Miller David Scott, Blessing John A, Lentz Samuel S, McMeekin D Scott
Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Cancer. 2003 Oct 15;98(8):1664-9. doi: 10.1002/cncr.11690.
Topotecan, administered intravenously at a dose of 1.5 mg/m(2) per day for 5 days every 21 days, is an established regimen in the treatment of recurrent ovarian carcinoma. Alternate dosing strategies have sought to improve toxicity. The authors evaluated the tolerability and antitumor activity of a 3-day topotecan regimen.
A multicenter Phase II study, which included patients with platinum-sensitive ovarian carcinoma, was conducted. Patients were to receive an intravenous dose of topotecan of 2.0 mg/m(2) per day for 3 days every 21 days until disease progression or unacceptable toxicity occurred. Doses were modified in 0.25-mg/m(2) increments based on tolerability. Granulocyte-colony-stimulating factor support was used as necessary.
From February to June 2000, 30 patients were enrolled. Their median age was 56 years (range, 41-81 years). Twenty-nine patients were evaluable for toxicity and efficacy. A median of 5 courses (range, 1-11 courses) of topotecan was administered. Eighteen of 30 (60%) patients experienced Grade 4 neutropenia. There was one report each of Grade 4 thrombocytopenia, anemia, and gastrointestinal toxicity (grading performed according to National Cancer Institute Common Toxicity Criteria). Ten patients developed Grade 3 leukopenia and 9 had Grade 3 neutropenia. Serious nonhematologic events were rare. There were 2 (7%) complete and 2 (7%) partial responses, for an overall response rate of 14%. Sixteen (55%) patients had stable disease and 9 (31%) experienced disease progression.
A 3-day regimen of topotecan at a dose of 2.0 mg/m(2) per day was generally well tolerated, although the response rate was lower than that for the standard 5-day schedule.
拓扑替康以每日1.5mg/m²的剂量静脉给药，每21天给药5天，是复发性卵巢癌治疗中的一种既定方案。其他给药策略试图改善毒性。作者评估了一种3天拓扑替康方案的耐受性和抗肿瘤活性。
进行了一项多中心II期研究，纳入铂敏感型卵巢癌患者。患者每21天接受静脉注射拓扑替康，剂量为每日2.0mg/m²，共3天，直至疾病进展或出现不可接受的毒性。根据耐受性以0.25mg/m²的增量调整剂量。必要时使用粒细胞集落刺激因子支持。
2000年2月至6月，30例患者入组。他们的中位年龄为56岁（范围41 - 81岁）。29例患者可评估毒性和疗效。拓扑替康的中位给药疗程为5个疗程（范围1 - 11个疗程）。30例患者中有18例（60%）出现4级中性粒细胞减少。各有1例4级血小板减少、贫血和胃肠道毒性报告（根据美国国立癌症研究所通用毒性标准分级）。10例患者出现3级白细胞减少，9例出现3级中性粒细胞减少。严重非血液学事件罕见。有2例（7%）完全缓解和2例（7%）部分缓解，总缓解率为14%。16例（55%）患者疾病稳定，9例（31%）疾病进展。
每日剂量为2.0mg/m²的3天拓扑替康方案总体耐受性良好，尽管缓解率低于标准的5天给药方案。
