Thursday, February 16, 2012
abstract: Complications of laparoscopic surgery
Complications of laparoscopic surgery
"Laparoscopic surgery is the standard of care for many gynaecological conditions with documented benefits and excellent outcomes for patients and healthcare providers. However, in addition to the general complications associated with surgery and anaesthesia, laparoscopy poses unique complications relating to abdominal entry and surgical instrumentation. Governing bodies, representing both the surgical specialities and gynaecology, have attempted to gain consensus on the safest technique for abdominal entry to no avail. Studies comparing techniques to date are underpowered and the likelihood of high-grade evidence ever becoming available is low due to the prohibitive patient numbers and costs. This review will examine complications of laparoscopy and current recommendations from surgical training organizations for abdominal entry in laparoscopic surgery."
open access: The nutritional risk in oncology: a study of 1,453 cancer outpatients
"In 2003, during a scientific meeting in Milan, which involved both oncologists and nutritionists, it was clearly appreciated that there was a substantial discrepancy of view between these specialists as regard the impact that malnutrition might have on the outcome of the cancer patient and the potential role of the nutritional support. As a consequence, an open working group was constituted with the aim of steering a protocol to prospectively screen the nutritional status of the oncologic outpatients (hence the acronym SCRINIO, that is SCReenIng the Nutritional status In Oncology)."
"...Such a percentage of nutritionally at risk outpatients is especially remarkable and worrisome when considering that patients able to attend an ambulatory consultation or therapy should represent a favourably selected segment of the cancer population..."
Table 1 Patient distribution according to demographic and disease characteristics
Table 2 Mean NRS score and percentage of patients with nutritional risk (NRS score ≥3), according to main patients’ characteristics
Table 3 Frequency of patients at nutritional risk (NRS score ≥3), estimated by the multivariable logistic model
American Society of Clinical Oncology - ASCO - ACT Network
Welcome to ASCO's ACT Network
Legislative Alerts and Updates
- Take Action
Contact Your Representative to Support Written Care Plans!
Bill Calling for Written Care Plans for Cancer Patients Introduced - Take Action
Take Action to Address Drug Shortages!
Contact Your Representative to Support This Legislation!
New ASCO analysis on Comprehensive Cancer Care Improvement Act
| New ASCO analysis on Comprehensive Cancer Care Improvement Act |
| 16 Feb 2012 |
| A new ASCO issue brief examines the Comprehensive Cancer Care Improvement Act, introduced in December 2011 by Representatives Lois Capps (D-Calif.) and Charles Boustany (R-La). The issue brief examines the Act’s potential to improve survivorship care throughout the cancer care continuum by supporting coverage of comprehensive cancer care planning, establishing grant programs to increase provider education of palliative care and symptom management, and investing in survivorship-related research. ASCO supports the CCIA, along with 38 National Cancer Institute designated comprehensive cancer centers across the country and 23 cancer advocacy organizations. To voice support for H.R. 3705 and learn about other ASCO policy initiatives, please visit ASCO’s ACT Network at http://capwiz.com/asco/home/. |
US firm (Myriad) corners exclusive license for RAD51C (breast/ovarian)cancer gene : The Lancet Oncology
abstract
"Already facing a legal challenge to its BRCA1 and BRCA2 patents, Myriad Genetics (Salt Lake City, UT, USA) has secured an exclusive licence for another breast and ovarian cancer-associated gene, RAD51C , under agreement with the German Consortium for Hereditary Breast and Ovarian Cancers, which will share exclusivity in Germany. RAD51C will be used to test patients' hereditary breast and ovarian cancer risks.
“I think it is unfortunate for both the clinical and research communities”, Jim Evans (University ..."
To read this article in full you will need to make a payment
To read this article in full you will need to make a payment
Wednesday, February 15, 2012
How Big Pharma Undermined Medical Innovation for Financial Gain - Forbes
Blogger's Note: discusses such concerns as Avastin in Breast Cancer; clinical trials, small biotech ventures...
"The Apothecary is a blog about health-care and entitlement reform".
abstract: Electronic Healthcare: The Development and Change Management Strategy of Sunnybrook Health Sciences Centre's MyChart
Feature
The Development and Change Management Strategy of Sunnybrook Health Sciences Centre's MyChart™* 
Abstract
The e-Health environment has focused primarily, to date, on enabling clinicians; patients and families, on the other hand, have not been the target of focus.Across the globe, there has been mixed success in the patient-focused e-Health marketplace – including a few high-profile failures.
