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.

Abstract

BACKGROUND:

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.

METHODS:

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).

RESULTS:

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 < or = .001)

CONCLUSIONS:

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.

• Authors: Ricardo H Alvarez, Daniel J Booser, Massimo Cristofanilli, Aysegul A Sahin, Eric A Strom, Laura Guerra, Shu-Wan Kau, Ana M Gonzalez-Angulo, Gabriel N Hortobagyi, Vicente Valero
• Journal: Cancer (Cancer) Vol. 116 Issue 5 Pg. 1210-7 (Mar 01 2010) ISSN: 0008-543X [Print] United States
• PMID: 20082452 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Taxoids
• Docetaxel
• Doxorubicin
• Cyclophosphamide
• Fluorouracil
• Methotrexate

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols
• Breast Neoplasms (drug therapy, pathology, radiotherapy, surgery, therapy)
• Chemotherapy, Adjuvant
• Combined Modality Therapy
• Cyclophosphamide
• Disease-Free Survival
• Docetaxel
• Doxorubicin (administration & dosage)
• Drug Administration Schedule
• Female
• Fluorouracil
• Humans
• Methotrexate
• Middle Aged
• Radiotherapy, Adjuvant
• Taxoids (administration & dosage)