Friday, June 17, 2011
(from asco 2011) video: Dr Steven Joffe – Dana-Farber Cancer Institute, Boston - Ethics of early-phase clinical trials on ecancer tv. Cancer journal: online cancer news, clinical oncology research, cancer information and latest cancer studies - open access cancer journal: ecancermedicalscience
Editorial :: VIEWPOINT: Randomised controlled trials using invasive ‘placebo’ controls are unethical and should be excluded from Cochrane Reviews - The Cochrane Library
"Placebo controls are frequently used to ‘blind’ participants, trial personnel and outcome assessors to intervention and control in clinical trials. Effective blinding of treatment reduces the risk of performance bias (differences between groups in the care provided apart from the intervention being evaluated) and detection bias (differences between groups in how outcomes are ascertained, diagnosed or verified). A placebo has traditionally been defined as an “inert or innocuous substance”, such as a ‘sugar pill’. However, some randomised controlled trials (RCTs) have been shown to erroneously use the term ‘placebo’ to describe an invasive intervention that exposes participants, allocated to a control group, to risks of serious harm.[2,3] In this context therefore, the term ‘placebo’ describes an invasive intervention which is neither inert nor innocuous.
In a recent study of local anaesthesia RCTs, over half the RCTs used an invasive ‘placebo’ control. The ‘placebo’ interventions mostly involved deep-needle insertion through body tissues with potential damage to nerves, vessels and other structures such as liver and bowel. These interventions exposed control group participants to risks of serious morbidity.[2,3].......
Thursday, June 16, 2011
Wednesday, June 15, 2011
Sustainability is not the issue: Let's focus on quality -- Hébert et al. 183 (8): 885 -- Canadian Medical Association Journal
"It’s no exaggeration to say that people have been proclaiming a crisis in Canadian health care for decades. Perhaps that rhetoric is wearing thin....)
"While private health providers argue that patients are demanding private health care and triggering the growth, those who oppose two-tier systems say patients are feeling increasingly coerced into paying out of pocket for services caused by underfunding in the public system.
"Provinces are delisting services. The medicare blanket is shrinking," says McBain. "The government is letting us down."
overview ASCO text + video: Bevacizumab: The Sleeping Giant in Ovarian Cancer (maintenance, PARPs, mutations/genetics/molecular testing/genetic profiles/screening/single agent Avastin/ICON7....)
Bevacizumab: The Sleeping Giant in Ovarian Cancer
Tuesday, June 14, 2011
When researchers placed ovarian cancer cells and mesothelial cells together in a dish, the cancer cells formed a hole in the mesothelial layer, mirroring behavior that would occur in the body as an invasion proceeds. The team interfered with molecular components of the cancer cells one by one and used time-lapse microscopy to watch the result. If the hole failed to form, the researchers knew that they'd discovered a critical player in the invasion process.
GEN | News Highlights:Scientists Find Ovarian Cancer Cells Barge Through Mesothelium to Invade New Organs
|A layer of mesothelial cells grown in cell culture, featuring the typical "cobblestone" appearance|
On paper, the LHINS are exceedingly powerful, with over $20billion of funding authority and the power to issue integration orders compelling healthcare organizations to alter and even merge services to improve healthcare. In spite of these formidable powers, in 2006, I wrote: “Many fear that LHINs will simply be a funding conduit, perpetuating the status quo; or that they will simply do the Ministry’s bidding and add another layer of unnecessary bureaucracy and contribute further to the inefficiency of the “system”. Sadly, this prediction has largely come true, with LHINs largely reverting to traditional planning exercises, throttled by Ministry directives, and acting much like their predecessor District Health Councils, which were broadly viewed within the Ontario healthcare community as ineffectual......So what went wrong?..........
