Efficacy and safety of neoadjuvant trastuzumab combined with paclitaxel and epirubicin : A retrospective review of the M. D. Anderson experience

✍ Scribed by Shaheenah Dawood; Ana M. Gonzalez-Angulo; Florentia Peintinger; Kristine Broglio; William F. Symmans; Shu-Wan Kau; Rabiul Islam; Gabriel N. Hortobagyi; Aman U. Buzdar

• Publisher: John Wiley and Sons
• Year: 2007
• Tongue: English
• Weight: 114 KB
• Volume: 110
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/cncr.22895

✦ Synopsis

Abstract

BACKGROUND.

A previously published prospective randomized phase 3 trial showed that administration of 24 weeks of primary systemic chemotherapy (PST) with paclitaxel and FEC~75~ (fluorouracil, epirubicin, cyclophosphamide) concurrently with trastuzumab in patients with HER2‐positive primary breast cancer resulted in a 60% pathologic complete response rate (PCR) with no associated severe cardiac toxicity. The purpose of this study was to review the efficacy and safety of a similar regimen outside the setting of a clinical trial.

METHODS.

Patients with HER2‐positive breast cancer (defined as either immunohistochemical 3+ or fluorescence in situ hybridization‐positive) that had received 24 weeks of neoadjuvant trastuzumab concurrently with taxane and anthracycline‐based chemotherapy between 2004 and 2006 were included in the analysis. PST chemotherapy consisted of paclitaxel (80 mg/m^2^) weekly for 12 weeks followed by 4 cycles of FEC~75~ (500 mg/m^2^, 75 mg/m^2^, and 500 mg/m^2^, respectively).

RESULTS.

Forty patients were identified. The median age was 48 years (range, 29–81). In all, 60% of patients had stage III disease and 4 had inflammatory breast cancer. The PCR rate was 55% (95% confidence interval [CI], 38.5%–70.7%). At a median follow‐up of 19 months. 5 patients had a recurrence, of which 4 did not achieve a PCR. No severe cardiac events were observed.

CONCLUSIONS.

Stage II and III HER2‐positive breast cancer patients achieved a high rate of PCR with trastuzumab given concurrently with paclitaxel and FEC~75~ chemotherapy. No severe cardiac events were observed with the regimen. The data concur with the results of a previously published trial. Cancer 2007. © 2007 American Cancer Society.