Phase II study of neoadjuvant treatment with doxorubicin, docetaxel, and capecitabine (ATX) in locally advanced or inflammatory breast cancer

Background Pathologic complete response (pCR) after preoperative systemic chemotherapy (PSCh) is associated with better outcome in locally advanced breast cancer (LABC). Patients and methods PSCh included: doxorubicin (A) 50 mg/m 2 i.v. on day 1; docetaxel (T) 30 mg/m 2 i.v. on days 1, 8 and 15; and...

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Published in:Breast cancer (Tokyo, Japan) Vol. 17; no. 3; pp. 205 - 211
Main Authors: Manga, Gumersindo Pérez, Shahi, Parham Khosravi, Ureña, Miguel Méndez, Pereira, Rosa Quiben, Plaza, María Isabel Palomero, Peron, Yann Izarzugaza, Val, Ricardo González Del, Carrión, Joaquín Belón, Cañón, Esperanza Pérez, Alfonso, Pilar García
Format: Journal Article
Language:English
Published: Japan Springer Japan 01-07-2010
Springer
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Summary:Background Pathologic complete response (pCR) after preoperative systemic chemotherapy (PSCh) is associated with better outcome in locally advanced breast cancer (LABC). Patients and methods PSCh included: doxorubicin (A) 50 mg/m 2 i.v. on day 1; docetaxel (T) 30 mg/m 2 i.v. on days 1, 8 and 15; and capecitabine (X) 1,500 mg/m 2 /day p.o. on days 1–14, in a 4-week course repeated for up to four cycles (ATX), followed by surgery. The primary end point of this study was to evaluate the pCR rate. Secondary endpoints included clinical response rate, disease-free survival (DFS), overall survival (OS), and the toxicity profile. Results A total of 60 patients were included in the analysis. Median age was 49 years, and 63.3% of patients were hormone receptor positive. The median number of cycles of PSCh was four (95% CI: 3–4). Five patients (8.3%) achieved pCR in both breast and nodes, and 16.7% reached pCR only in nodes. The clinical response rate was 77% (27% complete response), but only 18% of the patients underwent conservative surgery. With a median follow-up of 20 months, 3-year DFS and OS were 76 and 90%, respectively. Grade III/IV toxicity included neutropenia (74%), febrile neutropenia (9%), mucositis (12%), and diarrhea (12%). Conclusions ATX every 28 days for four cycles is associated with a modest activity (low pCR rate) in the neoadjuvant setting of LABC.
ISSN:1340-6868
1880-4233
DOI:10.1007/s12282-009-0136-6