Annals of Oncology 15:100-103, 2004
© 2004 European Society for Medical Oncology
Original Paper |
Long-term survival in a phase III, randomised study of topotecan versus paclitaxel in advanced epithelial ovarian carcinoma
Received 22 May 2003; revised 22 August 2003; accepted 17 September 2003Background:
We have continued to monitor the survival of patients randomised in a previously reported multicentre phase III study of topotecan versus paclitaxel in patients with advanced epithelial ovarian cancer who had failed one prior platinum-based regimen.
Patients and methods:
Patients with bidimensionally measurable disease were randomised to topotecan (1.5 mg/m2/day for 5 days) or paclitaxel (175 mg/m2/day as a 3-h infusion) every 21 days. Patients were eligible for treatment with the alternate therapy at third line. The European Organisation for Research and Treatment of Cancer Quality of Life (EORTC QOL)-C30 questionnaire was also used to measure eight symptoms at baseline and during each course (pain, anorexia, diarrhoea, fatigue, nausea and vomiting, dyspnea, constipation and insomnia).
Results:
A total of 226 patients were evaluable for response. Demographic characteristics were similar in both treatment groups, as were results of the EORTC QOL-30 questionnaire. For the topotecan group, median time to progression was 18.9 weeks (range <1 to 92.6+ weeks; 25% censored), and, for paclitaxel, 14.7 weeks (range <1 to 137.3+ weeks; 12.3% censored); P = 0.076. At 4 years post-randomisation, median survival in the topotecan group was 63.0 weeks (range <1 to 238.4+ weeks; 20.5% censored) and, for paclitaxel, 53.0 weeks (range <1 to 226.3+ weeks; 12.3% censored); P = 0.44.
Conclusion:
Topotecan continues to demonstrate comparable efficacy and survival to paclitaxel with manageable and non-cumulative haematological toxicity. Non-haematological toxicity was generally mild for both groups. The long-term survival rate indicates substantial therapeutic benefit for this group of patients receiving topotecan at relapse of ovarian cancer.
1 The Netherlands Cancer Institute, Amsterdam, The Netherlands; 2 GlaxoSmithKline, Collegeville, PA, USA and Harlow, UK
Key words: ovarian carcinoma, paclitaxel, platinum, topotecan
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