Monday, May 21, 2012
Editorial: Why You Should Care about Screening Flexible Sigmoidoscopy — NEJM
Blogger's Note: read the whole editorial for further information regarding colonoscopies, this blog also has trial data on colonoscopies/research/opinions
Why You Should Care about Screening Flexible Sigmoidoscopy — NEJM
"...The real question for U.S. (blogger's note: and others) clinicians is whether we are prepared to refocus attention on a screening strategy that has been likened to performing mammography on one breast..."
...Where does this leave us with regard to screening flexible sigmoidoscopy? First, it should be acknowledged that flexible sigmoidoscopy reduces colorectal-cancer incidence and mortality for the portion of the colon that it is designed to examine. Next, high-quality evidence must show the superiority of colonoscopy over other screening tests before we dismiss the use of flexible sigmoidoscopy and fecal occult-blood testing, both of which have randomized, controlled trials supporting their benefit. Especially critical are data that confirm the ability of colonoscopy to reduce mortality from proximal cancers. Finally, patient preferences for screening tests should be identified and respected — in this case, the best test is the one that gets done.
add your opinions
colonoscopy
,
signmoidoscopy
New Data Concludes Wait Times for Patients With Gastrointestinal Disease Are Increasing Across Canada - MarketWatch
New Data Concludes Wait Times for Patients With Gastrointestinal Disease Are Increasing Across Canada - MarketWatch
OAKVILLE, ONTARIO, May 17, 2012 (MARKETWIRE via COMTEX) --
The Canadian Association of Gastroenterology (CAG) today joined the
Ontario Association of Gastroenterology (OAG) in voicing their
objection to the Government of Ontario's May 7, 2012 decision to
overhaul the fee structure for approximately 40 medical procedures
and services that Ontario doctors provide. Colonoscopies are among
the medical tests for which professional fees face a cut of 10%.
Pointing to new initial data gathered in April 2012 from the Canadian
Association of Gastroenterology Survey of Access to GastroEnterology
(SAGE), Desmond Leddin, Lead of the SAGE, says "a comparison of data
from surveys performed in 2005 and 2008 shows that wait times for
patients with gastrointestinal disease have increased across Canada."
"This CAG national survey information combined with the new fee
structure in Ontario gives us cause for concern about patient
safety," says CAG President Dan Sadowski.
"With evidence in hand that patient wait times have been increasing
over the past seven years, we can't support any government decision -
in Ontario or elsewhere in Canada - that results in reduced access
to, or longer wait times for, important medical procedures including
colonoscopy, which can prevent and reduce cancer rates.".....
add your opinions
colonoscopy
,
ontario government
,
wait times
Roche will report new data on important progress for people with advanced cancers at ASCO 2012 - AURELIA trial ovarian/Avastin+
Roche will report new data on important progress for people with advanced cancers at ASCO 2012
Data from AURELIA, the first Phase III study of Avastin plus chemotherapy in people with platinum-resistant recurrent ovarian cancer will be presented. This study will be highlighted as part of ASCO’s official press program.
add your opinions
AURELIA
,
Avastin
,
Bevacizumab
Petitions | The White House re: free access to scientific journal articles....
Petitions | The White House
we petition the obama administration to:
Require free access over the Internet to scientific journal articles arising from taxpayer-funded research.
add your opinions
access to information
,
open access
,
taxpayer funded reserch
Genetic Testing and Counseling Nevada Surgery and Cancer Care
Genetic Testing and Counseling | NVSCC: Nevada Surgery and Cancer Care
Genetic Testing and Counseling
We offer:
Genetic Counseling and Genetic Screening for Breast, Ovarian and Colorectal Cancer.Personal or Family History of Breast and Ovarian Cancer*
( * Hereditary Breast and Ovarian Cancer (HBOC) syndrome is an inherited condition that causes an increased risk for ovarian, breast, pancreatic and prostate cancer. The vast majority of hereditary breast and ovarian cancer is due to an alteration or gene mutation in either the BRCA1 or BRCA2 genes. These gene mutations can be inherited from either your mother or father.)
Personal and Family History of Colorectal Cancer
(* Lynch Syndrome, also known as hereditary nonpolyposis colorectal cancer (HNPCC), is an inherited condition that causes an increased risk for early onset colorectal cancer (often before age 50) as well as other related cancers†. The majority of Lynch Syndrome is due to a mutation in the MLH1, MSH2 or MSH6 genes. These mutations can be inherited from either your mother or father.
† colorectal, endometrial, stomach, ovarian, kidney/urinary tract, brain, small bowel, pancreatic, sebaceous adenoma/carcinoma)
add your opinions
Nevada
,
nevada genetic testing
Sunday, May 20, 2012
U.S. Medicare - new - 'Blue Button' MyMedicare.gov: Portal of Personalized Information
MyMedicare.gov: Portal of Personalized Information
What's New?
Blue Button is here! Blue Button allows you to download your data to a text file. Look for the Blue Button as you search claims and view your On the Go Report.

add your opinions
blue button
,
U.S. Medicare
Loss of ARID1A expression is related to shorter progression-free survival and chemoresistance in ovarian clear cell carcinoma.
Blogger's Note: varying studies show different %'s of ARID1A gene expression in clear cell ovarian cancer
~~~~~~~~~~~~~~~~~~~~~~~~
Loss of ARID1A expression is related to shorter progression-free survival and chemoresistance in ovarian clear cell carcinoma.:
Mod Pathol. 2012 Feb;25(2):282-8
Abstract
Recently, the ARID1A gene has been identified as a novel tumor suppressor in ovarian clear cell carcinoma. The prognostic significance of the loss of ARID1A expression is not known. The current study was designed to evaluate whether ARID1A was a prognostic factor for progression, survival, and chemoresistance in ovarian clear cell carcinoma.
add your opinions
ARID1A
,
clear cell ovarian cancer
Saturday, May 19, 2012
Microscopic Hematuria Not Predictive of Cancer
Microscopic Hematuria Not Predictive of Cancer
"In 4414 patients with asymptomatic microscopic hematuria, the rate of urinary tract cancer was 2.1%, (compared with the 0.43% the researchers previously found)."
