Taylor A E, Wiltshaw E, Gore M E, Fryatt I, Fisher C
Gynaecology Unit, Royal Marsden Hospital, London, United Kingdom.
J Clin Oncol. 1994 Oct;12(10):2066-70. doi: 10.1200/JCO.1994.12.10.2066.
A phase III trial was performed between October 1981 and June 1984 to compare the efficacy of single-agent cisplatin and single-agent carboplatin in previously untreated patients with International Federation of Gynecology and Obstetrics stage III or IV carcinoma of the ovary following surgery. This report describes the survival rates of patients in this study after a minimum follow-up duration of 8 years.
Sixty-four patients were randomized to receive cisplatin and 67 patients to receive carboplatin. Cisplatin was administered every 4 weeks for a total of 10 courses, courses 1 to 5 at a dosage of 100 mg/m2 and courses 6 to 10 at 30 mg/m2. Carboplatin was administered at a dosage of 400 mg/m2 every 4 weeks for 10 courses. Patients who had clinical or radiologic evidence of response after five courses of chemotherapy underwent second-look surgery. The study was designed to allow crossover between the two arms. Thirteen patients were excluded from response analyses because they were incorrectly randomized. Patients were crossed over to the other arm of the study because of progressive disease (PD), nonresponse, or toxicity.
The overall response rate for patients randomized to the cisplatin arm was 53.8% (28 of 52; 95% confidence interval [CI], 39% to 68%) and for those randomized to the carboplatin arm, 38.4% (20 of 52; 95% CI, 25% to 53%). There were 16 (30.8%) and 14 (26.9%) complete remissions (CRs) in the cisplatin and carboplatin arms, respectively. None of these differences were statistically significant. The median duration of response for the cisplatin and carboplatin arms was 21 months and 17 months, and the 5-year relapse-free survival rates were 22% and 25%, respectively. The median survival durations for the cisplatin and carboplatin arms were 19.5 and 13 months, and the 5-year survival rates were 15% (95% CI, 8% to 26%) and 19% (95% CI, 11% to 30%), respectively. None of these differences was statistically significant. The median follow-up duration of patients is 9 years. Crossover due to toxicity was more frequent in the cisplatin than the carboplatin arm, occurring in 50% and 3.3% of patients, respectively.
The mature data from this study of patients with advanced ovarian cancer show that cisplatin and carboplatin have similar long-term survival results.
1981年10月至1984年6月进行了一项III期试验，以比较顺铂单药和卡铂单药对既往未接受过治疗、国际妇产科联盟（FIGO）分期为III期或IV期卵巢癌患者术后的疗效。本报告描述了本研究中患者在至少8年的随访期后的生存率。
64例患者被随机分配接受顺铂治疗，67例患者接受卡铂治疗。顺铂每4周给药一次，共10个疗程，第1至5疗程剂量为100mg/m²，第6至10疗程为30mg/m²。卡铂剂量为400mg/m²，每4周给药一次，共10个疗程。接受5个疗程化疗后有临床或影像学缓解证据的患者接受二次探查手术。该研究设计允许两组之间交叉。13例患者因随机分组错误被排除在缓解分析之外。患者因疾病进展（PD）、无反应或毒性而交叉至研究的另一组。
随机分配至顺铂组的患者总体缓解率为53.8%（52例中的28例；95%置信区间[CI]，39%至68%），随机分配至卡铂组的患者为38.4%（52例中的20例；95%CI，25%至53%）。顺铂组和卡铂组分别有16例（30.8%）和14例（26.9%）完全缓解（CR）。这些差异均无统计学意义。顺铂组和卡铂组的中位缓解持续时间分别为21个月和17个月，5年无复发生存率分别为22%和25%。顺铂组和卡铂组的中位生存持续时间分别为19.5个月和13个月，5年生存率分别为15%（95%CI，8%至26%）和19%（95%CI，11%至30%）。这些差异均无统计学意义。患者的中位随访时间为9年。因毒性导致的交叉在顺铂组比卡铂组更频繁，分别发生在50%和3.3%的患者中。
这项晚期卵巢癌患者研究的成熟数据表明，顺铂和卡铂具有相似的长期生存结果。
