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Clinical Trials in Ovarian Cancer, Part 2

Clinical Trials in Ovarian Cancer, Part 2

The American Cancer Society has estimated that 23,300 women will develop ovarian cancer in 2002, and 13,900 women will die from the disease.[1] The 5-year survival rate is about 80% for women with stage I disease, 50% for women with stage II disease, 25% for women with stage III disease, and 15% for women with stage IV disease. Among women with advanced-stage disease, optimal debulking surgery, as well as platinum/taxane-based adjuvant therapy prolongs disease-free and median survival.[2,3] Population-based data suggest that guidelines for therapy are not uniformly followed in community practice.[4] In addition, older patients appear to receive less aggressive treatment than younger patients.

Part 2 of this two-part series will discuss diagnosis and treatment trials for recurrent disease. Part 1, published in last month’s issue of ONCOLOGY, discussed prevention, screening, adjuvant treatment, neoadjuvant chemotherapy, and adjuvant chemotherapy trials for ovarian cancer.

Treatment of Persistent or Progressive Ovarian Cancer

Disease that persists or progresses during primary chemotherapy is termed "resistant" or "refractory." In such cases, the response to alternative agents such as gemcitabine (Gemzar), topotecan (Hycamtin), anthracyclines, hexamethylmelamine (Hexalen), and tamoxifen is generally modest and of short duration. These patients should be encouraged to consider early (phase I/II) trials of new investigational agents.

Treatment of Recurrent Ovarian Cancer

It has been hypothesized that women with recurrent ovarian cancer may benefit from surgery to debulk recurrent disease, followed by additional chemotherapy. The Gynecologic Oncology Group (GOG) will soon open a phase III clinical trial evaluating the role of secondary surgery, as well as two different chemotherapy regimens (GOG-0202). Women who have never received a platinum agent or those with disease recurring more than 12 months after platinum-based therapy should be treated with a platinum drug, which has demonstrated the most activity against epithelial ovarian cancer. If the patient has never received platinum or taxanes, ie, in the case of recurrent stage I disease, then use of a platinum/taxane combination is reasonable.

We do not know whether combination chemotherapy, sequential chemotherapy, or single-agent platinum therapy is most effective in women with previously treated ovarian cancer. These patients should be encouraged to consider enrolling in the phase I-III trials for which they may be eligible.

Patient Counseling

Women at possible familial risk for ovarian cancer should undergo appropriate pedigree analysis and counseling by either a cancer genetic counselor or a gynecologic/medical oncologist with expertise in ovarian cancer genetics. Women diagnosed with ovarian cancer should be told about available resources for support and information. Particularly helpful are professionally led groups such as the Gynecologic Cancer Foundation and the American Society of Clinical Oncology, patient-led organizations such as the Ovarian Cancer National Alliance (www.ovariancancer.org), the National Coalition of Cancer Survivorship, the newsletter Conversations, SHARE-Self-Help for Women With Breast or Ovarian Cancer (www.sharecancersupport.org), voluntary associations such as Cancer Care (www.cancercare.org), the Wellness Community, Gilda’s Club, and of course, the National Cancer Institute (NCI). Most offer printed materials as well as websites, and several provide teleconferences and online support groups. In addition, a number of hospitals host support groups, usually facilitated by an oncology nurse or social worker.

Acute toxicities during treatment often include alopecia and fatigue. Chronic toxicities after treatment may include fatigue, depression, and cognitive deficiencies ("chemobrain"). Clinicians should counsel patients about these potential side effects and make recommendations for appropriate interventions as needed.

Recurrent Disease: Diagnosis

Title: Pilot Diagnostic Study of Proteomic Evaluation in Patients With Stage III or IV Primary Peritoneal, Fallopian Tube, or Ovarian Epithelial Cancer, or Stage IIC Ovarian Clear Cell Cystadenocarcinoma in First Clinical Remission to Develop a Protein Profile Associated With Relapse (active)
Protocol Number: NCI-00-C-0018
Participating Institutions: Center for Cancer Research (NCI)
Contact: Mahrukh Hussain, (301) 435-0591

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