American Urological Association (AUA) 2012 Annual Scientific Meeting: Abstract 62. Presented May 19, 2012
add your opinions
Microscopic Hematuria
Canadian breast implant cohort: Extended follow-up of cancer incidence - Pan - 2012 - International Journal of Cancer - Wiley Online Library
Canadian breast implant cohort: Extended follow-up of cancer incidence - International Journal of Cancer
Abstract
Cosmetic
breast implants are not associated with increased breast cancer
incidence, but variations of risk according to implant characteristics
are still poorly understood. As well, the assessment of cancer risk for
sites other than breast needs to be clarified. The purpose of this study
was to fill these research gaps. This study presents an extended
analysis of 10 more years of follow-up of a large Canadian cohort of
women who received either cosmetic breast implants (n = 24,558)
or other cosmetic surgery (15,893). Over 70% of the implant cohort was
followed for over 20 years. Cancer incidence among implant women was
compared to those of controls using multivariate Poisson models and the
general female population using the standardized incidence ratios
(SIRs). Women with breast implants had reduced rates of breast and
endometrial cancers compared to other surgery women. Subglandular
implants were associated to a reduced rate of breast cancer compared to
submuscular implants [incidence rate ratio (IRR) = 0.78, 95% confidence
interval (CI) = 0.63–0.96] and this reduction persisted over time. We
observed a sevenfold increased rate (IRR = 7.36, 95% CI = 1.86–29.12) of
breast cancer in the first 5 years after the date of surgery for
polyurethane-coated subglandular implant women but this IRR decreased
progressively over time (p value for trend = 0.02). We also
observed no increased risk of rarer forms of cancer among augmented
women. A reduction in breast cancer incidence was observed for women
with subglandular implants relative to women with submuscular implants.
Possible increase of breast cancer incidence shortly after breast
augmentation with polyurethane implants needs to be verified.
add your opinions
breast implants
paywalled: Quality of Life After Surgery for Colon Cancer in Patients With Lynch Syndrome: Partial Versus Subtotal Colectomy.
Quality of Life After Surgery for Colon Cancer in Patients With Lynch Syndrome: Partial Versus Subtotal Colectomy
BACKGROUND:: Lynch syndrome is a disorder caused by mismatch repair gene mutations. Mutation carriers have a high risk of developing colorectal cancer. In patients with Lynch syndrome in whom colon cancer has been diagnosed, in general, subtotal colectomy instead of partial colectomy is recommended because of the substantial risk of metachronous colorectal cancer. However, the effect of more extensive surgery on quality of life and functional outcome is unknown.
add your opinions
colectomy
,
Lynch Syndrome
,
partial colectomy
,
prophylactic lynch syndrome surgery
,
subtotal colectomy
paywalled: Antigen-specific immunotherapy in ovarian cancer and p53 as tumor antigen.
Antigen-specific immunotherapy in ovarian cancer and p53 as tumor antigen.:
Abstract
Immunotherapy for ovarian cancer is one of the new treatment strategies currently investigated in epithelial ovarian cancer. This review discusses the results of different immunization strategies, identifies possible drawbacks in study design and provides potential solutions for augmentation of clinical efficacy. A potential target for cancer immunotherapy is p53, as approximately 50% of ovarian cancer cells carry p53 mutations. Therefore we review the immunological and clinical responses observed in ovarian cancer patients vaccinated with p53 targeting vaccines in particular. In most studies antigen-specific vaccine-induced immunological responses were observed. Unfortunately, no clinical responses with significant reduction of tumor-burden have been reported. Based on the currently available results we emphasize the necessity of multimodality treatment of ovarian cancer, combining classical cytoreductive surgery, (neo) adjuvant chemotherapy, immunotherapy and/or targeted therapy.
add your opinions
cancer vaccines
,
immunotherapy
,
p53
paywalled: Models of care in outpatient cancer centers [Nurs Econ. 2012 Mar-Apr] - PubMed - NCBI
Nurs Econ. 2012 Mar-Apr;30(2):108-16.
Models of care in outpatient cancer centers.
Abstract
While rapid changes in the treatment of cancer have been driven by research-based evidence, innovations in cancer care delivery have lagged behind that seen in cancer treatment. A literature review and ten semi-structured interviews were conducted to identify models of care in the ambulatory oncology setting to be adopted by a comprehensive cancer center. Four models were identified from the literature review but none were widely recognized or adopted by administrators. Findings suggested some common themes that should be included in an optimal model of care. These themes are in support of the burgeoning efforts seen in the promotion of interprofessional education and practice for quality improvement. Unique challenges related to the contextual factors in the ambulatory oncology settings suggest quality improvement interventions should be tailored to meet the specific needs of the care facility and its workforce.
add your opinions
cancer care delivery
,
cancer patient care
,
institutions
2nd report: Stats Canada - Conditional survival analyses across cancer sites
Blogger's Note: html version; stop reading if looking for ovarian cancer specfic references
Conditional survival analyses across cancer sites
For this article...
Survival estimates are typically presented as the probability—or the ratio of observed and expected probabilities in the case of relative survival—of surviving a given length of time (for example, five years) after diagnosis. However, these estimates are less informative for people who have survived one or more years, as the risk of death due to cancer is often greatest in the first few years. After this initial period, the prognosis can improve substantially, so the earlier estimates no longer apply.6 The outlook for such people can be estimated more appropriately using conditional survival.
For the first time in Canada, predicted conditional relative survival estimates are presented for a large number of cancers. Cancers with the greatest relative improvement in prognosis since diagnosis are highlighted. Cancers showing less improvement are also identified. (See The data)
add your opinions
cancer canada
,
conditional survival rates
,
stats canada
2012 Canadian trends in cancer prevalence - Stats Canada
Blogger's Note: aside from 2 lines of stats, there is no specific reference/s to ovarian cancer (use search term: ovary)
(html version) http://www.statcan.gc.ca/pub/82-003-x/2012001/article/11616-eng.htm
pdf - Canadian trends in cancer prevalence
"In Canada, the rate at which new cancer cases are diagnosed continues to
rise,4 and survival is also increasing.5-7 A recent study provided a detailed report of cancer prevalence in Canada as of January 1, 2005.8 However, cancer prevalence trends are rarely published, and until now, have not been reported for Canada......
Conclusion
This study presents the f rst Canadian cancer prevalence trend estimates to be reported. Trends in prevalence for an extensive list of cancers by time since diagnosis, sex and age group signachanges in the extent of disease in the Canadian population. Rising cancer prevalence proportions are due to increases in incidence, which partly result from the aging of the population, and to improvements in survival. Information about the degree to which changes in prevalence are occurring, and for which cancers in particular, is valuable for
resource planning
add your opinions
statistics canada
Chapter 22: Integration of Herbal Medicine into Evidence-Based Clinical Practice - Herbal Medicine - NCBI Bookshelf
Integration of Herbal Medicine into Evidence-Based Clinical Practice - Herbal Medicine - NCBI Bookshelf
- INTRODUCTION
- CURRENT STATUS AND MAJOR ISSUES OF INTEGRATION OF HERBAL MEDICINE IN EVIDENCE-BASED MEDICAL THERAPY
- FACTORS RELEVANT TO/AFFECTING INTEGRATION OF HERBAL MEDICINE INTO MODERN MEDICAL PRACTICES
- RESEARCH NEEDS
- CONCLUSIONS
- REFERENCE
"....However, proof of efficacy or safety for the vast majority of herbal medicine has not been fully established through an evidence-based approach. Further, other issues, such as scientific, cultural, educational, economical, and legal, need to be addressed. In this chapter, we examine the current status and major scientific issues or factors that affect the integration of herbal medicine into evidence-based medical therapy."
