizing Treatment and Managing Patient Concerns—Podcast Series (Activity OCPS03)1943.02 (MAY 2010)
Note: discusses adverse/risks of numerous NSAID's
media: June 9th: "Correlogic Systems, Inc. announced today that OvaCheck, the company's blood test for the detection of epithelial ovarian cancer, has fulfilled European Union regulatory requirements (CE marking) for distribution and sale of the test. The path is now cleared for the test to be made available to patients in Europe through their physicians...."
Note: ACOR members see notes from Chicago
Abstract (in research/technical):
"Our findings highlight the possible confounding events that may affect the usefulness of RNAi in a therapeutic setting for disrupting EOC cell survival in ascites."
CONTEXT: Although rare, appendiceal endocrine tumors are the most common neoplasms of the appendix. Pathologic analysis is important for guiding the management of patients.
OBJECTIVE: To provide recent data that focus on the pathology of endocrine tumors of the appendix including classifications and guidelines for patient management.
DATA SOURCES: A review of the recent literature including TNM classifications and patient management guidelines.
CONCLUSIONS: Appendiceal endocrine tumors are separated into 2 main groups: classic endocrine tumors and goblet cell carcinoids. They can be classified according to World Health Organization and TNM classifications. Evaluation of their prognoses and risks of malignancy, according to these classifications, depends on several parameters including tumor size, proliferation rate, and infiltration of appendiceal wall and mesoappendix. Most patients with classic endocrine tumors of the appendix have a favorable prognosis. Indications for postappendectomy, complementary surgery, which are still controversial, especially for tumors between 1 and 2 cm, are presented and discussed. In contrast, in patients presenting with a goblet cell carcinoid, a right hemicolectomy after the initial appendectomy is considered the standard surgical intervention.
"...reviewed is the largely resolved controversy about whether ovarian mucinous tumors in this setting are separate primaries or are metastases from the appendiceal tumor."
General scaling laws are developed for projecting measurements of the plasma concentrations of anticancer drugs from laboratory animals to humans and among humans of different sizes. Associated scaling laws for critical drug doses are established from these laws. Broad categories of single and periodic i.v. bolus dosings are considered. Validity of the relations is shown using measurement from the literature for several well-known cytotoxic agents. The scaling theory is also shown to apply to novel anticancer drugs now available or presently under development, as represented by the p.o. administered prodrug capecitabine, the gene silencing inhibitor zebularine, and the blood vessel inhibitor bevacizumab(Avastin). Scaling considerations for the modern practice of combination chemotherapy are also discussed.
JAMA -- Abstract: Genome-wide Analysis of Genetic Loci Associated With Alzheimer Disease, May 12, 2010
"Conclusions Two genetic loci for AD were found for the first time to reach genome-wide statistical significance. These findings were replicated in an independent population. Two recently reported associations were also confirmed. These loci did not improve AD risk prediction. While not clinically useful, they may implicate biological pathways useful for future research."
Future Oncology - Summary - Different volatile signals emitted by human ovarian carcinoma and healthy tissue
Note: in plain english this refers to a small study using 'electronic' smelling (eg. past articles regarding dogs with the ability to 'smell' ovarian cancer)
"...Undoubtedly we should pay more attention to the effect that aging has on the immune system. To optimally stimulate an anti-tumor immune response in the old, it is necessary to identify and understand the intrinsic defects of the old immune system and use relevant models that closely reflect those of cancer patients, where self-tolerance and aging are present simultaneously. Then it will be possible to develop cancer immunotherapeutic strategies that are customized to be effective in the young and the old."
Tuesday, June 08, 2010
One to 2-Year Surveillance Intervals Reduce Risk of Colorectal Cancer in Families With Lynch Syndrome
Background & Aims
Two percent to 4% of all cases of colorectal cancer (CRC) are associated with Lynch syndrome. Dominant clustering of CRC (non-Lynch syndrome) accounts for 1%–3% of the cases. Because carcinogenesis is accelerated in Lynch syndrome, an intensive colonoscopic surveillance program has been recommended since 1995. The aim of the study was to evaluate the effectiveness of this program.
With surveillance intervals of 1–2 years, members of families with Lynch syndrome have a lower risk of developing CRC than with surveillance intervals of 2–3 years. Because of the low risk of CRC in non-Lynch syndrome families, a less intensive surveillance protocol can be recommended.
Anti-MUC1 Antibodies and Ovarian Cancer Risk: Prospective Data from the Nurses' Health Studies — Cancer Epidemiology, Biomarkers & Prevention
Conclusion: Anti-MUC1 antibodies evaluated several years before diagnosis may be associated with lower risk of subsequent ovarian cancer in women <64 years old at assessment.
Impact: Key elements of an “immune model” to explain ovarian cancer risk factors are confirmed and should be evaluated in larger prospective studies.
Monday, June 07, 2010
And the progress being made is costly. Take, for instance, the use of Avastin to slow the growth of ovarian tumors by about four months — at a cost of around $72,000.
“Many would not consider this cost effective for the gain seen,” said Dr Elizabeth A. Eisenhauer of the Canada's National Cancer Institute, according to the New York Times.
