Ovarian Cancer National Alliance Submits Comments to Government Regarding Ovarian Cancer Screening

Ovarian Cancer National Alliance Submits Comments to Government Regarding Ovarian Cancer Screening:

The Ovarian Cancer National Alliance submitted the following comments in response to the United States Preventive Service Task Force request for comments on draft recommendations for ovarian cancer screening.

Comments to USPSTF re:

Draft Reaffirmation Recommendation Statement

Screening for Ovarian Cancer: U.S. Preventive Services Task Force Reaffirmation Recommendation Statement

As a patient advocacy organization dedicated to promoting the interests of women with ovarian cancer, the Ovarian Cancer National Alliance is pleased to provide comments on the Draft Screening Statement for Ovarian Cancer.
The United States Preventive Services Task Force is to be commended for reviewing the recent scientific publications regarding ovarian cancer screening. As the Task Force correctly noted, the latest studies confirm that the current blood and imaging tests are not useful for population based screening.
However, the Recommendation Statement does not specify that these tools are valid as part of the diagnostic protocol for women suspected of having ovarian cancer, due in large part to the presence of symptoms.
Further, the Task Force did not appear to use the results of studies that indicate more favorable results of using the CA-125 in tailored ways. For example, a study presented at the 2010 American Society of Clinical Oncology Annual Meeting had more than 3,000 post-menopausal women stratified into high, medium and low risk categories based on an algorithm. The women, based on risk, then had different follow up procedures. The practice followed in this study had a low false-positive rate.
While we are by no means arguing that the CA-125 and/or transvaginal ultrasound be recommended as appropriate screening tools, we urge the Task Force to consider all available information when making its recommendations.
We also request that the recommendation include language regarding the symptoms of ovarian cancer (bloating, difficulty eating/feeling full quickly, urinary frequency or urgency, abdominal pain). We encourage the Task Force to also note that if women have symptoms of the disease these screening recommendations do not apply. We suggest: These recommendations apply only to asymptomatic women at average risk (or instead of “at average risk”, “without any hereditary or family history that would put them at an elevated risk”.)
We thank the Committee for noting that this recommendation does not apply to high risk women, including those with a known genetic mutation that puts them at an increased risk of developing ovarian cancer.
About Ovarian Cancer
According to the American Cancer Society, approximately 21,000 American women are diagnosed with ovarian cancer each year, and approximately 15,000 women die from the disease annually. Ovarian cancer is the deadliest gynecologic cancer and the fifth leading cause of cancer death among women in America. Currently, more than half of the women diagnosed with ovarian cancer die within five years.
About the Ovarian Cancer National Alliance
The Ovarian Cancer National Alliance is a survivor-led national umbrella organization with state and local groups representing grassroots activists, women’s health advocates and health care professionals. The Ovarian Cancer National Alliance submits this testimony as a patient advocacy group dedicated to promoting the interests of women with ovarian cancer.

Why we need a good screening test for ovarian cancer - CNN.com

Why we need a good screening test for ovarian cancer - CNN.com

2012 April Screening for Ovarian Cancer: Evidence Update for the U.S. Preventive Services Task Force Reaffirmation Recommendation Statement

Screening for Ovarian Cancer: Evidence Update for the U.S. Preventive Services Task Force Reaffirmation Recommendation Statement

 Screening for Ovarian Cancer

Evidence Update for the U.S. Preventive Services Task Force Reaffirmation Recommendation Statement

Release Date: April 2012

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By Mary B. Barton, MD, MP, and Kenneth Lin, MD.

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This report is based on research conducted by staff at the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD. The investigators involved have declared no conflicts of interest with objectively conducting this research. The findings and conclusions in this document are those of the authors, who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help clinicians, employers, policymakers, and others make informed decisions about the provision of health care services. This report is intended as a reference and not as a substitute for clinical judgment.
This report may be used, in whole or in part, as the basis for the development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

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Contents

Abstract
Introduction
Methods
Results
Conclusion
References

Abstract

Background: Ovarian cancer has the highest mortality rate of all gynecologic malignancies, and was the fifth leading cause of cancer death among women in 2004.

Purpose: To perform a literature search for new, substantial evidence that would inform the reaffirmation of the U.S. Preventive Services Task Force's recommendation on screening for ovarian cancer.

Data Sources: We searched the MEDLINE and Cochrane databases. The searches were limited to English-language articles on studies of adult humans (age >18 years) that were published between July 1, 2002 and January 15, 2008 in core clinical journals.