The
authors wish to thank the WHO Collaborating Centre for Traditional
Medicine at the School of Health Sciences, RMIT University, Bundoora,
Victoria, Australia, and the WHO Collaborating Centre for Traditional
Medicine at the College of Pharmacy, University of Illinois at Chicago,
Chicago, Illinois, for their consent and encouragement to undertake the
present collaboration.
add your opinions
book
,
herbal medicine
,
integrated medicine
Multiple VEGF Family Members are Simultaneously Expressed in Ovarian Cancer: a Proposed Model for Bevacizumab Resistance
Multiple VEGF Family Members are Simultaneously Expressed in Ovarian Cancer: a Proposed Model for Bevacizumab Resistance.:
Curr Pharm Des. 2012 May 14;
Abstract
Objective Insight into the expression of multiple vascular endothelial growth factor (VEGF) family members can support the implementation of anti-angiogenic therapy. This study aimed to assess VEGF family member expression in ovarian cancers and related omental metastases.
Methods Tissue microarrays encompassing 270 primary cancers and 112 paired metastases were immunostained for VEGF-A, VEGF-B, VEGF-C and VEGF-D. Staining intensities were categorized as absent, weak, moderate or strong. Expression was related to clinicopathological characteristics and survival.
Results Immunohistochemical positivity (defined as moderate or strong expression) was observed for VEGF-A in 90%, VEGF-B in 4%, VEGF-C in 41% and VEGF-D in 55% of the primary ovarian cancers. ....... VEGF family member expression showed no independent prognostic significance in multivariate survival analysis.
Conclusion VEGF-A, VEGF-C and VEGF-D are widely and often simultaneously expressed in ovarian cancer, which may contribute to bevacizumab resistance. Measuring their expression could support a rational, individualized choice of anti-angiogenic therapy and might be of predictive value. Studies are warranted to determine whether combinatorial analysis of VEGF family member expression can be used to predict anti-angiogenic drug efficacy.
add your opinions
Avastin
,
beva
,
omental masses
,
omentum
,
VEGF
The role of bevacizumab in advanced epithelial ovarian cancer.
The role of bevacizumab in advanced epithelial ovarian cancer.:
Curr Pharm Des. 2012 May 14;
Abstract
Background: There is a strong rationale for usage of anti-angiogenic agents in epithelial ovarian cancer. Bevacizumab is the most widely investigated anti-VEGF agent and has shown promising results in recent clinical trials.
Objective: To review the rationale and usage of bevacizumab in advanced epithelial ovarian cancer; as mono-therapy, in combination with chemotherapy both as first line and for recurrent ovarian cancer as well as in combination with other targeted therapies.
Results: In epithelial ovarian cancer, angiogenesis promotes tumor growth, ascites formation and metastasis. Targeting VEGF in ovarian cancer patients may have indirect and direct cytotoxic effects. Results of placebo controlled phase III trials, the GOG-218 and ICON7, of carboplatin-paclitaxel alone or combined with bevacizumab in chemo-naive patients and the OCEAN trial comparing carboplatin-gemcitabine with or without bevacizumab in women with recurrent platinum-sensitive epithelial ovarian cancer all suggest a benefit for the addition of bevacizumab on progression free survival. Additionally, bevacizumab in combination with other targeted therapies, such as sorafenib and everolimus are under investigation in phase II trials and the current knowledge of molecular predictors is discussed.
In conclusion: Until now no survival benefit has been observed, but bevacizumab is the first anti-angiogenic agent demonstrating a progression free survival benefit in addition to standard chemotherapy regimens in advanced epithelial ovarian cancer, both in the upfront and recurrent setting. Mature overall survival data and the search for predictive biomarkers are important for the future role of bevacizumab in epithelial ovarian cancer.
add your opinions
Avastin
,
Bevacizumab
paywalled: Guideline-Based Peer-to-Peer Consultation Optimizes Pegfilgrastim Use With No Adverse Clinical Consequences [Original Contributions]
Guideline-Based Peer-to-Peer Consultation Optimizes Pegfilgrastim Use With No Adverse Clinical Consequences [Original Contributions]:
Purpose:
Practice guidelines do not recommend the routine use of colony-stimulating factors when there is a low risk (< 10%) of febrile neutropenia (FN). We prospectively determined whether expert peer-to-peer consultation with prescribing oncologists would improve adherence to guidelines and whether there would be any adverse events associated with that adherence.
Methods:
Commencing in March 2010, we reviewed requests for pegfilgrastim from 22 community oncology practices comprising 78 physicians providing service to approximately 97,000 Medicare members. Paid claims data on all chemotherapy and supportive care medications were reviewed from fourth quarter (Q4) 2009 through third quarter (Q3) 2010. In total, 82 patients received pegfilgrastim. If the prescribed chemotherapy was associated with a low risk (< 10%) for FN, then a peer review was initiated. The treating physician made the final decision to use, or not use, pegfilgrastim, and no denials were issued.
Results:
A total of 245 units (1 unit = 6 mg) of pegfilgrastim were administered during the four quarters analyzed. Use in the low-risk category decreased from 52 units in Q4 2009 to 15 units in Q3 2010. The per-member per-month (PMPM) cost of pegfilgrastim decreased across quarters, with an average cost of $1.07 PMPM for Q4 2009 and $0.57 PMPM for Q3 2010. No studied patient was admitted for neutropenic fever.
Conclusion:
Active expert peer-to-peer consultation with prescribing oncologists can promote adherence to guidelines and potentially lead to significant cost reductions without significant risk of neutropenic fever, with or without hospitalization, for patients with cancer.
add your opinions
anemia drugs
,
blood products
,
colony-stimulating factors
,
CSF
,
febrile neutropenia
paywalled: Patient Out-of-Pocket Payments for Oral Oncolytics: Results From a 2009 US Claims Data Analysis [Original Contributions]
Patient Out-of-Pocket Payments for Oral Oncolytics: Results From a 2009 US Claims Data Analysis [Original Contributions]:
Purpose:
Oral oncolytics are an increasingly important treatment option for cancer. These agents often fall within the pharmacy benefit, with the potential for increased out-of-pocket (OOP) cost burden for patients. The purpose of this study was to evaluate patient OOP payments for oral oncolytic therapies in US managed care plans.
