Abstract
BackgroundThe topic of trastuzumab therapy without chemotherapy in early breast cancer (EBC) has been repeatedly discussed at international consensus meetings, but is compromised by the lack of solid evidence from clinical studies.MethodsAn observational study database of patients with EBC receiving trastuzumab-containing (neo)adjuvant therapy was screened to identify those patients who did not receive cytostatic agents.ResultsOf 3935 patients, 232 (6%) were identified who received no chemotherapy, being characterized by older age, worse performance status, and/or less aggressive histology. Relapse-free survival in this cohort was 84% (95% confidence interval [CI] 78–89%) at 3 years and 80% (95% CI 74–87%) at 5 years. However, these rates were significantly worse than those in the group of patients who received chemotherapy (hazard ratio 1.49; 95% CI 1.06–2.09; P = 0.022). A similar pattern was observed for overall survival, with marginally non-significant inferiority in the group receiving no chemotherapy (hazard ratio 1.56; 95% CI 1.00–2.44; P = 0.052). Survival rates in patients receiving no chemotherapy were 93% (95% CI 88–97%) and 87% (95% CI 81–93%) at 3 and 5 years, respectively. These findings were confirmed by a propensity score analysis accounting for selection bias.ConclusionsTrastuzumab plus chemotherapy should remain the preferred option in all patients with HER2-positive EBC with an indication for adjuvant treatment. However, a limited proportion of patients will need an alternative treatment approach, either because of contraindications or the patient’s preference. In these selected patients, trastuzumab monotherapy, eventually combined with endocrine agents, might be a reasonable option offering favorable long-term outcomes by addressing the high-risk profile associated with HER2-positive disease.
Highlights
The topic of trastuzumab therapy without chemotherapy in early breast cancer (EBC) has been repeatedly discussed at international consensus meetings, but is compromised by the lack of solid evidence from clinical studies
* Correspondence: peter.dall@klinikum-lueneburg.de 1Department of Obstetrics and Gynaecology and Breast Cancer Center, Städtisches Klinikum Lüneburg, Bögelstraße 1, D-21339 Lüneburg, Germany Full list of author information is available at the end of the article considered the standard of care in patients with this biologically aggressive subtype of breast cancer. This evidence has led to unequivocal improvements in outcomes for the vast majority of patients with Human epidermal growth factor receptor 2 (HER2)-positive disease, the question remains as to whether there is a place for anti-HER2 therapy without chemotherapy in individually selected patients with EBC [7]
Baseline and treatment characteristics of patients with and without chemotherapy Between September 2006 and July 2011, a total of 3940 eligible patients with HER2-positive breast cancer were recruited, 3935 of whom could be unequivocally categorized into groups with (n = 3703; 94%) or without (n = 232; 6%) any sequential or concurrentadjuvant chemotherapy
Summary
The topic of trastuzumab therapy without chemotherapy in early breast cancer (EBC) has been repeatedly discussed at international consensus meetings, but is compromised by the lack of solid evidence from clinical studies. The issue of adjuvant trastuzumab monotherapy has repeatedly been discussed at international consensus meetings, resulting in weak recommendations and the recurrent request for randomized clinical trials. Such trials are difficult to perform due to the limited cohort size and the predictably low event rate. We decided to approach this question within the framework of our database of about 4000 patients with EBC receiving trastuzumab
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