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Annals of Oncology Advance Access originally published online on April 7, 2005
Annals of Oncology 2005 16(5):749-755; doi:10.1093/annonc/mdi147
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© 2005 European Society for Medical Oncology

Randomized phase II trial of carboplatin versus paclitaxel and carboplatin in platinum-sensitive recurrent advanced ovarian carcinoma: a GEICO (Grupo Español de Investigación en Cáncer de Ovario) study

A. J. González-Martín1,*, E. Calvo2, I. Bover3, M. J. Rubio4, A. Arcusa5, A. Casado6, B. Ojeda7, C. Balañá8, E. Martínez9, A. Herrero10, B. Pardo11, E. Adrover12, J. Rifá13, M. J. Godes14, A. Moyano1 and A. Cervantes15

1 Medical Oncology Service, Hospital Universitario Ramón y Cajal, Madrid; 2 Hospital Virgen del Rocío, Sevilla; 3 Hospital Sant Joan, Reus; 4 Hospital Reina Sofía, Córdoba; 5 Hospital de Terrasa, Barcelona; 6 Hospital Clínico San Carlos, Madrid; 7 Hospital Sant Creu i Sant Pau, Barcelona; 8 Hospital Trias i Puyol de Badalona, Barcelona; 9 Hospital Virgen de la Luz, Cuenca; 10 Hospital Miguel Servet, Zaragoza; 11 Institut Catalá de Oncología, Barcelona; 12 Hospital General de Alicante, Alicante; 13 Hospital Son Dureta, Palma de Mallorca; 14 Hospital General Universitario, Valencia; 15 Hospital Clínico de Valencia, Valencia, Spain

* Correspondence to: Dr A. J. González Martín, Medical Oncology Service, Hospital Universitario Ramón y Cajal, Ctra. Colmenar Viejo Km. 9,100, Madrid, Spain. Tel: +34-91-336-8263; Fax: +34-91-336-8263; Email: agonzalezm{at}seom.org

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.

Key words: combination chemotherapy, platinum sensitive, randomized clinical trial, recurrent ovarian carcinoma


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