Leaving Critical Functions Outside
“While the role of the new LHINs is massive, at least on paper, there are significant omissions that may limit their effectiveness in truly improving patient care. Public health, physician services, ambulance services, laboratories and provincial drug programs are all excluded from the mandate of the new organizations.” I wrote this five years ago and these omissions continue to hamper an effective integration model today. Primary care is particularly problematic. Ontario now has an alphabet soup of primary care models, with Family Health Teams holding the most promise, but with none of them being held publicly accountable for service or performance standards. It is past time to move to truly integrated care.......
........ "Who's the customer?" Well, of course, our answer was, "It's the patient." The board told us to take a closer look.
So we did. We performed a deep dive on our processes, and we found out that most of them were designed around us, not the patient. If you think about it, what are waiting rooms but places for patients to hurry up, be on time and then wait for us? What happens in most hospitals on Saturdays and Sundays? Patients wait for Monday so that things can get done.
The more we probed, the more we realized that the patient did not come first. I emphasize this point, because it is our true north and basic to everything we have done in the years since.
full free access: - Pathways to the diagnosis of ovarian cancer in the UK: a cohort study in primary care - 2010 - BJOG
Implications of the findings
"The main finding is that only a minority of patients take the standard route of GP referral to a gynaecologist........"
Canada's Pathologists Issue Guidelines on Investigations into Labs - Press Release - Digital Journal
Note: as specialists key in cancer diagnoses, the number of professional pathologists in Canada is at such a low level that patient care is impacted (negatively)
Monday, June 13, 2011
A considerable proportion of cancer survivors in the UK have a high level of hospital utilisation soon after diagnosis or before death, but the large majority of them are neither recently diagnosed nor near the end of their life, and do not utilise acute health services for cancer-related care.
Selenium for preventing cancerSelenium is a trace element that is important for human health, but might also be harmful for humans when the taken in excess.
Fifty-five studies with more than one million participants were included in this systematic review. Forty-nine studies observed and analysed whether healthy people with high selenium levels in blood or toenail samples or with a high selenium intake developed cancer more or less often than other people. We found that people with higher selenium levels or intake had a lower frequency of certain cancers (such as bladder or prostate cancer) but no difference for other cancers such as breast cancer.
However, it was not possible to determine from these studies that selenium levels or selenium intake were really the reason for the lower risk of cancer in some people. Factors apart from higher selenium levels could also influence the cancer risk: They might have had a healthier nutritional intake or lifestyle, have had a more favourable job or overall living conditions.
Six randomised controlled trials (RCTs) assessed whether the use of selenium supplements might prevent cancer. In general, there are two types of selenium supplements: one type uses the salt of selenium as main ingredient, the other type uses organic selenium. These two types may act differently in the human body when ingested. We assessed the quality of each trial according to four established methodological criteria. The trials with the most reliable results found that organic selenium did not prevent prostate cancer in men and increased the risk of non-melanoma skin cancer in women and men. Other trials found that participants using selenium salt or organic supplements had a decrease in liver cancer cases. However, due to methodological shortcomings this evidence was less convincing. We advise further investigation of selenium for liver cancer prevention before translating results into public health recommendations. We also recommend that there should be further evaluation of the effects of selenium supplements in populations according to their nutritional status as they may differ between undernourished and adequately nourished groups of people.
To maintain or improve health, access to healthy food and a healthy diet is important. Currently, there is no convincing evidence that individuals, particularly those who are adequately nourished, will benefit from selenium supplementation with regard to their cancer risk.
Supplementation with ω3 fatty acids appears to offer benefits that are verifiable at a biochemical, clinical and functional level. Related literature, however, provides conflicting results; therefore further studies will be required to confirm their efficacy.
Supplementation with glutamine appears to support the efficacy of chemoradiotherapy treatment while reducing toxicity of the tissues and improving outcomes. Oral supplementation with branched amino acid appears to reduce the length of hospital stay, decrease morbidity and improve the quality of life, without any changes in mortality. Perioperative supplementation with arginine has shown a reduced incidence of complications and a significant increase in long-term survival.
abstract : Changes in the management and outcome of central nervous system involvement from ovarian cancer since 1994
To identify differences in the management and outcome of patients with central nervous system metastases from epithelial ovarian cancer.
