Bolis G, Parazzini F, Scarfone G, Villa A, Amoroso M, Rabaiotti E, Polatti A, Reina S, Pirletti E
Clinica Ostetrico Ginecologica, Università di Milano, Milan.
Gynecol Oncol. 1999 Jan;72(1):60-4. doi: 10.1006/gyno.1998.5237.
We conducted a randomized clinical trial to compare the efficacy and safety of paclitaxel and a combination including paclitaxel and epidoxorubicin as second-line treatment in platinum-refractory or -resistant ovarian cancer. Patients who had progressive or stable disease during first-line therapy with regimens containing cisplatin or carboplatin (platinum-refractory patients) or who responded and subsequently relapsed within 6 months after discontinuation of first-line platinum-based regimen (platinum-resistant patients) were eligible for the study. They were randomly allocated to paclitaxel 175 mg/m2 every 28 days (41 women) for five cycles or epidoxorubicin 120 mg/m2 iv plus paclitaxel 150 mg/m2 iv every 28 days (40 women). The overall response rates (complete plus partial response) were, respectively, 17.1% in the paclitaxel and 34.2% in the epidoxorubicin plus paclitaxel group (P = 0.10). The 2-year percentage survival was 18 in the paclitaxel group and 10 in the epidoxorubicin plus paclitaxel group. A higher frequency of leukopenia and thrombocytopenia was reported in women allocated to epidoxorubicin plus paclitaxel than in the paclitaxel alone group, but the frequency of neurotoxicity was higher in the paclitaxel alone group. An important limitation of the study is the small sample size. With this sample size we can exclude that multiagent therapy in comparison with single-agent therapy improves response in platinum-refractory and -resistant ovarian cancer of more than 25%.
我们进行了一项随机临床试验，以比较紫杉醇以及紫杉醇与表柔比星联合用药作为铂类难治性或耐药性卵巢癌二线治疗的疗效和安全性。在含顺铂或卡铂的一线治疗方案中疾病进展或稳定的患者（铂类难治性患者），或对一线铂类方案有反应且在停药后6个月内复发的患者（铂类耐药性患者）符合本研究条件。他们被随机分配至每28天接受175 mg/m²紫杉醇治疗（41名女性），共五个周期，或每28天接受120 mg/m²表柔比星静脉注射加150 mg/m²紫杉醇静脉注射治疗（40名女性）。总体缓解率（完全缓解加部分缓解）在紫杉醇组中为17.1%，在表柔比星加紫杉醇组中为34.2%（P = 0.10）。紫杉醇组的2年生存率为18%，表柔比星加紫杉醇组为10%。分配至表柔比星加紫杉醇组的女性白细胞减少和血小板减少的发生率高于单用紫杉醇组，但单用紫杉醇组神经毒性的发生率更高。本研究的一个重要局限性是样本量小。基于这个样本量，我们可以排除与单药治疗相比，多药联合治疗使铂类难治性和耐药性卵巢癌的缓解率提高超过25%的可能性。
