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Observational Study
. 2018 Jan 8;18(1):51.
doi: 10.1186/s12885-017-3857-5.

Trastuzumab without chemotherapy in the adjuvant treatment of breast cancer: subgroup results from a large observational study

Peter Dall  1 , Thorsten Koch  2 , Thomas Göhler  3 , Johannes Selbach  4 , Andreas Ammon  5 , Jochen Eggert  6 , Nidal Gazawi  7 , Daniela Rezek  8 , Arthur Wischnik  9 , Carsten Hielscher  10 , Nicolas Schleif  11 , Ursula Cirrincione  12 , Axel Hinke  12 , Gabriele Feisel-Schwickardi  13
Affiliations
Observational Study

Trastuzumab without chemotherapy in the adjuvant treatment of breast cancer: subgroup results from a large observational study

Peter Dall et al. BMC Cancer. .

Abstract

Background: 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.

Methods: An 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.

Results: Of 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.

Conclusions: Trastuzumab 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.

Keywords: HER2-positive; Monotherapy; Overall survival; Propensity score analysis; Relapse-free survival.

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Conflict of interest statement

Ethics approval and consent to participate

This was an observational study in which physicians’ choices were guided by drug registration status and treatment guidelines (rather than the observation protocol). As the study was started prior to 2007, it was in agreement with the German FSA Codex and the German Arzneimittelgesetz Amendment 12, that there was no need/requirement for ethics committee approval or written informed consent. For non-interventional studies started in 2007 or later, the FSA Codex asks for submission to the ethics committee (recommended) and to the regulators [https://www.fsa-pharma.de/verhaltenskodizes/fachkreise/] (in German), accessed 07 August 2017]. Furthermore, in the European Union, clinical research has to be performed according to the Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use dating from April 4th, 2001 (OJ. L121:34-44). This regulation differentiates between the requirements for “interventional” and “non-interventional” studies. This observational study clearly fulfils the criteria for “non-interventional” as defined in Article 2, c.

Consent for publication

Not applicable.

Competing interests

Peter Dall: Roche Pharma AG, Novartis, Astra Zeneca (Honoraria received), Roche Pharma AG (Travel, accommodations or expenses); Carsten Hielscher: Roche Pharma AG, Celgene, Oncovis (Honoraria received); Pfizer, Oncovis (Travel, accommodations or expenses); Nicolas Schleif: Roche Pharma AG (Employment); Axel Hinke: Roche Pharma AG (Honoraria received). The other authors indicated no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Kaplan-Meier plots of (a) relapse-free survival and (b) overall survival in patients with early breast cancer receiving adjuvant trastuzumab with or without chemotherapy
Fig. 2
Fig. 2
Kaplan-Meier plots of (a) relapse-free survival and (b) overall survival in propensity score matched patients with early breast cancer receiving adjuvant trastuzumab with or without chemotherapy
See this image and copyright information in PMC

References

    1. Figueroa-Magalhaes MC, Jelovac D, Connolly RM, et al. Treatment of HER2-positive breast cancer. Breast. 2014;23:128–136. doi: 10.1016/j.breast.2013.11.011. - DOI - PMC - PubMed
    1. Coates AS, Winer EP, Goldhirsch A, et al. Tailoring therapies—improving the management of early breast cancer: St Gallen international expert consensus on the primary therapy of early breast cancer 2015. Ann Oncol. 2015;26:1533–1546. doi: 10.1093/annonc/mdv221. - DOI - PMC - PubMed
    1. Smith I, Procter M, Gelber RD, et al. 2 year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomized controlled trial. Lancet. 2007;369:29–36. doi: 10.1016/S0140-6736(07)60028-2. - DOI - PubMed
    1. Perez EA, Romond EH, Suman VJ, et al. Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31. J Clin Oncol. 2011;29:3366–3373. doi: 10.1200/JCO.2011.35.0868. - DOI - PMC - PubMed
    1. Slamon D, Eiermann W, Robert N, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365:1273–1283. doi: 10.1056/NEJMoa0910383. - DOI - PMC - PubMed

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