The clinical and pathologic characteristics, treatment, and outcome of 23 patients with brain metastases from epithelial ovarian cancer who were treated during 1982–1994 were compared with those of 20 patients treated during 1995–2010 at the same center.
No differences were found in terms of primary tumor characteristics, time interval from ovarian cancer diagnosis to brain involvement diagnosis, sites of metastasis, and presence of extracranial disease. The main difference between the 2 groups was the therapeutic approach. During 1982–1994, most patients received radiotherapy only, whereas most patients during 1995–2010 underwent surgical resection followed by radiotherapy and/or chemotherapy. The duration of survival during 1982–1994 was 5 months, which was significantly shorter than the duration of survival (18 months) during 1995–2010.
An aggressive multimodal treatment approach might prolong the survival of patients with brain involvement from ovarian cancer.
abstract : Circulating tumor cells predict progression free survival and overall survival in patients with relapsed/recurrent advanced ovarian cancer - multinational trial
Serial circulating tumor cell (CTC) counts have demonstrated predictive and prognostic value in patients with metastatic breast, colorectal, and prostate cancer.
In a phase III study of pegylated liposomal doxorubicin (PLD) with trabectedin vs. PLD for relapsed ovarian cancer, we evaluated the correlation, if any, between numbers of CTCs and progression free survival, (PFS) and overall survival (OS).
Results from this study indicate that elevated numbers of CTCs impart an unfavorable prognosis for ovarian cancer patients.
abstract: Consolidation paclitaxel is more cost-effective than bevacizumab following upfront treatment of advanced epithelial ovarian cancer (taxol/avastin)
Randomized trials have demonstrated significant improvements in progression-free survival (PFS) with consolidation paclitaxel (P) and bevacizumab (B) following cytoreduction and adjuvant carboplatin/paclitaxel (CP) for advanced epithelial ovarian cancer (EOC). We sought to evaluate the cost-effectiveness (C/E) of these consolidation strategies.
In this model, B consolidation for advanced EOC was associated with a modest improvement in effectiveness that is less than that with P consolidation and more costly. A statistically significant improvement in survival may improve the value of B consolidation.
abstract: Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy as upfront therapy for advanced epithelial ovarian cancer: Multi-institutional phase-II trial
In selected patients with advanced stage EOC, upfront CRS and HIPEC provided promising results in terms of outcome. Morbidity was comparable to aggressive cytoreduction without HIPEC. Postoperative recovery delayed the initiation of adjuvant systemic chemotherapy but not sufficiently to impact negatively on survival. These data warrant further evaluation in a randomized clinical trial.
► Maximal surgical effort and intraperitoneal chemotherapy have been proposed as upfront treatment in epithelial ovarian cancer.
► Primary cytoreduction and hyperthermic intraperitoneal chemotherapy was performed in advanced epithelial ovarian cancer patients.
► Promising survival rates and acceptable morbidity were reported.
abstract - Gynecologic Oncology : The revolving door: Hospital readmissions of gynecologic oncology patients
ConclusionsHospital readmissions affect the cost of care, but also the quality of care delivered to our patients. When extrapolated across institutions and across the country, unplanned readmissions are a costly expenditure to patients and the health system, deserving of attention.
