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Publications

Journal Article Ahead of print

PubMed: 41558201 DOI: 10.1016/j.esmoop.2025.106050

Pathological complete response with neoadjuvant pembrolizumab and chemotherapy in non-metastatic triple-negative inflammatory breast cancer.

ESMO Open 11(2):106050

Authors: F Lynce, C Valenza, S M Niman, F Bertucci, M Kai, S Ryan, E Troll, R M Layman, K A Fanucci, A Giordano, A Nasrazadani, F Nakhlis, J Bellon, L Warren, C Block, S Schumer, A Lucci, S Krishnamurthy, D Trapani, F Lerebours, F Dalenc, C Levy, T Petit, M Leheurteur, T Bachelot, O Tredan, J M Ribeiro, B Pistilli, P Zagami, S Ladoire, L Lopez Almeida, C Zemmour, L A Carey, S M Tolaney, V Valero, G Curigliano, M M Regan, A Goncalves, W A Woodward

Affiliations

  • Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA.
  • Division of New Drugs and Early Drug Development for Innovative Therapies, European Institute of Oncology, IRCCS, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy; Harvard T.H. Chan School of Public Health, Boston, USA.
  • Dana-Farber Cancer Institute, Boston, USA.
  • Institut Paoli-Calmettes, Marseille, France.
  • The University of Texas MD Anderson Cancer Center, Houston, USA.
  • Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA.
  • Division of New Drugs and Early Drug Development for Innovative Therapies, European Institute of Oncology, IRCCS, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.
  • Institut Curie, Paris, France.
  • Oncopole Claudius-Regaud, IUCT, Toulouse, France.
  • Centre François Baclesse, Caen, France.
  • Centre Paul Strauss, Strasbourg, France.
  • Centre Henri Becquerel, Rouen, France.
  • Centre Léon Bérard, Lyon, France.
  • Department of Cancer Medicine, Gustave Roussy, Villejuif, France.
  • Division of New Drugs and Early Drug Development for Innovative Therapies, European Institute of Oncology, IRCCS, Milan, Italy; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, USA.
  • Centre Georges François Leclerc, Dijon, France.
  • Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, USA.

Abstract

BACKGROUND

The efficacy of neoadjuvant chemoimmunotherapy in patients with non-metastatic triple-negative inflammatory breast cancer (TN-IBC) remains unclear, as patients with IBC have been poorly represented in pivotal clinical trials.

PATIENTS AND METHODS

We conducted an observational, retrospective/prospective, multicenter cohort study from 2023 to 2024 of patients with non-metastatic TN-IBC who received at least one cycle of neoadjuvant pembrolizumab plus multi-agent chemotherapy from September 2018 to April 2023. The median follow-up was 1.4 years [95% confidence interval (CI) 1.2-1.7 years]. The primary endpoint was pathological complete response (pCR).

RESULTS

Overall, 63 female patients with TN-IBC were included from four cohorts. The most common regimen was pembrolizumab, taxane/carboplatin, and anthracycline/cyclophosphamide (61.9%). Among all patients, 59 (94%) underwent surgery and 4 (6.4%) experienced local and/or distant disease progression during the neoadjuvant treatment. The pCR rate was 31.7% (20/63; 95% CI 20.6% to 44.7%).

CONCLUSIONS

The combination of neoadjuvant chemotherapy and pembrolizumab resulted in a pCR rate of 31.7% in patients with non-metastatic TN-IBC. Compared with triple-negative non-IBC, the lower pCR rate with this combination regimen highlights the need for biomarkers for better patient selection and more active treatment options for this rare and aggressive breast cancer subtype.

MeSH

Breast Neoplasms, Neoplasms, Inflammatory Breast Neoplasms, Multiple Chronic Conditions, Drug Therapy, Breast, Therapeutics, Chemotherapy