Tuesday, May 01, 2012
Medscape: Many Clinical Trials Unable to Supply High-Quality Evidence
Many Clinical Trials Unable to Supply High-Quality Evidence
"Given the deficit in evidence to support key decisions in clinical practice guidelines…as well as concerns about insufficient numbers of volunteers for trials…the desire to provide high-quality evidence for medical decisions must include consideration of a comprehensive redesign of the clinical trial enterprise," they continue. Currently, less than 15% of major guideline recommendations are evidence-based, they write........
Women, Minorities More Likely to Leave Surgery Career Path
Women, Minorities More Likely to Leave Surgery Career Path
May 1, 2012 — Women and minority trainees in general surgery are more likely to fall short of board certification than their peers, according to a study published yesterday in the May issue of the Journal of the American College of Surgeons (JACS).......
paywalled: Epigenetic Resensitization to Platinum in Ovarian Cancer (low-dose decitabine/carboplatin)
Epigenetic Resensitization to Platinum in Ovarian Cancer
"Together, the results of this study suggest that low-dose decitabine altered DNA methylation of genes and cancer pathways, restoring sensitivity to carboplatin in patients with heavily pretreated ovarian cancer and resulting in a high RR and prolonged PFS."
Abstract
Preclinical studies have shown that hypomethylating agents reverse platinum resistance in ovarian cancer. In this phase II clinical trial, based upon the results of our phase I dose defining study, we tested the clinical and biologic activity of low-dose decitabine administered before carboplatin in platinum-resistant ovarian cancer patients. Among 17 patients with heavily pretreated and platinum-resistant ovarian cancer, the regimen induced a 35% objective response rate
paywalled: Requirements to Assess Feasibility of Phase 0 Trials during Major Abdominal Surgery: Variability of PARP Activity
Requirements to Assess Feasibility of Phase 0 Trials during Major Abdominal Surgery: Variability of PARP Activity
Abstract
Purpose: The aim of this
study was to evaluate the feasibility of phase 0 trials in the setting
of a routine surgical procedure. Logistic
considerations, tissue sampling and tissue
handling, and variability of a biomarker during surgery, in here PARP,
were evaluated.
Experimental Design:
Patients with highly suspicious or proven diagnosis of advanced ovarian
cancer, planned for debulking surgery were asked
to allow sequential tumor biopsies during surgery.
Biopsies were frozen immediately and PARP activity was measured
subsequently.
Conclusions: Conducting phase 0 trials during surgery seems to be feasible in terms of logistic considerations. In preparation of a phase 0 trial during surgery, a feasibility study like this should be conducted to rule out major interactions of the surgical intervention with respect to the targeted biomarker.
Conclusions: Conducting phase 0 trials during surgery seems to be feasible in terms of logistic considerations. In preparation of a phase 0 trial during surgery, a feasibility study like this should be conducted to rule out major interactions of the surgical intervention with respect to the targeted biomarker.
A Comprehensive Analysis of Human Gene Expression Profiles Identifies Stromal Immunoglobulin κ C as a Compatible Prognostic Marker in Human Solid Tumors
A Comprehensive Analysis of Human Gene Expression Profiles Identifies Stromal Immunoglobulin κ C as a Compatible Prognostic Marker in Human Solid Tumors
"No association was observed in ovarian cancer."
phase 1 - A Open-Label, Multiple Ascending Dose Study of DS-3078a, an Oral TORC1/2 Kinase Inhibitor, in Subjects With Advanced Solid Tumors or Lymphomas - Full Text View - ClinicalTrials.gov
A Open-Label, Multiple Ascending Dose Study of DS-3078a, an Oral TORC1/2 Kinase Inhibitor, in Subjects With Advanced Solid Tumors or Lymphomas - Full Text View - ClinicalTrials.gov
This study is currently recruiting participants.
Verified April 2012 by Daiichi Sankyo Inc.
First Received on April 26, 2012.
