Adjuvant trastuzumab: A milestone in the treatment of HER-2-positive early breast cancer

José Baselga, Edith A. Perez, Tadeusz Pienkowski, Richard Bell

Research output: Contribution to journalArticle

169 Citations (Scopus)

Abstract

Up to one fourth of women diagnosed with early breast cancer (EBC) have tumors that are human epidermal growth factor receptor 2 (HER-2) positive. This is associated with a high risk of relapse and death from metastatic disease. Trastuzumab, a monoclonal antibody directed against the extracellular domain of HER-2, improves survival and quality of life in women with HER-2-positive metastatic breast cancer receiving chemotherapy. Four major adjuvant trials - Herceptin® Adjuvant (HERA), National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31, North Central Cancer Treatment Group (NCCTG) N9831, and Breast Cancer International Research Group (BCIRG) 006 - including between them >13,000 women with HER-2-positive EBC, have investigated different adjuvant treatment approaches with trastuzumab. These trials have shown that trastuzumab reduces the 3-year risk of recurrence by about half in this population. The benefit was similar across the trials despite differences in patient populations, chemotherapy regimens, and sequencing of treatment. At a 2-year follow-up, interim results from the combined analysis of the NSABP B-31 and NCCTG N9831 trials showed a one third lower mortality for trastuzumab, and there was a trend toward an overall survival benefit in the HERA and BCIRG trials. A small Finnish trial, FinHer, investigating another regimen of trastuzumab, has also shown similarly positive results. Further follow-up of the major adjuvant trials will clarify the survival benefit for women receiving trastuzumab, as well as the optimal treatment duration (1 or 2 years). Notably, cardiac events in the trastuzumab-containing arms of these trials have remained within acceptable levels, with a slightly higher (0.6%-3.3%) incidence of congestive heart failure that mostly responded to treatment. Further follow-up will provide information on long-term cardiac safety. Overall, results from clinical trials are sufficiently compelling to consider 1 year of adjuvant trastuzumab treatment for women with HER-2-positive EBC based on the risk:benefit ratio demonstrated in these studies.

Original languageEnglish (US)
Pages (from-to)4-12
Number of pages9
JournalOncologist
Volume11
Issue numberSUPPL. 1
DOIs
StatePublished - 2006

Fingerprint

Breast Neoplasms
Therapeutics
Survival
Breast
human ERBB2 protein
Trastuzumab
Recurrence
Drug Therapy
Neoplasms
Research
Population
Arm
Heart Failure
Odds Ratio
Monoclonal Antibodies
Quality of Life
Clinical Trials
Safety
Mortality
Incidence

Keywords

  • Adjuvant
  • Clinical trial
  • Early breast cancer
  • HER-2 positive
  • Trastuzumab

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Hematology

Cite this

Adjuvant trastuzumab : A milestone in the treatment of HER-2-positive early breast cancer. / Baselga, José; Perez, Edith A.; Pienkowski, Tadeusz; Bell, Richard.

In: Oncologist, Vol. 11, No. SUPPL. 1, 2006, p. 4-12.

Research output: Contribution to journalArticle

Baselga, José ; Perez, Edith A. ; Pienkowski, Tadeusz ; Bell, Richard. / Adjuvant trastuzumab : A milestone in the treatment of HER-2-positive early breast cancer. In: Oncologist. 2006 ; Vol. 11, No. SUPPL. 1. pp. 4-12.
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