Thursday, September 27, 2012

Would Patient Ownership of Health Data Improve Confidentiality? | Virtual Mentor

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Would Patient Ownership of Health Data Improve Confidentiality? | Virtual Mentor

The protections patients currently have under the Health Insurance Portability and Accountability Act Privacy Rule and the Common Rule are surprisingly similar to those they would have if they owned their data and biospecimens. One response to patient concerns about confidentiality has been to press state legislators to give patients actual ownership of their medical information. Five states have done so with respect to genetic information, and a number of other states are considering whether to recognize patient ownership of health records. Virtual Mentor is a monthly bioethics journal published by the American Medical Association.

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Patient representative sought for CTTI Steering Committee — Clinical Trials Transformation Initiative

Patient representative sought for CTTI Steering Committee

CTTI is seeking a qualified patient representative to fill one of two designated patient seats on its Steering Committee. Interested candidates should read the informational materials below to gain an understanding of the Patient Representative responsibilities and submit the required materials to CTTI@duke.edu by 5:00pm on October 12, 2012 for consideration.

Request for applications

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https://www.ctti-clinicaltrials.org/news/ctti-news-archives/patient-representative-sought-for-ctti-steering-committee

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Rare Diseases and Orphan Products Shaping the Future Now - conference

http://www.diahome.org/Tools/Content.aspx?type=eopdf&file=%2fproductfiles%2f29565%2f12017.pdf

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Wednesday, September 26, 2012

Cytoreductive surgery plus HIPEC in platinum-sensitive recurrent ovarian cancer patients: A case–control study on survival in patients with two year follow-up

Highlights

► In this study, post-relapse survival and duration of secondary response is longer in recurrent platinum-sensitive cases treated with SCR plus HIPEC (Cases).
► These data are statistically significant when compared to a similar group of women not experimenting HIPEC (Controls).
► The combined management, cytoreductive surgery plus HIPEC followed by systemic chemotherapy, might be the treatment of choice in selected recurrent platinum-sensitive patients.

Abstract

Objectives

To compare survival data in platinum sensitive recurrent ovarian cancer patients submitted to secondary cytoreduction (SCR) plus hyperthermic intraperitoneal intraoperative chemotherapy (HIPEC) (Cases) and a similar group of women not experiencing HIPEC (Controls).

Methods

Case–control study, matching 37 Cases with 37 Controls, with at least 24 months of follow up.

Results

Groups were comparable for all characteristics, except for a higher proportion of patients with single-nodule relapses is the Controls (19 vs. 6; p = 0.011). Median follow up time was 46 months in the Cases and 36 months in the Controls. Twenty patients (66.6%) experienced secondary recurrence in the Cases and 37 women (100%) in the Controls (p = 0.001). Moreover, 7 (23.3%) and 23 (62.2%) patients died of disease in the Cases and Controls respectively (p = 0.003). The duration of secondary response was 26 months in the Cases and 15 months in the Controls (p = 0.004).

Conclusions

The combination of SCR and HIPEC seems to improve survival rate in patients suffering from platinum-sensitive EOC recurrence with respect to no-HIPEC treatments. This result further supports the need of a randomized trial.

Highlights

NIH funds will strengthen national capacity for cost-effective, large-scale clinical studies, September 25, 2012 News Release - National Institutes of Health (NIH)

NIH funds will strengthen national capacity for cost-effective, large-scale clinical studies, September 25, 2012 News Release

ACLU asks Supreme Court to reconsider gene patenting case - baltimoresun.com (BRCA 1/2...)

ACLU asks Supreme Court to reconsider gene patenting case - baltimoresun.com

The American Civil Liberties Union has asked for a second time that the Supreme Court invalidate Myriad Genetics Inc.'s patents on two genes associated with hereditary breast and ovarian cancers, the latest salvo in a case with broad consequences for the future of gene-based medicine.

The lawsuit against Myriad and the University of Utah Research Foundation, which hold patents that allow the company to control testing for the genes, alleges that the patents are illegal and restrict scientific research and patients' access to medical care.

