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Phase 2 trial of primary systemic therapy with doxorubicin and docetaxel followed by surgery, radiotherapy, and adjuvant chemotherapy with cyclophosphamide, methotrexate, and 5-fluorouracil based on clinical and pathologic response in patients with stage IIB to III breast cancer†‡
Long-term results from The University of Texas M. D. Anderson Cancer Center Study ID97-099
Version of Record online: 15 JAN 2010
Published 2010 by the American Cancer Society
Volume 116, Issue 5, pages 1210–1217, 1 March 2010
How to Cite
Alvarez, R. H., Booser, D. J., Cristofanilli, M., Sahin, A. A., Strom, E. A., Guerra, L., Kau, S.-W., Gonzalez-Angulo, A. M., Hortobagyi, G. N. and Valero, V. (2010), Phase 2 trial of primary systemic therapy with doxorubicin and docetaxel followed by surgery, radiotherapy, and adjuvant chemotherapy with cyclophosphamide, methotrexate, and 5-fluorouracil based on clinical and pathologic response in patients with stage IIB to III breast cancer. Cancer, 116: 1210–1217. doi: 10.1002/cncr.24901
Presented at the 4h Annual Meeting of the American Society of Clinical Oncology, Chicago, Illinois, May 30-June 3, 2008.
This article is US Government work and, as such, is in the public domain in the United States of America.
- Issue online: 18 FEB 2010
- Version of Record online: 15 JAN 2010
- Manuscript Accepted: 16 JUL 2009
- Manuscript Revised: 10 JUL 2009
- Manuscript Received: 21 MAY 2009
- breast cancer;
- primary systemic therapy;
- inflammatory breast cancer;
- locally advanced breast cancer;
- CMF regimen
This study was performed to evaluate the outcomes of patients with locally advanced breast cancer (LABC) who were treated with a multidisciplinary approach including primary systemic chemotherapy and noncross-resistant adjuvant chemotherapy.
Patients with LABC received 4 or 6 cycles of doxorubicin and docetaxel (DT) as primary systemic chemotherapy (PST) every 21 days. Patients with adequate response underwent surgery followed by adjuvant chemotherapy according to pathologic response: complete (pCR), 2 more cycles of DT; partial (pPR), 2 more cycles of DT followed by 6 cycles of cyclophosphamide, methotrexate, and 5-fluorouracil (5-FU) (CMF); and minor (pMR), 6 cycles of CMF. Patients then received radiation and tamoxifen (hormone receptor-positive patients only).
Eighty-eight patients were evaluable. Seventy-four patients had an adequate response to DT and were considered operable, and 72 underwent surgery. Ten patients (13.9%) achieved a pCR, 22 (30.5%) achieved a pPR, and 40 achieved a pMR (55.5%). Fourteen patients were considered nonoperable after DT and underwent salvage CMF therapy. Five of these patients underwent surgery and 1 had achieved a pCR. The estimated 5-year recurrence-free survival (RFS) rates for patients with pCR, pPR, and pMR were 80%, 77%, and 59%, respectively, and the estimated 5-year overall survival (OS) rates were 90%, 91%, and 74%, respectively. The 5-year OS rates were 82% for initially operable and 21% for initially inoperable patients (P ≤ .001)
Multidisciplinary therapy that includes PST with DT and adjuvant therapy with CMF administered according to the clinical and pathologic response is associated with high long-term RFS and OS rates in patients with LABC. Clinical or pathologic PR or CR to DT predicts improved RFS and OS. Cancer 2010. Published 2010 by the American Cancer Society.