Lancet. 1998 Nov 14;352(9140):1571-6.
A series of meta-analyses of randomised controlled trials raised the question of whether the three-drug combination of CAP (cyclophosphamide, doxorubicin, and cisplatin) was more or less effective than optimal-dose single-agent carboplatin for women with advanced ovarian cancer.
We carried out an international, multicentre, randomised trial to compare CAP with single-agent carboplatin in women with ovarian cancer requiring chemotherapy. 1526 patients were entered from 132 centres in nine countries. Analyses were by intention to treat.
728 patients have died (368/766 allocated CAP vs 360/760 allocated carboplatin) and the survival curves show no evidence of a difference between CAP and carboplatin (hazard ratio 1.00 [95% CI 0.86-1.16]; p=0.98). The results indicate a median survival of 33 months and a 2-year survival of 60% for both groups. We found no evidence that CAP or carboplatin were more or less effective in different subgroups defined by age, stage, residual disease, differentiation, histology, and coordinating centre. CAP was substantially more toxic than carboplatin, causing more alopecia, leucopenia, and nausea. More thrombocytopenia occurred with carboplatin.
Single-agent carboplatin, with the dose calculated by the area-under-the-curve method, is a safe, effective, and appropriate standard of treatment for women with advanced ovarian cancer.
一系列随机对照试验的荟萃分析提出了一个问题，即对于晚期卵巢癌女性患者，环磷酰胺、阿霉素和顺铂（CAP）三联药物组合与最佳剂量的单药卡铂相比，疗效是更好还是更差。
我们开展了一项国际多中心随机试验，以比较CAP与单药卡铂在需要化疗的卵巢癌女性患者中的疗效。来自9个国家132个中心的1526例患者参与了试验。分析采用意向性治疗原则。
728例患者死亡（766例分配接受CAP治疗的患者中有368例死亡，760例分配接受卡铂治疗的患者中有360例死亡），生存曲线显示CAP与卡铂之间没有差异的证据（风险比1.00 [95%可信区间0.86 - 1.16]；p = 0.98）。结果表明两组的中位生存期均为33个月，2年生存率均为60%。我们没有发现证据表明CAP或卡铂在按年龄、分期、残留病灶、分化程度、组织学类型和协调中心定义的不同亚组中疗效更好或更差。CAP的毒性明显高于卡铂，导致更多的脱发、白细胞减少和恶心。卡铂组发生更多的血小板减少。
采用曲线下面积法计算剂量的单药卡铂，是晚期卵巢癌女性患者安全、有效且合适的标准治疗方案。