Voreloxin - Sunesis Announces Data From Phase 2 Clinical Program of Voreloxin in Acute Myeloid Leukemia Support Phase 3 Trial in Relapsed or Refractory Patients - plus Ovarian Cancer
"Responses to single agent voreloxin observed in women with ovarian cancer for whom multiple prior therapies have failed, including some for whom both platinum-based chemotherapy and Doxil(R) had failed, are promising," said Hal Hirte (medical oncologist), M.D., Associate Professor, McMaster University, Department of Oncology and Chief of Oncology, Juravinski Cancer Centre at Hamilton Health Sciences (Ontario, Canada) and an investigator for the Phase 2 clinical trial. "These data warrant further investigation of voreloxin in this vastly underserved patient population, both in this later stage, salvage setting and in earlier lines of therapy."
"...A legal challenge to the validity of an Australian patent for breast and ovarian cancer genes will be launched in the Federal Court on Tuesday.
The patent for the BRCA1 and BRCA2 genes, which make women more suceptible to the cancers, is owned by American biotechnology company Myriad Genetics. Melbourne-based company Genetic Technologies Limited (GTL) has the exclusive licence from Myriad to carry out testing for the genes in Australia. But law firm Maurice Blackburn is filing a case in the Federal Court in Sydney, challenging the right of the companies to hold exclusive rights to the gene...."
"Our analysis represents the first study investigating the relevance of primary surgical outcome for survival after recurrence in ovarian cancer," Mahner and colleagues concluded in their poster presentation. "Our data show that the prognostic importance of initial surgery extends beyond initial treatment to recurrent disease, particularly for patients who have a platinum-free interval of more than 12 months."
- Explain to interested patients that an analysis of three large trials found that successful primary surgery increased progression-free and overall survival in ovarian cancer patients who had been platinum-free for at least 12 months.
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
Transdermal and oral hormone replacement therapy and the risk of stroke: a nested case-control study
Conclusions The use of transdermal HRT containing low doses of oestrogen does not seem to increase the risk of stroke. The presence of residual confounding, however, cannot be entirely excluded in the interpretation of this finding.
7 JUNE 2010
These Clinical Spotlight interviews, with accompanying eNewsflash and downloadable slides, discuss the topic of targeting angiogenesis in the treatment of ovarian cancer with a focus on the following data release:
#LBA1: Phase III trial of bevacizumab (BEV) in the primary treatment of advanced epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), or fallopian tube cancer (FTC): A Gynecologic Oncology Group study
The first interview is an expert analysis with Gini Fleming, MD, from the University of Chicago, Illinois in the United States, and Bradley Monk, MD, from the University of California Irvine, Orange, California, United States
The second interview is a supplemental perspective and discussion with Bradley Monk, MD, from the University of California Irvine, Orange, California, United States, and Michael Birrer, MD, PhD, from the Massachusetts General Hospital, Boston, Massachusetts in the United States.
View the expert analysis with Gini Fleming, MD, and Bradley Monk, MD
View the expert analysis with Bradley Monk, MD, and Michael Birrer, MD, PhD
Note: registration is required/ free
Ovarian Cancer Source: CCO Independent Conference Coverage of the CCO Independent Conference Coverage of the 2010 American Society of Clinical Oncology Annual Meeting*
Expert Analysis: Ovarian Cancer (coming soon)
* Thomas J. Herzog, MD
* Bradley J. Monk, MD, FACOG, FACS
* Randomized, Double-Blind, Placebo-Controlled Phase II Study of AMG 386 Combined With Weekly Paclitaxel in Patients (pts) With Recurrent Ovarian Carcinoma (coming soon)
* Efficacy and Safety of Farletuzumab, a Humanized Monoclonal Antibody to Folate Receptor alpha, in Platinum-Sensitive Relapsed Ovarian Cancer Subjects: Final Data From a Multicenter Phase II Study (coming soon)
* A Phase II Study of Bevacizumab With Nab-Paclitaxel in Patients With Recurrent, Platinum-Resistant Primary Epithelial Ovarian or Primary Peritoneal Carcinoma (coming soon)
* Phase II Study of NKTR-102 in Women With Platinum-Resistant/Refractory Ovarian Cancer (coming soon)
* Phase III Trial of Bevacizumab (BEV) in the Primary Treatment of Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal Cancer (PPC), or Fallopian Tube Cancer (FTC): A Gynecologic Oncology Group Study (coming soon)
* Phase III Trial of Induction Gemcitabine (G) or Paclitaxel (T) Plus Carboplatin (C) Followed by Elective T Consolidation in Advanced Ovarian Cancer (OC): Final Safety and Efficacy Report (coming soon)
* Carboplatin (C) Plus Paclitaxel (P) vs Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Patients With Advanced Ovarian Cancer (AOC): Final Analysis of the MITO-2 Randomized Multicenter Trial (coming soon)
Medical News: ondansetron - Cancer Antiemetic Recalled By Drugmaker - in Product Alert, Prescriptions from MedPage Today
Cancer Antiemetic Recalled By Drugmaker
By Cole Petrochko, Staff Writer, MedPage Today
Published: June 07, 2010
The distributor of intravenous ondansetron for use in preventing nausea and vomiting in patients undergoing chemotherapy initiated a voluntary recall due to debris and possible contamination of lots of the product.
Nonsterile bags of the treatment may result in potentially fatal infections, particularly in immunocompromised patients.
Affected lot numbers include A090309 through A090312. The pouches were distributed from August 2009 to May 2010.....
