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

• Published in: Annals of oncology Vol. 16; no. 5; pp. 749 - 755
• Main Authors: 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.
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.05.2005
• Subjects: Adult; Aged; Antineoplastic agents; Biological and medical sciences; Carboplatin - administration & dosage; Carboplatin - adverse effects; Chemotherapy, Adjuvant; combination chemotherapy; Confidence Intervals; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Female genital diseases; Gynecology. Andrology. Obstetrics; Humans; Medical sciences; Middle Aged; Neoplasm Recurrence, Local - drug therapy; Neoplasm Recurrence, Local - mortality; Neoplasm Recurrence, Local - pathology; Neoplasm Staging; Ovarian Neoplasms - mortality; Ovarian Neoplasms - pathology; Ovarian Neoplasms - therapy; Ovariectomy - methods; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; Palliative Care; Pharmacology. Drug treatments; platinum sensitive; Probability; Prognosis; Quality of Life; randomized clinical trial; recurrent ovarian carcinoma; Risk Assessment; Spain; Survival Analysis; Treatment Outcome; Tumors; Spain; Antineoplastic agent; Human; Relapse; Ovary carcinoma; recurrent ovarian carcinoma; combination chemotherapy; randomized clinical trial; Malignant tumor; platinum sensitive; Female genital diseases; Ovarian diseases; Taxane derivatives; Phase II trial; Paclitaxel; Carboplatin; Clinical trial; Advanced stage; Combined treatment; Antimitotic; Comparative study; Platinum II Complexes
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdi147

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.