Study Selection: For the literature on benefits of screening, we included controlled trials as well as systematic reviews and meta-analyses. For harms, we included controlled trials, cohort studies, case-control studies, and case series, as well as systematic reviews and meta-analyses. Two reviewers independently reviewed titles, abstracts, and full articles for inclusion.
 (Results: Our literature search returned 64 potentially relevant titles that were entered into a reference database. A total of 60 articles were excluded after title and abstract review, and two more were excluded after full article review. We excluded 18 studies not related to ovarian cancer, 34 studies that did not describe screening, two studies that described no relevant outcomes, two studies that described a high-risk or special patient population, and three studies that were an inappropriate study type. One additional report of a prospective screening study that was included in the evidence for harms was identified after a supplemental search of MEDLINE for publications by selected authors)


Data Extraction: No new evidence was found on the benefits of screening for ovarian cancer. A single reviewer extracted data from studies on the harms of screening.

Data Synthesis: No new evidence was found on the benefits of screening for ovarian cancer. New evidence on the combination of ultrasonography and cancer antigen-125 blood tests for screening suggests that abnormal test results may result in surgery for a substantial proportion of women who do not have cancer.

Limitations: The search strategy employed may have missed some smaller studies on the benefits and harms of screening for ovarian cancer.

Conclusion: No new evidence was found on the benefits of screening for ovarian cancer. Screening asymptomatic women can result in unnecessary interventions, including surgery.

Screening of symptomatic women for ovarian cancer: 4 articles (correspondence -RECAP OF LINKS) : The Lancet Oncology : Volume 13, Number 4, 1 April 2012

Blogger's Note: with some exceptions, the Lancet is a subscriber based journal ($$$), registration (free) may be required to view abstracts and/or articles

The Lancet Oncology : Volume 13, Number 4, 1 April 2012

e137 - open access

Screening of symptomatic women for ovarian cancer

Christopher P Crum

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e137 - open access

Screening of symptomatic women for ovarian cancer

Alicia A Tone, David G Huntsman, Dianne M Miller

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e138 - open access

Screening of symptomatic women for ovarian cancer

Aleksandra Gentry-Maharaj, Jatinderpal Kalsi, Matthew Burnell, Ranjit Manchanda, Usha Menon

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e139 - open access (authors' response)

Screening of symptomatic women for ovarian cancer – Authors' reply

Lucy Gilbert, Olga Basso, for the DOvE Study Group

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open access: Expert Reviews - Current developments in ovarian cancer screening (March 2012)

Expert Reviews - Expert Review of Obstetrics & Gynecology - 7(2):131 - Full Text

ABSTRACT

Over 150 delegates from the UK, USA and Europe with a core interest in risk prediction and screening for ovarian cancer attended the International Conference on Ovarian Cancer Screening held on 29–30 November 2011 in London, UK. The scientific program was driven by two experts in the field – Usha Menon and Ian Jacobs – with assistance from the scientific committee, which included Steve Skates, Jatinderpal Kalsi, Anna Lokshin, Uzi Beller, Tim Mould and Ranjit Manchanda. Over the 2 days, key opinion leaders and researchers reported on the latest developments, and debated the future of risk prediction and screening for ovarian cancer.

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The conference started with a welcome from Ian Jacobs (University of Manchester, Manchester, UK), followed by an overview of the current management of ovarian cancer (OC) by Tim Mould (University College Hospitals NHS Trust, London, UK). Stuart Campbell (Create Health Ltd, London, UK), a stalwart in the field of pelvic ultrasonography, chaired the first session on differential diagnosis in symptomatic patients. Robert Bast (University of Texas MD Anderson Cancer Center, TX, USA), who in the early 1980s discovered CA125, discussed recent biomarker panels and algorithms (Risk of Malignancy Index [RMI], Risk of Ovarian Malignancy Algorithm [ROMA] and OVA1) for OC diagnosis. His view was that the current challenge, especially in the USA, was implementation so that OC patients could be operated on by trained gynecological oncologists. Of the many OC markers, CA125 and HE4 provided the greatest discrimination between malignant and benign adnexal masses, with the latter particularly useful in premenopausal women..........cont'd

Vignette-Based Study of Ovarian Cancer Screening: Do U.S. Physicians Report Adhering to Evidence-Based Recommendations?

Abstract

"Background: No professional society or group recommends routine ovarian cancer screening, yet physicians' enthusiasm for several cancer screening tests before benefit has been proven suggests that some women may be exposed to potential harms.

Objective: To provide nationally representative estimates of physicians' reported nonadherence to recommendations against ovarian cancer screening.