Please sign the Ovarian Cancer Pettion & Circulate widely: U.S. Ovarian Cancer Awareness Postage Stamp
In memory of Carolyn Benivegna, survivors, family and friends of those touched by ovarian cancer, please click on the link and help us send our message through the U. S. Postal Service. http://www.ipetitions.com/petition/ovcastamp
BOTHELL, WA, and VANCOUVER, June 7 /CNW/ - OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced final results from a Phase 1 trial. The primary purpose of this trial was to evaluate the safety and tolerability of OGX-427 up to doses of 1000 mg for the treatment of various solid tumors. Patients enrolled had a diagnosis of castrate resistant prostate cancer, breast cancer, ovarian cancer or non-small cell lung cancer. Final results showed that OGX-427 was safe and well tolerated as a monotherapy as well as in combination with docetaxel. In addition, OGX-427 when used as a single agent demonstrated declines in circulating tumor cells at all doses and in all diseases evaluated, as well as evidence of reduction in tumor markers in prostate and ovarian cancer. Results were presented today at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO)...."
GOG 218 Phase III Study Showed Avastin-Based Regimen Helped Women with Advanced Ovarian Cancer Live Longer Without Their Disease Worsening | news
Note: more detailed information in this article
Note: registration is required to view this video/site (free)
Note: this does not include surgical menopause
"Other POF patients have survived cancer in their youth, only to learn that they will have to spend their entire life dealing with the ramifications of that early treatment."
Barriers to participation in cancer prevention clinical trials; Acta Oncologica - 0(0):Pages 1-10 - Informa Healthcare
Background. Cancer prevention clinical trials seek to enroll individuals at increased risk for cancer. Little is known about attitudes among physicians and at-risk individuals towards cancer prevention clinical trials. We sought to characterize barriers to prevention trial participation among medical oncologists and first-degree relatives of their patients.
Methods. Physician participants were practicing oncologists in Pennsylvania. Eligible first-degree participants were adult relatives of a cancer patient being treated by one of the study physicians. The influence of perceived psychosocial and practical barriers on level of willingness to participate in cancer prevention clinical trials was investigated.
Results. Response rate was low among physicians, 137/478 (29%), and modest among eligible first-degree relatives, 82/129 (64%). Lack of access to an eligible population for prevention clinical trials was the most commonly cited barrier to prevention clinical trials among oncologists. Nearly half (45%) of first-degree relatives had not heard of cancer prevention clinical trials, but 68% expressed interest in learning more, and 55% expressed willingness to participate. In the proportional odds model, greater information source seeking/responsiveness (i.e., interest in learning more about clinical prevention trials from more information sources) (p = 0.04), and having fewer psychosocial barriers (p = 0.02) were associated with a greater willingness to participate.
Conclusions. Many individuals who may be at greater risk for developing cancer because of having a first-degree relative with cancer are unaware of the availability of clinical cancer prevention trials. Nonetheless, many perceive low personal risk associated with these studies, and are interested in learning more.
"There was also news from Roche about another often-deadly form of cancer (ovarian cancer). Continuing the use of Avastin for two years following a chemo/Avastin regimen gave ovarian cancer patients an additional four months of progression-free survival, to 14 months total. Long-term use of Avastin is a pricey proposition, however, given its cost of up to $56,000 a year. Here’s the WSJ story.
Fox News posts story making preposterous claim about breast cancer - Gary Schwitzer's HealthNewsReview Blog
Note: dissecting media reports
Blogger's Note: the financial health of the healthcare industries (global) is very much in discussion. This website has numerous articles for discussion on topics such as below. After a cursory look, it seems charities have not been touched which may be a cause for concern for many given the time of year when many charities focus on their events. In one recent example in Toronto, the head of the hospital charity/fundraising conglomerate earned more than the head of the actual hospital itself. Whether it is a charity or whether it is the hospital/insurance/system itself, the question begs consideration of all factors - where is the money going?
Life at all Costs: The Politics
Life at All Costs: Dying Abroad
Life at All Costs: The Solutions
Life at All Costs: The Choices
Life at All costs: The Mid-Death Crisis
Justice Holmes Had it Right on Taxes
Social Security: Getting Facts Right
The Evil of Taxation
Sunday, June 06, 2010
YouTube - Ovarian Cancer News from the 2010 ASCO Annual Meeting video (Avastin/maintenance/advanced stage OC)
ASCO: New AMG 386 Data Demonstrate Promising Antitumor Activity in Patients With Recurrent Ovarian Cancer - MarketWatch
ASCO: Striking the Balance: Community Experts Come Together for High-Level Dialogue on Cancer Care - MarketWatch
More information about Breakaway from Cancer, including valuable resources offered by Amgen's partners, is available at www.breakawayfromcancer.com.