Conclusion:
Among 21 oral oncolytics, average OOP cost ranged from $15 to > $500. These results confirm previous findings showing OOP payments differing widely among oral oncolytic options. As cost for therapy becomes a greater part of treatment decisions, an understanding of patient OOP cost will be critical in informing choices.
add your opinions
cancer costs
,
oral drugs
,
out of pocket expenses
paywalled: Visit Duration for Outpatient Physician Office Visits Among Patients With Cancer
Visit Duration for Outpatient Physician Office Visits Among Patients With Cancer
Conclusion:
Higher use of performance-based payment mechanisms and capitated arrangements are associated with a decrease in the amount of time physicians spend with their patients with cancer. It is unclear whether shorter visit times impact the quality of medical care provided or whether physicians in these settings have become more proficient in caring for their patients.
add your opinions
doctor appointments
,
time allocation
paywalled: Meat and fish consumption and risk of pancreatic cancer – results from the european prospective investigation into cancer and nutrition - International Journal of Cancer
Blogger's Note: implications for all cancers/research
Meat and fish consumption and risk of pancreatic cancer – results from the european prospective investigation into cancer and nutrition - Rohrmann - International Journal of Cancer
Conclusion:
Our
results do not support the conclusion of the World Cancer Research Fund
that red or processed meat consumption may possibly increase the risk
of pancreatic cancer. The positive association of poultry consumption
with pancreatic cancer might be a chance finding as it contradicts most
previous findings.
add your opinions
cancer risks
,
diet
,
fish
,
meat
,
nutrition
UPDATE: New Website Selling Miracle Mineral Solution Sodium Chlorite Solution Not Authorized for Oral Consumption by Humans
Blogger's Note: the website is still active as of the date of this positing
UPDATE: New Website Selling Miracle Mineral Solution Sodium Chlorite Solution Not Authorized for Oral Consumption by Humans
Information Update
2012-74
May 18, 2012
For immediate release
OTTAWA - Further to our previous communications, Health Canada is advising Canadians that a new website has been identified selling "MMS", also known as Miracle Mineral Solution or Miracle Mineral Supplement. The website is http://www.buymms.biz
When new websites or retailers are identified, Health Canada will continue to update our current list of MMS products. Canadians are advised to monitor this list of affected products for any possible updates.
Health Canada continues to remind Canadians that there are no therapeutic products containing sodium chlorite authorized for oral consumption by humans. MMS may cause serious health problems that include poisoning, kidney failure and harm to red blood cells that reduces the ability of the blood to carry oxygen. Additional health problems may also include abdominal pain, nausea, vomiting, and diarrhoea.
Consumers should consult their health care practitioner if they have used or are using MMS products and report any adverse reaction to Health Canada.
Health Canada has notified distributors identified to date that the sale of sodium chlorite for human consumption is in contravention of the Food and Drugs Act. We have also requested that identified distributors remove product from the Canadian market. As such, this website (http://www.buymms.biz) may or may not be operational. (Blogger's Note: is active)
add your opinions
health canada
,
supplements
May 21 Webinar: Steps to Addressing Health Disparities
May 21 Webinar: Steps to Addressing Health Disparities:
Michelle Yeboah of FDA's Office of Minority Health tells how the agency is addressing health disparities among minority populations in America.
add your opinions
minorities
,
webinar
Google goes cancer: Researchers use search engine algorithm to find cancer biomarkers
Google goes cancer: Researchers use search engine algorithm to find cancer biomarkers:
The strategy used by Google to decide which pages are relevant for a search query can also be used to determine which proteins in a patient's cancer are relevant for the disease progression. Researchers from Dresden University of Technology, Germany, have used a modified version of Google's PageRank algorithm to rank about 20,000 proteins by their genetic relevance to the progression of pancreatic cancer. In their study, published in PLoS Computational Biology, they found seven proteins that can help to assess how aggressive a patient's tumor is and guide the clinician to decide if that patient should receive chemotherapy or not.
read more
add your opinions
cancer research algorithms
,
google
Cancerworld.org: GrandRound - A second opinion, because there’s no second chance
A second opinion, because there’s no second chance
Patients want the option of consulting a second doctor, and the evidence shows that, for a minority of them, treatment decisions have altered significantly as a result. But could granting every patient the legal right to a second opinion tie up precious resources as each one ‘shops around’ in search of the opinion they want to hear?.....
"The fear that many have about ‘upsetting’ their doctor should not be underestimated"
IN SHORT
- Women, especially breast cancer patients, are among the most likely to seek second opinions, probably because of the many different treatment options for breast cancer and its high visibility in the media.
- Computers networks are obvious second opinion enablers. The European Union’s e-Health
- action plan predicts that by 2008 the majority of European health organisations should have the technical capability to provide online teleconsultation services for second opinions and other needs.
- More than a quarter (29%) of US adults reported that they or a member of their family received a second medical opinion from a doctor in the past five years, according to a 2005 Harris Interactive survey. In 30% of these, the diagnosis differed from the original. Another Harris poll in 2006 found that 36% of US adults never get a second opinion and nearly one in ten (9%) ‘rarely or never understand’ their diagnosis.
- Australian researchers have found that ‘Googling’ symptoms on the Internet came up with the right diagnosis in 15 out of 26 cases (reported in the New England Journal of Medicine). At Duke University in the US, medical physicists are using a Google-like approach to compare mammograms with the most highly ranked images returned from a database.
add your opinions
second opinions
Patient-Centered Outcomes Research Institute PCORI: What Is It? How Does It Work? The Director Explains
PCORI: What Is It? How Does It Work? The Director Explains
In this segment of Medscape One-on-One, Joseph Selby, MD, talks with Eli Adashi, MD, about his new role as head of the Patient-Centered Outcomes Research Institute, its mission, and how physicians might benefit from this institute created under the Affordable Care Act.
excerpt:
"How Does PCORI Differ From the Cochrane Collaboration?
Dr. Adashi: A question you almost certainly have heard before and that some of our viewers almost certainly contemplated has to do with the distinction between PCORI and other undertakings, such as the Cochrane Collaboration and programs that engage in systematic reviews or meta-analysis of data. In what way does PCORI stand out to other efforts? Where is it unique and distinct?
Dr. Selby: I think the most striking difference is that we are a research funding institution. The Cochrane Collaboration collects, disseminates, and guides the creation of evidence syntheses. We will fund some evidence syntheses, but we'll also fund a lot of empirical research, including observational research and randomized comparisons. So, we are a funding institute of substantial size in distinction to, as you mentioned, the Cochrane Collaboration and several European organizations that synthesize data and go beyond synthesis to supporting policymaking.
The other distinguishing characteristic is that we don't make policy; we generate information....
add your opinions
Patient-Centered Outcomes Research Institute
,
PCORI
Friday, May 18, 2012
Experts Report Little Certainty in Vitamin D’s Potential Benefits « news@JAMA
Experts Report Little Certainty in Vitamin D’s Potential Benefits « news@JAMA
Conclusions in the statement include the following:
• Topical or oral vitamin D may help treat psoriasis, but more evidence is needed to determine its efficacy in treating other skin disorders or preventing skin cancer.
• No strong evidence exists to support the theory that vitamin D supplements reduce the risk of type 2 diabetes or the metabolic syndrome.
• Clinical trial evidence does not support taking vitamin D supplements to lower cardiovascular disease risk.
• Observational studies linking vitamin D with reduced cancer incidence are strongest for colorectal cancer but weak or inconsistent for breast, prostate, and all cancers combined.