Sunnybrook Health Sciences Centre's personal health record (PHR) MyChart™ is a true Canadian success story in patient-focused e-Health.
This paper describes the development, history and change management strategy utilized in establishing a successful patient-focused e-Health solution in a Canadian setting. Our ultimate goal is to not only share the lessons learned in developing and implementing MyChart™ but also to measure and investigate the connection between patient-focused e-Health solutions and health outcomes.
Steven Lewis: This Just In: Systems Designed to Fail, Fail :: Longwoods.com (apology, inquiries, restitution....)
Blogger's Note: Steven Lewis is always worthwhile reading, this particular essay discusses several widely known national traumatic events of which harm was caused to many due to system failures, in part; Longwoods Publishing (sometimes) requires registration (free/sometimes free)
~~~~~~~~~~~~~~
This Just In: Systems Designed to Fail, Fail
Steven Lewis
"First there is the disaster that comes to light long after the fact. Then there is the inquiry. Then there is the scathing report that meticulously unearths the causes of the disaster. Then there is the apology (they're allowed now - it's the law!). Then there is restitution. Finally there is the commitment: never again. And then the same thing happens, somewhere else, again, and again, and again....."
"It is delusional to believe that everything is now out in the open, with nothing more to uncover. It's not just the outliers who cause harm; because medicine is so fraught with unjustifiable variations in practice, it is certain that the errors resulting from "satisfactory" practice far outnumber the misdeeds of the visibly incompetent. The graveyards are filled with anonymous victims whose stories will never surface in a public inquiry."
Consejos de alimentación - National Cancer Institute (Spanish version "eating Hints: Before, During and After Cancer Treatment"
Consejos de alimentación - National Cancer Institute
Spanish version of “Eating Hints: Before, During, and After Cancer Treatment” is now live on cancer.gov/espanol
Medscape: Integrative Medicine Use Up, but Outcomes Still Uncertain
Blogger's Note: to view subscribe (free)
Largest Trial of VTE (blood clots) Prophylaxis in Cancer Patients on Chemo
Blogger's Note: several articles posted on the same subject, some easier to read (plain english)
Largest Trial of VTE Prophylaxis in Cancer Patients on Chemo:
The new trial adds to previous data showing a benefit, but it is up to individual patients to decide whether or not to use this option, says editorialist.
Medscape Medical News
February 15, 2012 — The largest study to date of thromboprophylaxis in cancer patients on chemotherapy shows that the use of a heparin product significantly reduces the risk for thromboembolic events with no apparent increase in bleeding.
The positive results add to several previous studies showing a benefit from thromboprophylaxis in cancer patients, and reopen an ongoing debate about whether such use should be routine.
The latest study, known as SAVE-ONCO, was conducted in 3212 cancer patients who were beginning chemotherapy and used the hemisynthetic ultra-low-molecular-weight heparin (LMWH) semuloparin (Visamerin, Sanofi; marketed in Europe, but not available in the United States). The study, by Giancarlo Agnelli, MD, from the University of Perugia, Italy, and colleagues, is published in the February 16 issue of the New England Journal of Medicine......
Low Molecular Weight Heparin Use in Cancer Treatment
Low Molecular Weight Heparin Use in Cancer Treatment
The blood thinning effect of heparin is well established, but should it be used in cancer treatment?
Newswise — Hamilton, ON (Feb. 13, 2012) -"For decades, the blood thinner heparin has been used to prevent and treat blood clots. Could it be just as effective in treating cancer?
In an editorial published today in the New England Journal of Medicine, researchers from McMaster University and the University at Buffalo suggest conclusive answers to key questions on the benefits of low molecular weight heparin (LMWH) for cancer patients remain elusive - despite promising results from large studies...."
Feb 15th - Study Explains High Platelets in Ovarian Cancer Patients; Survival Reduced - MDAnderson
Study Explains High Platelets in Ovarian Cancer Patients; Survival Reduced
Newswise — HOUSTON -
"Highly elevated platelet levels fuel tumor growth and reduce the survival of ovarian cancer patients, an international team of researchers led by scientists at The University of Texas MD Anderson Cancer center reports in the New England Journal of Medicine.
By pinpointing a powerful cause-and-effect relationship at the heart of a clinical observation that dates back more than 100 years, the team's findings reveal a new factor in cancer progression and new potential approaches for treatment.
