Focus on Ovarian Cancer

Cancer Program report Focus on Ovarian Cancer Introduction from the Chairman Magee-Womens Hospital of UPMC continues its commitment to provide comp...
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Cancer Program report

Focus on Ovarian Cancer

Introduction from the Chairman Magee-Womens Hospital of UPMC continues its commitment to provide comprehensive cancer care for its patients through a multidisciplinary approach. State-of-the-art services provide the highest level in prevention, diagnosis, and treatment. The physician and associated health care team work with the patients and their families to develop personalized treatment plans to customize care. Physician specialists include breast and gynecologic oncologists, urologists, gastroenterologists, surgical and medical oncologists, radiation oncologists, behavioral health professionals, plastic and reconstructive surgeons, pathologists, geneticists, radiologists, palliative care specialists, and melanoma specialists. Other health care professionals include nursing services, pharmacists, dietitians, social workers, sonographers, and technologists specializing in women’s cancers. Support groups, varied educational activities, a patient resource room, and Internet access to the Magee website are available. Magee, Magee-Womens Research Institute, and the University of Pittsburgh Cancer Institute, an NCIdesignated Comprehensive Cancer Center, offer the most current therapies and clinical trials. The Magee-Womens High Risk Breast Cancer and Ovarian Cancer Programs provide women with a thorough assessment of their individual risks, along with risk-reduction and surveillance strategies. A multidisciplinary team consisting of medical staff and allied health professionals meets weekly for a breast cancer conference and a separate gynecologic oncology Tumor Board Conference to discuss patient evaluations, both for prospective and continuing care, and plans for future care of selected patients with malignancies. The Cancer Committee provides leadership and guidance to the cancer program, ensuring that the highest quality of health care continues to be provided for its patients. It also monitors and coordinates all cancer-related activities. The committee meets bimonthly and consists of representatives from each department involved in cancer management and care. The 2008-2009 Cancer Program Report describes the accomplishments and commitment to excellence that the cancer program maintains at Magee. This year, we decided to focus our annual report on ovarian cancer and highlight key program accomplishments supporting ovarian cancer patients.

Paniti Sukumvanich, MD Chairman, Cancer Committee

Program INNOVATIONS

Novel Chemotherapy Treatment to Improve Patient Outcomes – Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Magee Womens Cancer Program remains at the forefront of patient care and state-of-the-art technology and treatment. Through its commitment to clinical innovations and quality initiatives, Magee’s cancer program continues to expand its capabilities in diagnosing and treating cancer, as well as managing patient survival.

Gynecologic oncologists are combining surgical intervention with concentrated chemotherapy and hyperthermia to improve prognosis for patients with metastatic ovarian tumors. Unlike conventional chemotherapy, which when administered orally or intravenously, becomes diluted in the blood stream, hyperthermic intraperitoneal chemotherapy (HIPEC) bathes the affected cancerous region with a high concentration of heated chemotherapy, with minimal to no exposure to the rest of the body. The synergistic effect of cytoreductive surgery, chemotherapy, and hyperthermia offers an attractive treatment alternative for the ideal patient. After surgery to remove as much of the tumor as possible, the abdomen is closed off. Inflow and outflow tubes are placed through the abdominal walls and heated chemotherapy drugs are circulated through the abdominal cavity for 90 to 120 minutes. The lining of the abdominal cavity acts as a barrier to drug absorption into the blood stream, so that higher concentrations of drugs can be delivered directly to the tumor site safely. Recirculating the fluid through the abdominal cavity and manually moving the patient during the procedure assures even distribution of the drug and heat throughout the cavity. At the end of the procedure, the drug is flushed out to avoid further absorption. Studies have shown that women with recurrent ovarian carcinoma who undergo HIPEC treatment tolerate this procedure well with acceptable morbidity. The largest series to date has

suggested that the time to progression after HIPEC is 10 months, with an overall survival in this group of 31 months.

A Case Study: Intraperitoneal Chemotherapy Patient profile: A 45-year-old female presented to her primary care provider with complaints of fullness in her abdomen, loss of appetite, and abdominal and pelvic pressure. During a physical examination, a potential abdominal mass was identified. CT imaging of the abdomen and pelvis confirmed a 6 cm mass on the left ovary and a small amount of fluid in the abdomen and pelvis. The patient’s primary care provider referred her to the Magee-Womens Gynecologic Oncology Program of UPMC Cancer Centers for a possible surgical intervention. After being seen and evaluated by a gynecologic oncologist, she was scheduled for further testing, including preoperative colonoscopy, chest x-ray, and serum tumor markers, to determine the best options for treatment. Testing revealed that the CA-125 was elevated to 257 U/ml and the CEA, CA 19-9 were normal. After further review of her case, the patient’s gynecologic oncologist determined that the patient was a good candidate for surgery. During the procedure, part of her colon that was in the pelvis was removed, along with her uterus, ovaries, fallopian tubes, and the pelvic mass. Her omentum, which was noted to be infiltrated with metastatic ovarian cancer, was removed, along with enlarged pelvic and paraaortic lymph nodes. The patient’s large bowel was reconnected, and the surgeon placed an intraperitoneal PORT-A-CATH®.