The statement will be published in the June issue of the Endocrine Society’s Endocrine Reviews.
add your opinions
vitamin D
The Disparity of Motivational Drivers in International Health Care Systems
OMICS Publishing Group | Full-text | The Disparity of Motivational Drivers in International Health Care Systems
".......Undeniably, some industrialized countries, particularly in Europe, are far closer to attaining sustainable, universal (timely) healthcare access than others and yet no country can claim perfection.....
add your opinions
healthcare systems
,
international healthcare
An alternative approach to identify women at risk for colorectal cancer. | 2012 ASCO Annual Meeting Abstracts
An alternative approach to identify women at risk for colorectal cancer. | 2012 ASCO Annual Meeting Abstracts
Abstract:
Background:
Hereditary colorectal cancer (CRC) is preventable; however, identification of individuals at sufficiently high risk to warrant heightened surveillance is difficult. Lynch Syndrome (LS) is an inherited cancer syndrome due to germline mutation in a DNA mismatch repair gene. For women with LS, the lifetime risk of endometrial cancer (EC) is 64% and CRC is 54%. Fifty percent of women with LS will present with EC or ovarian cancer prior to CRC. Therefore, women with LS associated EC represent an ideal group for CRC prevention. The optimal method to identify women with LS associated EC is not known. The purpose of this study was to determine the utility of Amsterdam II and Society of Gynecologic Oncology (SGO) Criteria (modified Bethesda criteria that use EC as the sentinel cancer) in identifying women with LS associated EC. Our ultimate goal is to identify women at increased risk of CRC.
Our data suggest that classic clinical screening criteria are inadequate to detect patients with LS who present with EC, potentially missing up to 25% of these patients.
| Gene | MLH1 | MSH2 | MSH6 | PMS2 | Total |
|---|---|---|---|---|---|
| Total number | 14 | 27 | 11 | 7 | 59 |
| Median age at diagnosis (range) | 52 (42-79) |
44 (33-81) |
56 (31-76) |
66 (45-87) |
50 (31-87) |
| Diagnosis at greater than 50 years | 7 | 8 | 9 | 6 | 30 |
| FH CRC | 3 | 16 | 4 | 3 | 26 |
| Amsterdam criteria | 3 | 13 | 0 | 1 | 17 |
| SGO criteria | 11 | 22 | 7 | 4 | 44 |
add your opinions
Lynch Syndrome
,
sentinel cancer
2012 ASCO Annual Meeting Abstracts (searchable)
2012 ASCO Annual Meeting Abstracts
|
||||||||
|
add your opinions
2012 asco
paywalled: Lipid Profiles and Risk of Breast and Ovarian Cancer in the Swedish AMORIS Study
WIKI: Lipid metabolism refers to the processes that involve the intercourse and degradation of lipids.
The types of lipids involved include:
- Bile salts
- Cholesterols
- Eicosanoids
- Glycolipids
- Ketone bodies
- Fatty acids - see also fatty acid metabolism
- Phospholipids
- Sphingolipids
- Steroid - see also steroidogenesis
- Triacylglycerols (fats) - see also lipolysis and lipogenesis
Lipid Profiles and Risk of Breast and Ovarian Cancer in the Swedish AMORIS Study
Background:
Obesity is a risk factor for
breast (BCa) and ovarian cancer (OCa); the mechanisms of action are not
completely
understood. Perturbed lipid metabolism often
accompanies obesity; we therefore ascertained the associations between
lipid
components and BCa and OCa risk in a
prospective cohort study.
Methods:
234,494 women with baseline measurements
of triglycerides (TG) and total cholesterol(TC) and glucose were
selected
from the AMORIS database. 27,394 had measurements
of HDL,LDL, apolipoprotein (Apo) B and A-I. Associations between quartiles
and dichotomized values of lipid components and BCa
and OCa risk were analysed using Cox proportional hazard models.
Results:
We identified 6,105 women diagnosed with
BCa and 808 women diagnosed with OCa. A weak trend was observed between
TG and BCa (HR: 1.01 (CI95% 0.94-1.09), 0.93
(0.86-1.00) 0.91
(0.84-0.99) 2nd 3rd and 4th quartiles; P = 0.01).
No other associations between lipid components and risk of BCa or OCa
showed
statistical significance.
Conclusions:
A weak protective association was
found between levels of TG and risk of BCa.
Impact: An analysis including information on tumour
characteristics of OCa and BCa may provide more insight in possible
links
between lipid metabolism and the risk of these
cancers.
add your opinions
cholesterol
,
fats
,
HDL
,
LDL
,
lipid levels
,
obesity
,
Triglycerides
paywalled: CT diagnosis of intrasplenic metastasis from ovarian carcinoma
CT diagnosis of intrasplenic metastasis from ovarian carcinoma
We concluded that CT can demonstrate intraparenchymal and infiltrative splenic metastasis in patients with ovarian cancer even in the absence of increased CA 125 levels.
add your opinions
CA-125
,
CA125
,
CT scans
,
intraparenchymal
,
metastasis
,
spleen
Thursday, May 17, 2012
2012 CDC/NCI report - United States Cancer Statistics (USCS)
Cancer - NPCR - USCS - View Data Online
| The 1999–2008 United States Cancer Statistics (USCS): Incidence and Mortality Web-based Report
marks the tenth time that the Centers for Disease Control and
Prevention (CDC) and the National Cancer Institute (NCI) have jointly
produced official federal cancer incidence statistics for each state
having high-quality cancer data. The report is produced in collaboration
with the North American Association of Central Cancer Registries. This year's report features information on more than one million invasive cancer cases diagnosed during 2008 among residents of all 50 states, six metropolitan areas, and the District of Columbia. Incidence data are from CDC's National Program of Cancer Registries (NPCR) and NCI's Surveillance, Epidemiology and End Results (SEER) Program. Data from population-based central cancer registries in these states and metropolitan areas meet the selected criteria for inclusion in this report. The report also provides cancer mortality data collected and processed by CDC's National Center for Health Statistics (NCHS). Mortality statistics, based on records of deaths that occurred during 2008, are available for all 50 states and the District of Columbia. Report Highlights
United States Cancer Statistics (USCS)View Data Online1999–2008 Cancer Incidence and Mortality DataThis Web-based report includes the official federal statistics on cancer incidence from registries that have high-quality data and cancer mortality statistics for each year and 2004–2008 combined. It is produced by the Centers for Disease Control and Prevention (CDC) and the National Cancer Institute (NCI), in collaboration with the North American Association of Central Cancer Registries (NAACCR). |
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U.S. cancer statistics
paywalled: Presence of a sarcomatous component outside the ovary is an adverse prognostic factor for primary ovarian malignant mixed mesodermal/mullerian tumors: a clinicopathologic study of 47 cases
Blogger's Note: also known by short form MMMT
Abstract
Primary ovarian malignant mixed mesodermal tumors are uncommon. There exist few data in the literature on the significance of the sarcomatous (sarcoma) component (SC) in these tumors. Here we investigated this aspect in 47 such tumors, with particular interest in whether the presence of SC outside the ovary confers a worse prognosis. .......................We advocate listing the specific extraovarian tumor component (SC and/or CC) in the pathology report for primary ovarian malignant mixed mesodermal tumors.
add your opinions
carcinosarcoma
,
mixed mesodermal
,
MMMT
Gamma knife surgery for brain metastases from ovarian cancer.
numerous tables including:
Table 1 Patient characteristics of 16 patients with 119 brain metastases
Conclusions
Brain metastases from ovarian cancer are
rare, but their incidence is increasing as patient survival has been
extended by
successful platinum-based chemotherapy and improved
imaging techniques have enabled the identification of smaller lesions.