Deals Of The Week: The ASCO Edition: "ASCO is just moving into full swing, but already the press releases are flying fast and furious. Biotechs have long looked to this meeting as a means to showcase their smarts and increase their profile with public investors. But as big pharmas have set their sights on oncology as the therapeutic area of choice -- given its high unmet medical need and, historically, generous reimbursement, there's no doubt ASCO is now a critical meeting for even the biggest players in the industry......cont'd
Live From ASCO: Time To Cool Down?: "
There is the typical fervor surrounding promising early data, a few major advances to report (for instance, the melanoma data from Roche and BMS covered by among others, the NYT, WSJ, Reuters, and, of course, 'The Pink Sheet' Daily), and the meeting halls are packed with clinicians, investors, and journos. (Saturday's clinical science symposium on ovarian cancer had such throngs waiting for it to start that McCormick Place called in bouncers, from 'Armageddon Security,' nonetheless. And if you weren't in the initial crush, you probably got diverted to an overflow room. Or the second overflow room.)
Still, compared to other years, analysts aren't finding much to write home about. And, increasingly, the importance of the data being presented before packed meeting halls is being questioned. 'We need to get away from things that add cost but not value,' UnitedHealthcare's Lee Newcomer noted during a panel on health care reform.................cont'd
Image courtesy of flickrer Joe Seggiola through a creative commons license.
Physicians often have insufficient knowledge about fatigue and its treatments or underestimate the impact of fatigue on quality of life, while patients may consider it an unavoidable and untreatable side-effect and fear that reporting it may incite a change toward less aggressive cancer treatment.
Note: study on lung cancer but pertinent for all cancer patients/families
Even more important, he writes, patient preferences vary from one individual to another and these preferences are often unheard: “Quality in end-of-life care will continue to elude us if we assume that societal average preferences indicate the care individual patients want and need,” he writes.
Drugs that interfere with HER3’s better-known cousins, EGFR and HER2, have already proven effective in treating many types of cancer, and early-stage clinical trials are underway with antibodies directed against HER3. HER3 is of great interest to cancer biologists because it is commonly involved in two of the deadliest forms of the disease, ovarian and pancreatic cancer, says MIT Professor Linda Griffith, who led the research team with Harvard Stem Cell Institute and Brigham and Women’s cardiologist Richard Lee.
The study, published online May 26 in the Journal of Biological Chemistry....
Sunday, June 12, 2011
abstract: Randomized surgical training for medical students: resident versus peer-led teaching (trial and error)
Randomized surgical training for medical students: resident versus peer-led teaching
Available online 16 March 2011.
Medical students spend significant portions of their time in the operating room, with many learning skills through trial and error. Peer-assisted learning is a useful teaching and learning method. Our hypothesis is that students will perform basic skills in the operating room environment more often when taught by their peers.
Sixty third-year medical students participated in an operating room introduction course. Learners were randomized into 2 cohorts: 1 led by obstetrics and gynecology residents, 1 led by fourth-year medical students. Assessment was performed using an objective, structured clinical exercise.
Peer-assisted learners performed more steps correctly during the objective exercise compared with resident-assisted learners (16.1 vs 14.4 of 22 total steps assessed, P < .01).
Peer-assisted learning may be a useful teaching method for simulation training. Third-year medical students may benefit from this low threat and informal environment.
abstract: Treating cervical cancer: Breast and Cervical Cancer Prevention and Treatment Act patients - access to care
Note: not ovarian cancer related but access to care issues
Treatment patterns among Georgia Medicaid cases appear appropriate to stage but 18% with invasive cervical cancer received no cancer treatment, although Medicaid enrolled.
abstract : Posttreatment surveillance and diagnosis of recurrence in women with gynecologic malignancies: Society of Gynecologic Oncologists recommendations authors U.S./Canada
b University of Ottawa, Ontario, Canada
c David Geffen School of Medicine at UCLA, Los Angeles, CA
d University of Louisville Louisville, KY
e University of California Irvine Medical Center Orange, CA
f University of Washington School of Medicine Seattle, WA
Although gynecologic cancers account for only 10% of all new cancer cases in women, these cancers account for 20% of all female cancer survivors. Improvements in cancer care have resulted in almost 10 million cancer survivors, and this number is expected to grow. Therefore, determining the most cost-effective clinical surveillance for detection of recurrence is critical. Unfortunately, there has been a paucity of research in what are the most cost-effective strategies for surveillance once patients have achieved a complete response. Currently, most recommendations are based on retrospective studies and expert opinion. Taking a thorough history, performing a thorough examination, and educating cancer survivors about concerning symptoms is the most effective method for the detection of most gynecologic cancer recurrences. There is very little evidence that routine cytologic procedures or imaging improves the ability to detect gynecologic cancer recurrence at a stage that will impact cure or response rates to salvage therapy. This article will review the most recent data on surveillance for gynecologic cancer recurrence in women who have had a complete response to primary cancer therapy.