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PROGRAM INNOVATIONS continued

The patient was in the hospital for six days and was discharged without any significant postoperative complications. The chemotherapy plan included a combination of intravenous (IV) chemotherapy and intraperitoneal (IP) chemotherapy. The schedule included IV paclitaxel on day one, IP cisplatin on day two, and then IP paclitaxel on day eight. This schedule was repeated six times through completion of therapy. Prior to the start of the first course of chemotherapy, the patient’s CA-125 levels dropped to 115 U/ml. The patient continued to have her CA-125 monitored before the start of each cycle of chemotherapy. Her CA-125 rapidly declined to eight by the third cycle of therapy. The patient’s fourth cycle of chemotherapy was delayed due to the development of nausea, fatigue, and a low white blood cell count, requiring the addition of IV fluids and medications to keep her white blood cell count high enough for chemotherapy. Although the patient felt slightly fatigued and had mild numbness and tingling in her hands and feet, at the completion of IV and IP chemotherapy treatment, she had no significant complications. The patient’s IP port was removed in the operating room approximately four weeks after completion of chemotherapy.

Concerned about recurrence of her ovarian cancer, the patient discussed additional therapeutic options with her gynecologic oncologist, including additional chemotherapy with monthly treatments of paclitaxel; enrollment in a clinical trial evaluating 12 months of paclitaxel compared to 12 months of paclitaxel poliglumex to no further therapy; or observation. After considering her options, the patient chose to be enrolled on Gynecologic Oncology Group protocol 212 where she received 12 additional treatments of paclitaxel. During therapy she received all treatment on schedule, but had worsening of the numbness and tingling in her hands and feet. As part of the clinical trial, the patient had CT scans every three months and monthly CA-125 values drawn. Her CA-125 values returned to normal with a highest reported value of 15. The patient was then followed by the Magee-Womens Gynecologic Oncology Program and her surgeon every three months for the first 24-months, and was seen yearly by her primary care provider. At the 24-month visit, the patient had a slight elevation of her CA-125 to 37. As follow-up, a repeat CA-125 analysis and a CT scan were performed a month later. The CA-125 was 52, and her CT scan showed a 4 cm left pelvic mass. The patient underwent a second surgery for removal of the pelvic mass, and during surgery was treated with hyperthermic chemotherapy using cisplatin. Postoperatively she was hospitalized for 11 days. After discharge she was

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treated with a combination of chemotherapy of carboplatin and gemcitabine for six treatments. At the end of treatment, her CA-125 was 12, and her CT scan showed no evidence of cancer. The patient is now in her second remission four months after completion of her second course of chemotherapy.

RoboticTechnology Enhances a Suite of Surgical Procedures The Division of Gynecologic Oncology at Magee-Womens Hospital of UPMC, a leader in the use of minimally invasive surgery to manage gynecologic cancers, is using robotic technology to enhance the surgical treatment of endometrial carcinoma, isolated pelvic masses, and cervical carcinoma. Robotic surgical technology offers enhanced visualization and dexterity that conventional minimally invasive surgery (MIS), performed using two-dimensional, long-shafted instruments, does not provide. Studies have shown that robotic surgery outcomes are consistent with standard MIS. With recovery times reduced, patients with malignant cancer can start follow-up chemotherapy or radiation therapy almost immediately, giving the drugs a chance to work before the tumor potentially returns.

Patient and Family-Centered Care Initiatives

Patient Navigator Program In January 2008, as a result of the Oncology Patient and Family-Centered Care Initiative, an Oncology Patient Navigator Program was initiated with one year of funding thanks to support from the Susan G. Komen for the Cure®, Pittsburgh. Subsequently the program has grown with additional funding from the Magee Volunteer Service Board. Through the program, patient navigators are available to provide individualized assistance to patients, family, and caregivers throughout their health care experience. Their mission is to help guide the patient through their cancer diagnosis and treatment, answering questions and providing information about available resources to ensure a comfortable experience for the patient. Since its inception, the patient navigators have interacted with over 1,500 patients.

“LiveWell” Survivorship Program Patient advisors, as part of the Patient and Family-Centered Care Initiative, have assisted the Magee-Womens Cancer Program in developing the “LiveWell” Cancer Survivorship Program in 2009 along with a multidisciplinary team of physicians, nurses,

social workers, navigators, and educators. Set to be fully implemented in 2010, the program has been introduced to cancer survivors at Magee through a few key programs: Cancer Survivorship Workshop Held in September 2009, nearly 300 cancer survivors and family attended the workshop, which focused on issues relevant to survivorship, including genetics, nutrition, surveillance, recurrence, research, and a panel of breast and gynecologic cancer survivors telling their stories of survival. In addition, survivors completed a program assessment, which is being used to develop the full survivorship program for 2010. Cancer Survivors Day Planned by a multidisciplinary committee, this program has become a tradition at Magee. The celebration of survivorship includes an uplifting program with a welcome from one of the oncology physicians, along with music and food. More than 250 survivors and their families, physicians, and other care providers from Magee attend each year.

