Randomized controlled trial of single-agent paclitaxel versus cyclophosphamide, doxorubicin, and cisplatin in patients with recurrent ovarian cancer who responded to first-line platinum-based regimens

被引:104
作者
Cantù, MG
Buda, A
Parma, G
Rossi, R
Floriani, I
Bonazzi, C
Dell'Anna, T
Torri, V
Colombo, N
机构
[1] Mario Negri Inst Pharmacol Res, Lab Oncol Clin Res, I-20157 Milan, Italy
[2] European Inst Oncol, Dept Gynecol Oncol, Milan, Italy
[3] Univ Milano Bicocca, Osped San Gerardo dei Tintori, Dept Gynaecol Oncol, Monza, Italy
关键词
D O I
10.1200/JCO.20.5.1232
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: To assess the activity, efficacy, and tolerability of single-agent paclitaxel and a platinum-containing regimen in previously treated patients with recurrent ovarian cancer. Patients and Methods: Patients who achieved complete remission with platinum-based regimens and whose disease recurred after a progression-free interval of more than 12 months were included in the study. Every 21 days, patients received paclitaxel 175 mg/m(2) intravenously (IV) over 3 hours or cyclophosphomide 500 mg/m(2), doxorubicin 50 mg/m(2), and cisplatin 50 mg/m(2) (CAP) IV. Results: Between June 1992 and May 1995,97 consecutive patients with assessable or measurable disease were randomized to paclitaxel (n = 50) or CAP (n = 47). The median number of cycles on each arm was six. Toxicities included grade 3/4 leukopenia (4% for paclitaxel v 34% for CAP), grade 3/4 neutropenia (13% v 36%), grade 1/2 myalgia (19% v 4%), allergic reactions (15% v 2%), and grade 2/3 nausea and vomiting (17% v 51%). Complete responses were achieved in 17% and 30% of patients receiving paclitaxel and CAP, respectively, and partial responses were achieved in 28% and 25%, respectively (P = .062). At a median follow-up time of 49 months, median progression-free intervals were 9 months for paclitaxel and 15.7 months for CAP (Cox analysis: hazards ratio [HR], 0.60; 95% confidence interval [Cl], 0.37 to 0.97; P = .038); median overall survival times were 25.8 months for paclitaxel and 34.7 months for CAP (Cox analysis: HR, 0.58; 95% Cl, 0.34 to 0.98; P = .043). Conclusion: Rechallenge with either single-agent paclitaxel or platinum-based chemotherapy is effective in this patient population. Preliminary results suggest that single-agent paclitaxel may not be as active as platinum-based chemotherapy in recurrent ovarian cancer. Larger randomized trials are needed. (C) 2002 by American Society of Clinical Oncology.
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页码:1232 / 1237
页数:6
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