Abstract |
The aim of this phase II study was to evaluate safety and efficacy of an oxaliplatin/ vinorelbine/ 5-fluorouracil (FON) combination in anthracycline and taxane-pretreated metastatic breast cancer patients. The following treatment was given: on day 1 of a 21-day cycle, oxaliplatin 130 mg/m (2-h intravenous infusion); on days 1 and 5, vinorelbine [dose level (DL) 1: 17.5 mg/m; DL2: 22 mg/m]; on days 1-5, continuous infusion 5-fluorouracil (DL1: 600 mg/m/day; DL2: 750 mg/m/day). Forty-seven patients were treated (DL1: 43; DL2: 4). Median age was 54 years; 68% had liver metastases, 53% were taxane refractory/resistant and 38% were anthracycline refractory/resistant. Patients received a median of six treatment cycles. Of 46 eligible patients, 16 had partial response; the overall response rate was 34.8% (95% confidence interval 21.3-50.3%), 11 had stable disease lasting more than 4 months. Median follow-up was 13.0 months, median time to progression 5.7 months and estimated overall survival 18.8 months. DL2 was too toxic with three patients having grade 3-4 toxicity, including one death. At DL1, 26 patients (60%) experienced grade 3-4 neutropenia (six febrile neutropenia) and eight had grade 3 oxaliplatin-specific peripheral neuropathy after a median of 646.4 mg/m oxaliplatin (range 124-1619 mg/m). Oxaliplatin (130 mg/m, day 1)/ vinorelbine (17.5 mg/m, days 1,5)/ 5-fluorouracil (600 mg/m/day, days 1-5) demonstrate encouraging activity and a manageable safety profile in anthracycline- and taxane-pretreated metastatic breast cancer patients.
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Authors | Thierry Delozier, Jean-Paul Guastalla, Alejandro Yovine, Christelle Levy, Philippe Chollet, Mireille Mousseau, Rémy Delva, David Coeffic, Jean-Michel Vannetzel, Eliette-Sudriez Zazzi, Silvano Brienza, Esteban Cvitkovic |
Journal | Anti-cancer drugs
(Anticancer Drugs)
Vol. 17
Issue 9
Pg. 1067-73
(Oct 2006)
ISSN: 0959-4973 [Print] England |
PMID | 17001180
(Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anthracyclines
- Organoplatinum Compounds
- Taxoids
- Oxaliplatin
- Vinblastine
- Vinorelbine
- Fluorouracil
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Topics |
- Adult
- Aged
- Anthracyclines
(therapeutic use)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Breast Neoplasms
(drug therapy)
- Female
- Fluorouracil
(administration & dosage)
- Humans
- Middle Aged
- Neoplasm Metastasis
- Organoplatinum Compounds
(administration & dosage)
- Oxaliplatin
- Taxoids
(therapeutic use)
- Vinblastine
(administration & dosage, analogs & derivatives)
- Vinorelbine
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