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Advocacy, Community Outreach, and Education

Part of the mission of Magee-Womens Hospital of UPMC is to raise awareness and offer support to cancer patients, their families, and friends through advocacy, education, and community events. The 2008 ovarian cancer-focused highlights include:

Community Education

Advocacy and Awareness

• Research Updates

Throughout the year, health care professionals have participated in numerous professional presentations and community events both locally and nationally.

• Cancer Risk Assessment

Walk to Break the Silence on Ovarian Cancer Magee was the presenting sponsor of the National Ovarian Cancer Coalition-Pittsburgh Division’s annual Walk to Break the Silence on Ovarian Cancer, which takes place in September/October each year. Many of Magee’s employees and patients participated in this event.

Support Programs Oncology social workers provide counseling and support to patients and their families, and facilitate group support meetings and peer support programs focused on ovarian cancer patients. • Ovarian Cancer Volunteer Program • Picking Up the Pieces: a peer support program sponsored by the National Ovarian Cancer Coalition (NOCC) in collaboration with Magee. Ovarian Cancer Patient Care Fund Through a generous donation from the National Ovarian Cancer Coalition, an ovarian cancer patient care fund was established in 2008 to provide financial assistance to ovarian cancer patients. The fund is administered by the Oncology Patient Navigators.

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Magee experts presented a variety of community programs throughout 2008-2009. Program topics included: • Living with Cancer • Clinical Innovations

Ovarian Cancer Education Series The Ovarian Cancer Education Series was initiated in 2006 in partnership with the National Ovarian Cancer Coalition (NOCC) and consists of monthly lectures designed for all individuals seeking up-to-date information about ovarian cancer: cancer survivors, women recently diagnosed with the illness, or women and their family members concerned about the disease.

Continuing Medical Education Magee specialists presented at a variety of professional education venues regionally, nationally, and internationally in 2008. Our experts continue to publish research, clinical care and outcome articles, and abstracts in national and international peer reviewed journals.

Tumor Board Conference The Division of Gynecologic Oncology sponsors a weekly multidisciplinary Tumor Board Conference which focuses on patient management issues and current trends in gynecologic oncology. It is attended by individuals within the subspecialties of gynecologic oncology, medical oncology, radiation oncology, radiology, pathology, patient care services, and social work. Clinical dilemmas or controversial and unusual patient cases are selected by the attending staff, presented by the senior resident, and discussed by the participants.

Radiographic and pathologic findings are correlated with the clinical findings. Rationale for an approach to the clinical problem is discussed by the attendees. At the end of each presentation, senior residents, in conjunction with the attending gynecologist, are asked to formulate and explain their management strategies to the group. This conference allows discussion of different approaches to the problems encountered in oncology. The meeting also provides the opportunity for possible recruitment of patients within research protocols.

The goal of the program is to provide information to women and their loved ones to help understand their illness.

Research

Magee physicians and researchers remain on the cutting edge of discovering new treatments with promising outlooks for patients. Magee-Womens Research Institute (MWRI) works in collaboration with the University of Pittsburgh Cancer Institute (UPCI) to investigate cancers that affect primarily women, including breast, ovarian, uterine, and cervical cancers. Magee and UPCI have a joint program in care and research relevant to breast cancer, and Magee and MWRI have formed the Jennie K. Scaife Ovarian Cancer Center of Excellence. Basic and clinical studies in progress include clinical investigation, mechanistic studies, and assessment of the psychosocial and behavioral impact of these diseases.

ClinicalTrials for Patients with Hereditary Breast and Ovarian Cancers UPCI will be the primary site for a clinical trial of ABT-888, a drug previously proven in combination treatments to improve chemotherapy’s effectiveness by lowering cancer cells’ resistance to treatment. This trial will, for the first time, examine ABT-888 as a single agent for patients with cancers related to BRCA 1 or 2 genetic mutations, which predispose patients to breast and ovarian cancers.

cells in patients with BRCA mutations are particularly reliant on the mechanism of DNA repair that is inhibited by PARP. In previous trials in which ABT-888 was used as a combination treatment, it appeared to inhibit PARP, making cancer cells more sensitive to chemotherapy. The hope with this trial is that patients with BRCA mutations or certain other breast or ovarian cancers may respond to ABT-888 as a single agent. This drug also is intriguing because breast cancer patients with BRCA mutations, who have exhausted all other therapeutic options, may have an additional treatment option. Other trials also have suggested that ABT-888 also may have fewer side effects than many other therapies. The study is part of a National Cancer Institute (NCI)-funded initiative to develop new therapies to treat cancer more effectively. The program at UPCI is one of 15 in the country. Early-phase clinical trials are the first step for all new therapeutics, and they are designed to evaluate the safety and dosing of novel therapies that have shown promise in earlier animal and preclinical studies.

