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Oxaliplatin or Paclitaxel in Patients With Platinum-Pretreated Advanced Ovarian Cancer: A Randomized Phase II Study of the European Organization for Research and Treatment of Cancer Gynecology Group

From the Institut Jules Bordet and European Organization for Research and Treatment of Cancer, Brussels; Universitaire Ziekenhuis Gasthuisberg, Leuven, Belgium; Clatterbridge Hospital, Bebington; Western Infirmary, Glasgow, United Kingdom; Hospital General de Asturias, Oviedo; Universidad Hospital 12 de Octubre, Madrid, Spain; Libera Universita "Campus Bio-Medico," Rome; Ospedale Civile Maggiore, Verona; Spedali Civili di Brescia, Brescia, Italy; Instituto Portugues, Lisbon, Portugal; and Debiopharm, Lausanne, Switzerland.

Address reprint requests to M.J. Piccart, MD, Institut Jules Bordet, 1 rue Héger Bordet, 1000 Bruxelles, Belgique; email mpiccart{at}ulb.ac.be

PURPOSE: This was a multicentric, open, randomized, phase II study of single-agent paclitaxel and oxaliplatin to evaluate the efficacy of oxaliplatin in a relapsing progressive ovarian cancer patient population and to analyze the safety profile and impact of both agents on quality of life, time to progression, and survival.

PATIENTS AND METHODS: Eighty-six patients with platinum-pretreated advanced ovarian cancer were randomly assigned to two arms: 41 received paclitaxel at 175 mg/m² over 3 hours every 3 weeks, and 45 received oxaliplatin at 130 mg/m² over 2 hours every 3 weeks. For inclusion, patients had to have a performance status of 0 to 2 and to have received at least one and no more than two prior cisplatin- and/or carboplatin-containing chemotherapy regimens within the last 12 months.

RESULTS: Seven confirmed responses were observed in each arm, for an overall response rate in the total treated population of 17% (95% confidence interval [CI], 7% to 32%) in the paclitaxel arm and 16% (95% CI, 7% to 29%) in the oxaliplatin arm. Median time to progression was 14 weeks and 12 weeks, and overall survival was 37 weeks and 42 weeks in the paclitaxel and oxaliplatin arms, respectively. Among 63 patients with a 0- to 6-month progression-free, platinum-free interval, there were five objective responses with paclitaxel in 31 patients and two objective responses with oxaliplatin in 32 patients. Nine patients (22%) in the paclitaxel arm had grade 3 or 4 neutropenia (National Cancer Institute of Canada [NCIC] Common Toxicity Criteria). Two patients (4%) experienced grade 3 thrombocytopenia in the oxaliplatin arm. Maximum grade (grade 3) NCIC neurosensory toxicity was experienced by three patients (7%) in the paclitaxel arm and by four patients (9%) in the oxaliplatin arm.

CONCLUSION: Single-agent oxaliplatin at 130 mg/m² every 3 weeks is active with moderate toxicity in patients with cisplatin-/carboplatin-pretreated advanced ovarian cancer.

Presented at the Twenty-Third Congress of the European Society for Medical Oncology, Athens, Greece, November 6-10, 1998, and, in part, at the Thirty-Fourth Annual Meeting of the American Association for Cancer Research, Los Angeles, CA, May 16-20, 1998.

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