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

Breast Cancer Research and Treatment volume 171, pages 747–758 (2018)Cite this article

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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Acknowledgements

We want to thank all study groups that conduced the clinical trials, especially the Arbeitsgemeinschaft für Gynäkologische Onkologie Brust (AGO-B), German Breast Group (GBG). Furthermore, we want to thank all patients taking part in clinical trials and the clinical tumor registry follow-up program. Furthermore, we want to thank Dennis J. Slamon, MD, PhD, Sara Hurvitz, MD, and Dorothy Wiley, FAAN, RN, PhD.

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Affiliations

  1. Division of Hematology and Oncology, Department of Medicine, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA, USA

    Meghan Brennan

  2. Department of Gynecology and Obstetrics, University Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander-University Erlangen-EMN, Erlangen, Germany

    Paul Gass, Lothar Häberle, Michael P. Lux, Matthias W. Beckmann & Peter A. Fasching

  3. Biostatistics Unit, Department of Gynecology and Obstetrics, University Hospital Erlangen, Erlangen, Germany

    Lothar Häberle

  4. School of Public Heath, Biostatistics Department, University of California at Los Angeles, Los Angeles, CA, USA

    Daidong Wang

  5. Institute of Pathology, University Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Friedrich- Alexander-University Erlangen-EMN, Erlangen, Germany

    Arndt Hartmann

  6. Department of Obstetrics and Gynecology, Helios Klinikum Berlin-Buch, Berlin, Germany

    Michael Untch

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  1. Meghan Brennan
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Correspondence to Meghan Brennan.

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PAF reports to have received honoraria from Amgen, Novartis, Pfizer, Celgene, Genomic Health, and Nanostring. PAF’s institution conducts research sponsored by Novartis, Amgen, and Celgene.

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Brennan, M., Gass, P., Häberle, L. et al. The effect of participation in neoadjuvant clinical trials on outcomes in patients with early breast cancer. Breast Cancer Res Treat 171, 747–758 (2018). https://doi.org/10.1007/s10549-018-4829-4

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Keywords

  • Breast cancer
  • Neoadjuvant therapy
  • Clinical trial participation
  • pCR
  • Mastectomy
  • Trial participation outcomes