RANDOMIZED TRIAL IN ADVANCED OVARIAN-CANCER COMPARING CISPLATIN AND CARBOPLATIN
RANDOMIZED TRIAL IN ADVANCED OVARIAN-CANCER COMPARING CISPLATIN AND CARBOPLATIN
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DOI：
10.1093/jnci/81.19.1464
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发表时间：
1989-10-04
影响因子：
10.3
通讯作者：
MARSONI, S
中科院分区：
文献类型：
--
作者：
MANGIONI, C;BOLIS, G;MARSONI, S
这项多中心随机试验的目的是比较卡铂（400 mg/m2）和顺铂（100 mg/m2）治疗未经治疗的晚期上皮性卵巢癌患者的疗效。通过病理学缓解率、无进展生存期和生存期评估的毒性和治疗疗效是研究的终点。173例晚期卵巢上皮癌患者，F.I.G.O.（国际妇产科联合会）III期和IV期。中位随访时间为15个月（最长34个月）;每个治疗组中有3例患者不符合条件（4例，非上皮性卵巢癌类型; 1例，无数据，1例，II期）。两组患者的特征相似。在卡铂治疗组中，总体病理学缓解率为57.3%，完全病理学缓解率为26.8%。在顺铂治疗组中，总体病理学缓解率为71.6%，完全病理学缓解率为24.7%。两组的生存期或无进展生存期无统计学差异。顺铂的肾毒性更强，而卡铂诱导的骨髓抑制程度更高，尤其是血小板减少症;然而，很少观察到严重的血液学毒性。卡铂是一种顺铂类似物，在卵巢癌中具有明确的活性，但其活性并不比母体化合物高。由于非血液学毒性较小，卡铂无疑是不能给予顺铂的患者的有用替代品。需要进一步的经验来表明在卵巢癌的临床治疗中卡铂是否应该完全取代顺铂。
The aim of this multicenter randomized trial was to compare carboplatin (400 mg/m2) and cisplatin (100 mg/m2) in patients with untreated advanced epithelial ovarian cancer. Toxicity and treatment efficacy assessed by pathological response rate, progression-free survival, and survival were the endpoints of the study. One hundred seventy-three patients with advanced epithelial ovarian cancer, F.I.G.O. (International Federation of Gynecology and Obstetrics) stages III and IV were accrued in the trial. The median follow-up time was 15 months (maximum, 34); three patients in each treatment arm were not eligible (four, nonepithelial ovarian cancer type; one, no data, and one, stage II). Patient characteristics were similar in the two groups. In the carboplatin-treatment arm, the overall pathological response rate was 57.3% and the complete pathological response rate was 26.8%. In the cisplatin-treatment arm, the overall pathological response rate was 71.6% and the complete pathological response rate was 24.7%. There was no statistical difference in the two arms in survival or progression-free survival. Cisplatin was more nephrotoxic while carboplatin induced a higher degree of myelosuppression, especially thrombocytopenia; however, severe hematological toxicity was seldom observed. Carboplatin is a cisplatin analog with definite activity in ovarian cancer, but it is not more active than the parent compound. Because of less nonhematological toxicity, carboplatin is undoubtedly a useful substitute in patients who cannot be given cisplatin. Further experience is needed to indicate whether or not carboplatin should completely displace cisplatin in the clinical treatment of ovarian cancer.