According to the study’s principal investigator, Shannon Puhalla, MD, assistant professor at the University of Pittsburgh School of Medicine and breast oncologist at Magee-Womens Cancer Program of UPMC Cancer Centers, ABT-888 targets the polymerase (PARP) family of enzymes responsible for a wide variety of cellular processes in cancer cells. Cancer cells have been shown to have increased levels of PARP, which is believed to cause resistance to chemotherapies and other cancer treatments. Tumor

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RESEARCH continued

Ovarian Cancer ClinicalTrials Principal Investigator

Sponsor

Protocol Title Ovarian Epithelial Cancer Phase I

Kristin Zorn, MD

Sanofi-AventisOX-06-009

Phase I dose-escalation parallel study of intravenous docetaxel/intraperitoneal oxaliplatin and intraperitoneal docetaxel/intravenous oxaliplatin in platinum-sensitive and platinum-resistant recurrent ovarian, primary peritoneal, and fallopian tube cancer Phase II

Thomas Krivak, MD

Genentech07-081

A Phase II, multicenter, randomized, blinded, placebo-controlled trial of carboplatin and gemcitabine plus bevacizumab in patients with platinum-sensitive recurrent ovary, primary peritoneal, or fallopian tube carcinoma

Robert P. Edwards, MD

GOG 170N

A Phase II evaluation of a urokinase-derived peptide (A6) (IND# 64,298) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (170 series)

Kristin Zorn, MD

Novartis/ GenentechRAD-BEV

Phase II study of RAD001 and bevacizumab in recurrent ovarian, peritoneal, and fallopian tube cancer. An investigator-initiated, single-institution trial at Magee-Womens Hospital of UPMC Phase III

Joseph P. Kelley III, MD

GOG 212

A randomized, Phase III trial of maintenance chemotherapy comparing 12 monthly cycles of single agent paclitaxel or XYOTAXTM (CT-2103) (IND 70177) vs. no treatment until documented relapse in women with advanced ovarian or primary peritoneal cancer who achieved a complete clinical response to primary platinum/taxane chemotherapy (NCI Version 01 27 05) (GOC 05-004)

Robert P. Edwards, MD

GOG 252

A Phase III clinical trial of bevacizumab with IV versus IP chemotherapy in ovarian, fallopian tube, and primary peritoneal carcinoma NCI-supplied agent(s): bevacizumab (NSC#704865, IND #7921) NCI Version 6/12/09

Robert P. Edwards, MD

MorphoteckMORab003-003

A randomized, double-blind, placebo-controlled, Phase III study to assess the efficacy and safety of weekly farletuzumab (MORAb-003) in combination with carboplatin and taxane in subjects with platinum-sensitive ovarian cancer in first relapse

Robert P. Edwards, MD

MorphoteckMORab003-004

A randomized, double-blind, placebo-controlled, Phase III study to assess the efficacy and safety of weekly farletuzumab (MORAb-003) in combination with carboplatin and taxane in subjects with platinum-sensitive ovarian cancer in first relapse Prospective/Retrospective Study

Francesmary Modugno, PhD

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Novel risk factors and potential early detection markers for ovarian cancer HOPE (Hormones and Ovarian Cancer Prediction)

RESEARCH continued

Principal Investigator

Sponsor

Protocol Title Ovarian Low Malignant Potential Tumor Phase II

Robert P. Edwards, MD

GOC 06-03

A single-arm open label, Phase II study to assess the safety and efficacy of the trifunctional antibody catumaxomab (anti-EpCAM x anti-CD3) administered intraperitoneally in ovarian cancer patients with recurrent symptomatic malignant ascities

Non-Treatment (Specimen/High Risk) Robert P. Edwards, MD

GOG 136

Acquisition of human gynecologic specimens to be used in studying the causes, diagnosis, prevention, and treatment of cancer

Thomas Krivak, MD

DOD-GynOnc# 04-124

Tissue and data acquisition activity for the study of gynecologic disease as part of the gynecologic disease program

Robert P. Edwards, MD

Precision Therap.-PT- 301

A non-Interventional prospective study of the accuracy of the Precision Therapeutics, Inc. Chemoresponse Assay in patients with recurrent epithelial ovarian, peritoneal, or fallopian tube cancer

Robert P. Edwards, MD

Scaife Foundation-Gyn-Onc 22-096

Prognostic marker: acquisition of blood samples and tissue for research purposes

Gyn-Onc# 23-071

Magee-Womens Hospital of UPMC Women's Cancer and Cancer-Like Disorders Registry

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2008 Site Specific Analysis

Ovarian Cancer

FIGURE 1: 2008 GYN PRIMARY SITE DISTRIBUTION

Ovarian cancer accounts for approximately 3% of all cancers in women. It ranks second in the nation among gynecologic cancers, following cancer of the uterine corpus. An estimated 21,650 new cases are expected in the U.S. in 2008. During 1987-2004, ovarian cancer incidence declined at a rate of 0.9% per year. A woman’s lifetime risk of developing invasive ovarian cancer is one in 71.

