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Annals of Oncology 13:258-266, 2002
© 2002 European Society for Medical Oncology

Multicentre phase II study of oxaliplatin as a single-agent in cisplatin/carboplatin ± taxane-pretreated ovarian cancer patients

V. Dieras1,+, P. Bougnoux2, T. Petit3, P. Chollet4, P. Beuzeboc1, C. Borel3, F. Husseini5, A. Goupil6, P. Kerbrat7, J. L. Misset8, M. A. Bensmaïne9, I. Tabah-Fisch10 and P. Pouillart1

1Institut Curie, Paris, 2Hôpital Bretonneau, Tours, 3Centre Paul Strauss, Strasbourg, 4Jean Perrin, Clermont-Ferrand, 5Hospitaux Civils, Colmar, 6Centre René Huguenin, Saint-Cloud, 7Centre Eugène Marquis, Rennes, 8Hôpital Paul Brousse, Villejuif, 9Cvitkovic and Associates, Consultants, Kremlin-Bicêtre and 10Sanofi-Synthelabo, Chilly-Mazarin, France

Received 6 February 2001; revised 20 July 2001; accepted 23 August 2001.

Background: This multicentre phase II open-label study evaluated safety and antitumour activity of oxaliplatin in cisplatin or carboplatin (cis/carboplatin) ± taxane-pretreated advanced ovarian cancer (AOC) patients.

Patients and methods: Forty-eight patients received oxaliplatin 130 mg/m2 intravenously every 3 weeks, 94% having a performance status (PS) 0–1. All were pretreated with cis/carboplatin and 21 (44%) with paclitaxel. The median number of involved organs was two, 18 (38%) had liver metastasis, 23 (48%) were platinum-resistant and 14 (29%) were taxane-resistant. Forty-two patients were evaluable for a response, 18 (43%) were platinum-resistant and 11 (26%) were taxane-resistant.

Results: A total of 253 cycles was administered (median: 5.5/patient). Median cumulative oxaliplatin dose was 666 mg/m2. National Cancer Institute–Common Toxicity Criteria toxicity analysis showed that seven patients (15%) had grade 3/4 thrombocytopenia, two patients (4%) had grade 3 neutropenia, and one patient had grade 3 anaemia. Eleven patients (23%) experienced grade 3 neurosensory toxicity. Of the 29 patients with peripheral neuropathy at the end of treatment, 55% had recovered or improved 1 month later. Eleven objective responses (two complete) were obtained in the 42 evaluable patients [ORR 26%, 95% confidence interval (CI) 14% to 42%], with 10/24 (42%, 95% CI 22% to 63%) in platinum-sensitive, and 1 of 18 (5.6%, 95% CI 0% to 27%) in platinum-resistant patients. Median response duration was 9.2 months (95% CI 6.6% to 11.8%), and median progression-free and overall survival in all treated patients were 4.3 months (95% CI 3.0% to 5.7%) and 15.0 months (95% CI 11.1% to 18.8%), respectively.

Conclusion: Oxaliplatin has a good safety profile and is active in cis/carboplatin ± paclitaxel-pretreated AOC patients.

Key words: diaminocyclohexane platinum, neurotoxicity, salvage chemotherapy, taxanes


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