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  • Randomized phase II trial o...
    González-Martín, A. J.; Calvo, E.; Bover, I.; Rubio, M. J.; Arcusa, A.; Casado, A.; Ojeda, B.; Balañá, C.; Martínez, E.; Herrero, A.; Pardo, B.; Adrover, E.; Rifá, J.; Godes, M. J.; Moyano, A.; Cervantes, A.

    Annals of oncology, 05/2005, Letnik: 16, Številka: 5
    Journal Article

    Background:: The aim of this study was to determine whether the response rate for the paclitaxel–carboplatin combination is superior to carboplatin alone in the treatment of patients with platinum-sensitive recurrent ovarian carcinoma. Patients and methods:: Patients with recurrent ovarian carcinoma, 6 months after treatment with a platinum-based regimen and with no more than two previous chemotherapy lines, were randomized to receive carboplatin area under the curve (AUC) 5 (arm A) or paclitaxel 175 mg/m2 + carboplatin AUC 5 (arm B). The primary end point was objective response, following a ‘pick up the winner’ design. Secondary end points included time to progression (TTP), overall survival, tolerability and quality of life (QoL). Results:: Eighty-one patients were randomized and included in the intention-to-treat analysis. The response rate in arm B was 75.6% 26.8% complete response (CR) + 48.8% partial response (PR) 95% confidence interval (CI) 59.7% to 87.6% and 50% in arm A (20% CR + 30% PR) (95% CI 33.8% to 66.2%). No significant differences were observed in grade 3–4 hematological toxicity. Conversely, mucositis, myalgia/arthralgia and peripheral neurophaty were more frequent in arm B. Median TTP was 49.1 weeks in arm B (95% CI 36.9–61.3) and 33.7 weeks in arm A (95% CI 25.8–41.5). No significant differences were found in the QoL analysis. Conclusions:: Paclitaxel–carboplatin combination is a tolerable regimen with a higher response rate than carboplatin monotherapy in platinum-sensitive recurrent ovarian carcinoma.