abstract: Description of anaphylactic reactions to paclitaxel and docetaxel reported to the FDA, with a focus on the role of premedication
Note: this study concerns the clinical criteria for evidence of progressive/new disease
In 9,741 (patients), survival after development of new lesions as the sole reason for progression did not significantly differ from patients with other reasons of PD (progressive disease). These findings give further validation to the use of new lesions as a classifier of PD according to established criteria. (RECIST)
Clinical trials use established criteria (RECIST or WHO) to determine objective tumor behavior on therapy. Participants are labeled to have progressive disease (PD) and are taken off study if they meet specific parameters of increase in size of their known lesions, but can also be labeled as PD if they develop new lesions without meeting criteria for progression in known lesions. To determine whether there are outcome disparities among these patients, we explored survival differences by reason of progression among patients who developed PD on study using data from the phase III Intergroup trial N9741 which compared IFL, FOLFOX4, and IROX as first-line therapy in advanced colorectal cancer (Goldberg JCO 2004).
multinational study: Brivanib -oral- (BMS-582664) in advanced solid tumors (AST): Results of a phase II randomized discontinuation trial (RDT)-- ASCO Meeting Abstract
Brivanib (B) is an oral once daily selective dual inhibitor of FGF and VEGF signaling currently in phase III development for advanced hepatocellular carcinoma and colorectal cancer.
"Biomarker exploration with potential for enrichment continues; breast and ovarian cohorts have been added to the trial."
abstract: The activity of trabectedin (Yondelis)as a single agent or in combination with everolimus for clear cell carcinoma of the ovary
Note: in research (lab)
".......Four patients who received long-term PLD for advanced-stage ovarian cancer developed malignant and/or premalignant lesions of the tongue and/or oral cavity. Dr. Cannon points out that there were only about 16 patients who received PLD for an extended period of time, "so 4 out of 16 patients is quite high."
All 4 of the patients had received maintenance therapy with PLD for at least 3 years. Of this group, 3 women were subsequently diagnosed with squamous cell carcinoma (SCC) of the tongue and/or oral cavity, and 1 patient was diagnosed with sublingual mucosa high-grade dysplasia. All 3 cases of SCCs were negative for human papillomavirus.
Of note, said Dr. Cannon, was a patient who presented with 3 separate lesions of SCC of the oral cavity.
"I don't think this is a coincidence, that 4 of 16 patients receiving this treatment developed oral cancers," he said. "If this treatment for ovarian cancer becomes more popular, then this is something that should become known. Early dental screening would need to be initiated, and the treatment may need to be stopped after a certain time period."
It is relatively uncommon for ovarian cancer patients to receive PLD for this length of time.......cont'd
also: see chart
"Pharma giant AstraZeneca will no longer fund.....cont'd
Grey Lit 102: Advanced Search Strategies for Grey LiteratureNEW: View the Grey Lit 102 archived recording and access the presentation slides here.
Date: Thursday, April 7, 2011 12:00 p.m.-1:00 p.m. (EDT)
Course Level: 101
Faculty: Melissa Ratajeski, M.L.I.S., R.L.A.T., University of Pittsburgh; Ahlam Saleh, M.D., M.L.S., University of Pittsburgh
Duration: 60 min.
Overview: This free Web conference (the "consumer's" perspective) discussed the challenges inherent in conducting advanced searches for grey literature and presents tactics for overcoming these challenges. Participants in this session learned:
- Who are the major users of grey literature, and why?