Medical News: ASCO: Biologic Agent Reduces Ovarian Cancer Relapse Risk - in Meeting Coverage, ASCO (Avastin trial) plus video
Abstract/full free access: Tracking the evolution of hospice palliative care in Canada: A comparative case study analysis of seven provinces
Saturday, June 05, 2010
Friday, June 04, 2010
Cancers of the reproductive organs (i.e., ovaries, uterus and testes), like other cancers, occur as a result of a multi-stage interaction of genetic and environmental factors. A small proportion of cancers of the reproductive organs occur as part of a recognised cancer syndrome, as a result of inheritance of mutations in highly penetrant cancer susceptibility genes (e.g., BRCA1, BRCA2, MLH1 or MSH2). Recognition of individuals and families with inherited cancer predisposition syndromes and individuals at high risk due to familial cancer clustering is fundamentally important for the management and treatment of the current cancer and for future prevention of further cancers for the individual and their extended family
'The worst thing about hospice is that they talk about death': contrasting hospice decisions and experience among immigrant Central and South American Latinos with US-born White, non-Latino cancer caregivers
Hospice care is promoted as a model for improving end of life care and decreasing burden on caregivers. However, hospice use is low in Latinos and little is known about how Latinos make hospice decisions and experience hospice once enrolled. Qualitative methods were used in this study to conduct in-depth interviews and focus groups with 15 Latino bereaved hospice family caregivers and 15 White non-Latino bereaved hospice family caregivers to describe hospice experiences and evaluate whether cultural factors affected the experience. Differences in decision-making and caregiving experience were identified that were influenced by culture. For example, cultural values of denial, secrecy about prognosis and a collective, family-centered system influenced hospice decisions and experience in Latinos but not non-Latinos. This study identifies a significant dilemma: that is, how to discuss hospice with a patient and family who prefer not to discuss a terminal prognosis. Future research is needed to extend these preliminary results; such results may be useful for designing interventions to improve end of life care and caregiving in Latinos.
'They've got to learn' -- a qualitative study exploring the views of patients and staff regarding medical student teaching in a hospice
UK medical school curricula incorporate training in end-of-life care as recommended by Tomorrow’s Doctors.
Previous research suggests that hospice staff have concerns about the burden on patients when participating in medical student teaching and may gatekeep access to patients.
This qualitative study uses semistructured interviews to explore and compare the views of hospice patients and health care staff about patient involvement in medical student teaching. Fifteen patients and 14 staff members were recruited from a single UK hospice involved in teaching third year medical students.
Hospice patients, who have been involved in teaching, are strongly positive about meeting medical students and staff carefully select patients based on a number of issues.
Abstract/full free access: The distribution of the therapeutic monoclonal antibodies cetuximab and trastuzumab within solid tumors
Cetuximab (Erbitux) and trastuzumab (Herceptin) distribute slowly, but at higher doses achieve a relatively uniform distribution after about 24 hours, most likely due to their long half-lives in the circulation. There remains poor distribution within hypoxic (hypoxia - a deficiency of oxygen reaching the tissues of the body) regions of tumors.
Thursday, June 03, 2010
It's a choice to move forward: women's perceptions about treatment decision making in recurrent ovarian cancer
OBJECTIVE: This research explores the treatment decision-making (TDM) experiences of women with recurrent ovarian cancer (ROC) with regard to treatment options; their understanding of risks and benefits of various treatment options; the decision-making role they want for themselves and for their oncologist; and the social context of the consultation as it pertains to the decision.
METHODS: We conducted semi-structured interviews with 26 women at the time of first recurrence. Through inductive data analysis key themes were identified.
RESULTS: Many women describe self-identifying the cancer recurrence fairly quickly due to new symptoms. Many feel that the goal for treating their recurrence is to control versus cure the cancer. They describe the subsequent process of diagnosis and TDM for ROC as quick and straightforward with all women accepting the oncologists' treatment recommendation. They feel that the type and number of treatment options are limited. They have a strong desire for physician continuity in their care. Participants feel that their doctor's recommendations as well as their previous experience with ovarian cancer are strong factors influencing their current TDM process.
CONCLUSIONS: Shared decision making is based on a simultaneous participation of both the physician and patient in TDM. When faced with ROC, women feel that their doctor's recommendation and their past experience with treatment and TDM are prominent factors influencing the current TDM process.
Note: Trabectedin is also known as Yondelis PURPOSE The objective of this study was to compare the efficacy and safety of trabectedin plus pegylated liposomal doxorubicin (PLD) with that of PLD alone in women with recurrent ovarian cancer after failure of first-line, platinum-based chemotherapy CONCLUSION When combined with PLD, trabectedin improves PFS and ORR over PLD alone with acceptable tolerance in the second-line treatment of recurrent ovarian cancer.
Comprehensive Analysis of Missense Variations in the BRCT Domain of BRCA 1 by Structural and Functional Assays
Comprehensive Analysis of Missense Variations in the BRCT Domain of BRCA1 by Structural and Functional Assays.
Lee MS, Green R, Marsillac SM, Coquelle N, Williams RS, Yeung T, Foo D, Hau DD, Hui B, Monteiro AN, Glover JN.
Authors' Affiliations: Department of Biochemistry, School of Systems Molecular Medicine, University of Alberta, Edmonton, Alberta, Canada; National Institute of Environmental Health Sciences, Durham, North Carolina; Risk Assessment, Detection, and Intervention Program, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida; and Molecular Biology Program, Institute of Biophysics Carlos Chagas Fo., Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
Genetic screening of the breast and ovarian cancer susceptibility gene BRCA1 has uncovered a large number of variants of uncertain clinical significance. Here, we use biochemical and cell-based transcriptional assays to assess the structural and functional defects associated with a large set of 117 distinct BRCA1 missense variants within the essential BRCT domain of the BRCA1 protein that have been documented in individuals with a family history of breast or ovarian cancer....... Through a correlation of the assay results with available family history and clinical data, we define limits to predict the disease risk associated with each variant. Forty-two of the variants show little effect on function and are likely to represent variants with little or no clinical significance; 50 display a clear functional effect and are likely to represent pathogenic variants; and the remaining 25 variants display intermediate activities. The excellent agreement between the structure/function effects of these mutations and available clinical data supports the notion that functional and structure information can be useful in the development of models to assess cancer risk.
