Abstract | PURPOSE: Combination of intravenous (i.v.) vinorelbine and capecitabine was shown to be feasible and effective in metastatic breast cancer (MBC). In an effort to improve patient convenience and to prolong infusion-free survival, we investigated in first-line treatment a regimen combining oral vinorelbine and capecitabine in a phase II study. PATIENTS AND METHODS: Fifty-two patients (median age, 60 years) with MBC received the combination consisting of oral vinorelbine 60 mg/m(2) on days 1, 8 and 15 plus capecitabine 1,000 mg/m(2) bid given from day 1 to day 14 in an open-label, multicentre phase II study [the recommended doses were established in a phase I study (Nolé et al. in Ann Oncol 17:332-339, 2006)]. Cycles were repeated every 3 weeks. RESULTS: Seventy-nine percent of the patients had received prior adjuvant chemotherapy and 81% presented with visceral involvement. The median number of administered cycles per patient was 7 (range 1-18). Twenty-three responses were documented and validated by an independent panel review, yielding response rates of 44.2% (95% CI, 30.5-58.7) in the 52 enrolled patients and 54.8% (95% CI, 38.7-70.2) in the 42 evaluable patients. Median progression-free survival and median overall survival were 8.4 and 25.8 months, respectively. Neutropenia was the main dose-limiting toxicity but complications were uncommon, only one patient having experienced febrile neutropenia. Other frequently reported adverse events included, fatigue, nausea, vomiting, diarrhoea and constipation, stomatitis and hand-foot syndrome, which were rarely severe. CONCLUSIONS: This regimen combining oral vinorelbine with capecitabine is effective and manageable in the first-line treatment of MBC. Oral vinorelbine on days 1, 8 and 15 with capecitabine from days 1 to 14 every 3 weeks represents a convenient option which offers an all-oral treatment to the patients and prolongs their infusion-free survival.
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Authors | Franco Nolè, D Crivellari, R Mattioli, G Pinotti, P Foa, E Verri, R Fougeray, M Brandely, A Goldhirsch |
Journal | Cancer chemotherapy and pharmacology
(Cancer Chemother Pharmacol)
Vol. 64
Issue 4
Pg. 673-80
(Sep 2009)
ISSN: 1432-0843 [Electronic] Germany |
PMID | 19184601
(Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Deoxycytidine
- Vinblastine
- Capecitabine
- Vinorelbine
- Fluorouracil
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Topics |
- Administration, Oral
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage, adverse effects, therapeutic use)
- Breast Neoplasms
(drug therapy, pathology)
- Capecitabine
- Deoxycytidine
(administration & dosage, analogs & derivatives)
- Female
- Fluorouracil
(administration & dosage, analogs & derivatives)
- Humans
- Middle Aged
- Neoplasm Metastasis
- Vinblastine
(administration & dosage, analogs & derivatives)
- Vinorelbine
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