Corpus Uteri - 328 Ovary - 153 Cervix Uteri - 84 Vulva - 80 Fallopian Tube - 21

In 2008, ovarian cancer was the second most common gynecologic cancer site diagnosed and treated at Magee-Womens Hospital of UPMC, with a total of 153 cases. Total analytic (cases first course diagnosed and or treated at this facility) ovarian cancer cases were 134 and total nonanalytic (cases first course diagnosed and treated at an outside facility) were 19. [Table 1] [Figure 1] TABLE 1

Primary Site

Total

Percent

Class of Case Analytical

Non Analytical

Corpus Uteri

328

46.9%

313

15

Ovary

153

21.9%

134

19

Cervix Uteri

84

12.0%

76

8

Vulva

80

11.4%

74

6

Fallopian Tube

21

3.0%

18

3

Peritoneal

20

2.9%

18

2

Vagina

14

2.0%

12

2

700

100.0%

645

55

Data Source: Magee-Womens Hospital Cancer Registry

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Peritoneal - 20 Vagina -14

Data Source: Magee - Womens Hospital Cancer Registry

2008 Geographic Distribution by County and State As a large referral center, Magee provides services to many western Pennsylvania counties [Table 2] and surrounding states [Table 3]. In 2008, the total gynecologic cancer patient population in Allegheny County equaled 41.7% and the ovarian cancer patient population equaled 38.6%. The out-of-county patient population was 51.7% for GYN cases in Westmoreland County, Fayette County, Butler County, and Washington County having the largest number of referring patients. Out-of-state patient population was 6.6%. The out-of-county patient population was 51.6% for ovarian cases with Westmoreland County, Washington County, Fayette County, and Beaver County having the largest number of referring patients. The out-of-state patient population was 9.8%.

2008 SITE SPECIFIC continued

TABLE 2: 2008 SUMMARY BY STATE AND COUNTY — PENNSYLVANIA

GYN Cases Total #

GYN Cases Total %

Ovary Cases Total #

Ovary Cases Total %

GYN Cases Total #

GYN Cases Total %

Ovary Cases Total #

Ovary Cases Total %

Allegheny

292

41.7%

59

38.6%

Jefferson

8

1.1%

2

1.3%

Westmoreland

75

10.7%

13

8.5%

Somerset

6

0.9%

1

0.7%

Fayette

39

5.6%

7

4.6%

Greene

5

0.7%

0

0.0%

Butler

30

4.3%

5

3.3%

Indiana

5

0.7%

0

0.0%

Washington

29

4.1%

12

7.8%

McKean

5

0.7%

3

2.0%

Erie

25

3.6%

6

3.9%

Venango

4

0.6%

1

0.7%

Beaver

23

3.3%

7

4.6%

Bedford

3

0.4%

0

0.0%

Mercer

23

3.3%

6

3.9%

Cameron

3

0.4%

0

0.0%

Cambria

18

2.6%

4

2.6%

Warren

3

0.4%

0

0.0%

Lawrence

12

1.7%

1

0.7%

Centre

2

0.3%

1

0.7%

Blair

12

1.7%

6

3.9%

Clarion

2

0.3%

0

0.0%

Armstrong

9

1.3%

1

0.7%

Elk

2

0.3%

0

0.0%

Clearfield

9

1.3%

1

0.7%

Huntington

1

0.1%

1

0.7%

Crawford

8

1.1%

1

0.7%

Lycoming

1

0.1%

0

0.0%

654

93.4% 138

90.2%

County

Total cases PA counties gyn cases Total cases PA counties ovarian cases

County

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2008 SITE SPECIFIC continued

TABLE 3: OUT OF STATE

2005 Incidence Comparison United States-Pennsylvania-Allegheny County-Magee-Womens Hospital

GYN Cases Total #

GYN Cases Total %

Ovary Cases Total #

Ovary Cases Total %

Florida

2

0.3%

1

0.7%

Indiana

1

0.1%

1

0.7%

Primary Peritoneal Cancers

Missouri

1

0.1%

0

0.0%

2006 Primary Peritoneal Cancer (Female) Magee-Womens Hospital – United States – Pennsylvania

New York

5

0.7%

2

1.3%

Ohio

13

1.9%

4

2.6%

Tennessee

1

0.1%

1

0.7%

Texas

1

0.1%

1

0.7%

West Virginia

22

3.1%

5

3.3%

Total

46

6.6%

15

9.8%

Total PA counties and out of state

700

100.0%

153

100.0%

State

In 2005, there were 19,842 cases of ovarian cancer in the US, 1,134 cases of in PA, 130 cases in Allegheny County, and 131 cases at Magee. [Figure 2]

In 2006, there were 705 cases of primary peritoneal cancer or extra-ovarian cancer in the United States, 46 cases in Pennsylvania, and 18 cases at Magee. In primary peritoneal cancer, only the surface of the ovary is involved with the majority of the tumor in the peritoneal cavity. The clinical presentation, surgery, treatment, and prognosis are the same as those of ovarian cancer. [Table 4]

FIGURE 2: 2007 GEOGRAPHIC BREAKDOWN OUTSIDE STATES Data Sources: Magee-Women’s Hospital Cancer Registry [Table 3]. Commonwealth of Pennsylvania Department of Health. Bureau of Health Statistics and Research, Harrisburg, PA: September 2009 [Figure 2].

