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W OMEN AT HIGH RISK for ovarian cancer — the most lethal gynecological malig- nancy—can now benefit from cutting- edge research that has yielded several methods for early detection, all of which are available at NYU Medical Center. “Until recently, there were no tests to accurately diagnose ovarian cancer or disease confined to the ovary, much less predict the development of any cancer ,” explains David A. Fishman, M.D., Professor of Obstetrics and Gynecology, and Director of Gyneco- logic Oncology. “Today, based on our research employing new computer sophistication and ultrasensitive technol- ogy, we can look beyond cells to genes and proteins for abnormalities that may indicate precancerous changes.” As Director of the National Cancer Institute’s (NCI) National Ovarian Cancer Early Detection Program ( NOCEDP ), Dr. ...

BRCA1/2 Mutation Testing and Breast/ Ovarian Cancer in the Ashkenazi Jewish Population Glenn E Palomaki, B.S. Foundation for Blood Research Scarborough, Maine (207) 883-4131 palomaki@fbr.org Page 2 Integrated Approach p (1,000,000) Cumulative incidence (N) = cs (cf) CF= Carrier Frequency (carrier rate as a percentage) CS = Clinical sensitivity (%) P = Penetrance (%) Use consensus estimates/ranges for each variable. Page 3 Carrier Rate The rate of three founder BRCA1/2 mutation carriers among the Ashkenazi Jewish population 6174delT ( BRCA2 ) All three combined 5382insC ( BRCA1 ) 185delAG ( BRCA1 ) 1 in 66 to 1 in 111 1 in 33 to 1 in 56 1 in 33 to 1 in 56 1 in 250 to 1 in 833 1 in 92 to 1 in ...

OVARIAN CANCER SCREENING FACTS: • Ovarian cancer is the fourth leading cause of cancer death among women in the United States • Ovarian cancer occurs in women of all ages, over 50% of cases occur in women over age 50. • 75% of ovarian cancer is diagnosed in stage III or IV when 5 year survival rates are less than 25%. • 5 year survival rates for ovarian cancer diagnosed in stage I is 90%, and diagnosed in stage II is 60-70%. • Screening for ovarian cancer has been shown to result in earlier detection and thus improved survival. • There is no uniformly accepted method for ovarian cancer screening • The US preventive services task force(USPSTF) found that screening with CA-125 or ultrasound can detect ovarian cancer at an earlier stage, and earlier detection ...

continued on back Ovarian cancer is the rapid growth of abnormal cells in the ovaries of the female reproductive system. The ovaries are the two small egg-filled sacs on each side of the uterus which produce estrogen and play a key role in conception and menstruation. Cancer can occur in one or both ovaries. When there is a malignancy, the ovaries typically enlarge, and cancer cells may fall off the ovary’s surface and implant themselves throughout the abdominal cavity. Each one of these seedlings can then grow into a separate ovarian cancer tumor nodule. Who is at risk for ovarian cancer ? Each year, more than 20,000 American women will be diagnosed with ovarian cancer . The disease most often affects post- menopausal women, although women of any age may develop it. While scientists have not uncovered the cause, women in any of the ...

Ovarian Cancer Patient Survey 2006 ABOUT YOU We would like to understand some basic information about you and your ovarian cancer which will help us with analysing your later answers 1. What year were you born? Enter date 2. What age were you at diagnosis? Enter age 3. What year was your diagnosis? Enter date 4. What type of Ovarian Cancer (OC) do you/did you have? Epithelial ovarian cancers: Mucinous Serous Clear Cell Borderline Germ cell Other I don’t know 1 1 Page 2 5. What 'stage' was your ovarian cancer at diagnosis? I II III IV FAMILY HISTORY 6. Has anyone in your family had Breast Cancer or OC? Yes – please go to questions 6a and 6b No – please go to question 7 6a. What is or was their relationship to you? (for example ...

