Phase II study of concurrent administration of doxorubicin and docetaxel as first-line chemotherapy for metastatic breast cancer

被引:10
作者
Aihara, T
Takatsuka, Y
Itoh, K
Sasaki, Y
Katsumata, N
Watanabe, T
Noguchi, S
Horikoshi, N
Tabei, T
Sonoo, H
Hiraki, S
Inaji, H
机构
[1] Kansai Rosai Hosp, Dept Surg, Amagasaki, Hyogo 6608511, Japan
[2] Natl Canc Ctr Hosp E, Div Hematol & Oncol, Chiba, Japan
[3] Natl Canc Ctr, Dept Internal Med, Tokyo, Japan
[4] Osaka Univ, Sch Med, Dept Surg Oncol, Osaka, Japan
[5] Canc Inst Hosp, Dept Med Oncol, Japanese Fdn Canc Res, Tokyo, Japan
[6] Saitama Canc Ctr Hosp, Dept Internal Med, Ina, Saitama, Japan
[7] Kawasaki Med Sch, Dept Surg Breast & Thyroid, Kawasaki, Kanagawa, Japan
[8] Okayama Red Cross Hosp, Dept Internal Med, Okayama, Japan
[9] Osaka Med Ctr Canc & Cardiovasc Dis, Dept Surg, Osaka, Japan
关键词
breast cancer; chemotherapy; doxorubicin; docetaxel; phase II study;
D O I
10.1159/000067771
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Objective: To evaluate the efficacy and toxicity of concurrent administration of doxorubicin and docetaxel, without prophylactic use of granulocyte colony-stimulating factor, as first-line chemotherapy in patients with metastatic breast cancer (MBC). Methods: This multi-institutional study enrolled 40 women; 37 were assessable for efficacy and all 40 patients were evaluated for toxicity. Treatment consisted of 50 mg/m(2) doxorubicin and 60 mg/m2 docetaxel on day 1 every 3-4 weeks. Results: Patients received a total of 251 cycles of chemotherapy (median, 5 cycles; range, 1-13 cycles). Of the 37 patients assessable for efficacy, 2 had a complete response and 24 had partial responses, which accounted for a 70% objective response rate (95% confidence interval, 53-84%). The median time to treatment failure was 30.1 weeks (range, 3.3-80.7 weeks). Grade 4 neutropenia was observed in 88% of patients and was the most frequent haematological toxicity. Febrile neutropenia was seen in 40% of patients, but no severe infections were observed. Non-haematological toxicity was generally tolerable. There were 2 grade 4 adverse events, which included 1 bleeding duodenal ulcer and 1 hypersensitivity reaction, but grade 3 episodes were infrequent. None of the patients developed congestive heart failure or asymptomatic decrease of left ventricular ejection fraction to less than 50%. Fluid retention syndrome : grade 2 was observed in 25% of patients at a median cumulative dose of docetaxel of 270 mg/m(2). Conclusion: Concurrent administration of 50 mg/m(2) doxorubicin and 60 mg/m(2) docetaxel is active with a manageable toxicity profile as first-line chemotherapy for MBC. Copyright (C) 2003 S. Karger AG, Basel.
引用
收藏
页码:124 / 130
页数:7
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