2nd media article: HE4: Abbott gets FDA approval for ovarian cancer test - Chicago Breaking Business
"Abbott partnered with Fujirebio Diagnostics Inc. to develop the test. It also is approved for use in Europe, and other countries in the Asia Pacific and Latin American regions."
full free access: Breast Cancer Dormancy Can Be Maintained by Small Numbers of Micrometastases -- Cancer Research
Gastric perforation following cytoreductive surgery with perioperative intraperitoneal chemotherapy HIPEC
OCATS Ovarian Cancer Awareness & Treatment in Saskatchewan ------------------------------------------------------------------------------------- GYNECOLOGIC CANCER SURVIVORS & SUPPORT PEOPLE WELCOME MONDAY, June 7th 4:00 p.m. to 6:00 p.m. Knox Met United Church 2340 Victoria Avenue (Pls Use Vic Ave Entrance, Ring Buzzer for Room 105) Light Supper, $4 Donation This month our peer support gathering will have our regular check in, and then a facilitated discussion about the challenges and coping strategies for socializing and traveling after diagnosis, while having treatment, during recovery. We don’t have the answers exactly but we’ll share some of the experiences we’ve had for air travel, car travel, hotels, family holidays, special events and share how people have coped and what things they found were useful and helpful or things to avoid. Please come share in the discussion, meet other cancer survivors. It’s good to get out once in awhile and share with others, learn from others. It’s even okay to be grumpy about it! If that’s where you’re at. Please call Darlene at 775-1848 or email and let us know if you plan to attend. This helps Joan prepare those lovely meals she making for us! Thank you, Darlene Gray OCATS Ovarian Cancer Awareness & Treatment in Saskatchewan A SUPPORT & ACTION GROUP FOR ANYONE AFFECTED BY GYNECOLOGIC CANCERS RPO Box 35067, Regina, SK S4X 4C6 Ph 306-775-1848, Fx 306-775-1853 Find us on Facebook too! http://www.ocats.ca
Study Testing Methylphenidate for Cancer-Related Fatigue Indicate That It Is Certainly Not a Panacea but May Be Effective for Some Groups of Patients
VIDEO ALERT: Additional audio and video resources, including excerpts from an interview with Dr. Deb Barton is available on the http://newsblog.mayoclinic.org/2010/06/02/mayo-clinic-study-shows-drug-may-be-effective-in-treating-cancer-related-fatigue-in-some-patients/ Mayo Clinic News Blog.
The BRCA1 c.5434C→G (p.Pro1812Ala) variant induces a deleterious exon 23 skipping by affecting exonic splicing regulatory elements -- Gaildrat et al. 47 (6): 398 -- Journal of Medical Genetics
Blogger's Note: in plain english - many patients who have undergone genetic testing show test results of 'unknown variants' or variants of unknown clinical significance but negative for known mutations ie; BRCA 1/2; MSH2/6; MLH1; PMS2.
Some of these unclassified variants may or may not be related to cancer. With recent research, databases are now showing UV (unclassified variants) as true mutations.
This article is one of many which shows the work being done to explain and find the significance of these variants. Many patients undergoing genetic testing will test negative for the commonly known mutations, but this is not the'end of the story', so to speak.
Conclusion These data, together with segregation data, argue for the classification of BRCA1 c.5434C→G as a pathogenic splicing mutation. These results also suggest that UVs (unclassified variants)in highly conserved nucleotide sequences of short exons may be good candidates for detecting functionally relevant splicing regulatory elements.
""A high proportion of adults in the United States consume at least one of the drugs known to have some level of interaction with one of the new oral anticoagulants," the Loyola researchers write."
"The findings could have implications in fighting cancer because DNA methylation patterns go awry in cancer, often causing tumor suppressor genes to switch off. The more scientists know about the cellular mechanisms that lay down the correct DNA methylation patterns, the more that process can be manipulated. In the future, this type of research may lead to techniques that result in the ability to control the patterns that go awry and lead to cancer, thus preventing a malignancy"
Wednesday, June 02, 2010
Chronix Biomedical to Launch Cancer Detection and Monitoring Service at ASCO to Advance Clinical Research Using Its Apoptotic DNA Blood Test | Business Wire
Note: in research "Chronix Biomedical to Launch Cancer Detection and Monitoring Service at ASCO to Advance Clinical Research Using Its Apoptotic DNA Blood Test —ASCO Data Show Chronix’s Apoptotic DNA Blood Test Detects Early-Stage Cancer with Excellent Sensitivity and Specificity— —“For Investigational Use Only” Clinical Trial Service Is Designed to Provide Early Data on Patient Response and Disease Progression"
Identifying and Eliminating the Roadblocks to Comparative-Effectiveness Research | Health Care Reform Center
Functional Proteomic Analysis of Advanced Serous Ovarian Cancer Using Reverse Phase Protein Array: TGF-β Pathway Signaling Indicates Response to Primary chemotherapy
Abstract Purpose: Using reverse phase protein array, we measured protein expression associated with response to primary chemotherapy in patients with advanced-stage, high-grade serous ovarian cancer. Conclusion: TGF-β pathway signaling likely plays an important role as a marker or mediator of chemoresistance in advanced serous ovarian cancer. On this basis, future studies to develop and validate a useful predictor of treatment failure are warranted.
