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Annals of Oncology Advance Access published online on April 7, 2005
Annals of Oncology, doi:10.1093/annonc/mdi147
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© 2005 European Society for Medical Oncology
Received October 12, 2004
Revised December 8, 2004
Accepted December 9, 2004

Original article

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-Martín 1*, E. Calvo 2, I. Bover 3, M. J. Rubio 4, A. Arcusa 5, A. Casado 6, B. Ojeda 7, C. Balañá 8, E. Martínez 9, A. Herrero 10, B. Pardo 11, E. Adrover 12, J. Rifá 13, M. J. Godes 14, A. Moyano 1, and A. Cervantes 15

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

* To whom correspondence should be addressed.
A. J. González-Martín, E-mail: agonzalezm{at}seom.org


  Abstract

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.

Keywords: combination chemotherapy; platinum sensitive; randomized clinical trial; recurrent ovarian carcinoma.
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