In our study, the median survival from brain metastases
was 12.5 months, and the local control rate was 86.4 %. The KPS and
total volume of brain metastases were important factors
predictive of survival. Our results suggest that GKS is an acceptable
therapy for brain metastases from ovarian cancer.
Conflicts of interest
None.
Open Access
add your opinions
brain metastases
,
gamma knife surgery
,
ovarian cancer brain metastases
,
radiotherapy
update March 15th Grants.gov - Find Grant Opportunities - Opportunity Synopsis
Grants.gov - Find Grant Opportunities - Opportunity Synopsis
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 03/15/2012 . If updates have been made to the opportunity synopsis, update information is provided below the synopsis.....
add your opinions
DOD
,
ovarian cancer grants
News : Many Primary Care Docs Don't Know Long-Term Effects of Chemo: Survey
Blogger's Note: general/non-ovarian cancer specific
HON - News : Many Primary Care Docs Don't Know Long-Term Effects of Chemo: Survey
"....The findings highlight the need for more communication between the different doctors involved in a patient's care, one expert stressed.
The burden of that communication lies not only with doctors (oncologists and primary care physicians) but also with patients, said Dr. Stephanie Bernik, chief of surgical oncology at Lenox Hill Hospital in New York City.....
add your opinions
adverse effects
,
communication
,
long term side effects
paywalled- Gynecologic Oncology - Response to: “Management of ovarian cancer has changed”
ScienceDirect.com - Gynecologic Oncology - Response to: “Management of ovarian cancer has changed”
In Press, Accepted Manuscript, Available online 15 May 2012
Joyce N. Barlin, Dennis S. Chi
paywalled - Gynecologic Oncology - Comparison of ERCC1/XPF genetic variation, mRNA and protein levels in women with advanced stage ovarian cancer treated with intraperitoneal platinum
ScienceDirect.com - Gynecologic Oncology - Comparison of ERCC1/XPF genetic variation, mRNA and protein levels in women with advanced stage ovarian cancer treated with intraperitoneal platinum
Abstract
Objective
Approximately 20% of patients receiving platinum-based chemotherapy for epithelial ovarian cancer (EOC) are refractory or develop early recurrence. Identifying these patients early could reduce treatment-associated morbidity and allow quicker transfer to more effective therapies. Much attention has focused on ERCC1 as a potential predictor of response to therapy because of its essential role in the repair of platinum-induced DNA damage. The purpose of this study was to accurately measure protein levels of ERCC1 and its essential binding partner XPF from patients with EOC treated with platinum-based therapy and determine if protein levels correlate with mRNA levels, patient genotypes or clinical outcomes.Methods
ERCC1 and XPF mRNA and protein levels were measured in frozen EOC specimens from 41 patients receiving intraperitoneal platinum-based chemotherapy using reverse transcription polymerase chain reaction and western blots. Genotypes of common nucleotide polymorphisms were also analyzed. Patient outcomes included progression free (PFS) and overall survival (OS).Results
Expression of ERCC1 and XPF were tightly correlated with one another at both the mRNA and protein level. However, the mRNA and protein levels of ERCC1 were not positively correlated. Likewise, none of the SNPs analyzed correlated with ERCC1 or XPF protein levels. There was an inverse correlation between mRNA levels and patient outcomes.Conclusion
Neither genotype nor mRNA levels are predictive of protein expression. Despite this, low ERCC1 mRNA significantly correlated with improved PFS and OS.
add your opinions
dna damage
,
ERCC1
,
IP therapy
,
mRNA
,
proteins
paywalled - Gynecologic Oncology - Hormonal therapy for recurrent low-grade serous carcinoma of the ovary or peritoneum
ScienceDirect.com - Gynecologic Oncology - Hormonal therapy for recurrent low-grade serous carcinoma of the ovary or peritoneum
Objective
To determine whether hormonal therapies have efficacy in patients with recurrent low-grade serous carcinoma of the ovary or peritoneum.Methods
We searched departmental databases for patients with histologically-confirmed, evaluable, recurrent low-grade serous ovarian or peritoneal carcinoma who received hormonal therapy at our institution between 1989 and 2009. We retrospectively reviewed patients' medical records for demographic, disease, hormonal therapy, and estrogen receptor and progesterone receptor expression data. We used the Response Evaluation Criteria in Solid Tumors version 1.1 to determine patients' responses to hormonal therapy. Because patients could have received more than one evaluable hormonal therapy regimen, we chose to define the outcome metric as “patient-regimens.” Median time to disease progression (TTP) and overall survival (OS) were also calculated. Regression analysis was also performed.Results
We identified 64 patients with recurrent low-grade serous carcinoma of the ovary or peritoneum. Patients' median TTP and median OS were 7.4 and 78.2 months, respectively. Patients received 89 separate hormonal patient-regimens, which produced an overall response rate of 9% (6 complete responses and 2 partial responses). Sixty-one percent of the patient-regimens resulted in a progression-free survival duration of at least 6 months. Patient-regimens involving ER +/PR + disease produced a longer median TTP (8.9 months) than patient-regimens involving ER +/PR − disease did (6.2 months; p = 0.053). This difference approached but did not reach statistical significance.Conclusions
Hormonal therapies have moderate anti-tumor activity in patients with recurrent low-grade serous carcinoma of the ovary or peritoneum. Further study to determine whether ER/PR expression status is a predictive biomarker for this rare cancer subtype is warranted.
add your opinions
hormonal therapy
,
low grade serous
paywalled - Gynecologic Oncology - A phase II study of a urokinase-derived peptide (A6) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma: GOG
ScienceDirect.com - Gynecologic Oncology - A phase II study of a urokinase-derived peptide (A6) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma: A Gynecologic Oncology Group study
Conclusion
A6 was well tolerated but had minimal activity in patients with persistent or recurrent EOC/FTC/PPC.paywalled- Gynecologic Oncology - Economic impact of paclitaxel shortage in patients with newly diagnosed ovarian cancer ($8,699,872 monthly.