A genomic and transcriptomic approach for a differential diagnosis between primary and secondary ovarian carcinomas in patients with a previous histor
CONCLUSIONS: In patients with ovarian carcinoma and a previous history of breast cancer, SNP array analysis can be used to distinguish primary and secondary ovarian tumors.
Reproducible diagnosis of ovarian carcinoma cell types is critical for cell type-specific treatment. The purpose of this study was to test the reproducibility of cell type diagnosis across Canada. Analysis of the interobserver reproducibility of histologic tumor type was performed among 6 pathologists after brief training in the use of modified World Health Organization criteria to classify ovarian carcinomas into 1 of 6 categories: high-grade serous, endometrioid, clear cell, mucinous, low-grade serous, and other. These 6 pathologists independently reviewed a test set of 40 ovarian carcinomas. A validation set of 88 consecutive ovarian carcinomas drawn from 5 centers was subject to local review by 1 of the 6 study pathologists, and central review by a single observer. Interobserver agreement was assessed through calculation of concordance and kappa values for pair-wise comparison. For the test set, the paired concordance between pathologists in cell type diagnosis ranged from 85.0% to 97.5% (average 92.3%), and the kappa values were 0.80 to 0.97 (average 0.89). Inclusion of immunostaining results did not significantly improve reproducibility (P=0.69). For the validation set, the concordance between original diagnosis and local review was 84% and between local review and central review was 94%. The kappa values were 0.73 and 0.89, respectively. With a brief training exercise and the use of defined criteria for ovarian carcinoma subtyping, there is excellent interobserver reproducibility in diagnosis of cell type. This has implications for clinical trials of subtype-specific ovarian carcinoma treatments.
"Public confidence in clinical trials has been eroded by data suppression, misrepresentation and manipulation. Although various attempts have been made to achieve universal trial registration- e.g., Declaration of Helsinki, WHO clinical Trial Registry Platform (WHO ICTRP), the International Committee of Medical Journal Editors requirement- they have not succeeded, probably because they lack the enough power of enforcement. Legislation appears to be the most efficient and effective means to ensure that all researchers register their trials and disseminate their data accurately and in a timely manner. We propose that a global network be established. This could be accomplished in two steps. The first step is to legislate about trial registration and data transparency, such as USA's FDAAA Act 2007; and the second step to establish a global network to ensure uniform, international consistency in policy and enforcement of trial registration and data transparency."
focus on: Cancer Neuropathic Pain: Overview of Current Status and Future Objectives -- The Oncologist
- Cancer Neuropathic Pain: Overview of Current Status and Future Objectives
Frederick H. Hausheer, Kathleen M. Foley
The Oncologist 2010; 15(Supplement 2): 1-2; doi:10.1634/theoncologist.2009-S506
[Full Text] [PDF]
Mark J. Lema, Kathleen M. Foley, Frederick H. Hausheer
The Oncologist 2010; 15(Supplement 2): 3-8; doi:10.1634/theoncologist.2009-S505
[Abstract] [Full Text] [PDF]SUMMARY: This article briefly surveys the types and causes of neuropathic pain and then discusses what is known about the epidemiology of cancer-related neuropathic pain.
Gary J. Bennett
The Oncologist 2010; 15(Supplement 2): 9-12; doi:10.1634/theoncologist.2009-S503
[Abstract] [Full Text] [PDF]SUMMARY: The article reviews some of the work that has been done to study the peripheral causes of neuropathic pain as it relates to cancer.
Charles S. Cleeland, John T. Farrar, Frederick H. Hausheer
The Oncologist 2010; 15(Supplement 2): 13-18; doi:10.1634/theoncologist.2009-S501
[Abstract] [Full Text] [PDF]SUMMARY: This article briefly outlines the currently accepted measures of neuropathy and neuropathic pain, discusses their commonalities and limitations, and offers thoughts on improvements to current assessment strategies.
Barrie R. Cassileth, Francis J. Keefe
The Oncologist 2010; 15(Supplement 2): 19-23; doi:10.1634/theoncologist.2009-S504
[Abstract] [Full Text] [PDF]SUMMARY: This article briefly describes research illustrating the promise of important integrative oncology therapies for the treatment of cancer-related neuropathic pain, including massage therapy, acupuncture, and psychological/behavioral interventions.
Miroslav Backonja, Clifford J. Woolf
The Oncologist 2010; 15(Supplement 2): 24-29; doi:10.1634/theoncologist.2009-S502
[Abstract] [Full Text] [PDF]SUMMARY: This article briefly reviews emerging treatments for neuropathic pain and discusses specific opportunities to alter the drug discovery paradigm, stressing the need for an approach that emphasizes the unbiased evaluation of the particular neurobiological mechanisms contributing to neuropathic pain in individual patients.
Tuesday, June 01, 2010
"The landscape of oncolgy continues to evolve as the results from studies are evaluated. All of us at http://www.cancereducation.com are pleased to provide coverage of these critical issues in oncology through our attendance at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL, from June 4–8.
With over 30,000 oncology professionals gathering to discuss the latest innovations in research, quality of life issues, practice, and technology in the oncology community, our staff will attend several of the education and scientific sessions at ASCO.
Their daily updates will be posted on our blog* which can be accessed by clicking on the link at the top of the http://www.cancereducation.com home page."
