Abstract |
Owing to the increased number of patients treated with anthracycline-based adjuvant chemotherapy, there is a need for new effective and tolerable nonanthracycline regimens in metastatic breast cancer. Patients with HER2-negative metastatic breast cancer previously treated with anthracyclines in (neo)adjuvant setting were randomized to fully oral 3 weekly cycles of the combination of oral vinorelbine with capecitabine (V + C), to the same drugs alternating every three cycles (V↔C), or to the combination of docetaxel and capecitabine (D + C). V was given at 80 mg/m(2) (after the first cycle at 60 mg/m(2)) on days 1 and 8 in the V + C arm and weekly in the V↔C arm, C at 1,000 mg/m(2) bid from days 1 to 14, and D on day 1 at 75 mg/m(2). The primary end point was disease control rate (CR + PR + NC ≥ 3 months). A total of 139 patients were randomly assigned to V + C (44 patients), V↔C (47 patients), and D + C (48 patients). After an independent review, the disease control rate in the intent-to-treat population in the V + C, V↔C, and D + C arms [95% CI] was 70.5% [54.8-83.2], 37.0% [23.2-52.5], and 70.8% [55.9-83.1], and the median overall survival 22.2, 19.4, and 24.2 months, respectively. When taken into account the disease control rate, the alternating V↔C regimen seems to be less effective compared with V + C or D + C combinations. Combinations of V + C or D + C showed similar efficacy and a different toxicity profile; V + C induced less neutropenia, infection, hand-foot syndrome, fatigue/ asthenia, and alopecia, whereas D + C - less gastrointestinal toxicity. V + C combination constitutes a valuable fully oral alternative option to D + C in patients with metastatic breast cancer previously treated with anthracyclines in (neo)adjuvant setting, while offering the advantages of an all-oral treatment.
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Authors | Mario Campone, Natalya Dobrovolskaya, Serjei Tjulandin, Shin-Chen Chen, Sameul Fourie, Fawzia Mefti, Maria Konstantinova, Florence Lefresne, Nadege Meheust, Jacek Jassem |
Journal | The breast journal
(Breast J)
2013 May-Jun
Vol. 19
Issue 3
Pg. 240-9
ISSN: 1524-4741 [Electronic] United States |
PMID | 23528159
(Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2013 Wiley Periodicals, Inc. |
Chemical References |
- Anthracyclines
- Taxoids
- Deoxycytidine
- Docetaxel
- Vinblastine
- Capecitabine
- Vinorelbine
- Fluorouracil
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Topics |
- Administration, Oral
- Adult
- Aged
- Anthracyclines
(therapeutic use)
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Breast Neoplasms
(drug therapy, pathology)
- Capecitabine
- Deoxycytidine
(administration & dosage, adverse effects, analogs & derivatives)
- Docetaxel
- Female
- Fluorouracil
(administration & dosage, adverse effects, analogs & derivatives)
- Humans
- Middle Aged
- Neoplasm Metastasis
- Taxoids
(administration & dosage, adverse effects)
- Vinblastine
(administration & dosage, adverse effects, analogs & derivatives)
- Vinorelbine
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