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Efficacy and safety of concurrent trastuzumab plus weekly paclitaxel–FEC as primary therapy for HER2-positive breast cancer in everyday clinical practice

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Abstract

One of the most efficacious primary therapies in HER2-positive breast cancer was published by the M.D. Anderson group in 2005. This randomized trial evaluated the addition of trastuzumab to a taxane–anthracycline based chemotherapy. Despite largely significant differences in pathological complete response (pCR) in the trastuzumab group (65 vs. 26 %) this regimen did not become a common standard due to toxicity concerns and its premature closure with a small sample size. In order to evaluate the efficacy and safety of this regimen in an off-trial setting we conducted a prospectively monitorized series of consecutive patients with early or locally advanced Her-2 positive breast cancer following the same treatment strategy. Stage II–IIIC HER2-positive breast cancer patients, including inflammatory disease, were treated with weekly-trastuzumab for 24 weeks administered concurrently with all primary chemotherapy containing paclitaxel (80 mg/m2) for 12 weeks and 4 cycles of FEC-75 (fluorouracil 500 mg/m2, epirubicine 75 mg/m2, and cyclophosphamide 500 mg/m2) followed by surgery. The objectives were efficacy, in terms of pCR in both the breast and lymph nodes, and safety, with close cardiac monitoring during and after treatment. From August 2004 to February 2009, 83 patients were included. Most patients (73.5 %) had node involvement and 13.2 % had inflammatory disease. Fifty-one patients (61.4 %) achieved a pCR in breast and axilla (95 % CI 50–72 %). HR-negative tumors were associated with higher pCR rate than HR-positive tumors (77 vs. 48 %, P = 0.006). At a median follow-up of 50.2 months no patient developed symptomatic cardiac failure, and 9 patients (10.8 %) presented a transient asymptomatic decrease in left ventricular ejection fraction. Primary therapy with concurrent trastuzumab plus paclitaxel–FEC for HER2-positive breast cancer in everyday practice is highly effective and safe confirming the results observed in a randomized trial stopped prematurely.

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Acknowledgments

We would like to thank all the patients and the following people: Anna Clopés and Montse Rey (Farmacy Department, Institut Català d’Oncologia), Idoia Morilla and Josep Maria Piulats (Medical Oncology Department, Institut Català d’Oncologia), Ramon Colomer (Senior Consultant, Scientific Direction, Institut Català d’Oncologia), Arantxa Eraso and Ferran Moreno (Radiaton Oncology, Institut Català d’Oncologia) Luis Prieto and Raul Ortega (Radiology Department, H.U. Bellvitge), and Teresa Soler (Pathology Department, HU. Bellvitge).

Conflict of interest

All authors have no conflicts of interest.

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Authors and Affiliations

  1. Department of Medical Oncology, Breast Unit, Institut Català d’Oncologia-Hospital Universitari de Bellvitge-Bellvitge Research Institute (IDIBELL), Av Gran via 199-203, 08907, L’Hospitalet de Llobregat, Barcelona, Spain

    Sonia Pernas, Miguel Gil-Gil, María Ochoa de Olza, Cati Falo, Adela Fernandez-Otega, Carlos Mesia, Ander Urruticoechea & Josep Ramon Germà

  2. Department of Radiology, Breast Unit, Institut Català d’Oncologia-Hospital Universitari de Bellvitge-Bellvitge Research Institute (IDIBELL), Av Gran via 199-203, 08907, L’Hospitalet de Llobregat, Barcelona, Spain

    Anna Gumà

  3. Department of Pathology, Breast Unit, Institut Català d’Oncologia-Hospital Universitari de Bellvitge-Bellvitge Research Institute (IDIBELL), Av Gran via 199-203, 08907, L’Hospitalet de Llobregat, Barcelona, Spain

    Fina Climent & Anna Petit

  4. Department of Gynecology, Breast Unit, Institut Català d’Oncologia-Hospital Universitari de Bellvitge-Bellvitge Research Institute (IDIBELL), Av Gran via 199-203, 08907, L’Hospitalet de Llobregat, Barcelona, Spain

    María Jesús Pla & Amparo García-Tejedor

  5. Department of Plastic Surgery, Breast Unit, Institut Català d’Oncologia-Hospital Universitari de Bellvitge-Bellvitge Research Institute (IDIBELL), Av Gran via 199-203, 08907, L’Hospitalet de Llobregat, Barcelona, Spain

    Ana López-Ojeda

  6. Clinical Research Unit, Institut Català d’Oncologia, Hospital Universitari de Bellvitge-Bellvitge Research Institute (IDIBELL), Av Gran via 199-203, 08907, L’Hospitalet de Llobregat, Barcelona, Spain

    Francisco Javier Pérez-Martin

Authors
  1. Sonia Pernas
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  2. Miguel Gil-Gil
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  3. María Ochoa de Olza
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  9. Ana López-Ojeda
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  10. Cati Falo
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  11. Adela Fernandez-Otega
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  12. Carlos Mesia
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  13. Francisco Javier Pérez-Martin
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  15. Josep Ramon Germà
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Correspondence to Sonia Pernas.

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Pernas, S., Gil-Gil, M., de Olza, M.O. et al. Efficacy and safety of concurrent trastuzumab plus weekly paclitaxel–FEC as primary therapy for HER2-positive breast cancer in everyday clinical practice. Breast Cancer Res Treat 134, 1161–1168 (2012). https://doi.org/10.1007/s10549-012-2149-7

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  • DOI: https://doi.org/10.1007/s10549-012-2149-7

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