Paclitaxel plus carboplatin versus carboplatin alone in women with platinum-sensitive recurrent ovarian carcinoma

ABSTRACT

To compare the efficacy and safety of paclitaxel plus carboplatin versus carboplatin alone in the treatment of patients with platinum-sensitive recurrent ovarian carcinoma. Forty patients with platinum-sensitive ovarian carcinoma relapsing after 6 months of being treatment-free and with no more than two previous chemo-therapy lines were enrolled in this trial. Twenty one patients were randomized to receive carboplatin [300 mg/m[2] and 19 to receive the same dose of carboplatin plus paclitaxel [175mg/m[2] The primary outcome measure was objective response. Secondary outcomes were progression-free survival [PFS], overall survival [OS] and toxicity. The response rate in the combination arm was 79% [26% complete response [CR] and 53% partial response [PR]] compared with 48% in the carboplatin arm [19% CR and 29 PRI [p=0.041]. Median PFS was higher in paclitaxel carboplatin arm [12 versus 8 months]. Median OS was also better in the combination arm [24 versus 18 months]. However, these differences were not statistically significant [p=0.23 and 0.35 respectively]. No significant differences were observed in grade 3-4 hematological toxicity. Conversely, alopecia, mucositis, myalgia/arthralgia and sensory neuropathy were more frequent in the combination arm and the differences were statistically significant [p=0.0009, 0.027, 0.001, and 0.027 respectively]. Paclitaxel plus carboplatin is a tolerable regimen. It seems to be more effective among patients with platinum-sensitive recurrent ovarian carcinoma compared with single-agent carboplatin