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
2005; Elsevier BV; Volume: 16; Issue: 5 Linguagem: Inglês
10.1093/annonc/mdi147
ISSN1569-8041
AutoresAntonio González‐Martín, E. Calvo, Isabel Bover, María Jesús Rubio, Àngels Arcusa, Antonio Casado, B. Ojeda, Carmen Balañá, E Hortelano Martínez, Ana Herrero, Beatriz Pardo, Encarna Adrover, Juli Rifà, María José Godes, A Moyano, Andrés Cervantes,
Tópico(s)Endometrial and Cervical Cancer Treatments
ResumoBackgroundThe 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 methodsPatients 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).ResultsEighty-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.ConclusionsPaclitaxel–carboplatin combination is a tolerable regimen with a higher response rate than carboplatin monotherapy in platinum-sensitive recurrent ovarian carcinoma.
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