Medical News: FDA Warns Against Contaminated IV Antibiotics - in Product Alert, Prescriptions from MedPage Today
Marshall Edwards Announces Final Results From Halted Phase 3 Clinical Trial of Phenoxodiol - MarketWatch
Note: these results have been awaited since late last year as per past blogged postings (pending compilation of data)
June 1, 2010, 8:31 a.m. EDT · Recommend · Post:
Marshall Edwards Announces Final Results From Halted Phase 3 Clinical Trial of Phenoxodiol
SYDNEY, AUSTRALIA and SAN DIEGO, CA, Jun 01, 2010 (MARKETWIRE via COMTEX) -- Marshall Edwards, Inc., an oncology company focused on the clinical development of novel anti-cancer therapeutics, announced today that a final analysis of its Phase 3 OVATURE trial of orally administered phenoxodiol in women with recurrent ovarian cancer determined that the trial did not show a statistically significant improvement in its primary (progression-free survival) or secondary (overall survival) endpoints. As previously announced, the trial was closed for recruitment before completion of enrolment with only 142 out of a planned 340 patients enrolled.
This multi-center, randomized, double-blind trial assessed the safety and efficacy of daily phenoxodiol in combination with weekly carboplatin versus weekly carboplatin with placebo in patients with platinum-resistant or platinum-refractory, late-stage epithelial ovarian, fallopian or primary peritoneal cancer following at least second line platinum therapy.
"Owing to the fact that this trial was significantly underpowered due to the small number of patients enrolled, we were disappointed, but not entirely surprised by the final outcome," said Dr. Daniel P. Gold, newly appointed Chief Executive Officer of Marshall Edwards. "However, we remain confident that our investigational isoflavone platform, including triphendiol, a potentially more potent, second-generation analogue of phenoxodiol, may be of benefit to women with ovarian cancer, particularly when administered intravenously.
"Previously reported results of a Phase 2 trial," continued Dr. Gold, "which tested the activity of intravenous phenoxodiol plus weekly cisplatin in a similar platinum-resistant or refractory patient population, demonstrated a 30% response rate (6 out of 20) compared to less than 1% (1 out of 142) in the OVATURE study in which phenoxodiol was administered orally. In addition, we remain excited with the progress of another product candidate in our pipeline, NV-128, a novel isoflavone analogue with a mode of action distinct from both phenoxodiol and triphendiol.
"Lastly, I want to take this opportunity to personally thank the patients and their families for their participation in this trial. I would also like to thank the clinical investigators and trial coordinators for their dedication and support."
As previously noted, phenoxodiol had a good safety profile and was well tolerated. The number of patients experiencing at least one adverse event was similar in each treatment group, as was the number of patients experiencing adverse events of Grade 3 or higher.
About OVATURE and the Phenoxodiol Clinical Program
The OVATURE ("OVArian TUmor REsponse") trial was a multi-center international Phase 3 clinical trial of orally administered investigational drug phenoxodiol in combination with carboplatin in women with advanced ovarian cancer resistant or refractory to platinum-based drugs to determine its safety and effectiveness when used in combination with carboplatin.
The trial recruited ovarian cancer patients whose cancer initially responded to chemotherapy, but had since become resistant or refractory to traditional platinum treatments. The study was closed to enrolment in April 2009 at which time 142 patients had been randomized to the study. Changes in standards of care over the period of the trial and the stringency of inclusion/exclusion criteria of the OVATURE protocol had slowed patient recruitment rates and consequently the Company deemed it prudent not to continue the trial to completion. The Independent Data Monitoring Committee (IDMC) supported the Company's decision to close the study to accrual, and, in a review of the available safety data, the IDMC confirmed that there were no safety concerns with phenoxodiol in these subjects.
Phenoxodiol is being developed as a chemosensitizing agent in combination with platinum drugs for late stage, chemoresistant ovarian cancer and as a monotherapy for prostate and cervical cancers. It is believed to have a unique mechanism of action, binding to cancer cells via a cell membrane oxidase, causing major downstream disturbances in expression of proteins necessary for cancer cell survival and responsible for the development of drug resistance.
Phenoxodiol appears to selectively inhibit the regulator known as S-1-P (sphingosine-1-phosphate) that is overexpressed in cancer cells. In response to phenoxodiol, S-1-P content is decreased, with a consequent decrease in expression of the pro-survival proteins XIAP and FLIP, inducing cell death via caspase expression and promoting sensitivity to other chemotherapeutics. In laboratory studies, it has been demonstrated that drug-resistant ovarian cancer cells pre-treated with phenoxodiol were killed with lower doses of chemotherapy drugs. Importantly, phenoxodiol has been shown not to adversely affect normal cells in animal and laboratory testing.
Phenoxodiol has been granted Fast Track status from the FDA to facilitate its development as a therapy for recurrent ovarian and prostate cancers. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need and provides the option to file a New Drug Application on a rolling basis. This permits the FDA to review the filing as it is received, expediting the review process. Phenoxodiol is an investigational drug and, as such, is not commercially available. Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by FDA as being safe and effective for the intended use.
June 1, 2010, 8:00 a.m. EDT · Recommend · Post:
Memorandum to Shareholders From Dr. Amnon Gonenne, MabCure's Chief Executive Officer
HASSELT, Belgium, Jun 01, 2010 (BUSINESS WIRE) -- MabCure, Inc. /quotes/comstock/11k!mbci (MBCI 0.32, -0.01, -3.03%) :
I am pleased to update you on the progress of our research and development.
