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Oral Topotecan as Single-Agent Second-Line Chemotherapy in Patients With Advanced Ovarian Cancer

From Duke University Medical Center, Durham, NC; University of North Carolina, Chapel Hill, NC; Medical Center of Delaware, Newark, DE; Abington Memorial Hospital, Abington; SmithKline Beecham Pharmaceuticals, Oaks, PA; Albany Medical College, Albany, NY; Norwegian Radium Hospital, Oslo, Norway; Royal South Hants Hospital, Southampton; and SmithKline Beecham Pharmaceuticals, Harlow, United Kingdom.

Address reprint requests to Daniel L. Clarke-Pearson, MD, Department of Obstetrics & Gynecology #3079, Duke University Medical Center, Durham, NC 27710-0001; email: clark011{at}mc.duke.edu

PURPOSE: To evaluate oral topotecan as single-agent, second-line therapy in patients with ovarian cancer previously treated with a platinum-based regimen.

PATIENTS AND METHODS: Patients (N = 116) received oral topotecan 2.3 mg/m² daily for 5 days every 21 days. Eligibility criteria included histologic diagnosis of International Federation of Gynecology and Obstetrics stage III or IV epithelial ovarian cancer, bidimensionally measurable disease, prior platinum-containing chemotherapy, age 18 years, performance status 2, and life expectancy 12 weeks.

RESULTS: Overall response rate was 21.6% (25 of 116 patients). Median duration of response was 25.0 weeks; median time to response was 8.4 weeks. Median time to progression was 14.1 weeks; median survival was 62.2 weeks. Grade 4 neutropenia was experienced by 50.4% of patients in 13.4% of courses administered. Grade 4 thrombocytopenia was experienced by 22.1% of patients in 5.1% of courses. Grade 3 or 4 anemia was experienced by 29.2% of patients in 8.5% of courses. Most frequent nonhematologic toxicities were predominantly (> 90%) grade 1 or 2 and included nausea, alopecia, diarrhea, and vomiting.

CONCLUSION: Second-line oral topotecan administered at 2.3 mg/m² for 5 days every 21 days demonstrated activity in patients with progressive or recurrent ovarian cancer after first-line platinum-based chemotherapy. This activity was comparable to that seen in previous studies with intravenous topotecan. Grade 4 neutropenia was less frequent with oral topotecan than previously reported for intravenous topotecan. Oral topotecan is an active, tolerable, and convenient formulation of an established agent for the second-line treatment of advanced epithelial ovarian cancer and may also facilitate exploring prolonged treatment schedules.

G.A.R., S.R.L., and M.H.D. are employees of SmithKline Beecham Pharmaceuticals. R.A.B. and S.Z.F. were employees of SmithKline Beecham Pharmaceuticals.

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				R. L. Coleman Emerging Role of Topotecan in Front-Line Treatment of Carcinoma of the Ovary Oncologist, October 1, 2002; 7(90005): 46 - 55. [Abstract] [Full Text] [PDF]