The lawsuit was filed by the ACLU and the Public Patent Foundation on behalf of medical associations, geneticists, patients and breast cancer and women's health groups, the ACLU said Tuesday.....

Scientific Reproducibility: Begley's Six Rules - Forbes

Scientific Reproducibility: Begley's Six Rules - Forbes

The lack of robust reproducibility in the scientific literature is both shocking and troubling, and has been a widely covered topic over the past couple years.
One of the earliest blogs here at LifeSciVC was on the dirty secret that more than half of academic work couldn’t be replicated in an industrial setting, and how it shaped the way we view starting new companies as venture investors. It got the attention of BioCentury/SciBX as well as the Wall Street Journal.
Later in 2011, some real data was added to strengthen the case: a Bayer Healthcare team published work showing that only 25% of the academic studies they examined could be replicated.....

Maintenance Therapies Fail in Ovarian Cancer

Maintenance Therapies Fail in Ovarian Cancer
Erlotinib produces no benefit; PARP inhibitor olaparib produces modest PFS improvement

Chicago—After front-line chemotherapy, maintenance erlotinib (Tarceva, Genentech) failed to show any significant benefit in patients with ovarian cancer, according to results of a Phase III trial presented at the 2012 annual meeting of the American Society of Clinical Oncology (abstract LBA5000).

If the link below does not open, please copy and past this link into your browser:
http://www.clinicaloncology.com/ViewArticle.aspx?d=Solid+Tumors&d_id=148&i=September+2012&i_id=887&a_id

Clinical Oncology News
http://www.clinicaloncology.com

Tuesday, September 25, 2012

Expanding Horizons in the Therapeutic Landscape for Relapsed Ovarian Cancer

Meeting Overview

We are pleased to invite you to join us on 28 September 2012 for Expanding Horizons in the Therapeutic Landscape for Relapsed Ovarian Cancer, an ESMO Vienna 2012 Industry Satellite Symposium to be held on 28 September 2012 in Vienna, Austria.

Agenda

12.30		Welcome and introduction Ignace Vergote, MD, PhD
12.35		Clinical opinion poll
12.40		The pathogenesis of relapsed ovarian cancer: Defining new targets Robert Coleman, MD
13.00		Clinical opinion poll
13.05		Platinum-sensitive, relapsed ovarian cancer: A look to the future Nicoletta Colombo, MD
13.25		Clinical opinion poll
13.30		How can we improve treatment of platinum-resistant/refractory disease? Thomas Herzog, MD
13.45		Ask the experts All Faculty
13.55		Closing comments Ignace Vergote, MD, PhD

Faculty

Chair
- Ignace Vergote, MD, PhD
  University Hospital Gasthuisberg
  Leuven, European Union
Faculty
- Robert Coleman, MD
  University of Texas
  M. D. Anderson Cancer Center
  Houston, Texas, United States
- Nicoletta Colombo, MD
  University of Milan-Bicocca
  Milan, Italy
- Thomas Herzog, MD
  Columbia University Medical Center
  New York, New York, United States

Target Audience

This educational activity is specifically designed for medical oncologists, surgical oncologists, gynecologic oncologists, and other healthcare professionals interested and/or involved in the treatment of patients with ovarian cancer.

Learning Objectives

After successful completion of this educational activity, participants should be able to:

Describe the rationale and mechanisms of action for novel therapies in patients with relapsed ovarian cancer as it relates to disease pathogenesis
Examine current and emerging treatment options for patients with platinum-sensitive ovarian cancer, including integration of novel targeted agents
Discuss optimal treatment approaches for patients with platinum-resistant/refractory ovarian cancer based on patient and disease characteristics
Evaluate strategies for improving the overall treatment of patients with relapsed ovarian cancer, including treatment individualization, biomarker use, and multidisciplinary management

Disclosures

Disclosure of Conflicts of Interest

prIME Oncology assesses conflicts of interest with its instructors, planners, managers, and other individuals who are in a position to control the content of activities. All relevant conflicts of interest that are identified are thoroughly vetted by prIME Oncology for fairness, balance, and scientific objectivity of data, as well as patient care recommendations. prIME Oncology is committed to providing its learners with high-quality activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial entity.