Last Updated on April 27, 2012
History of Changes
paywalled: Evaluation of prevalent and incident ovarian cancer co-morbidity : British Journal of Cancer
Access : Evaluation of prevalent and incident ovarian cancer co-morbidity : British Journal of Cancer
British Journal of Cancer , (1 May 2012) | doi:10.1038/bjc.2012.164
Evaluation of prevalent and incident ovarian cancer co-morbidity
Abstract
Background:
The
peak in incidence of ovarian cancer occurs around 65 years and
concurrent increasing risk by age for a number of diseases strongly
influence treatment and prognosis. The aim was to explore prevalence and
incidence of co-morbidity in ovarian cancer patients compared with the
general population.
Methods:
The study population was patients with ovarian cancer in Sweden 1993–2006 (n=11 139) and five controls per case (n=55 687).
Co-morbidity from 1987 to 2006 was obtained from the Swedish Patient
Register. Prevalent data were analysed with logistic regression and
incident data with Cox proportional hazards models.
Results:
Women
developing ovarian cancer did not have higher overall morbidity than
other women earlier than 3 months preceding cancer diagnosis. However,
at time of diagnosis 11 of 13 prevalent diagnosis groups were more
common among ovarian cancer patients compared with controls. The
incidence of many common diagnoses was increased several years following
the ovarian cancer and the most common diagnoses during the follow-up
period were thromboembolism, haematologic and gastrointestinal
complications.
Conclusion:
Women
developing ovarian cancer do not have higher overall morbidity the
years preceding cancer diagnosis. The incidence of many common diagnoses
was increased several years following the ovarian cancer. It is crucial
to consider time between co-morbidity and cancer diagnosis to
understand and interpret associations.
Next-generation 'epigenetic' cancer pill shown to be safe in phase I trial (CHR-3996)
Next-generation 'epigenetic' cancer pill shown to be safe in phase I trial
" CHR-3996 was tested in 39 patients with a range of advanced cancers."
BMJ » Blog Archive » Chris Williams: When will we learn HOW to deliver healthcare?
BMJ » Blog Archive » Chris Williams: When will we learn HOW to deliver healthcare?
Chris Williams is a medical student at the University of Liverpool, currently intercalating at the Liverpool School of Tropical Medicine for an MSc in Humanitarian studies.
paywalled: Conveying empathy to hospice family caregivers: Team responses to caregiver empathic communication
Conveying empathy to hospice family caregivers: Team responses to caregiver empathic communication: Publication year: 2012
Source: Patient Education and Counseling
Objective The goal of this study was to explore empathic communication opportunities presented by family caregivers and responses from interdisciplinary hospice team members.
Methods Empathic opportunities and hospice team responses were analyzed from bi-weekly web-based videoconferences between family caregivers and hospice teams. The authors coded the data using the Empathic Communication Coding System (ECCS) and identified themes within and among the coded data.
Results Data analysis identified 270 empathic opportunity-team response sequences. Caregivers expressed statements of emotion and decline most frequently. Two-thirds of the hospice team responses were implicit acknowledgments of caregiver statements and only one-third of the team responses were explicit recognitions of caregiver empathic opportunities.
Conclusion Although hospice team members frequently express emotional concerns with family caregivers during one-on-one visits, there is a need for more empathic communication during team meetings that involve caregivers.
Practice implications Hospice clinicians should devote more time to discussing emotional issues with patients and their families to enhance patient-centered hospice care. Further consideration should be given to training clinicians to empathize with patients and family caregivers.
press release: New surgical technique for removing inoperable tumors of the abdomen
New surgical technique for removing inoperable tumors of the abdomen
New surgical technique for removing inoperable tumors of the abdomen
Abdominal tumors involving both roots of the celiac and superior mesenteric artery (SMA) are deemed unresectable by conventional surgical methods, as removal would cause necrosis of the organs that are supplied by those blood vessels.A case report published in the journal American Journal of Transplantation presents a novel surgical technique that enables surgeons to remove tumors that are unresectable by the usual surgical techniques.
Diamond Pet Foods Expands Voluntary Recall to Include Diamond Puppy Formula due to Possible Salmonella Contamination
Diamond Pet Foods Expands Voluntary Recall to Include Diamond Puppy Formula due to Possible Salmonella Contamination:
Diamond Pet Foods is expanding a voluntary recall to include Diamond Puppy Formula dry dog food. The company took this precautionary measure because sampling revealed Salmonella in the product.
