Bolis G, Scarfone G, Giardina G, Villa A, Mangili G, Melpignano M, Presti M, Tateo S, Franchi M, Parazzini F
I(a) Clinica Ostetrico Ginecologica, Università di Milano, Milan, Italy.
Gynecol Oncol. 2001 Apr;81(1):3-9. doi: 10.1006/gyno.2001.6151.
The aim of the study was to analyze the benefit/toxicity profile of a second-line treatment with carboplatin alone or carboplatin plus another non-cross-resistant drug (epidoxorubicin) in ovarian cancer patients sensitive to cisplatin-based chemotherapy at first-line treatment.
We conducted a randomized clinical trial. Women with epithelial ovarian cancer FIGO Stage II--IV who had a complete or partial response to first-line treatment with cisplatin or carboplatin-based regiments and subsequently progressed or relapsed more than 6 months after discontinuation of first-line treatment were eligible for the study. A total of 190 subjects entered the study. They were randomly allocated to either 300 mg/m(2) of carboplatin every 28 days for five cycles (95 patients) or 120 mg/m(2) of epidoxorubicin and 300 mg/m(2) of carboplatin every 28 days for five cycles (95 patients).
A complete response was reported, respectively, in 32 (36%) women allocated to carboplatin alone and in 28 (31.8%) of those allocated to carboplatin plus epidoxorubicin. The corresponding figures for partial response were 18 (20.2%) and 26 (29.9%). Comparing the frequency of complete response, partial response, no change, and progression, the differences between the two groups were not significant (chi(2)(3) 5.10, P = 0.16). The median duration of response was 16 months in the carboplatin alone and 20 months in the carboplatin plus epidoxorubicin group (P = not significant). The 3-year percentage of survival was 29% in the carboplatin alone and 42% in the carboplatin plus epidoxorubicin group; this difference was not statistically significant. The frequency of leukopenia, anemia, and thrombocytopenia grade 3-4 was higher in the epidoxorubicin plus carboplatin than in the carboplatin alone group. Alopecia G3 was present in 88% of women treated with epidoxorubicin plus carboplatin.
The general results of this study do not show any marked differences in response to second-line treatment among women treated with single-agent (carboplatin) or multiagent (carboplatin plus epidoxorubicin) schedules. Toxicity, particularly hematological, was more relevant in women treated with the multiagent schedule.
本研究旨在分析在一线治疗中对基于顺铂化疗敏感的卵巢癌患者，采用单药卡铂或卡铂联合另一种非交叉耐药药物（表柔比星）进行二线治疗的获益/毒性情况。
我们开展了一项随机临床试验。符合条件的研究对象为国际妇产科联盟（FIGO）分期为II - IV期的上皮性卵巢癌女性患者，她们对一线使用顺铂或基于卡铂的化疗方案有完全或部分反应，且在一线治疗停药后6个月以上病情进展或复发。共有190名受试者进入研究。她们被随机分为两组，一组每28天接受300mg/m²卡铂，共五个周期（95例患者），另一组每28天接受120mg/m²表柔比星和300mg/m²卡铂，共五个周期（95例患者）。
单独接受卡铂治疗的32名（36%）女性和接受卡铂加表柔比星治疗的28名（31.8%）女性报告有完全缓解。部分缓解的相应数字分别为18名（20.2%）和26名（29.9%）。比较完全缓解、部分缓解、病情无变化和进展的频率，两组之间的差异不显著（χ²(3)=5.10，P = 0.16）。单独使用卡铂组的中位缓解持续时间为16个月，卡铂加表柔比星组为20个月（P = 无显著差异）。单独使用卡铂组的3年生存率为29%，卡铂加表柔比星组为42%；这一差异无统计学意义。表柔比星加卡铂组3 - 4级白细胞减少、贫血和血小板减少的发生率高于单独使用卡铂组。接受表柔比星加卡铂治疗的女性中88%出现3级脱发。
本研究的总体结果显示，单药（卡铂）或多药（卡铂加表柔比星）方案治疗的女性在二线治疗反应方面没有明显差异。多药方案治疗的女性毒性更大，尤其是血液学毒性。