Design: Cross-sectional survey of physicians offering women's primary care. The 12-page questionnaire contained a woman's annual examination vignette and questions about offers or orders for transvaginal ultrasonography (TVU) and cancer antigen 125 (CA-125).........."

Many Doctors Don’t Follow Ovarian-Cancer Screening Guidelines - Health Blog - WSJ

The study is published in the Annals of Internal Medicine.

abstract: Physician Knowledge and Awareness of CA-125 as a Screen for Ovarian Cancer in the Asymptomatic, Average-Risk Population - CDC study

Physician Knowledge and Awareness of CA-125 as a Screen for

Abstract

Effective early detection strategies for ovarian cancer do not exist. 

Current screening guidelines recommend against routine screening using CA-125 alone or in combination with transvaginal ultrasonography (TVS). 

In this study, the authors used the 2008 DocStyles survey to measure clinician beliefs about the effectiveness of CA-125 and TVS in the asymptomatic, average-risk population in the United States. 

To assess the need for provider education, the authors used the 2008 HealthStyles survey to examine public awareness of CA-125. 

Of 1,250 physician respondents, 40.4% said both CA-125 and TVS were effective screens, and 28.3% said neither was an effective ovarian cancer screen in the asymptomatic, average-risk population. 

Obstetrician/gynecologists [OB/GYNs] more often had responses consistent with current guidelines: 56.5% of OB/GYNs, compared with 34.4% and 29.8% of family/general practitioners and internists, respectively, said neither CA-125 nor TVS was an effective screen. 

Almost one third of women (patients/the public) surveyed reported having heard of CA-125, and about one tenth said they had the CA-125 test. 

These findings support the need for additional provider education. Educational efforts should include lack of evidence for, as well as the potential harms of, screening for ovarian cancer with CA-125.

Top Cancer News — Cancer Matters podcasts - Johns Hopkins

June 23rd, 2011 | Hot Topics |

This month, in Dr. Bill Nelson's Cancer News Review podcast, you'll hear about cell phone hazards, breast and prostate cancer prevention drugs, and screening for ovarian cancer.

Gastroenterology & Endoscopy News - Gastros Outperform Oncologists in Recognition of Inherited CRC (Lynch Syndrome/PJS/FAP....extracolonic tumors)

Note: access is free/requires registration

"......Overall, physicians benefited from the educational intervention, scoring significantly higher on exams about genetic testing for Lynch syndrome, FAP and Peutz-Jeghers syndrome post-test than at baseline. The education session also significantly improved physicians’ recognition of Lynch syndrome family pedigrees and surveillance of the disease, but did not effectively enhance awareness of extra-colonic manifestations.

Although the educational intervention improved the ability of physicians to identify families with multiple members affected by CRC, it did not help them spot extra-colonic cancers in families with Lynch syndrome. Identifying extra-colonic cancers is important because Lynch syndrome increases a person’s risk for endometrial cancer and is associated with cancers of the stomach (6%-9%); ovaries (6%-12%); and ureter and renal pelvis (3%-8%) (and others), according to the Colon Cancer Alliance for Research and Education for Lynch Syndrome...........cont'd

"Ms. (Kate) Murphy has survived ovarian and breast cancer as well as three episodes of colon cancer."

Ovarian cancer: early detection saves lives | McGill University (Montreal) Health Centre - the Dove Project

For more information about DOVE: http://muhc.ca/royalvic/article/dove-project

still recruiting: Quality of Life Associated With a Low-Risk Screening Program for Ovarian Cancer - Full Text View - ClinicalTrials.gov

Purpose

The goal of this research study is to learn more about how women feel about an ovarian cancer screening program that involves getting a blood test to measure CA 125 levels. This includes finding out about women's quality of life and whether they are concerned or worried about their risk of developing cancer. This study also seeks to find out whether elevated CA 125 levels affect participants in terms of cancer worries or concerns.

2011 (pdf/slides) Screening for Ovarian Cancer - University of Manitoba - Dr Lotocki

Epithelial Ovarian Cancer
Cancer Day for Primary Care
Friday, January 14, 2011

Pathologic findings following false-positive screening tests for ovarian cancer in the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening

Abstract

OBJECTIVE: In the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO), ovarian cancer screening with transvaginal ultrasound (TVU) and CA-125 produced a large number of false-positive tests. We examined relationships between histopathologic diagnoses, false-positive test group, and participant and screening test characteristics.

CONCLUSIONS: False-positive ovarian cancer screening tests were associated with a range of histopathologic diagnoses, some of which may be related to patient and screening test characteristics. Further research into the predictors of false-positive ovarian cancer screening tests may aid efforts to reduce false-positive results.

