Phase II evaluation of 9-aminocamptothecin (9-AC, NSC #603071) in platinum-resistant ovarian and primary peritoneal carcinoma: A Gynecologic Oncology Group Study

被引:17
作者
Miller, DS
Blessing, JA
Waggoner, S
Schilder, J
Sorosky, J
Bloss, J
Schilder, R
机构
[1] Univ Texas, SW Med Ctr, Dept Obstet & Gynecol, Div Gynecol Oncol, Dallas, TX 75390 USA
[2] Roswell Pk Canc Inst, Gynecol Oncol Grp, Stat & Data Ctr, Buffalo, NY 14263 USA
[3] Case Western Reserve Univ, Div Obstet & Gynecol, Cleveland, OH 44106 USA
[4] Indiana Univ, Med Ctr, Dept Gynecol Oncol, Indianapolis, IN 46202 USA
[5] Univ Iowa Hosp & Clin, Div Gynecol Oncol, Iowa City, IA 52242 USA
[6] Univ Missouri, Dept Obstet & Gynecol, Columbia, MO 65203 USA
[7] Fox Chase Canc Ctr, Dept Med Oncol, Philadelphia, PA 19111 USA
关键词
9-aminocamptothecin; primary peritoneal carcinoma; ovarian cancer;
D O I
10.1016/j.ygyno.2004.09.015
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Objective. To estimate the antitumor activity of 9-aminocamptothecin (9-AC) in patients with recurrent platinum-"resistant' ovarian cancer; and to determine the nature and degree of toxicity of 9-AC in this cohort of patients. Methods. A multicenter phase II study was conducted by the Gynecologic Oncology Group (GOG). Patients were to receive 9-AC (colloidal dispersion) 25 mug/m(2)/h (600 mug/m(2)/day) IV over 120 h (5 days) beginning days 1 and 8. Dose adjustment was permitted for toxicity. This schedule was repeated every 21 days until disease progression or unacceptable adverse events. Hematopoietic growth factor support was used as necessary. Results. From January 1999 to December 2000, 29 member institutions of the GOG enrolled 58 patients. Two patients received no therapy; thus, 56 (97%) were evaluable. Median age was 61 (range: 33-81) years. A median of four (range: 1-32) courses of 9-AC was administered. The most frequent grade 3 or 4 toxicities were neutropenia in 46%, leukopenia in 37%, gastrointestinal in 29%, anemia in 25%, and thrombocytopenia in 21%. There was one possible treatment-related death. There were four (7%) complete and four (7%) partial responses, for an overall response rate of 14%. Eighteen (32%) patients had stable disease, 22 (39%) progressed, and response could not be assessed in 8 (14%). Conclusion. The 9-AC at this dose and schedule showed limited activity comparable to that seen with other agents in platinum-resistant ovarian or primary peritoneal cancer. (C) 2004 Elsevier Inc. All rights reserved.
引用
收藏
页码:67 / 71
页数:5
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