ScienceDirect.com - Gynecologic Oncology - Economic impact of paclitaxel shortage in patients with newly diagnosed ovarian cancer
Objective
To determine the potential economic impact of a paclitaxel drug shortage in patients with newly diagnosed, untreated ovarian cancer.Methods
A modified Markov state transition model with a 6 cycle time horizon compared two scenarios: (1) Standard treatment (STD): paclitaxel 175 mg/m2/carboplatin AUC 5 × 6 cycles; (2) Paclitaxel drug shortage (DS): docetaxel 75 mg/m2/carboplatin AUC 5 × 6 cycles. Adverse events, quality of life, and costs of chemotherapy, neuropathy, febrile neutropenia, and anemia were incorporated. Key assumptions: (1) Costs and consequences were assigned only to grade 2 + neuropathy, febrile neutropenia, and grade 3–4 anemia; (2) Grade 2 + neuropathy prompted a switch from paclitaxel/carboplatin to docetaxel/carboplatin or from docetaxel/carboplatin to carboplatin alone; (3) Febrile neutropenia resulted in inpatient hospitalization followed by G-CSF prophylaxis.Results
The mean cost of 6 cycles of chemotherapy was $4939 in the STD and $16,107 in the DS scenario, for a cost difference of $11,168 per patient over 6 cycles of treatment. STD was the dominant strategy (less expensive and more effective than the drug shortage scenario). In sensitivity analysis, DS was more costly over a wide range of clinical estimates in each arm. A drug shortage that affects approximately 50% of women initiating chemotherapy is expected to impact 779 women and cost third party payers an additional $8,699,872 monthly.Conclusions
Our model indicates that chemotherapy drug shortages can have a significant negative impact on the average cost of primary treatment for ovarian cancer and have the potential to negatively impact health system costs.
add your opinions
drug shortages
,
Paclitaxel
,
Taxol
paywalled - Gynecologic Oncology - Predictors of severe and febrile neutropenia during primary chemotherapy for ovarian cancer
ScienceDirect.com - Gynecologic Oncology - Predictors of severe and febrile neutropenia during primary chemotherapy for ovarian cancer
Objective
To identify factors that increase the risk of neutropenic events in women with advanced ovarian carcinoma receiving initial chemotherapy.Methods
Multi-center retrospective study of women with FIGO stage III–IV epithelial ovarian cancer treated postoperatively with multi-agent intravenous chemotherapy from 1995 to 2008. Outcomes were severe (SN; absolute neutrophil count [ANC] < 500/mm3) and febrile neutropenia (FN; ANC < 1000/mm3 and temperature > 38.1 °C). Cumulative risk of neutropenic events was estimated by Kaplan Meier method. Multivariate analysis was by Cox proportional hazard regression.Results
Three hundred twenty-six patients met inclusion criteria. There were 251 SN events among 140 (43%) patients and 24 FN events among 22 (7%) patients. Univariate predictors of SN were body surface area < 2.0 m2 (p = 0.03), body mass index (BMI) < 30 kg/m2 (p < 0.01), Caucasian race (p < 0.01), treatment on research protocols (p < 0.01), non-carboplatin-containing regimens (p < 0.01), and planned relative dose intensity (RDI) > 85% of standard (p = 0.02). Women over age 60 were more likely to develop FN (p = 0.05). Multivariate predictors of SN were treatment on research protocols (hazard ratio [HR] 1.93; p < 0.01), Caucasian race (HR 2.13; p = 0.01), and planned RDI > 85% (HR 1.69; p = 0.05); predictors of FN were age > 60 (HR 2.84; p = 0.05) and non-carboplatin containing regimens (HR 4.06; p < 0.01).Conclusion
While SN is fairly common, FN occurs infrequently in women with EOC undergoing taxane and platin-based chemotherapy and primary prophylactic growth factor support is not indicated. However, women older than 60 years of age receiving non-carboplatin containing regimens are at higher risk for FN and warrant closer surveillance.
add your opinions
adverse events
,
neutropenia
,
side effects
paywalled - Gynecologic Oncology - Progression-free and overall survival of a modified outpatient regimen of primary intravenous/intraperitoneal paclitaxel and intraperitoneal cisplatin in ovarian, fallopian tube, and primary peritoneal cancer
ScienceDirect.com - Gynecologic Oncology - Progression-free and overall survival of a modified outpatient regimen of primary intravenous/intraperitoneal paclitaxel and intraperitoneal cisplatin in ovarian, fallopian tube, and primary peritoneal cancer
Highlights
► GOG 172 showed improved outcomes for optimally debulked ovarian carcinoma patients treated with IV/IP chemotherapy compared to IV chemotherapy.► The regimen has not been widely accepted due to its inpatient administration, toxicity profile, and limited completion rate.
► A modified GOG 172 treatment regimen improved convenience, toxicity, and tolerability, with outcomes similar to those of GOG 172.
add your opinions
GOG 172
,
IP cisplatin
,
IP taxol
,
IV/IP ovarian
paywalled - Gynecologic Oncology - Impact of smoking on perioperative pulmonary and upper respiratory complications after laparoscopic gynecologic surgery
ScienceDirect.com - Gynecologic Oncology - Impact of smoking on perioperative pulmonary and upper respiratory complications after laparoscopic gynecologic surgery
Abstract
Objective
To determine the impact of smoking on the rate of pulmonary and upper respiratory complications following laparoscopic gynecologic surgery.Methods
We retrospectively identified all patients who underwent laparoscopic gynecologic surgery at one institution between January 2000 and January 2009. Pulmonary and upper respiratory complications were defined as atelectasis, pneumonia, upper respiratory infection, acute respiratory failure, hypoxemia, pneumothorax, or pneumomediastinum occurring within 30 days after surgeryResults
Nine hundred three patients underwent attempt at laparoscopic surgery. Fifty-four were excluded because of conversion to laparotomy and 31 because of insufficient data. Of the 818 patients included, 356 (43%) had cancer. A total of 576 (70%) patients were never smokers, 156 (19%) were past smokers, and 86 (10%) were current smokers (smoked within 6 weeks before surgery). These three groups were similar with regard to median body mass index, operative time, and length of hospital stay. Compared to never and past smokers, current smokers were more likely to undergo high-complexity laparoscopic procedures (10.4%, 15.4%, and 19.8%, respectively; p = 0.015) and had younger median age 49 years, 51 years, and 46 years, respectively; p = 0.035. Nineteen (2.3%) patients experienced pulmonary complications — symptomatic atelectasis (n = 9), pneumonia (n = 5), acute respiratory failure (n = 2), hypoxemia (n = 1), pneumomediastinum (n = 1), and pneumothorax (n = 2). The rate of pulmonary complications was 2.1% (12 of 564 patients) in never smokers, 4.5% (7 of 156 patients) in past smokers, and zero in current smokers.Conclusion
In this cohort, smoking history did not appear to impact postoperative pulmonary and upper respiratory complications. In smokers scheduled for operative procedures, laparoscopy should be considered when feasible.
add your opinions
laparoscopic surgery
,
smoking
paywalled: Current advances in the management of malignant germ cell and sex cord-stromal tumors of the ovary
Current advances in the management of malignant germ cell and sex cord-stromal tumors of the ovary:
Abstract | References
No abstract is available for this article.
add your opinions
germ cell ovarian
,
sex cord-stromal ovarian
paywalled: Incidence of and risk factors for postoperative ileus in women undergoing primary staging and debulking for epithelial ovarian carcinoma
Blogger's Note/Opinion: in ovarian cancer this issue is seemingly underreported; from a patient's perspective it is underreported, abstract does not indicate expertize/impact/outcomes according to surgical skill/professional nor long term effects/in depth cause-related issues;
Medscape: Ileus occurs from hypomotility (decreased motility) of the gastrointestinal tract in the absence of mechanical bowel obstruction. Presumably, the muscle of the bowel wall is transiently impaired and fails to transport intestinal contents. This lack of coordinated propulsive action leads to the accumulation of gas and fluids within the bowel.....
