Phase II evaluation of three-day topotecan in recurrent platinum-sensitive ovarian carcinoma: a gynecologic oncology group study.

摘要: BACKGROUND Topotecan, administeredintravenously at a dose of 1.5 mg/m2 per day for 5 days every 21 days, is an established regimen in the treatment recurrent ovarian carcinoma. Alternate dosing strategies have sought to improve toxicity. The authors evaluated tolerability and antitumor activity 3-day topotecan regimen. METHODS A multicenter Phase II study, which included patients with platinum-sensitive carcinoma, was conducted. Patients were receive intravenous 2.0 3 until disease progression or unacceptable toxicity occurred. Doses modified 0.25-mg/m2 increments based on tolerability. Granulocyte–colony-stimulating factor support used as necessary. RESULTS From February June 2000, 30 enrolled. Their median age 56 years (range, 41–81 years). Twenty-nine evaluable efficacy. A courses 1–11 courses) administered. Eighteen (60%) experienced Grade 4 neutropenia. There one report each thrombocytopenia, anemia, gastrointestinal (grading performed according National Cancer Institute Common Toxicity Criteria). Ten developed leukopenia 9 had Serious nonhematologic events rare. 2 (7%) complete partial responses, overall response rate 14%. Sixteen (55%) stable (31%) progression. CONCLUSIONS A generally well tolerated, although lower than that standard 5-day schedule. 2003. © 2003 American Society. DOI 10.1002/cncr.11690