Maintenance Therapy Maintenance Therapy in Ovarian Cancer in Ovarian Cancer PFS and OS as Endpoints of PFS and OS as Endpoints of Therapeutic Clinical Trials Therapeutic Clinical Trials Robert F. Ozols, MD, PhD Fox Chase Cancer Center David R. Spriggs, MD Memorial Sloan-Kettering Cancer Center Page 2 Potential impact of maintenance therapy in ovarian cancer Potential impact of maintenance therapy in ovarian cancer • Early-stage disease 20-25% of all patients diagnosed with FIGO stage I and II Essentially all patients will be in a clinical CR after surgery and chemotherapy 25% of these patients will relapse • Advanced-stage disease 75-80% of patients diagnosed with FIGO stage III and IV disease ...

Regulatory Background Lee Pai-Scherf, MD CDER, FDA Page 2 Outline • FDA requirements for new drug approval • Regular and accelerated approval • Drug approval endpoints • Past FDA approvals in ovarian cancer Page 3 Requirements for Drug Approval • Safety (FD&C Act of 1938) • Efficacy demonstrated in adequate and well controlled studies (1962 amendment) • The methods of assessment of subjects’ response are well-defined and reliable – 21 CFR 314.126(b)(6) Page 4 Approval Pathways and Efficacy Requirements Regular approval • Clinical Benefit – Prolongation of life – Better life: Improvement in tumor- related symptoms • Established surrogate for clinical benefit Accelerated approval • Surrogate reasonably likely to ...

Endpoints in Ovarian Cancer Clinical Trials Recurrent Disease Page 2 Refractory/Persistent Disease (Median 1-1.5 year) Primary Therapy 1st Complete Remission (17-22 mo) Potentially Platinum Sensitive Disease Clinical Complete Remission (median 12 mo) P 1R P 1S P 2R P 3R P 4R P 2S P 3S P 4S Risk Estimates P 3S = 42% P 3R = 58% P 4S = 54% P 4R = 46% DEATH (From GOG 111) P 1S = 51% P 1R = 49% CURE Page 3 Refractory/Persistent Disease (Median ...

Investigation of a direct-to-consumer marketing campaign Genetic testing for breast and ovarian cancer susceptibility Melanie Myers, Cynthia Jorgensen, James Litch, Sidibe Kassim, Linda Bradley Centers for Disease Control and Prevention (CDC) Page 2 www.cdc.gov/genomics Page 3 Direct-to-Consumer (DTC) Marketing Campaign ? DNA-based test marketed directly to public • Women 25-54 years and their providers • Atlanta, GA and Denver, CO ? Stated objectives of campaign: • Create awareness among target population • Encourage consumers to talk to providers Page 4 DTC Campaign Consumers ? TV, radio, magazine • Sept 2002 – Feb 2003 Providers ? Mailer to inform about campaign ? Rollout meetings to promote ...

Ovarian cancer , genomics and CSC/IC Microarray Centre Imperial College London Hani Gabra Imperial College London Hammersmith Campus Tim Aitman MRC CSC Microarray Centre Hammersmith Hospital Page 2 Page 3 Page 4 Groups targeted for profiling studies • UNSELECTED COHORT IN CLINICAL PRACTICE • GENOME SCALE CLINICAL TRIALS Page 5 Biopharmaceutical industry IT-enabled network of clinical treatment sites Clinical Data WLGCC MDT/ Hammersmith Imaging Clinical Genomics Data Warehouse Laboratory Research Imaging Centre Informatics GCP-compliant clinical trial capability Integration ...

FOLIA HISTOCHEMICA ET CYTOBIOLOGICA Vol. 42, No. 2, 2004 pp. 123-126 Localization of human chorionic gonadotropin beta subunit transcripts in ovarian cancer tissue Ewa Nowak-Markwitz 1 , Anna Jankowska 2 , Anna Szczerba 2 , Miroslaw Andrusiewicz 2 and Jerzy B. Warchol 2 1 Division of Obstetric and Gynecology and 2 Department of Radiobiology and Cell Biology, University of Medical Sciences, Poznan, Poland Abstract: Recent studies demonstrated that besides placenta and malignant trophoblastic tumors, hCG and especially its ß -subunit is secreted by a varieties of tumors of different origin. The aim of the present investigation was to determine the expression pattern of human chorionic gonadotropin gene in ovarian cancer tissue. The study included 8 patients ...