Ovarian Cancer National Alliance Submits Comments to Government Regarding Ovarian Cancer Screening
Ovarian Cancer National Alliance Submits Comments to Government Regarding Ovarian Cancer Screening:
The Ovarian Cancer National Alliance submitted the following comments in response to the United States Preventive Service Task Force request for comments on draft recommendations for ovarian cancer screening.
Comments to USPSTF re:
Draft Reaffirmation Recommendation Statement
Screening for Ovarian Cancer: U.S. Preventive Services Task Force Reaffirmation Recommendation Statement
As a patient advocacy organization dedicated to promoting the interests of women with ovarian cancer, the Ovarian Cancer National Alliance is pleased to provide comments on the Draft Screening Statement for Ovarian Cancer.
The United States Preventive Services Task Force is to be commended for reviewing the recent scientific publications regarding ovarian cancer screening. As the Task Force correctly noted, the latest studies confirm that the current blood and imaging tests are not useful for population based screening.
However, the Recommendation Statement does not specify that these tools are valid as part of the diagnostic protocol for women suspected of having ovarian cancer, due in large part to the presence of symptoms.
Further, the Task Force did not appear to use the results of studies that indicate more favorable results of using the CA-125 in tailored ways. For example, a study presented at the 2010 American Society of Clinical Oncology Annual Meeting had more than 3,000 post-menopausal women stratified into high, medium and low risk categories based on an algorithm. The women, based on risk, then had different follow up procedures. The practice followed in this study had a low false-positive rate.
While we are by no means arguing that the CA-125 and/or transvaginal ultrasound be recommended as appropriate screening tools, we urge the Task Force to consider all available information when making its recommendations.
We also request that the recommendation include language regarding the symptoms of ovarian cancer (bloating, difficulty eating/feeling full quickly, urinary frequency or urgency, abdominal pain). We encourage the Task Force to also note that if women have symptoms of the disease these screening recommendations do not apply. We suggest: These recommendations apply only to asymptomatic women at average risk (or instead of “at average risk”, “without any hereditary or family history that would put them at an elevated risk”.)
We thank the Committee for noting that this recommendation does not apply to high risk women, including those with a known genetic mutation that puts them at an increased risk of developing ovarian cancer.
About Ovarian Cancer
According to the American Cancer Society, approximately 21,000 American women are diagnosed with ovarian cancer each year, and approximately 15,000 women die from the disease annually. Ovarian cancer is the deadliest gynecologic cancer and the fifth leading cause of cancer death among women in America. Currently, more than half of the women diagnosed with ovarian cancer die within five years.
About the Ovarian Cancer National Alliance
The Ovarian Cancer National Alliance is a survivor-led national umbrella organization with state and local groups representing grassroots activists, women’s health advocates and health care professionals. The Ovarian Cancer National Alliance submits this testimony as a patient advocacy group dedicated to promoting the interests of women with ovarian cancer.
NIH grants $10.5 Million for Genome Explorations -The Burrill Report
NIH grants $10.5 Million for Genome Explorations -The Burrill Report:
The National Human Genome Research Institute, part of the National Institutes of Health, is awarding $10.5 million in ten grants to help researchers identify millions of genomic elements that play a role in determining what genes are expressed and at what levels in different cells. The multi-year grants are part of the Encyclopedia of DNA Elements project, or ENCODE, set up to provide scientists with a comprehensive catalog of functional genomic elements. The project's goal is to help explain the role that the genome plays in health and disease.