100,000

U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999-2005 Incidence and Mortality Web-based Report. Atlanta (GA): Department of Health and Human Services, Centers for Disease Control and Prevention, and National Cancer Institute: 2009 [Figure 2].

10,000 1,000 100 10 1 Total Cases

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United States

PA

Allegheny County

Magee-Womens Hospital

19,842

1,134

130

131

2008 SITE SPECIFIC continued

TABLE 4

FIGURE 3: 2006 HYSTOLOGY COMPARISON US PA MWH 100%

Primary Peritoneal Cancer 2006 Comparison US vs. PA vs. MWH

90%

US

PA

MWH

705

46

18

80% 70%

Data Source: NCDB, Commission on Cancer, ACoS. Benchmark Reports, v9.0

60%

Histology

50%

2006 Histology Comparison – Ovarian Cancer Magee-Womens Hospital – United States – Pennsylvania

40% 30%

Primary ovarian tumors can be divided into three groups based on cell origin. Epithelial carcinomas are the most common and account for approximately 90% of all ovarian cancers. Sex-cord stromal tumors and germ cell tumors are relatively uncommon. Metastatic, pseudoneoplastic, or uncertain behavior, is a fourth group. According to the American Joint Committee on Cancer (AJCC), all epithelial ovarian tumors should be subdivided as presented by the World Health Organization (WHO) as follows: serous tumors, mucinous tumors, endometrioid tumors, clear cell tumors, Brenner, undifferentiated tumors, and unclassified tumors. Histologic evaluation is an important prognostic factor in that all stages of borderline tumors have a better prognosis. [Figure 3]

20% 10% 0%

US

PA

MWH

Papillary Serous Cystadenocarcinoma

21.1%

15.8%

32.4%

Other Specified Types

18.4%

17.2%

24.5%

Clear Cell Adenocarcinoma, NOS

5.4%

4.9%

10.8%

Endometrioid Carcinoma

10.1%

11.4%

8.8%

Serous Surface Papillary Carcinoma

8.1%

11.2%

6.9%

Serous Cystadenocarcinoma, NOS

19.8%

21.8%

6.9%

Adenocarcinoma, NOS

9.4%

8.2%

6.9%

Mucinous Carcinoma

3.6%

4.4%

2.9%

Carcinoma, NOS

4.2%

5.2%

0.0%

Data Source: NCDB, Commission on Cancer, ACoS. Benchmark Reports, v9.0

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2008 SITE SPECIFIC continued

Age

Race

2006 Age Comparison – Ovarian Cancer Magee-Womens Hospital – United States – Pennsylvania

2006 Race Comparison – Ovarian Cancer Magee-Womens Hospital – United States – Pennsylvania

About 90% of women who get ovarian cancer are older than 40 years of age, with the greatest number being 55 years or older. In women over the age of 45, an ovarian mass has approximately a 30–40% chance of being malignant. In women less than 45 years of age, or premenopausal women, an ovarian mass is more likely to be benign, with malignant tumors making up less than 15%.

White women have the highest incidence rate for ovarian cancer. [Figure 5]

Germ cell tumors occur more frequently in patients 20 years of age or less. Epithelial ovarian tumors are more common in women of reproductive age and in postmenopausal women. Within these two groups, malignant epithelial ovarian carcinomas tend to occur after the age of 60, whereas benign and low malignant potential or borderline ovarian tumors tend to occur in the 40–60 year age group. Sex-cord stromal tumors are most common in women from 40 to 60 years of age. [Figure 4] FIGURE 4: 2006 AGE COMPARISON US PA MWH 35% 30%

20% 15% 10% 5% 0% Pedi- 16-29 30-39 atric

40-49 50-59

60-69 70-79

80-89

90+

US

0.8%

2.7%

4.3% 14.3% 25.7% 23.3% 17.8% 10.6% 0.6%

PA

0.3%

1.4%

3.5% 10.1% 23.4% 24.5% 21.5% 14.2% 1.1%

MWH

0.0%

6.9%

2.9%

5.9% 32.4% 17.7% 18.6% 15.7% 0.0%

Data Source: NCDB, Commission on Cancer, ACoS. Benchmark Reports, v9.0

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100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Black