780 Promenade Echo Drive, Ottawa, ON K1S 5R7 Canada Tel.: 1.800.561.2416 ext. 250/613.730.4192 ext. 250 | Fax: 613.730.4314 | Web: www.g-o-c.org Page 1 of 2 January 10, 2006 Intraperitoneal chemotherapy for ovarian cancer : A complex strategy but what an exciting avenue! An estimated 2,400 new cases and 1,550 deaths were due to ovarian cancer in Canada last year. Currently, the optimal current care for ovarian cancer includes aggressive surgery, first-line chemotherapy and follow-up. After more than 20 years of investigation, there are now three (3) major North American phase III trials showing positive results (GOG-172, SWOG-9619, GOG-114/SWOG-9227). Chaired by Dr. Deborah Armstrong, the most recent study, GOG-172, observed an improvement in survival for those women treated with intraperitoneal chemotherapy as adjuvant treatment following optimal cytoreduction surgery for ovarian ...

www.cticseattle.com 501 Elliott Ave. W. #400 Seattle, WA 98119 T 206.282.7100 F 206.272.4010 GynecologicOncology Group to ConductFront-linePhaseIII Trial of XYOTAX™ in Ovarian Cancer Study PlacesXYOTAX in Handsof Clinical Leadersin GynecologicCancer Treatment Nov.5,2002 Seattle —Cell Therapeutics,Inc.(CTI) (NASDAQ: CTIC) andthe Gynecologic Oncology Group(GOG) announced today that the GOG will conduct a phase III trial of XYOTAX infront-line treatment of ovariancancer.The trial is expectedtobeginin2003and toenroll approximately 1,000patients over twelve months. “The missionof the GOG is toimprove the lives and outcomes of patients withgynecologic cancers.While we have made significant progress inprolonging the lives of womenwith ovariancancer,one of our biggest challenges is toimprove their quality of life,giventhe serious side effects of current chemotherapy,” notedLarry J.Copeland,M.D.,Department ...

First Line Ovarian Cancer Chemotherapy PATIENT INFORMATION Former Therapy Proposed New Therapy Day #1: Intravenous (IV) Paclitaxel (Taxol) infused over 24hours plus Intravenous (IV) Cisplatin Therapy infused every 21 days for 6 cycles Day #1: Intravenous (IV) Paclitaxel (Taxol) infused over 24hours Day #2: Intraperitoneal (IP) Cisplatin Day #8: Intraperitoneal (IP) Paclitaxel (Taxol) Therapy infused every 21 days for 6 cycles Background Information : Recently, the Gynecologic Oncology Group (GOG) has conducted a clinical trial which demonstrates a substantial increase in survival for patients receiving chemotherapy delivered directly into the abdominal cavity compared to the traditional intravenous route. This method is called intraperitoneal chemotherapy or “abdominal wash.” This delivery method provides direct access of the chemotherapy into the anatomic compartment ...

SAMPLE LETER OF MEDICAL NECESSITY For Hereditary Breast & Ovarian Cancer Testing ATTN: [Physician Name, M.D.] [Insurance Company/Institution] [Street Address] [City, State, Zip] Re: [Patient Name or ID/Claim Number] Dear Medical Director: I am writing to request coverage for a BRCA1 / BRCA2 DNA sequence analysis test for [patient name] due to a family history of the following: (Relevant cancers include: breast, ovarian , and pancreatic) Relationship_ Cancer Site __ Age Relationship_ Cancer Site __ Age Relationship_ Cancer Site __ Age This history is suggestive of hereditary susceptibility to breast and ovarian cancer , most of which is due to mutations in the BRCA1 and BRCA2 genes. If the patient were found to have a mutation in the BRCA1 or BRCA2 gene, then he/she would be considered at significantly increased risk ...