Disclosure of Unlabeled Use

This activity may contain discussion of published and/or investigational uses of agents that are not indicated by the US Food and Drug Administration or European Medicines Agency. Please refer to the official prescribing information for each product discussed for discussions of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Letter to the Editor: JCO: Before We Throw out Progression-Free Survival As a Valid End Point…

Before We Throw out Progression-Free Survival As a Valid End Point…

To the Editor:

Although it does not affect their argument against progression-free survival (PFS) as an end point, Booth and Eisenhauer¹ calculated incorrectly that a 20% increase in tumor diameter translates into a 44% increase in tumor volume. It actually translates into an increase in volume of 73%. They divided the volume increase by the final volume, not the initial volume.

They state that if PFS were an effective surrogate for overall survival (OS), then the hazard ratios (HRs) for PFS and OS should be similar.¹ However, this may often not be the case.

Second Malignant Neoplasms: Assessment and Strategies for Risk Reduction

Abstract

Improvements in early detection, supportive care, and treatment have resulted in an increasing number of cancer survivors, with a current 5-year relative survival rate for all cancers combined of approximately 66.1%. For some patients, these survival advances have been offset by the long-term late effects of cancer and its treatment, with second malignant neoplasms (SMNs) comprising one of the most potentially life-threatening sequelae. The number of patients with SMNs is growing, with new SMNs now representing about one in six of all cancers reported to the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) Program. SMNs reflect not only the late effects of therapy but also the influence of shared etiologic factors (in particular, tobacco and excessive alcohol intake), genetic susceptibility, environmental exposures, host effects, and combinations of factors, including gene-environment interactions. For selected SMNs, risk is also modified by age at exposure and attained age. SMNs can be categorized into three major groups according to the predominant etiologic factor(s): (1) treatment-related, (2) syndromic, and (3) those due to shared etiologic exposures, although the nonexclusivity of these groups should be underscored. Here we provide an overview of SMNs in survivors of adult-onset cancer, summarizing the current, albeit limited, clinical evidence with regard to screening and prevention, with a focus on the provision of guidance for health care providers. The growing number of patients with second (and higher-order) cancers mandates that we also further probe etiologic influences and genetic variants that heighten risk, and that we better define high-risk groups for targeted preventive and interventional clinical strategies.

JCO - Update on Progress in Cancer Survivorship Care and Research

Journal of Clinical Oncology Update on Progress in Cancer Survivorship Care and Research

Patricia A. Ganz, Fielding School of Public Health and David Geffen School of Medicine, University of California, Los Angeles;
Jonsson Comprehensive Cancer Center, Los Angeles, CA
Craig C. Earle, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Pamela J. Goodwin, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada

"It has been 7 years since the Institute of Medicine(IOM)issued its
report, entitled From Cancer Patient to Cancer Survivor: Lost in Transition,1 and a similar interval since Journal of Clinical Oncology published a special series issue on cancer survivorship.2 Since that time,
much has occurred to address the 10 recommendations of the IOM .....

Estrogen Plus Progestin and Colorectal Cancer Incidence and Mortality

Abstract

Purpose During the intervention phase in the Women’s Health Initiative (WHI) clinical trial, use of estrogen plus progestin reduced the colorectal cancer diagnosis rate, but the cancers were found at a substantially higher stage. To assess the clinical relevance of the findings, analyses of the influence of combined hormone therapy on colorectal cancer incidence and colorectal cancer mortality were conducted after extended follow-up.

Patients and Methods The WHI study was a randomized, double-blind, placebo-controlled clinical trial involving 16,608 postmenopausal women with an intact uterus who were randomly assigned to daily 0.625 mg conjugated equine estrogen plus 2.5 mg medroxyprogesterone acetate (n = 8,506) or matching placebo (n = 8,102). Colorectal cancer diagnosis rates and colorectal cancer mortality were assessed.