Development of an ovarian cancer screening decision model that incorporates disease heterogeneity: implications for potential mortality reduction.

Abstract

BACKGROUND: Pathologic and genetic data suggest that epithelial ovarian cancer may consist of indolent and aggressive phenotypes. The objective of the current study was to estimate the impact of a 2-phenotype paradigm of epithelial ovarian cancer on the mortality reduction achievable using available screening technologies.
CONCLUSIONS: The current analysis suggested that reductions in ovarian cancer mortality using available screening technologies on an annual basis are likely to be modest. A model that incorporated 2 clinical phenotypes of ovarian carcinoma into its natural history predicted an even smaller potential reduction in mortality because of the more frequent diagnosis of indolent cancers at early stages.

abstract: Pancreatic Cancer Screening in a Prospective Cohort of High-Risk Patients: A Comprehensive Strategy of Imaging and Genetics — Clinical Cancer Research

Results:

Fifty-one patients in 43 families were enrolled, with mean age of 52 years, 35% of whom were male. Of these patients, 31 underwent EUS and 33 MRI. EUS revealed two patients with pancreatic cancer (one resectable, one metastatic), five with intraductal papillary mucinous neoplasms (IPMN), seven with cysts, and six with parenchymal changes. Five had pancreatic surgery (one total pancreatectomy for pancreatic cancer, three distal and one central pancreatectomy for pancreatic intraepithelial neoplasia 2 and IPMN).

A total of 24 (47%) had genetic testing (19 for BRCA1/2 mutations, 4 for CDKN2A, 1 for MLH1/MSH2) and 7 were positive for BRCA1/2 mutations. Four extrapancreatic neoplasms were found: two ovarian cancers on prophylactic total abdominal hysterectomy and bilateral salpingo-oophorectomy, one carcinoid, and one papillary thyroid carcinoma. Overall, 6 (12%) of the 51 patients had neoplastic lesions in the pancreas and 9 (18%) had neoplasms in any location. All were on the initial round of screening. All patients remain alive and without complications of screening.

High detection rate of adenomas in familial colorectal cancer - Gut

Conclusion
The yield of colonoscopic surveillance in familial CRC is substantially higher than the yield of screening reported for the general population."

in research - Abstract: RNAi screening of the kinome identifies modulators of cisplatin response in ovarian cancer cells.

CONCLUSIONS: Our data provides kinase targets that could be exploited to design better therapeutics for ovarian cancer patients. We also demonstrate the effectiveness of high-throughput RNAi screening as a tool for identifying sensitizing targets to known and established chemotherapeutic agents.

SGO White Paper Ovarian Education Campaign [INTRODUCTORY PARAGRAPH-Herzog/Coleman] Project I-Background, Screening & Surveillance

Note: this journal requires subscription ($$$)

 Abstract

Ovarian cancer is a heterogeneous, rapidly progressive, highly lethal disease of low prevalence. The etiology remains poorly understood. Numerous risk factors have been identified, the most prominent involving an inherited predisposition in 10% of cases. Women with germline mutations associated with Hereditary Breast/Ovarian Cancer and Lynch syndromes have dramatically elevated risks (up to 46% and 12%, respectively). Risk-reducing salpingo-oophorectomy is the best method to prevent ovarian cancer in these high-risk women. Significant risk reduction is also seen in the general population who use oral contraceptives. Since up to 89% patients with early-stage disease have symptoms prior to diagnosis, increased awareness of the medical community may facilitate further workup in patients who otherwise would have had a delay. Despite enormous effort, there is no proof that routine screening for ovarian cancer in either the high-risk or general populations with serum markers, sonograms, or pelvic examinations decreases mortality. Further evaluation is needed to determine whether any novel biomarkers, or panels of markers, have clinical utility in early detection. Prospective clinical trials have to be designed and completed prior to offering of any of these new diagnostic tests. CA125 is currently the only biomarker recommended for monitoring of therapy as well as detection of recurrence. This commentary provides an overview on the background, screening and surveillance of ovarian cancer.

abstract : Whole blood-derived miRNA profiles as potential new tools for ovarian cancer screening : British Journal of Cancer

Conclusion:

Our proof-of-principle study strengthens the hypothesis that neoplastic diseases generate characteristic miRNA fingerprints in blood cells. Still, the obtained OvCA-associated miRNA pattern is not yet sensitive and specific enough to permit the monitoring of disease progression or even preventive screening. Microarray-based miRNA profiling from peripheral blood could thus be combined with other markers to improve the notoriously difficult but important screening for OvCA.