To Our Patients with Ovarian Cancer Important information about Intraperitoneal Chemotherapy Background Intraperitoneal (IP) chemotherapy refers to chemotherapy administered directly into your abdomen through a small catheter. This was a common route of administration for chemotherapy for women with ovarian cancer more than twenty years ago. There has recently been renewed interest in this form of therapy. What’s new Over the last decade, three large randomized, multi-center clinical trials have shown to be associated with a better survival for women treated with intraperitoneal chemotherapy. The most recent trial, conducted by the Gynecologic Oncology Group (GOG) is about to be published. When this trial is published, we anticipate that the National Cancer Institute (NCI) will recommend this form of treatment. Who is Eligible to Receive IP chemotherapy? Intra-peritoneal chemotherapy ...

Intraperitoneal Chemotherapy of Ovarian Cancer : A Review, With a Focus on Practical Aspects of Treatment Maurie Markman and Joan L. Walker INTRODUCTION On the basis of the results of three multicenter, ran- domized,phaseIIIclinicaltrials,intraperitoneal(IP) chemotherapy has now been shown to be superior to standard intravenous chemotherapy in the pri- mary chemotherapeutic management of small- volume, residual, advanced epithelial ovarian cancer . 1-3 The barriers to implementation of this treatment into clinical practice appear to be toxicity concerns, and a lack of technical expertise with the peritoneal infusion device. The goals of this article are to review the significant scientific evidence be- hind the rationale for implementing this therapy into routine clinical practice, highlighting the pre- ventionandmanagementofpotentialtoxicities.The ...

Model chemotherapy orders for women with optimally debulked stage III ovarian cancer , no prior chemotherapy, with appropriate performance status and physiologic function Paclitaxel 135 mg/m2 IV (by 3-hour infusion), Day 1 Cisplatin 75 mg/m2 IP, Day 2 Paclitaxel 60 mg/m2 IP, Day 8 All chemotherapy may be given in the outpatient setting Repeat every 3 weeks for 6 courses Laboratory evaluation prior to chemotherapy Day 1, 8 ANC > 1, platelets > 100K Day 2 Creatinine < 1.5 Day 0 Dexamethasone 20 mg po the night before Day 1 Dexamethasone 20 mg PO 6 hours before treatment (Substitution: single-dose regimen of intravenous dexamethasone 10 mg-20 mg given 30 minutes before paclitaxel) Ranitidine 50 mg IVPB x 1 give 30-60 minutes before paclitaxel Diphenhydramine 50 mg IVPB x 1 IV 30-60 minutes before paclitaxel Paclitaxel 135 mg/m2 IV (by 3-hour infusion) Day 2 Palonosetron ...

FY05 Ovarian Cancer Research Program Peer Reviewers Avigan, David M.D. Department of Medicine, Beth Israel Deaconess Medical Center Barnes, Mack M.D. Department of Obstetrics & Gynecology, University of Alabama-Birmingham Brattain, Michael Ph.D. Department of Pharmacology & Therapeutics, Roswell Park Cancer Institute Britten, Richard Ph.D. Department of Radiation Oncology, Eastern Virginia Medical School Buller, Richard M.D., Ph.D. Department of Oncology Medicine Development Centre, GlaxoSmithKline Cannon, Martin Ph.D. Department of Microbiology and Immunology, University of Arkansas for Medical Sciences Connolly, Denise Ph.D. Medical Science , Fox Chase Cancer Center Coukos, George M.D., Ph.D. Department of Obstetric & Gynecology, University ...

