Long-term survival in a phase III, randomised study of topotecan versus paclitaxel in advanced epithelial ovarian carcinoma.
BACKGROUND
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.


METHODS
Patients with bidimensionally measurable disease were randomised to topotecan (1.5 mg/m(2)/day for 5 days) or paclitaxel (175 mg/m(2)/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.


CONCLUSIONS
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.
ten Bokkel Huinink
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The Netherlands Cancer Institute, Amsterdam, The Netherlands. wtbh@nki.nl
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D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015994:Incidence; D007262:Infusions, Intravenous; D009364:Neoplasm Recurrence, Local; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D012680:Sensitivity and Specificity; D016019:Survival Analysis; D019772:Topotecan / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D019772:Topotecan; D017239:Paclitaxel