"We've long known that ovarian cancer patients often have markedly increased platelet counts but we haven't known why this happens or understood its relevance, if any, to disease progression," said senior author Anil Sood, M.D., professor in MD Anderson's Departments of Gynecologic Oncology and Reproductive Medicine and Cancer Biology....."
"Of 619 ovarian cancer patients, 192 (31 percent) had thrombocytosis. Importantly, less than 2 percent of those had an iron deficiency or a non-cancerous inflammatory condition, the two most common causes of elevated platelet levels."
Paraneoplastic Thrombocytosis in Ovarian Cancer — NEJM
Blogger's Note: (related) easier to read article is found at:
Study Explains High Platelets in Ovarian Cancer Patients; Survival Reduced
Highly elevated platelet levels fuel tumor growth and reduce the survival of ovarian cancer patients, an international team of researchers led by scientists at The University of Texas MD Anderson Cancer center reports in the New England Journal of Medicine.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
NEJM:
wiki: thrombocytosis ; Paraneoplastic syndrome
Background
The mechanisms of paraneoplastic thrombocytosis in ovarian cancer and the role that platelets play in abetting cancer growth are unclear.Methods
We analyzed clinical data on 619 patients with epithelial ovarian cancer to test associations between platelet counts and disease outcome. Human samples and mouse models of epithelial ovarian cancer were used to explore the underlying mechanisms of paraneoplastic thrombocytosis. The effects of platelets on tumor growth and angiogenesis were ascertained.Results
Thrombocytosis was significantly associated with advanced disease and shortened survival.Plasma levels of thrombopoietin (hormone which regulates the production of platelets by the bone marrow) and interleukin-6 were significantly elevated in patients who had thrombocytosis as compared with those who did not.
Conclusions
These findings support the existence of a paracrine circuit wherein increased production of thrombopoietic cytokines in tumor and host tissue leads to paraneoplastic thrombocytosis, which fuels tumor growth. We speculate that countering paraneoplastic thrombocytosis either directly or indirectly by targeting these cytokines may have therapeutic potential.open access: Regulation of Medical Devices in the United States and European Union — NEJM (comparing differences pro's/con's)
Conclusions
Systems for approving new medical devices must provide pathways to market for important innovations while also ensuring that patients are adequately protected. To achieve these goals, the United States and European Union use a combination of premarket testing and postmarket vigilance but with some marked contrasts in their approaches. Features of both environments require reform, as well as continuing research to assess policy changes.
Semuloparin for Thromboprophylaxis in Patients Receiving Chemotherapy for Cancer — NEJM
Free Preview
Original Article
Semuloparin for Thromboprophylaxis in Patients Receiving Chemotherapy for Cancer
N Engl J Med 2012; 366:601-609February 16, 2012
Background
Patients receiving chemotherapy for cancer are at increased risk for venous thromboembolism. Limited data support the clinical benefit of antithrombotic prophylaxis.Methods
In this double-blind, multicenter trial, we evaluated the efficacy and safety of the ultra-low-molecular-weight heparin semuloparin for prevention of venous thromboembolism (blood clots) in patients receiving chemotherapy for cancer. Patients with metastatic or locally advanced solid tumors who were beginning to receive a course of chemotherapy were randomly assigned to receive subcutaneous semuloparin, 20 mg once daily, or placebo until there was a change of chemotherapy regimen. The primary efficacy outcome was the composite of any symptomatic deep-vein thrombosis, any nonfatal pulmonary embolism, and death related to venous thromboembolism. Clinically relevant bleeding (major and nonmajor) was the main safety outcome.Results
The median treatment duration was 3.5 months. Venous thromboembolism occurred in 20 of 1608 patients (1.2%) receiving semuloparin, as compared with 55 of 1604 (3.4%) receiving placebo (hazard ratio, 0.36; 95% confidence interval [CI], 0.21 to 0.60; P<0.001), with consistent efficacy among subgroups defined according to the origin and stage of cancer and the baseline risk of venous thromboembolism. The incidence of clinically relevant bleeding was 2.8% and 2.0% in the semuloparin and placebo groups, respectively (hazard ratio, 1.40; 95% CI, 0.89 to 2.21). Major bleeding occurred in 19 of 1589 patients (1.2%) receiving semuloparin and 18 of 1583 (1.1%) receiving placebo (hazard ratio, 1.05; 95% CI, 0.55 to 1.99). Incidences of all other adverse events were similar in the two study groups.Conclusions
