Pembrolizumab in combination with nab-paclitaxel for the treatment of patients with early-stage triple-negative breast cancer – A single-arm phase II trial (NeoImmunoboost, AGO-B-041)

Fasching P, Hein A, Kolberg HC, Häberle L, Uhrig S, Rübner M, Belleville E, Hack C, Fehm TN, Janni W, Hartmann A, Erber R, Theuser AK, Brucker SY, Hartkopf AD, Untch M (2023)

Publication Type: Journal article

Publication year: 2023

Journal

European Journal of Cancer Elsevier

Book Volume: 184

Pages Range: 1-9

DOI: 10.1016/j.ejca.2023.01.001

Abstract

Background: Pembrolizumab is approved for the neoadjuvant/adjuvant treatment of early triple-negative breast cancer (TNBC) patients in combination with chemotherapy. The Keynote-522 trial used platinum chemotherapy. As neoadjuvant nab-paclitaxel (nP) is also highly effective in triple-negative breast cancer patients, this study investigates the response to nP-containing neoadjuvant chemotherapy in combination with pembrolizumab. Patients and methods: NeoImmunoboost (AGO-B-041/NCT03289819) is a multicenter, prospective single-arm phase II trial. Patients were treated with 12 weekly cycles of nP followed by four three-weekly cycles of epirubicin/cyclophosphamide. Pembrolizumab was given three-weekly in combination with these chemotherapies. The study was planned for 50 patients. After 25 patients, the study was amended to include a pre-chemotherapy single application of pembrolizumab. The primary aim was pathological complete response (pCR), and the secondary aims were safety and quality of life. Results: Of 50 included patients, 33 (66.0%; 95%confidence interval: 51.2%–78.8%) had a (ypT0/is ypN0) pCR. The pCR rate in the per-protocol population (n = 39) was 71.8% (95%confidence interval: 55.1%–85.0%). The most common adverse events of any grade were fatigue (58.5%), peripheral sensory neuropathy (54.7%) and neutropenia (52.8%). The pCR rate in the cohort of 27 patients with a pre-chemotherapy pembrolizumab dose was 59.3%, and 73.9% in the 23 patients without pre-chemotherapy dose. Conclusions: pCR rates after NACT with nP and anthracycline combined with pembrolizumab are encouraging. With acceptable side-effect profiles, this treatment might be a reasonable alternative to platinum-containing chemotherapy in cases of contraindications. However, without data from randomised trials and long-term follow up, platinum/anthracycline/taxane-based chemotherapy remains the standard combination chemotherapy for pembrolizumab.

Authors with CRIS profile

Peter Fasching Professur für Translationale Frauenheilkunde und Geburtshilfe Alexander Hein Department of Obstetrics and Gynaecology Sabrina Uhrig Department of Obstetrics and Gynaecology Matthias Rübner Department of Obstetrics and Gynaecology Carolin Hack Medizinische Fakultät Arndt Hartmann Lehrstuhl für Allgemeine Pathologie und Pathologische Anatomie Ramona Erber Institute of Pathology

Involved external institutions

Marienhospital Bottrop DE Germany (DE) HELIOS Kliniken DE Germany (DE) ClinSol GmbH & Co.KG DE Germany (DE) Universitätsklinikum Düsseldorf DE Germany (DE) Universitätsklinikum Ulm DE Germany (DE) Institut für Frauengesundheit GmbH DE Germany (DE) Universitätsklinikum Tübingen DE Germany (DE)

How to cite

APA:

Fasching, P., Hein, A., Kolberg, H.C., Häberle, L., Uhrig, S., Rübner, M.,... Untch, M. (2023). Pembrolizumab in combination with nab-paclitaxel for the treatment of patients with early-stage triple-negative breast cancer – A single-arm phase II trial (NeoImmunoboost, AGO-B-041). European Journal of Cancer, 184, 1-9. https://doi.org/10.1016/j.ejca.2023.01.001

MLA:

Fasching, Peter, et al. "Pembrolizumab in combination with nab-paclitaxel for the treatment of patients with early-stage triple-negative breast cancer – A single-arm phase II trial (NeoImmunoboost, AGO-B-041)." European Journal of Cancer 184 (2023): 1-9.

BibTeX: Download