Results After a mean of 5.6 years (standard deviation [SD], 1.03 years) of intervention and 11.6 years (SD, 3.1 years) of total follow-up, fewer colorectal cancers were diagnosed in the combined hormone therapy group compared with the placebo group (diagnoses/year, 0.12% v 0.16%; hazard ratio [HR], 0.72; 95% CI, 0.56 to 0.94; P = .014). Bowel screening examinations were comparable between groups throughout. Cancers in the combined hormone therapy group more commonly had positive lymph nodes (50.5% v 28.6%; P < .001) and were at higher stage (regional or distant, 68.8% v 51.4%; P = .003). Although not statistically significant, there was a higher number of colorectal cancer deaths in the combined hormone therapy group (37 v 27 deaths; 0.04% v 0.03%; HR, 1.29; 95% CI, 0.78 to 2.11; P = .320).

Conclusion The findings, suggestive of diagnostic delay, do not support a clinically meaningful benefit for combined hormone therapy on colorectal cancer.

Clinical Oncology News - The Real-World Effect of Evidence-Based Clinical Trials

The risk of malignancy in unilocular cysts: a study on 1148 adnexal masses classified as unilocular cysts at transvaginal scan with review of the literature.

http://www.ncbi.nlm.nih.gov/m/pubmed/23001924/?i=2&from=ovarian%20cancer

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A randomized phase II study evaluating the combination of carboplatin-based chemotherapy with pertuzumab versus carboplatin-based therapy alone in patients with relapsed, platinum-sensitive ovarian cancer.

http://www.ncbi.nlm.nih.gov/m/pubmed/23002282/?i=1&from=ovarian%20cancer

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ScienceDirect.com - Journal of Clinical Epidemiology - What is ‘best evidence’?

http://www.sciencedirect.com/science/article/pii/S0895435612002466

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Expanding Horizons in the Therapeutic Landscape for Relapsed Ovarian Cancer

MEETING OVERVIEW

We are pleased to invite you to join us on 28 September 2012 forExpanding Horizons in the Therapeutic Landscape for Relapsed Ovarian Cancer, an ESMO Vienna 2012 Industry Satellite Symposium to be held on 28 September 2012 in Vienna, Austria.

AGENDA

12.30		Welcome and introduction Ignace Vergote, MD, PhD
12.35		Clinical opinion poll
12.40		The pathogenesis of relapsed ovarian cancer: Defining new targets Robert Coleman, MD
13.00		Clinical opinion poll
13.05		Platinum-sensitive, relapsed ovarian cancer: A look to the future Nicoletta Colombo, MD
13.25		Clinical opinion poll
13.30		How can we improve treatment of platinum-resistant/refractory disease? Thomas Herzog, MD
13.45		Ask the experts All Faculty
13.55		Closing comments Ignace Vergote, MD, PhD

FACULTY

CHAIR
- Ignace Vergote, MD, PhD
  University Hospital Gasthuisberg
  Leuven, European Union
FACULTY

TARGET AUDIENCE

LEARNING OBJECTIVES

After successful completion of this educational activity, participants should be able to:

Describe the rationale and mechanisms of action for novel therapies in patients with relapsed ovarian cancer as it relates to disease pathogenesis
Examine current and emerging treatment options for patients with platinum-sensitive ovarian cancer, including integration of novel targeted agents
Discuss optimal treatment approaches for patients with platinum-resistant/refractory ovarian cancer based on patient and disease characteristics
Evaluate strategies for improving the overall treatment of patients with relapsed ovarian cancer, including treatment individualization, biomarker use, and multidisciplinary management

http://www.primeoncology.org/live_education/solid_tumor/ovarian_2012_vienna.aspx

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Monday, September 24, 2012

Genetics of Colorectal Cancer (PDQ®) - National Cancer Institute (Lynch Syndrome/extracolonic cancers/transitional cell carcinoma)

Genetics of Colorectal Cancer (PDQ®) - National Cancer Institute

"... Patients with LS are also at risk of developing transitional cell carcinoma of the ureters and renal pelvis, and cancers of the stomach, small intestine, liver and biliary tract, brain, breast, and ovary.[216,219-223]...

emedicine: Hereditary Colorectal Cancer (Lynch Syndrome)