Native Hispanic American

Asian/ Pacific

Other/ Unknown

Race

White

US

78.6%

8.7%

5.1%

0.2%

3.3%

4.1%

PA

85.8%

10.6%

0.8%

0.0%

0.5%

2.2%

MWH

97.1%

2.9%

0.0%

0.0%

0.0%

0.0%

Data Source: NCDB, Commission on Cancer, ACoS. Benchmark Reports, v9.0

25%

Age

FIGURE 5: 2006 RACE COMPARISON US PA MWH

2008 SITE SPECIFIC continued

Staging 2006 Stage Comparison – Ovarian Cancer Magee-Womens Hospital – United States – Pennsylvania Stage is an important prognostic factor. Clinical evaluation, operative findings, radiology, as well as histopathologic evaluation, are used to determine stage. Hysterectomy and resection of the ovarian mass start the pathologic staging procedure. Laparotomy and staging biopsies should be performed of all suspicious sites, such as the omentum, mesentery, liver, diaphragm, and pelvic and para-aortic lymph nodes are required for a complete staging procedure. Pelvic washings are also required for staging.

A tumor limited to the ovaries is Stage I disease. A tumor involving one or both ovaries with pelvic extension and/or implants is Stage II. Stage III is tumor involving one or both ovaries with microscopically confirmed peritoneal implants outside the pelvis. Superficial liver metastasis and tumor limited to the true pelvis but with histologically verified malignant extension to small bowel or omentum is also Stage III. Stage IV ovarian cancer is a tumor involving one or both ovaries with distant metastasis including pleural effusion and positive cytologic test results existing or parenchymal liver metastasis. Distant site spread is considered to be end stage disease. Germ cell tumors are most likely to spread to distant sites while sex-cord stromal tumors stay localized and take many years to spread to distant sites. [Figure 6] FIGURE 6: 2006 STAGE COMPARISON US PA MWH 50% 40% 30% 20% 10% 0% Stage

I

II

US

19.4%

7.7%

IV

Unknown

42.2%

PA

20.7%

MWH

27.5%

III

18.5%

12.2%

7.9%

38.2%

19.4%

13.9%

3.9%

33.3%

20.6%

14.7%

Data Source: NCDB, Commission on Cancer, ACoS. Benchmark Reports, v9.0

13

2008 SITE SPECIFIC continued

FIGURE 7: 2006 1ST COURSE TX COMPARISON US PA MWH

First Course ofTreatment 2006 First Course Treatment Comparison Magee-Womens Hospital – United States – Pennsylvania

100% 90%

Treatment options are usually surgery, including total abdominal hysterectomy, bilateral salpingo-oophorectomy, pelvic and para-aortic lymph node dissection, and ovarian tumor cytoreduction debulking. This would be followed by a primary chemotherapy that contains a platinum and a taxane based compound. Factors affecting treatment choice depends on the tumor type, stage, age, and co-morbidities of the patient. Magee-Womens Hospital participates in multiple clinical trials for ovarian cancer, including nationwide trials from the Gynecologic Oncology Group (GOG). Magee is the only parent GOG institution in southwestern Pennsylvania with the ability to open any national trial being run by the GOG. Magee is one of the first hospitals in southwestern Pennsylvania to use intraperitoneal chemotherapy. This treatment involves infusing cisplatin and paclitaxel directly into the abdomen and has been shown to improve survival by more than 16 months over traditional intravenous chemotherapy. This treatment can only be used in patients with optimal resection of disease. Magee is also the only hospital in southwestern Pennsylvania to use a newer treatment called hyperthermic intraoperative peritoneal chemotherapy (HIPEC) for ovarian cancer. The chemotherapy is poured into the peritoneal cavity while the patient is still in surgery at the time of debulking. A major advantage of such treatment is that chemotherapy can reach more places in the abdomen while the abdomen is open for surgery. The chemotherapy is heated to a temperature higher than the normal body temperature, and is thought to be more effective in destroying cancer cells. Intraperitoneal chemotherapy causes fewer side effects than chemotherapy given intravenously, because of the high concentrations of chemotherapy solution reaching the blood stream through IV chemotherapy. [Figure 7]

14

80% 70% 60% 50% 40% 30% 20% 10% 0%

US

PA

MWH

Surg. & Chem

59.7%

60.9%

65.7%

Surg. Only

23.4%

24.6%

16.7%

No 1st Course Rx

5.7%

5.5%

3.9%

Chem. Only

5.7%

6.5%

8.8%

Other Specified Therapy

5.5%

2.6%

4.9%

Data Source: NCDB, Commission on Cancer, ACoS. Benchmark Reports, v9.0

2008 SITE SPECIFIC continued

FIGURE 8: 2006 SURGICAL PROCEDURE COMPARISON US PA MWH

Surgery 2006 Surgical Procedure Comparison – Ovarian Cancer Magee-Womens Hospital – United States – Pennsylvania

100%

All primary ovarian cancers and borderline or low malignant potential tumors require surgical staging to determine future treatment. Patients with optimal debulking after surgery have a better prognosis than those with suboptimal debulking. Optimal debulking is considered less than one cm of residual tumor. [Figure 8]

80%

60%

40%

20%

0%

US

PA

MWH

Debulking; cytoreductive Surg.