Semuloparin reduces the incidence of thromboembolic events in patients receiving chemotherapy for cancer, with no apparent increase in major bleeding. (Funded by Sanofi; ClinicalTrials.gov number, NCT00694382.)Source Information
From the Division of Internal and Cardiovascular Medicine and Stroke Unit, Department of Internal Medicine, University of Perugia, Perugia, Italy (G.A.); Duke University Medical Center, Durham, NC (D.J.G.); the Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Orthopedic Surgery, McGill University Health Center, Montreal (W.F.); Spine Center Copenhagen, Copenhagen University Hospital Glostrup, Glostrup, Denmark (M.R.L.); the Clinical Pharmacology Unit, University Jean Monnet, Saint-Etienne, France (P.M.); Klinikum Frankfurt, Höchst, Germany (P.M.); Sanofi, Bridgewater, NJ (U.C., F.L.); and McMaster University, Hamilton, ON, Canada (A.G.G.T.).Editorial: Routine Heparin for Patients with Cancer? One Answer, More Questions — NEJM
Editorial
Routine Heparin for Patients with Cancer? One Answer, More Questions
N Engl J Med 2012; 366:661-662February 16, 2012
This article has no abstract; the first 100 words appear below. (requires subscription $$$)
The antithrombotic effect of heparins is established, and it is speculated that a direct antitumor effect of heparin might translate into a survival benefit in patients with cancer.
This antitumor activity of heparins mechanistically includes the inhibition of cell–cell interaction by blocking cell-adhesion molecules (selectins), the inhibition of extracellular-matrix protease heparanase, and the inhibition of angiogenesis.1
Should heparin, thus, be offered to patients with cancer who have no standard indication for anticoagulation therapy?
A large, randomized clinical trial addressing this question is reported by Agnelli and colleagues in this issue of the Journal.2 The SAVE-ONCO study (ClinicalTrials.gov number, NCT00694382) . . .
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.This antitumor activity of heparins mechanistically includes the inhibition of cell–cell interaction by blocking cell-adhesion molecules (selectins), the inhibition of extracellular-matrix protease heparanase, and the inhibition of angiogenesis.1
Should heparin, thus, be offered to patients with cancer who have no standard indication for anticoagulation therapy?
A large, randomized clinical trial addressing this question is reported by Agnelli and colleagues in this issue of the Journal.2 The SAVE-ONCO study (ClinicalTrials.gov number, NCT00694382) . . .
Source Information
From the Department of Medicine, State University of New York at Buffalo, Buffalo (E.A.A.); and the Departments of Clinical Epidemiology and Biostatistics (E.A.A., H.J.S.) and Medicine (H.J.S.), McMaster University, Hamilton, ON, Canada.abstract: Pregnant with metastatic neuroendocrine tumour of the ovary: what now?
cancermedicalscience. 2012;6:240. Epub 2012 Jan 3.
Abstract
"Neuroendocrine tumours (NET) are a heterogeneous group of neoplasms commonly occurring in the gastrointestinal tract or lungs but can occur in other regions. Primary ovarian NET account for 5% of all NET and 0.1% of all ovarian malignancies.In metastatic disease, the therapeutic goal is to extend survival and to improve quality of life.
As these tumours express somatostatin receptors, somatostatin analogues are frequently used to control symptoms. Here we present a case of a pregnant woman with an ovarian NET with liver metastases and carcinoid syndrome who was treated with the somatostatin analogue, Octreotide LAR.
We also summarize reported data of the use of somatostatin analogues during pregnancy. (with paid subscription)"
Making Sense of the Debate Over Patient Access to Medical Information
Making Sense of the Debate Over Patient Access to Medical Information:
By John Lumpkin, MD
“When it comes to health care, information is power.”
This comment from U.S. Department of Health & Human Services Secretary Kathleen Sebelius has sparked a heated debate among doctors and patient advocates about the merits and drawbacks of giving patients easy access to their lab results, doctors’ notes and other personal medical information. A deliberation in this month’s issue of SGIM Forum, the newsletter of the Society of General Internal Medicine (SGIM), is emblematic of how doctors’ and patients’ views on transparency vary.
Internist Douglas P. Olson, MD says it’s too early to offer patients electronic access to their lab results or medical records and that without systemic changes it could actually undermine the patient-doctor relationship lists among his concerns the potential to confuse or worry patients; a lack of evidence showing the positive effect on healthcare safety and quality; and the increased demands on doctors’ time to respond to patient questions.
