Phase III randomized study of cisplatin versus paclitaxel versus cisplatin and paclitaxel in patients with suboptimal stage III or IV ovarian cancer: A gynecologic oncology group study

被引:437
作者
Muggia, FM
Braly, PS
Brady, MF
Sutton, G
Niemann, TH
Lentz, SL
Alvarez, RD
Kucera, PR
Small, JM
机构
[1] NYU, Kaplan Canc Ctr, Dept Med, New York, NY 10016 USA
[2] NYU, Kaplan Canc Ctr, Dept Med Oncol, New York, NY 10016 USA
[3] Roswell Pk Canc Inst, Buffalo, NY 14263 USA
[4] Louisiana State Univ, Dept Obstet & Gynecol, Med Ctr, New Orleans, LA 70112 USA
[5] Indiana Univ, Sch Med, Div Gynecol Oncol, Indianapolis, IN 46204 USA
[6] Ohio State Univ, James Canc Hosp, Columbus Canc Council, Dept Pathol, Columbus, OH 43210 USA
[7] Wake Forest Univ, Sch Med, Gynecol Oncol Sect, Winston Salem, NC 27109 USA
[8] Univ Alabama, Div Gynecol Oncol, Dept Obstet & Gynecol, Birmingham, AL USA
[9] Oregon Hlth Sci Univ, Dept Obstet & Gynecol, Div Gynecol Oncol, Portland, OR 97201 USA
[10] Unipath, Ltd Liabil Corp, Denver, CO USA
[11] Rush Presbyterian St Lukes Med Ctr, Dept Pathol, Denver, CO USA
关键词
D O I
10.1200/JCO.2000.18.1.106
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: To assess progression-free survival (PFS) and overall survival (OS) in patients with suboptimally debulked epithelial ovarian cancer receiving cisplatin (100 mg/m(2)) or 24-hour infusion paclitaxel (200 mg/m(2)) or the combination of paclitaxel (135 mg/m(2)) followed by cisplatin (75 mg/m(2)). Patients and Methods: After stratification for disease measurability, patients were randomized to receive six cycles of one of the treatments every 3 weeks. If measurable, complete response (CR) or partial response (PR) was determined. Results: Six hundred fourteen of 648 patients who entered onto the trial were eligible. Monotherapies were discontinued more frequently (cisplatin because of toxicity or patient refusal [17%], and paclitaxel because of progression [20%]) compared with the combination therapy (7% and 6%, respectively). Neutropenia, fever, and alopecia were more severe with paclitaxel-containing regimens; whereas anemia, thrombocytopenia, neurotoxicity, nephrotoxicity, and gastrointestinal toxicity were more severe with cisplatin-containing regimens. The CR/PR rates on paclitaxel monotherapy were significantly lower compared with the cisplatin regimens (42% v 67%, respectively; P < .001), The relative hazard (RH) of first progression or death was significantly greater among those randomized to paclitaxel (RH = 1.41; 95% confidence interval [CI], 1.15 to 1.73; P < .001)when compared with cisplatin; however, RH did not differ significantly between the two cisplatin regimens (RH = 1.06; 95% CI, 0.895 to 1.30). Relative to cisplatin, the death rate on paclitaxel was 15% greater (RH = 1.15; 95% CI, 0.929 to 1.42), and the death rate on the combination treatment was 1% less (RH = 0.99: 95% CI, 0.795 to 1.23). These differences among treatment groups were not statistically significant (P = .31). Conclusion: Cisplatin alone or in combination yielded superior response rates and PFS relative to paclitaxel. However, OS was similar in all three arms, and the combination therapy had ct better toxicity profile. Therefore, the combination of cisplatin and paclitaxel remains the preferred initial treatment option. (C) 2000 by American Society of Clinical Oncology.
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收藏
页码:106 / 115
页数:10
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