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

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 (, the National Coalition of Cancer Survivorship,
the newsletter Conversations, SHARE-Self-Help for Women With Breast or
Ovarian Cancer (, voluntary associations such as
Cancer Care (, 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
Center for Cancer Research
Contact: Mahrukh
Hussain, (301) 435-0591


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