© 2002 by American Society of Clinical Oncology

Neoadjuvant Chemotherapy in Breast Cancer: Significantly Enhanced Response With Docetaxel

Ian C. Smith, Steven D. Heys, Andrew W. Hutcheon, Iain D. Miller, Simon Payne, Fiona J. Gilbert, Antoinne K. Ah-See, Oleg Eremin, Leslie G. Walker, Tarun K. Sarkar, S. Peter Eggleton

and Keith N. Ogston

From the Departments of Academic Radiology and Surgery, University of Aberdeen, Aberdeen; Departments of Oncology and Pathology, Grampian University Hospitals National Health Service Trust, Aberdeen, Grampian, Scotland; Department of Surgery, Lincoln and Louth

National Health Service Trust, Lincoln; Department of Rehabilitation Medicine, University of Hull, Hull, England; and Aventis Pharma, West Malling, Kent, United Kingdom.

Address reprint requests to Ian C. Smith, MB, ChB, Department of Academic Radiology, University of Aberdeen, Lilian Sutton Building, Foresterhill, Aberdeen AB25 2ZD, Scotland,

United Kingdom; email: i.c.smith@abdn.ac.uk.

AbstractPURPOSE: To compare the efficacy of neoadjuvant (NA) docetaxel (DOC) with anthracycline-based therapy and determine the efficacy of NA DOC in patients with breast cancer initially failing to respond to anthracycline-based NA chemotherapy (CT).

PATIENTS AND METHODS: Patients with large or locally advanced breast cancer received four pulses of cyclophosphamide 1,000 mg/m2, doxorubicin 50 mg/m2, vincristine 1.5 mg/m2, and prednisolone 40 mg (4 × CVAP) for 5 days. Clinical tumor response was assessed. Those who responded (complete response [CR] or partial response [PR]) were randomized to receive further 4 × CVAP or 4 × DOC (100 mg/m2). All nonresponders received 4 × DOC.

RESULTS: One hundred sixty-two patients were enrolled; 145 patients completed eight cycles of NA CT. One hundred two patients (66%) achieved a clinical response (PR or CR) after 4 × CVAP. After randomization, 50 patients received 4 × CVAP and 47 patients received 4 × DOC. In patients who received eight cycles of CT, the clinical CR (cCR) and clinical PR (cPR) (94% v 66%) and pathologic CR (pCR) (34% v 16%) response rates were higher (P = .001 and P = .04) in those who received further DOC. Intention-to-treat analysis demonstrated cCR and cPR (85% v 64%; P = .03) and pCR (31% v 15%; P = .06). Axillary lymph node examination revealed residual tumor in 33% of patients who received 8 × CVAP and 38% of patients who received further DOC. In patients who failed to respond to the initial CVAP, 4 × DOC resulted in a cCR and cPR rate of 55% and a pCR rate of 2%. Forty-four percent of these patients had residual tumor within axillary lymph nodes.

CONCLUSION: NA DOC resulted in substantial improvement in responses to DOC.