1 THE GENETICS OF BREAST AND OVARIAN CANCER III: A NEW MODEL OF FAMILY HISTORY WITH INSURANCE APPLICATIONS By Eng Hock Gui, Baopeng Lu, Angus Macdonald, Howard Waters and Chessman Wekwete abstract Insurers’ access to genetic test results is often restricted and the only genetic information that might be collected during underwriting in some countries is family history. Previous studies have included family history in a simple way but only for diseases which have no cause other than gene mutations, because then the event ‘affected parent’ contributes all possible information short of a genetic test result. We construct a model of breast cancer (BC) and ovarian cancer (OC) — common diseases with rare genetic variants — in which the development of a family history is represented explicitly as a transition between states, hence as part of the applicant’s own life history. This allows the impact ...

Pacific Ovarian Cancer Research Consortium Notice of Availability of Funds for Career Development Awards in Interdisciplinary Translational Ovarian Cancer Research Release Date: Friday, April 14, 2006 Application receipt date: Friday, June 16, 2006 Letter of Intent (LOI) is required by Friday, May 5, 2006. The POCRC Executive Committee will review LOIs for candidate eligibility and consistency with program priorities. Invitations to submit applications will be sent out approximately two weeks after the LOI due date. Detailed LOI instructions are included below. Program Goal The primary goal of the Pacific Ovarian Cancer Research Consortium (POCRC) Career Development Program (CDP) is to facilitate the development of translational, interdisciplinary, and leadership research skills in outstanding young and new investigators who are developing careers in translational ovarian ...

March 31, 2006 Contact: Jean Heyer Jessica Sachariason Minnesota Ovarian Cancer Alliance Roepke Public Relations 952-890-8775 612-677-1717 jheyer@mnovarian.org Jessica@roepkepr.com SILENT NO MORE MARATHON SWIM FOR OVARIAN CANCER Rochester, MN – At 5 am on Friday, May 19, 52-year-old Mary Johnson will begin a solo 12-hour marathon swim at the Rochester Area Family YMCA to raise awareness of ovarian cancer and raise funds to support the programs of Minnesota Ovarian Cancer Alliance (MOCA). Most days, after working as a chaplain at Mayo Clinic in the gynecology department, Ms. Johnson heads to the pool. She started distance swimming seven years ago and finds it to be a great stress reliever. The quietness of the sport gives her the opportunity to reflect on her day and pray for women who are in the hospital. “I came up with the idea of doing a marathon ...

P H O T O G R A P H Y B Y A N N E L L I O T T C U T T I N G C ANCER IS CRUELLY undemocratic: Some forms are relatively easy to beat, while others are just shy of a death sentence. For women, ovarian cancer lands in the killer category. Although experts already know how to conquer it—if they find it soon enough, it’s treatable and beatable—early detection is all but impossible. But that might be about to change. A new test that shows promise in detecting ovarian cancer at a curable stage should be available by year’s end. The test looks for a telltale fin- gerprint, or protein pattern, in your blood. Find that fingerprint early enough, and it could save your life. Find out you don’t have it, and you could receive S E C T I O N 2 DECEMBER 2003 h e a l t h 35 The latest news,views,and ...

Page 2 Ovarian cancer in England 1996 to 2004. A geographical profile of mortality. Authors: Michael Goldacre, David Yeates, Leicester Gill, Myfanwy Griffith, Henry McGuinness, Daniel Meddings Published by: Unit of Health-Care Epidemiology, Oxford University, and South East England Public Health Observatory, 2005 This document provides a geographical profile of mortality from ovarian cancer in England. The geographical areas covered are the standard local authority areas of England. The period covered is January 1 1996 to December 31 2004. The data are analysed from mortality files supplied to the Public Health Observatories by the Office for National Statistics. This analysis includes mortality data about females of all ages. The map, chart and table show standardised mortality ratios (SMRs). The data in the map are shown as quintiles of local authorities, ...

ovarian cancer 1581 Prevention of Ovarian Cancer Roberta B. Ness , M.D., M.P.H., Chair of the Department of Epidemiology, University of Pittsburgh, Graduate School of Public Health What Puts Women at Risk? Family history of ovarian and breast cancers Infertility Endometriosis Talc use Hormone replacement therapy Does Anything Prevent Ovarian Cancer ? Oral contraceptives Pregnancies Breast feeding (long duration) Tubal ligation Oophorectomy and hysterectomy Controversies NSAIDS Fertility drugs Androgens Diet: fat, coffee Ovarian Cancer Risk and Protection ...

