Gemcitabine/epirubicin/paclitaxel as neoadjuvant chemotherapy in locally advanced breast cancer: A phase II trial of the NSABP foundation research group

John T. Hamm, John W. Wilson, Priya Rastogi, Barry C. Lembersky, George C. Tseng, Young K. Song, Wanseop Kim, André Robidoux, Jane M. Raymond, Carl G. Kardinal, Ibrahim A. Shalaby, Rafat Ansari, Soonmyung Paik, Charles E. Geyer, Norman Wolmark

Research output: Contribution to journalArticle

8 Scopus citations

Abstract

Background: This phase II protocol of neoadjuvant chemotherapy with gemcitabine/epirubicin/paclitaxel (GET) was designed to determine the pathologic complete response (pCR) rate in the breast, clinical response rate, disease-free survival, and overall survival at 2 years as well as toxicity in patients with locally advanced breast cancer. This trial also evaluated the feasibility of tissue collection for gene-expression profiling. Patients and Methods: Seventy-six women with stage MB, MIA, and 1MB breast cancer were entered into this trial. Patients received a maximum of 6 cycles of neoadjuvant GET chemotherapy every 21 days (gemcitabine 1000 mg/m2 intravenously [I.V.] on days 1 and 4, epirubicin 90 mg/m2 I.V bolus on day 1, and paclitaxel 175 mg/m2 I.V. on day 1). After chemotherapy, patients underwent surgery and were assessed for pathologic response. Results: The pCR rate among the 74 patients evaluable for efficacy was 23% (95% CI, 14%-34.2%). Adverse events among the 76 patients evaluable for toxicity included anemia requiring transfusion (14.5%), infection with grade 3/4 neutropenia (10.5%), febrile neutropenia (7.9%), and platelet transfusion (6.6%). Infectious complications occurred in 24 patients (31.6%), of whom 18.4% were in the setting of neutropenia. High-quality RNA and successful probe synthesis were obtained from all pretreatment core biopsy specimens that contained tumor cells (n = 66; 88%). Conclusion: Neoadjuvant GET chemotherapy is an active regimen but with substantial toxicity. Tissue collection for gene-expression profiling is feasible in a multi-institutional setting.

Original languageEnglish (US)
Pages (from-to)257-263
Number of pages7
JournalClinical breast cancer
Volume8
Issue number3
DOIs
StatePublished - Jun 2008

Keywords

  • Desquamation
  • Diagonal linear discriminant analysis
  • Gene-expression profiling
  • Myalgia
  • P reoperative chemotherapy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Hamm, J. T., Wilson, J. W., Rastogi, P., Lembersky, B. C., Tseng, G. C., Song, Y. K., Kim, W., Robidoux, A., Raymond, J. M., Kardinal, C. G., Shalaby, I. A., Ansari, R., Paik, S., Geyer, C. E., & Wolmark, N. (2008). Gemcitabine/epirubicin/paclitaxel as neoadjuvant chemotherapy in locally advanced breast cancer: A phase II trial of the NSABP foundation research group. Clinical breast cancer, 8(3), 257-263. https://doi.org/10.3816/CBC.2008.n.029