29.1%

28.8%

47.1%

Unilateral or bilateral omentectomy, partial or total hysterectomy

28.5%

26.9%

16.7%

No surg. to the primary site

18.0%

18.6%

11.8%

BSO W/ hysterectomy

15.2%

17.3%

14.7%

Unilateral SO; unk if hysterectomy done

4.2%

3.6%

3.9%

Total removal of tumor or single ovary

1.6%

1.9%

2.9%

Surgery, NOS

1.2%

0.3%

1.0%

Pelvic exenteration

1.1%

0.8%

0.0%

Unk if surg. performed

1.0%

1.9%

2.0%

S-O, NOS

0.1%

0.0%

0.0%

Data Source: NCDB, Commission on Cancer, ACoS. Benchmark Reports, v9.0

15

2008 SITE SPECIFIC continued

Survival 1998-2001 Observed Survival of Ovarian Cancer Patients by AJCC Stage Magee-Womens Hospital – United States – Pennsylvania Ovarian cancer is the fifth most frequent cause of cancer death in women after lung and bronchus, breast, colorectal, and pancreatic cancers with an estimated 15,520 deaths in 2008. Ovarian cancer causes more deaths of any other cancer of the female reproductive system. Most patients with ovarian cancer have widespread disease at presentation. As a result, yearly mortality in ovarian cancer is approximately 65% of the incidence rate. A woman’s lifetime risk of dying from invasive ovariancancer is one in 95. [Figure 9] References American Cancer Society. Cancer Facts and Figures 2008. Atlanta: American Cancer Society; 2008. Commonwealth of Pennsylvania Department of Health. Bureau of Health Statistics and Research, Harrisburg, PA: September 2009. FIGURE 9: 5-YR OBSERVED SURVIVAL 1998 - 2001 US AND NJ, NY, PA AND MWH

American Joint Committee on Cancer. Ovary. In: AJCC Staging Manual. 6th edition.

100

New York: Springer; 2002: pg. 275-279.

90

U.S. Department of Health and Human Services; National Institute of Health, National Cancer Institute, Ovarian Cancer, Baltimore, MD: 2009.

70

PERCENT

http://www.cancer.gov/cancertopics/pdq/treatment/ovarianepithelial/healthprofessional/allpages

80

U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999-2005 Incidence and Mortality Web-based Report. Atlanta (GA): Department of Health and Human Services, Centers for Disease Control and Prevention; Washington, DC: National Cancer Institute; 2009.

60 50 40 30 20 10 0

0 Years

1 YEAR

2 YEARS

3 YEARS

US Stage I

100%

98%

95%

93%

4 YEARS 91%

5 YEARS 88%

NJ, NY, PA Stage I

100%

98%

95%

92%

90%

88%

MWH Stage I

100%

98%

95%

92%

92%

89%

US Stage II

100%

92%

86%

81%

75%

71%

NJ, NY, PA Stage II

100%

91%

83%

78%

71%

65%

MWH Stage II

100%

96%

93%

85%

81%

81%

US Stage III

100%

83%

67%

53%

42%

34%

NJ, NY, PA Stage III

100%

81%

64%

50%

41%

34%

MWH Stage III

100%

82%

64%

50%

41%

30%

US Stage IV

100%

63%

45%

32%

24%

19%

NJ, NY, PA Stage IV

100%

57%

40%

29%

21%

16%

MWH Stage IV

100%

68%

41%

20%

14%

12%

Data Source: NCDB, Commission on Cancer, ACoS. Benchmark Reports, v9.0

16

2008 CANCER Committee ROSTER

Paniti Sukumvanich, MD Chairman

Beverly Gaetano Medical Social Work

Shannon Puhalla, MD Medical Oncology

Gretchen Ahrendt, MD Department of Surgery

Priyanka Gopal Nutrition Services

Denise Stahl, RN, MSN Palliative Care Specialist

Anna Ardine-Jones Nutritional Services

Judy Herstine Administrator, Women’s Cancer Services

Susan Stollings, PhD Sr Clinician, Behavioral Medicine & Oncology

Ronald Johnson, MD Department of Surgery

Jules Sumkin, DO Radiology

Deidre Cleary Clinical Research Coordinator, Breast Cancer Research

Joseph Kelley III, MD Gynecologic Oncology

Winifred Teuteberg, MD Palliative Care

Jeannine Konzier Quality Management

Darcy Thull Cancer Genetics

Karen Cooper, LCSW Patient Navigation

Kim Marks Clinical Registry Information Services

Tracy C. Nagy, RN, BSN, MSN Women’s Cancer Center

Lindsay Corporon, Pharm D Clinical Pharmacist

Betsy Martinelli Senior Communications Manager

Sharon Winters Registry Information Services

David Dabbs, MD Pathology

Louise Mazur, RHIT, CTR Tumor Registry

Robert Edward, MD Gynecologic Oncology Research

Ketul Patel Vice President, Operations

Mary Ann Aviles, RN Patient Care Services Sushil Beriwal, MD Radiation Oncology

17

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