For more information: Inherited Breast and Ovarian Cancer Information for women attending the Family CancerClinic Last updated Nov 2001 Seen in clinic by. Who is at increased risk of inherited breast and ovarian cancer ? Women who may be at increased risk are those who have: - Either several close relatives on the same side of the family who have had breast and/or ovarian cancer , with at least one relative diagnosed before age 50. - Or at least one first degree relative (e.g. mother, sister, daughter) who has had breast cancer . What can you do if you are at increased risk? Sometimes we can do a blood test to find out if a person has inherited an altered BRCA1 or BRCA2 gene. The test is only possible if we find that somebody in the family who has had breast or ovarian cancer has an altered BRCA1 ...

March 24, 2006 Understanding Ovarian Cancer Screening Results from the PLCO Trial At the 2006 SGO Annual Meeting on Women’s Cancers™ results from the ovarian cancer screening arm of the Prostate, Lung, Colon and Ovarian (PLCO) trial were presented. Researchers reported new criteria that allowed for the detection of 87% of early ovarian cancers and 93% of advanced ovarian cancers in asymptomatic postmenopausal women who participated in the study. The PLCO trial is a randomized trial in which subjects are assigned to usual medical care versus annual screening for Prostate, Lung, Colon and Ovarian cancer . In this clinical trial, over 28,000 women, ages 55 – 74, were screened for ovarian cancer using a transvaginal ultrasound and serum CA 125 test. The study results provoke an obvious question for women : Should I have an annual ultrasound and CA 125 test? In this brief communication ...

• Ovarian cancer is fairly rare, but can be deadly. It affects over 20,000 U.S. women each year, compared to breast cancer that affects over 200,000 women yearly. • Finding ovarian cancer early is a challenge: there are no routine screening tests and symptoms vary from woman to woman. • You may be at increased risk if you have a family history of ovarian , breast or colon cancers, especially if several family members have cancer and if the cancers occurred at young ages. • Current research offers hope for better screening tests and treatments. • Many women know little about symptoms (see below). Symptoms of Ovarian Cancer – What You Need to Know Increased attention is being given to researching the symptoms experienced by ovarian cancer patients prior to diagnosis. At Fox Chase Cancer Center we interviewed 53 patients about their symptoms and found that all but two ...

Screening for Ovarian Cancer C HAPTER 72 By Cindy Quinton Gladstone Page 2 Screening for Ovarian Cancer 72 Prepared by Cindy Quinton Gladstone, MHSc, MD, FRCPC 1 O varian cancer is the leading cause of gynecologic cancer mortality in North America. The disease has usually spread beyond the ovary by the time of diagnosis, and is associated with a five-year survival of 35% or less, as compared with 90% for Stage I tumours. To date, standard treatments have had little impact on mortality, and attention has focused on early detection through screening. A review of the evidence does not support such action. In fact, given the poor positive predictive value of pelvic examination, abdominal and transvaginal sonography, and/or serum ...

February 22, 2006 Contact: Jean Heyer Jeremy Ziegler Minnesota Ovarian Cancer Alliance Aware Web Solutions 952-890-8775 612-384-8988 jheyer@mnovarian.org jziegler@awareweb.com Minnesota Ovarian Cancer Alliance (MOCA) Launches New Web Site Donated by Aware Web Solutions Minneapolis -- Minnesota Ovarian Cancer Alliance (MOCA) is thrilled to announce the launch of its new web site: www.mnovarian.org. Aware Web Solutions, who donated their design services for the project, worked closely with MOCA for the past 10 months developing the site. “Aware is honored to have the opportunity to support this wonderful organization in its online efforts,” said Trevor Olson, President of Aware Web Solutions. “We always set out to design and build the best looking and most practical Web site possible. Based on the positive response the site has received, I think we ...