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Previously, we have shown that the combination of cyclophosphamide, doxorubicin, and cisplatin (CAP) and singleagent carboplatin produce similar survival and progression-free survival rates in women with ovarian cancer. Subsequently, paclitaxel combined with platinum has become a widely accepted treatment for the disease. We aimed to compare the safety and efficacy of paclitaxel plus carboplatin with a control of either CAP or carboplatin alone. Between February, 1995, and October, 1998, we enrolled 2074 patients from 130 centres in eight countries. Women were randomly assigned paclitaxel plus carboplatin or control, the control (CAP or single-agent carboplatin) being chosen by the patient and clinician before randomisation. The primary outcome measure was overall survival. Secondary outcomes were progression-free survival and toxicity. Analysis was by intention to treat. With a median follow-up of 51 months, 1265 patients had died, and survival curves showed no evidence of a difference in overall survival between paclitaxel plus carboplatin and control (hazard ratio 0·98, 95% CI 0·87–1·10, p=0·74). The median overall survival was 36·1 months on paclitaxel plus carboplatin and 35·4 months on control (difference 0·7 months, 95% CI −3·6 to 4·7). 1538 patients had progressive disease or died, and again, Kaplan-Meier curves showed no evidence of a difference between the groups (hazard ratio 0·93, 95% CI 0·84–1·03, p=0·16). Median progression-free survival was 17·3 months on paclitaxel plus carboplatin and 16·1 months on control (difference 1·2 months, 95% CI −0·5 to 2·8). Paclitaxel plus carboplatin caused more alopecia, fever, and sensory neuropathy than carboplatin alone, and more sensory neuropathy than CAP. CAP was associated with more fever than paclitaxel plus carboplatin. Single-agent carboplatin and CAP are as effective as paclitaxel plus carboplatin as first-line treatment for women requiring chemotherapy for ovarian cancer. The favourable toxicity profile of single-agent carboplatin suggests that this drug is a reasonable option as first-line chemotherapy for ovarian cancer.

Paclitaxel was reported to be active in relapsed ovarian cancer in the late 1980s.7 The Gynecologic Oncology Group (GOG) have subsequently reported a series of randomised studies investigating paclitaxel in the management of ovarian cancer patients. Their results have been influential but not consistent.8,9 In mid-1993, GOG presented the preliminary results of a randomised trial of cisplatin and paclitaxel (given as a 24-h infusion) versus cyclophosphamide and cisplatin. The paclitaxel regimen prolonged progression-free survival, and the publication of these results in 1996 led to the promotion and wide acceptance of paclitaxel as a first-line drug in ovarian cancer. The Intergroup trial of cisplatinpaclitaxel (given as a 3-h infusion) versus cisplatincyclophosphamide in Canada and Europe enrolled 680 patients and reported the paclitaxel-containing regimen prolonged progression-free survival by 4 months (from 115 to 155 months). The investigators concluded that paclitaxel-cisplatin was the new standard regimen for the treatment of patients with advanced ovarian cancer.10 However, the paclitaxel regimen caused more severe hair-loss (51% vs 21%) and neurosensory symptoms (20% vs 1%) but less vomiting (11% vs 18%) and nausea (15% vs 20%).