These concerns are valid and shared by many other doctors. In a recent survey by OpenNotes―a project supported by the Robert Wood Johnson Foundation’s Pioneer Portfolio that enables doctors to share their visit notes with patients online―doctors were asked about their expectations and attitudes toward sharing electronic medical notes. The survey was conducted before doctors engaged with OpenNotes. Responses revealed doctors were worried about the impact on workflow and weren’t convinced that it would make a difference to patients’ health.
In contrast, patients in the OpenNotes survey were almost uniformly enthusiastic about being offered access to their doctor’s notes online.
Familial and Sporadic Breast Cancers: Differences in Clinical, Histopathological, and Immunohistochemical Features
Familial and Sporadic Breast Cancers: Differences in Clinical, Histopathological, and Immunohistochemical Features:
In the present study, the authors investigated the clinical, histopathological, and immunohistochemical features in familial breast cancer (FBC) patients and compared them with findings in sporadic breast cancers (SBCs); hormone receptor status was stratified by age. A total of 849 patients treated for breast cancer were included in the study. The patients were stratified into 2 groups: FBC, 160 patients (19%), and SBC, 689 patients (81%). FBC tumors differed from SBC tumors by earlier age of diagnosis and low content of progesterone receptor (PR). These characteristics should be of value in evaluating the possibility of mutation and in targeting mutation screening in such families. PR gene polymorphism leads to an increased risk of breast cancer because it determines inadequate control of estrogen receptor (ER)-driven proliferative function. ER+/PR– tumors more frequently showed HER2 (human epidermal growth factor receptor) overexpression and represent a distinct subset in FBC patients. The authors suggest that late-onset FBCs need more intensive therapy and a more careful follow-up.
open access: Developing and paying for medicines for orphan indications in oncology: utilitarian regulation vs equitable care? (references EU/US)
Defining orphan indications
"The US Orphan Drug Act (ODA) applies to conditions affecting fewer than 200
000 Americans. This currently translates to approximately 7 per 10000
individuals. It offers manufacturers 7 years of marketing exclusivity,
exceptions from certain FDA fees and additional regulatory advice and
tax benefits....."
000 Americans. This currently translates to approximately 7 per 10000
individuals. It offers manufacturers 7 years of marketing exclusivity,
exceptions from certain FDA fees and additional regulatory advice and
tax benefits.....""Despite ‘orphan drug' legislation, bringing new medicines for rare diseases to market and securing funding for their provision is sometimes both costly and problematic, even in the case of medicines for very rare ‘ultra orphan' oncological indications. In this paper difficulties surrounding the introduction of a new treatment for osteosarcoma exemplify the challenges that innovators can face. The implications of current policy debate on ‘value-based' medicines pricing in Europe, North America and elsewhere are also explored in the context of sustaining research into and facilitating cancer patient access to medicines for low-prevalence indications. Tensions exist between utilitarian strategies aimed at optimising the welfare of the majority in the society and minority-interest-focused approaches to equitable care provision. Current regulatory and pricing strategies should be revisited with the objective of facilitating fair and timely drug supply to patients without sacrificing safety or overall affordability. Failures effectively to tackle the problems considered here could undermine public interests in developing better therapies for cancer patients....."
Cancer Survivorship « Dr. Robert A. Nagourney – Rational Therapeutics – Blog including commentaries
"Some of you may have read the January report from the American Cancer Society (ACS) that described a decline in U.S. cancer death rates by 1.8 percent per year in men and 1.6 percent per year in women during the period between 2004 to 2008....."
Future Medicine - abstract: MRI in ovarian cancer
Abstract
To date MRI has primarily been used as a problem-solving modality for sonographically indeterminate adnexal masses owing to its excellent soft tissue contrast and functional properties. Qualitative diffusion-weighted imaging with visual assessment is helpful in lesion characterization and makes differentiation of solid adnexal masses more accurate. Diffusion-weighted imaging can obviate intravenous MRI contrast media, rendering this technique indispensable in cases of contraindications and in pregnancy.
Staging ovarian cancer remains a CT domain.
However, novel technical developments are at the brink of changing imaging and management in ovarian cancer in the years to come; MRI may shift from a problem-solving to a central management tool, possibly fulfilling a broad range of tasks from characterization, staging and even early assessment of response to treatment in the case of chemotherapy using quantitative diffusion-weighted imaging.
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