- What are best practices for searching and incorporating grey literature evidence into larger research efforts?
- Is it possible to systematically review grey literature (why or why not)?
- Are there critical assumptions or search parameters that can target a search and efficiently find desired evidence?
AcademyHealth is pleased to announce that the archived recordings for all three Web conferences in the Grey Literature Web Conference Series are now available on the AcademyHealth website.
Presentation slides are also available.
To access the archived recordings, visit the Grey Literature Web Conference Series page.
ASCO - the End Part II: "All the Focus on Research Advocates where asked to video a testimonial about their experience as a Focus on Research Advocate at ASCO. Below is my testimonial.
Saturday, June 11, 2011
"The Board of Directors of the Holistic Health Research Foundation of Canada has voted to wind up its operations due to insufficient financial and physical resources. After seven years working in this still-emerging field, we have not been able to attract the significant operational funding needed to sustain the organization and grow our programs.
Friday, June 10, 2011
Blogger's Note: decisions eg "buy groceries or not" is not new to cancer patients/families and is a rather old comment which seemingly has not made an impact (on instititional decision makers)
"Overall, this study provides a patient-centered view of a reality of modern day cancer care -- something that we call 'financial toxicity,'" senior author Dr. Amy Abernethy, an associate professor in Duke's medical oncology division, said in a Duke news release.
"We used to think about chemotherapy toxicity in terms of bad side effects like vomiting, nerve pain, confusion and risk of fatal infection. Now we are starting to think in terms of how treatment choices impact real aspects of daily living such as the ability to buy groceries or not," she added."
"Disability is a common, though uniquely personal experience that will affect increasing numbers of people as populations age. Common, because 1 billion people (15% of the world's population) are thought to have a disability. Unique, because how that disability affects an individual is mediated by environment and resources. For these reasons, the World Report on Disability, published on June 9, makes compelling reading for any citizen, and compulsory reading for health professionals, whose actions can moderate the effect of disabilities on people's lives."
"....This report reminds health professionals that people with disabilities are entitled to the highest standard of health without discrimination. Responsibilities go beyond primary prevention of disability, for instance by antenatal care, or secondary prevention after a cardiovascular event. To provide best care across the spectrum of comorbid physical and mental disabilities, health professionals need a sound understanding of access and communication needs, which should be central to all curricula.
JCO link - Germ-line BRCA mutations in high-grade ovarian cancer: A case for routine BRCA mutation screening after a diagnosis of invasive ovarian cancer. -- ASCO Meeting Abstracts
Conclusions: Pathogenic BRCA1/2 mutations are common in invasive ovarian cancer and are associated with improved overall survival and response to systemic chemotherapy. BRCA testing should be implemented for all ovarian cancer patients as mutation status has important prognostic and therapeutic clinical utility.
Note: search 'ovarian' brings up abstracts from ASCO 2011 (secondary source of info as a FYI)
Thursday, June 09, 2011
abstract & full free access: Impact of tumour volume on the potential efficacy of therapeutic vaccines | Gulley | Current Oncology
Impact of tumour volume on the potential efficacy of therapeutic vaccines
J.L. Gulley, MD PhD*, R.A. Madan, MD*, J. Schlom, PhD*
*Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, U.S.A.
With the recent approval by the U.S. Food and Drug Administration of the first therapeutic vaccine for cancer, the long-awaited goal of harnessing a patient’s immune system to attack cancer through this modality is finally realized. However,
1) What’s New:
Current Oncology showcases art, from the ART for Cancer Group
Cancer Charities Supported (click)
"....A meta-analysis of 18 studies of women who had been exposed to asbestos through their work was carried out. Earlier studies failed to prove the link because of concerns that tumours had been mis-classified - until recently it was difficult to discriminate between peritoneal mesothelioma and ovarian cancer...."