Phase II study of dose-dense doxorubicin and docetaxel as neoadjuvant chemotherapy with G-CSF support in patients with large or locally advanced breast cancer

被引:2
作者
Garcia-Mata, Jesus [1 ,2 ]
Garcia-Palomo, Andres [3 ]
Calvo, Lourdes [4 ]
Mel, Ramon [5 ]
Cruz, Juan Jesus [6 ]
Ramos, Manuel [7 ]
机构
[1] Complexo Hosp Ourense, Dept Oncol, ES-32005 Orense, Spain
[2] Hosp Santa Maria Nai, Orense, Spain
[3] Hosp Leon, Leon, Spain
[4] Complexo Hosp Univ Juan Canalejo, La Coruna, Spain
[5] Hosp Xeral Calde, Lugo, Spain
[6] Hosp univ Salamanca, Salamanca, Spain
[7] Ctr Oncol Reg, La Coruna, Spain
关键词
Anthracycline; Biweekly; Dose-intensity; Primary chemotherapy; Taxanes;
D O I
10.1007/s12094-008-0280-z
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
To evaluate the efficacy and safety profile of the concomitant dose-dense administration of doxorubicin and docetaxel as primary chemotherapy for patients with large or locally advanced breast cancer. Forty-seven patients were included and received 50 mg/m2 of doxorubicin and 75 mg/m2 of docetaxel every two weeks for four cycles. Primary prophylaxis with granulocyte colony stimulating factor was administered. Patients included had mainly stage III disease (66%). Efficacy and toxicity analyses were carried out on an intention-to-treat basis. After study treatment, the rate of clinical responses was 85% (95% CI: 75-95) with 6% judged as clinical complete responses. Surgery was performed on 94% patients for whom the breast was conserved in 27%. Only one patient obtained a pathological complete response (with no evidence of invasive or non-invasive tumour in the breast and the lymph nodes). In three additional patients, malignant cells were detected only in one lymph node. The single severe haematological toxicity was neutropenia, occurring in one patient (2%) and two cycles (1%), being grade 3 in one and grade 4 in the other. Severe non-haematological toxicities were grade 3, and the most common was asthenia (8% of patients), followed by cutaneous toxicity, arthromyalgia and stomatitis, which occurred in fewer than 4% of patients in each case. The concomitant dose-dense administration of doxorubicin and docetaxel as neoadjuvant chemotherapy with granulocyte colony stimulating factor support is a feasible and effective schedule with a safe toxicity profile for women with large or locally advanced breast cancer.
引用
收藏
页码:739 / 744
页数:6
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[45]   Phase 2 study of neoadjuvant treatment with NOV-002 in combination with doxorubicin and cyclophosphamide followed by docetaxel in patients with HER-2 negative clinical stage II-IIIc breast cancer [J].
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Hurley, J. ;
Koniaris, L. G. ;
Rumboldt, T. ;
Yasir, S. ;
Jorda, M. ;
Garret-Mayer, E. ;
Avisar, E. ;
Slingerland, J. ;
Silva, O. ;
Welsh, C. ;
Schuhwerk, K. ;
Seo, P. ;
Pegram, M. D. ;
Glueck, S. .
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[46]   PHASE-II STUDY OF HIGH-DOSE EPIRUBICIN IN COMBINATION WITH CYCLOPHOSPHAMIDE IN PATIENTS WITH ADVANCED BREAST-CANCER [J].
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BEITH, JM ;
SNYDER, RD ;
TATTERSALL, MH ;
BELL, D ;
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Tjulandin, S. .
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