Primary chemotherapy with gemcitabine, epirubicin and taxol (GET) in operable breast cancer: A phase II study

P. F. Conte, S. Donati, A. Gennari, V. Guarneri, C. Orlandini, M. Rondini, M. Roncella, L. Marini, P. Collecchi, P. Viacava, A. G. Naccarato, R. Degli Esposti, S. Bonardi, A. Bottini, S. Saracchini, S. Tumolo, G. Gullo, A. Santoro, L. Crino

Research output: Contribution to journalArticle

Abstract

This trial was conducted to assess the activity and tolerability of the gemcitabine, epirubicin, taxol triplet combination in patients with operable breast cancer. After core biopsy, 43 women with stage II-IIIA breast cancer were treated with gemcitabine 1000 mg m-2 over 30 min on days 1 and 4, epirubicin 90 mg m-2 as an intravenous bolus on day 1, and taxol 175 mg m-2 as a 3-h infusion on day 1, every 21 days for four cycles. The primary end point was the percentage of pathological complete responses (pCR) in the breast; secondary end points were tolerability, clinical response rates, overall and progression-free survival, tumour biomarkers before and after primary chemotherapy (PCT). All patients were included in safety and survival analyses; 41 eligible patients were evaluated for response. The overall clinical response rate was 87.8% (95% CI 77.8-97.8), with 26.8% complete responses (95% CI 13.3-40.3). A pCR in the breast was observed in six patients (14.6%; 95% CI 3.8-25.4); 15 patients (36.6%; 95% CI 21.9-51.3) had negative axillary lymph nodes. Grade 4 neutropenia was observed in 67.4% of the patients; febrile neutropenia occurred in 1.9% of cycles (granulocyte colony-stimulating factor was used in 3.2% of the cycles to shorten the duration of neutropenia). A statistically significant difference between Mib-1 at baseline (≥20% in 71.4% of the patients) and at definitive surgery (28.6%, P

Original languageEnglish
Pages (from-to)406-411
Number of pages6
JournalBritish Journal of Cancer
Volume93
Issue number4
DOIs
Publication statusPublished - Aug 22 2005

    Fingerprint

Keywords

  • Breast cancer
  • Epirubicin
  • Gemcitabine
  • Pathological complete response
  • Primary chemotherapy
  • Taxol

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Conte, P. F., Donati, S., Gennari, A., Guarneri, V., Orlandini, C., Rondini, M., Roncella, M., Marini, L., Collecchi, P., Viacava, P., Naccarato, A. G., Degli Esposti, R., Bonardi, S., Bottini, A., Saracchini, S., Tumolo, S., Gullo, G., Santoro, A., & Crino, L. (2005). Primary chemotherapy with gemcitabine, epirubicin and taxol (GET) in operable breast cancer: A phase II study. British Journal of Cancer, 93(4), 406-411. https://doi.org/10.1038/sj.bjc.6602723