Over the past several months we have been working intensively on advancing our various programs with an emphasis on melanoma and ovarian cancer diagnostics. We consider these two projects near-term in their respective development stages, as I describe below.
In January 2010, we announced the commencement of our clinical trials at the Ramathibodi Hospital in Bangkok, Thailand to evaluate the potential of our panel of monoclonal antibodies (MAbs) to diagnose ovarian cancer in high risk patients. Since the study began, patients have been recruited at a solid pace and in line with our schedule. In addition, we are privileged that the Thai National Cancer Institute has decided to join our study and is currently reviewing our study protocol. The study is estimated to be completed within 5-6 months, as originally planned.
In parallel to our study in Thailand, we are planning to commence a study in collaboration with a major medical center in Belgium of several hundred blood samples which were obtained from patients over the past several years. The purpose of this "retrospective" study is to provide additional proof of the ability of our MAbs to correctly diagnose ovarian cancer, and is of considerable importance given the significant number of blood samples to be tested.
The study will be "blind" to all involved (i.e. the samples will be coded and neither the clinicians nor MabCure scientists will know the identity of the specimens until the study is complete), so as to prevent any bias in the analysis of the results. The study is expected to last several weeks and will commence once a formal agreement has been signed with the Belgian medical center. As a prelude to this study, we conducted a pilot study on a limited number of these "retrospective" specimens to calibrate the optimal technical conditions for our MAbs.
BACKGROUND: The "exceptional patients" with cancer are survivors who had advanced cancer considered incurable by medical report and who subsequently became disease-free or experienced unexplained survival time given the nature of their disease or treatment. This experience is a puzzling phenomenon that has not been formally investigated in a cancer population. The purpose of this study was to understand exceptional patients' accounts of their experience.
MATERIALS AND METHODS: This study used a narrative approach with a cross-case thematic analysis. Recruitment took place at health care centers in the USA and Israel. Oncologists in both centers were asked to identify patients who had an exceptional disease course. Patients were then contacted and interviewed; an audio recording was made of each narrative account and then transcribed. Interviews and thematic analyses were conducted independently at each site. These thematic findings from each site were discussed with both research teams and a common underlying theme was identified, which is the focus of this report.
RESULTS: Twenty-six participants were interviewed: 14 from the USA and 12 from Israel. All the participants have had advanced disease with a range of diagnoses that included breast, colorectal, pancreatic, ovarian cancer, glioblastoma multiforme, and others. The main recurrent theme from both the US and Israeli sites was personal activism. This was manifested in taking charge and getting involved in the process of diagnosis and treatment, as well as becoming more altruistic in their relationships with others. In many cases, this was reflected in a change in a philosophy about life
CONCLUSIONS: In this study, we found that activism was a major theme that was independently observed in both Israel and the USA. This has implications for health care providers to facilitate patient engagement in the care and treatment of their disease. Further research on this phenomenon is needed.
Medical News: Hand Hygiene in Hospitals Not Up to Par - in Infectious Disease, Infection Control from MedPage Today
Each year, an estimated 2.5 million patients in the U.S. develop healthcare-associated infections that result in 90,000 deaths and cost the healthcare system an estimated $4.5 to $5.7 billion dollars
Anti-MUC1 Antibodies and Ovarian Cancer Risk: Prospective Data from the Nurses' Health Studies — Cancer Epidemiology, Biomarkers & Prevention
Note: MUC1 has been/is being studied in numerous cancers
Conclusion: Anti-MUC1 (glycoprotein) antibodies evaluated several years before diagnosis may be associated with lower risk of subsequent ovarian cancer in women <64 years old at assessment.
Note: clicking above uploads directly the pdf file version
Statement of Daniel L. Clarke-Pearson, M.D. President - Society of Gynecologic Oncologists Professor and Chair, Obstetrics and Gynecology University of North Carolina Medical School Chapel Hill, North Carolina On Behalf of The Society of Gynecologic Oncologists Before The House Defense Appropriations Subcommittee
Thursday, May 20, 2010 at 10:00 am
SGO's 41st Annual Meeting on Women's Cancer Webcast Available Now!
FREE Introduction to Presidential Address, Cornelius Granai, MD
FREE Presidential Address, David Mutch, MD
FREE ACS Lectureship, Paul Goodfellow, PhD
Monday, May 31, 2010
Primary Outcome Measures: Compare Predictors of Health-Related Quality of Life (QOL) among Colorectal Cancer (CRC) Survivors who have Lynch Syndrome (LS) with patients who have Sporadic CRC [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
The 5 Dumbest Cancer Myths? The 5 Dumbest Cancer Myths? PDF Print E-mail Written by Dr Vasilev Monday, 17 August 2009
HUYA Bioscience International forms strategic partnership with School of Chinese Materia Medica of BUCM
The apprenticeship model that surgical training has traditionally relied on has proven to be an expensive, time-consuming, and inconsistent model for producing skilled surgeons. Combined with increased public scrutiny on patient safety, financial concerns, restricted work hours, and expanding skill requirements, it has become clear that a new pedagogic paradigm is required. This article reviews the evidence supporting the need and justification of simulation in surgical education and explores the existing and potential roles of simulation in the training and evaluation of future surgeons.
LISTSERV Choice Awards: "The Mailys" Voting - May 2010