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01-10-2018 | Epidemiology

The effect of participation in neoadjuvant clinical trials on outcomes in patients with early breast cancer

Authors: Meghan Brennan, Paul Gass, Lothar Häberle, Daidong Wang, Arndt Hartmann, Michael P. Lux, Matthias W. Beckmann, Michael Untch, Peter A. Fasching

Published in: Breast Cancer Research and Treatment | Issue 3/2018

Abstract

Background

Clinical trials can offer novel and more advanced and/or novel treatments to cancer patients in advance of them being approved and available for all patients. While several studies have examined the effect of clinical trial participation on prognosis, there has been no clear conclusion from these studies. Therefore, we chose to test the influence of trial participation on pathological complete response (pCR) and mastectomy rates after neoadjuvant chemotherapy.

Methods

In this retrospective study, all patients treated with neoadjuvant chemotherapy from 2001 to 2014 were selected. A total of 1038 patients with complete treatment, patient, and tumor characteristics were included. A total of 260 of those were treated in clinical trials. We examined whether study participation status in addition to commonly known predictors for pCR improves prediction of pCR. Similar analyses were conducted for the mastectomy rate outcome measure. Finally, survival analyses were also conducted as part of an exploratory analysis.

Results

Study participation was an independent predictor of pCR in addition to commonly known predictors. Adjusted odds ratio (OR) for trial participants versus non-participants was 1.53 (95% CI 1.03–2.28). Additionally, study participation improved the prediction of mastectomy risk. The adjusted OR for trial participants versus non-participants was 0.62 (95% CI 0.42–0.90). Subgroup-specific differences concerning the impact of study participation could not be shown for either pCR or mastectomy rate. Survival comparisons could not be conducted due to large differences in follow-up data in patients participating in clinical trials versus those who did not participate; however, pCR was a predictor of prognosis in both groups.

Conclusion

Patients taking part in neoadjuvant chemotherapy clinical trials have a higher pCR rate and a lower mastectomy risk than patients not participating in clinical trials for their cancer care. This finding is a supporting factor for trial participation in neoadjuvant chemotherapy trials.

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Title: The effect of participation in neoadjuvant clinical trials on outcomes in patients with early breast cancer
Authors: Meghan Brennan
Paul Gass
Lothar Häberle
Daidong Wang
Arndt Hartmann
Michael P. Lux
Matthias W. Beckmann
Michael Untch
Peter A. Fasching
Publication date: 01-10-2018
Publisher: Springer US
Published in: Breast Cancer Research and Treatment / Issue 3/2018
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI: https://doi.org/10.1007/s10549-018-4829-4

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