~~~~~~~~~~~~~
Incidence of and risk factors for postoperative ileus in women undergoing primary staging and debulking for epithelial ovarian carcinoma:
Objective
Thorough primary cytoreduction for epithelial ovarian carcinoma (EOC) improves survival. The incidence of postoperative ileus (POI) in these patients may be underreported because of varying POI definitions and the evolving, increasingly complex contemporary surgical approach to EOC. We sought to determine the current incidence of POI and its risk factors in women undergoing debulking and staging for EOC.
Methods
We retrospectively identified the records of women who underwent primary staging and cytoreduction for EOC between 2003 and 2008. POI was defined as a surgeon's diagnosis of POI, return to nothing-by-mouth status, or reinsertion of a nasogastric tube. Perioperative patient characteristics and process-of-care variables were analyzed.
Results
Among 587 women identified, the overall incidence of POI was 30.3% (25.9% without bowel resection, 38.5% with bowel resection; P =.002). Preoperative thrombocytosis, involvement of bowel mesentery with carcinoma, and perioperative red blood cell transfusion were independently associated with increased POI. Postoperative ibuprofen use was associated with decreased POI risk. Women with POI had a longer length of stay (median, 11 vs 6days) and increased time to recovery of the upper (7.5 vs 4days) and lower (4 vs 3days) gastrointestinal tract (P <.001 for each).
Conclusions
The rate of POI is substantial among women undergoing staging and cytoreduction for EOC and is associated with increased length of stay. Modifiable risk factors may include transfusion and postoperative ibuprofen use. Alternative interventions to decrease POI are needed.
add your opinions
bowels
,
hypomotility
,
ovarian cancer surgery
,
postoperative ileus
press release: In drug-approval race, US FDA ahead of Canada, Europe (range: 322-393 days)
In drug-approval race, US FDA ahead of Canada, Europe
Public release date: 16-May-2012
The U.S. Food and Drug Administration (FDA) generally approves drug therapies faster and earlier than its counterparts in Canada and Europe, according to a new study by Yale School of Medicine researchers. The study counters perceptions that the drug approval process in the United States is especially slow.
Led by second-year medical student Nicholas Downing and senior author Joseph S. Ross, M.D., assistant professor of internal medicine at Yale School of Medicine, the study will be published May 16 online by the New England Journal of Medicine.
Regulatory review represents the final step in the process of bringing new medical technologies from the lab to the bedside. Efficient regulatory review processes may enable patients to get access to promising new therapies sooner, while ensuring drug safety.
"The perception that the FDA is too slow implies that sick patients are waiting unnecessarily for regulators to complete their review of new drug applications," said Downing, who decided to conduct the study because there have been no recent comparisons of the FDA's regulatory review speed with those of regulating agencies in other countries.
Downing, Ross, and colleagues reviewed drug approval decisions of the FDA, the Canadian drug regulator, Health Canada, and the European Medicines Agency (EMA) between 2001 and 2010. They studied each regulator's database of drug approvals to identify novel therapeutics as well as the timing of key regulatory events, allowing regulatory review speed to be calculated. Canada and Europe were chosen as a comparison because they face similar pressures to approve new drugs quickly while ensuring they do not put patients at risk.
The team found that the median total time to review was 322 days at FDA, 366 days at EMA and 393 days at Health Canada.
"Among the subsample of drugs approved for all three regulators, the FDA's reviews were over three months faster than those of the EMA or Health Canada," said Downing. "The total review time at the FDA was faster than EMA, despite the FDA's far higher proportion of applications requiring multiple regulatory reviews."
Downing added that most new drug therapies were first approved for use in the U.S. "Examining novel drugs approved in multiple markets, we found that 64% of medicines approved in both the U.S. and in Europe were approved for U.S. patients first, and 86% of medicines approved in both the U.S. and Canada were also approved first in the U.S." he said.
###
Other authors on the study included Jenerius A. Aminawung, Nilay D. Shah, Joel B. Braunstein, and Harlan M. Krumholz.The study was funded by the Pew Charitable Trusts.
Citation: New England Journal of Medicine, doi: 10.1056/NEJMoa1200223
add your opinions
drug approvals
Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies — NEJM (U.S./Canada/Europe) note references to safety
Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies — NEJM
"In conclusion, we found that among novel (new) therapeutics approved between 2001 and 2010, the FDA reviewed applications more quickly, on average, than did the EMA and Health Canada, and the vast majority of these novel therapeutics were first approved for use in the United States. Our findings contradict recent criticisms of the speed of review by the FDA and lead to questions about whether the speed of the review process is justified as an emphasis for PDUFA V, particularly since the FDA continues to outpace its European and Canadian peers."
add your opinions
drug approvals
Functional profiling of clear cell ovarian cancer. | 2012 ASCO Annual Meeting Abstracts
Functional profiling of clear cell ovarian cancer. | 2012 ASCO Annual Meeting Abstracts
Abstract:
Background: Clear cell ovarian cancer represents up to 15% of epithelial ovarian cancers. In comparison to other subtypes, clear cell ovarian carcinomas have a poorer prognosis and are relatively resistant to standard platinum based chemotherapy. Recently, loss of function mutations in the tumour suppressor gene ARID1A were identified in up to 50% of ovarian clear cell carcinomas. We have adopted an integral functional and molecular profiling approach as a route to identify new genetic dependencies and therapeutic targets for this disease.
Methods: Clear cell ovarian cancer cell lines were functionally profiled using high throughput screening with chemical and siRNA libraries. This has been integrated with molecular profiling data generated from exome and transcriptome sequencing to aid the discovery of novel targets.
Results: Using functional screens we have now identified critical gene dependencies and potential therapeutics in a series of clear cell ovarian cancer models. The comparison of functional viability profiles for models characterized by ARID1A loss of function mutations is now enabling an analysis of synthetic lethal effects that could be used to target clear cell ovarian cancers carrying these mutations.
Conclusions: The work undertaken so far provides the framework for the discovery of therapeutic targets for clear cell ovarian cancer using an integrated approach. Revalidation of these preliminary results is now underway to characterize new genetic dependencies for this disease.
add your opinions
ARID1A
,
clear cell ovarian cancer
ASCO '12 Abstract Dump: Cancer Stocks in Focus - TheStreet (financial)
ASCO '12 Abstract Dump: Cancer Stocks in Focus - TheStreet
.....While investors were flooded with new cancer drug data Wednesday, ASCO did hold back some of the some important and potentially stock-moving research for a more high-profile release at the meeting itself.
The following pages summarize new and important cancer drug data released tonight by ASCO from research abstracts for its upcoming annual meeting.......
add your opinions
2012 asco
,
Avastin
,
Bevacizumab
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