Phase II study of neoadjuvant treatment with doxorubicin, docetaxel, and capecitabine (ATX) in locally advanced or inflammatory breast cancer
- First Online:
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/m2 i.v. on day 1; docetaxel (T) 30 mg/m2 i.v. on days 1, 8 and 15; and capecitabine (X) 1,500 mg/m2/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.
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%).
ATX every 28 days for four cycles is associated with a modest activity (low pCR rate) in the neoadjuvant setting of LABC.
KeywordsPreoperative chemotherapy Capecitabine Taxanes Anthracyclines
- 7.Quiben R, Palomero MI, Cassinello J, Pérez-Manga G. Doxorubicin combined with weekly docetaxel in locally advanced or inflammatory breast cancer (BC). Goti Study Group Proc Am Soc Clin Oncol. 2001;37:1901. (abstr 1901).Google Scholar
- 14.Gianni L, Baselga L, Eiermann W, Guillem Porta V, Semiglazov V, Lluch A, et al. Feasibility and tolerability of sequential doxorubicin/paclitaxel followed by cyclophosphamide, methotrexate, and fluorouracil and its effects on tumor response as preoperative therapy. Clin Cancer Res. 2005;11:8715–21.CrossRefPubMedGoogle Scholar
- 15.Bear HD, Anderson S, Smith RE, Geyer CE, Mamounas EP, Fisher B, et al. Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer: National Surgical Adjuvant Breast and Bowel Project protocol B-27. J Clin Oncol. 2006;24:2019–27.CrossRefPubMedGoogle Scholar
- 18.von Minckwitz G, Raab G, Caputo A, Schütte M, Hilfrich J, Blohmer JU, et al. Doxorubicin with cyclophosphamide followed by docetaxel every 21 days compared with doxorubicin and docetaxel every 14 days as preoperative treatment in operable breast cancer: the GEPARDUO study of the German Breast Group. J Clin Oncol. 2005;23:2676–85.CrossRefGoogle Scholar
- 21.Khosravi P, Pérez-Manga G. La relevancia clínica de la sobreexpresión de HER-2 en el cáncer de mama. An Med Int. 2006;23:103–4.Google Scholar
- 22.Wenzel C, Hussian D, Bartsch R, Pluschnig U, Locker GJ, Rudas M, et al. Preoperative therapy with epidoxorubicin and docetaxel plus trastuzumab in patients with primary breast cancer: a pilot study. J Cancer Res Clin Oncol. 2004;30:400–4.Google Scholar
- 23.Buzdar AU, Ibrahim NK, Francis D, Booser DJ, Thomas ES, Theriault RL, et al. Significantly higher pathologic complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin chemotherapy: results of a randomized trial in human epidermal growth factor receptor 2-positive operable breast cancer. J Clin Oncol. 2005;23:3676–85.CrossRefPubMedGoogle Scholar