Hereditary Colorectal Cancer

"Mortality/Morbidity

Although not everyone who inherits the gene for hereditary nonpolyposis colorectal cancer (HNPCC) develops colorectal cancer, individuals with Lynch syndrome have a 70-80% lifetime risk of developing colon cancer. Of these cancers, two thirds occur in the proximal colon (proximal to the splenic flexure). In approximately 45% of affected individuals, multiple synchronous and metachronous colorectal may occur within 10 years of resection.
Other cancers associated with hereditary nonpolyposis colorectal cancer (HNPCC) (Lynch Syndrome) include the following:

Endometrial cancer: The lifetime risk is 30-40% by age 70 years. The average age at diagnosis is 46 years. Half of patients with both colon and endometrial cancer present with endometrial cancer first.
Ovarian cancer: The lifetime risk is 9-12% by age 70 years. The average age at diagnosis is 42.5 years. Approximately 30% of these tumors present before age 40 years.
Gastric cancer: The lifetime risk is around 13% (higher in Asians). The mean age at diagnosis of gastric cancer is 56 years; intestinal-type adenocarcinoma is the most commonly reported pathology, especially in Asian countries such as Japan, Korea, and China.
Transitional cell carcinoma: The lifetime risk is 4-10%. This principally affects the upper urinary tract (ureters and renal pelvis).
Adenocarcinoma of the small bowel cancers: The lifetime risk is 1-3%. These occur most commonly in the duodenum and jejunum.
Glioblastoma: The lifetime risk is 1-4%. Also known as Turcot syndrome, this is a variant of hereditary nonpolyposis colorectal cancer (HNPCC) (see below).
Malignancies of the larynx, breast, prostate, liver, biliary tree, pancreas, and the hematopoietic system are more common in patients with hereditary nonpolyposis colorectal cancer (HNPCC).

Table 2. Incidence of different types of cancers between individuals with Lynch syndrome and those in the general population. (Open Table in a new window)

Type of Cancer	General Population Risk (by age 70 y)	Lynch Syndrome Risk (by age 70 y)
Endometrial	1.5%	30-40%
Ovarian	1%	9-12%
Upper Urinary Tract	Less than 1%	4-10%
Stomach	Less than 1%	13% (higher in Asians)
Small Bowel	Less than 1%	1-3%
Brain	Less than 1%	1-4%
Biliary Tract	Less than 1%	1-5%	......cont'd

2012 Hereditary Cancer in Clinical Practice | Full text | Novel germline MSH2 mutation in Lynch syndrome patient surviving multiple cancers

Blogger's Note: worth reading for ovarian/ renal pelvis/ureter and all patients predisposed to the various cancers implicated in Lynch Syndrome

"Case report
Currently 63 year old index female patient (III:4) with a positive colorectal cancer family history was considered having LS after she presented with a colorectal cancer in her 47th year (1995), after she already had been diagnosed with ovarian cancer at the age of 38 (1986) (Figure 1)....

Hereditary Cancer in Clinical Practice | Full text | Novel germline MSH2 mutation in Lynch syndrome patient surviving multiple cancers

BBC News - Cancer death rates set for a 'dramatic fall'

http://www.bbc.co.uk/news/health-19703834

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Thursday, September 27, 2012

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Patient representative sought for CTTI Steering Committee

Document Actions

Wednesday, September 26, 2012

Highlights

Abstract

Objectives

Methods

Results

Conclusions

Highlights

Tuesday, September 25, 2012

Meeting Overview

Agenda

Faculty

Chair

Faculty

Target Audience

Learning Objectives

Disclosures

Disclosure of Conflicts of Interest

Disclosure of Unlabeled Use

Disclaimer

To the Editor:

Abstract

Abstract

MEETING OVERVIEW

AGENDA

FACULTY

CHAIR

FACULTY

TARGET AUDIENCE

LEARNING OBJECTIVES

Monday, September 24, 2012

"Mortality/Morbidity

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Sandi Pniauskas Ovarian Cancer and Us

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SURVIVORS' DEBATE: The Past Decade in Ovarian Cancer

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