Paclitaxel vs epidoxorubicin plus paclitaxel as second-line therapy for platinum-refractory and -resistant ovarian cancer

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 w ith regimens containing cisplatin or carboplatin (platinum-refractory patie nts) or who responded and subsequently relapsed within 6 months after disco ntinuation of first-line platinum-based regimen (platinum-resistant patient s) were eligible for the study. They were randomly allocated to paclitaxel 175 mg/m(2) every 28 days (41 women) for five cycles or epidoxorubicin 120 mg/m(2) iv plus paclitaxel 150 mg/m(2) iv every 28 days (40 women). The ove rall 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 l eukopenia and thrombocytopenia was reported in women allocated to epidoxoru bicin plus paclitaxel than in the paclitaxel alone group, but the frequency of neurotoxicity was higher in the paclitaxel alone group. An important li mitation of the study is the small sample size. With this sample size we ca n exclude that multiagent therapy in comparison with single-agent therapy i mproves response in platinum-refractory and -resistant ovarian cancer of mo re than 25%. (C) 1999 Academic Press.