paywalled: Mucin 16 (cancer antigen 125) expression in human tissues and cell lines and correlation with clinical outcome in adenocarcinomas of the pancreas, esophagus, stomach, and colon
Mucin 16 (cancer antigen 125) expression in human... [Hum Pathol. 2012] - PubMed - NCBI
Hum Pathol. 2012 Apr 26
Mucin 16 (cancer antigen 125) expression in human tissues and cell lines and correlation with clinical outcome in adenocarcinomas of the pancreas, esophagus, stomach, and colon
Abstract
Mucin 16 (cancer antigen 125) is a cell surface glycoprotein that plays a role in promoting cancer cell growth in ovarian cancer. The aims of this study were to examine mucin 16 expression in a large number of digestive tract adenocarcinomas and precursors and to determine whether mucin 16 up-regulation is correlated with patient outcome.Tissue microarrays were constructed using surgical resection tissues and included pancreatic (115 normal, 29 precursors, 200 pancreatic ductal adenocarcinomas), esophageal (86 normal, 104 precursors, 95 esophageal adenocarcinomas, 35 lymph node metastases), gastric (211 normal, 8 precursors, 119 gastric adenocarcinomas, 62 lymph node metastases), and colorectal (34 normal, 17 precursors, 39 colorectal adenocarcinomas) tissues. Mucin 16 was detected in 81.5%, 69.9%, 41.2%, and 64.1% of the pancreatic ductal adenocarcinomas, esophageal adenocarcinomas, gastric adenocarcinomas, and colorectal adenocarcinomas, respectively. Mucin 16 was seen in a subset of the precursors. On multivariate analysis, moderate/diffuse mucin 16 in pancreatic ductal adenocarcinomas was strongly associated with poor survival (P < .001), independent of other prognosis predictors. A similar trend was observed for esophageal adenocarcinomas (P = .160) and gastric adenocarcinomas (P = .080). Focal mucin 16 in colorectal adenocarcinomas was significantly correlated (P = .044) with a better patient outcome, when compared with mucin 16-negative cases. Using Western blot analysis, we found mucin 16 expression in 3 of 6 pancreatic ductal adenocarcinoma and 1 of 2 esophageal adenocarcinoma cell lines.
We conclude that most of the digestive tract adenocarcinomas and a
subset of their precursors express mucin 16. Mucin 16 expression is an
independent predictor of poor outcome in pancreatic ductal
adenocarcinomas and potentially in esophageal adenocarcinomas and
gastric adenocarcinomas. We propose that mucin 16 may function as a
prognostic marker and therapeutic target in the future.
paywalled: Prevalence of mismatch repair-deficient crypt foci in Lynch syndrome: a pathological study : The Lancet Oncology
Prevalence of mismatch repair-deficient crypt foci in Lynch syndrome: a pathological study : The Lancet Oncology
Methods
"Resections done for small and large bowel cancer between January, 2002, and January, 2011, were retrieved. We systematically analysed non-tumorous mucosa from carriers of a Lynch syndrome mutation (set 1: ten patients) and control patients without Lynch syndrome (set 1: nine patients) for MMR protein expression (MLH1, MSH2, and EPCAM) with immunohistochemistry.....
May 1st (open access) Commentary including link to original paper: Lynch syndrome: new tales from the crypt : The Lancet Oncology
Blogger's Note: commentary focus is primarily on colorectal cancer:
Lynch syndrome: new tales from the crypt : The Lancet Oncology
"...Unfortunately, these lesions are too small and subtle to be relied upon clinically to suggest a diagnosis of Lynch syndrome. Importantly, the investigators acknowledge that, although they noted these lesions occurred frequently, most patients with Lynch syndrome will develop zero to two cancers, and typically only a few adenomatous polyps, through their lifetimes.5 Small bowel cancers occur in no more than 1—4% of patients with Lynch syndrome,6 yet that organ has one MMR-deficient crypt per 2 cm2 of mucosa. Obviously, most of these lesions do not develop into cancer. So, what happens to them?....."
"...The missing link in this work is the contrast between the large number of MMR-deficient crypts and the relatively small number of clinically relevant neoplasms in this disease. That said, this work is highly novel, underscores the differences between Lynch syndrome and sporadic colorectal cancers, and raises a fresh group of important questions to be addressed."
Original paper - link/reference:
. Prevalence of mismatch repair-deficient crypt foci in Lynch syndrome: a pathological study. Lancet Oncol 201210.1016/S1470-2045(12)70109-2. published online May 1.
Monday, April 30, 2012
Ovarian Cancer and Us posts viewed per geographic locations: top 10 (April)
Blogger's Note: it's always interesting to see the demographic variations over time
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