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Phase II Study of Oxaliplatin and Fluorouracil in Taxane- and Anthracycline-Pretreated Breast Cancer Patients

From the Institut Gustave Roussy; Hôpital Paul Brousse; Cvitkovic et Associés Consultants, Villejuif; Hôpital Saint-Louis; Institut Curie, Paris; Centre René Huguenin, St Cloud; Clinique Hartmann, Neuilly sur Seine; Centre Jean Perrin, Clermont Ferrand; Centre Paul Papin, Angers; and Centre Régional de Lutte Contre le Cancer Val d’Aurelle, Montpellier, France.

Address reprint requests to M. Spielmann, MD, Institut Gustave Roussy, 39 rue Camille Desmoulins, 94805 Villejuif, France; email: spielman{at}igr.fr

PURPOSE: Phase II study evaluating efficacy and safety of combined oxaliplatin/fluorouracil (5-FU) in taxane-pretreated advanced and metastatic breast cancer (ABC) patients.

PATIENTS AND METHODS: Sixty-four taxane- and anthracycline-pretreated (within 6 months of study entry) women were treated with oxaliplatin 130 mg/m² (2-hour intravenous [IV] infusion), day 1, and 5-FU 1,000 mg/m²/d (continuous IV infusion) days 1 to 4, every 3 weeks.

RESULTS: Median patient age was 51 years (range, 34 to 71 years), with a median of two involved organs (range, one to six organs), and metastases in the liver (70%), bone (47%), and lung (34%). Patients had a median of two prior chemotherapy regimens (range, one to six regimens), and 78% had previous hormonal therapy, with clinical taxane and anthracycline resistance in 53% and 34%, respectively. A total of 367 cycles were administered, with a median of six cycles/patient (range, one to 15 cycles). Sixty patients were assessable for response (World Health Organization criteria): 17 partial response, 26 stable disease, and 17 disease progression, giving an overall response rate of 27% (95% confidence interval, 16.3% to 39.1%), and 26% and 36% in taxane- and anthracycline-resistant populations, respectively, all responders having metastatic liver disease. Median time to progression was 4.8 months, and median overall survival was 11.9 months. Four treatment-related serious adverse events occurred, seven patients withdrew because of treatment-related toxicity. Hematotoxicity was prevalent but rarely severe, with grade 3-4 neutropenia, leukopenia, and thrombocytopenia in 34%, 19%, and 16% of patients, respectively, and a single episode of febrile neutropenia. One third of patients developed grade 2-3 peripheral neuropathy (oxaliplatin-specific scale), with grade 3 in only 8%.

CONCLUSION: This oxaliplatin/5-FU combination is effective with an excellent safety profile in anthracycline/taxane-pretreated ABC patients, showing encouraging activity in patients with anthracycline/taxane-resistance or visceral disease.

Presented in part at the Thirty-Sixth Annual American Society of Clinical Oncology Meeting, New Orleans, May 20-23, 2000, and the Twenty-Third Annual St Antonio Breast Cancer Symposium, San Antonio, TX, December 6-9, 2000.

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