Phase I, dose-finding study of capecitabine in combination with docetaxel and epirubicin as first-line chemotherapy for advanced breast cancer

被引:16
|
作者
Venturini, M
Del Mastro, L
Garrone, O
Angiolini, C
Merlano, M
Bergaglio, M
Tolino, G
Lambiase, A
Baldini, A
Canavese, G
Rosso, R
机构
[1] Ist Nazl Ric Canc, Div Med Oncol, I-16132 Genoa, Italy
[2] Ist Nazl Ric Canc, Div Surg Oncol, I-16132 Genoa, Italy
[3] Osped S Croce & Carle, Div Med Oncol, Cuneo, Italy
[4] Roche, Milan, Italy
关键词
advanced breast cancer; capecitabine; docetaxel; epirubicin; phase I;
D O I
10.1093/annonc/mdf056
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: Capecitabine is an oral fluoropyrimidine with considerable activity and minimal myelosuppression and alopecia. This phase I study evaluated the addition of capecitabine to epirubicin/docetaxel combination therapy as first-line treatment for advanced breast cancer. Patients and methods: Twenty-three female patients with advanced breast cancer received capecitabine (765-1060 mg/m(2) twice daily on days 1-14 of a 3-week treatment cycle) in combination with epirubicin and docetaxel (75 mg/m(2) i.v. on day 1). Results: The maximum tolerated dose of capecitabine A as 985 mg/m(2) and the principal dose-limiting toxicity was febrile neutropenia. No grade 3/4 anemia or thrombocytopenia occurred. There were no grade 4 non-hematological events and grade 3 events other than alopecia were rare. Alopecia occurred in all patients and treatment cycles, and asthenia occurred in all patients and in 84% of treatment cycles. Other frequent adverse events included nausea, vomiting, fever, paresthesia and elevated transaminase levels. An objective response to treatment was observed in 91% (95% confidence interval 72% to 99%) of patients. Conclusions: The addition of capecitabine to docetaxel/epirubicin combination therapy provides a well-tolerated and active first-line chemotherapy regimen in patients with advanced breast cancer, and merits phase II/III evaluation.
引用
收藏
页码:546 / 552
页数:7
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