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Neoadjuvant Pembrolizumab Plus Chemotherapy in Early-Stage Triple-Negative Breast Cancer: A Nationwide Retrospective Turkish Oncology Group Study
by
, , and
Ebru Karci
1,*,
Ahmet Bilici
1,
Buket Bayram
2,
Melisa Celayir
3,
Neslihan Ozyurt
4,
Başak Oyan Uluc
3,
Aynur Eken
5,
Gul Basaran
3,
Umut Demirci
6,
Yasemin Kemal
7,
Mehmet Berk Oruncu
8,
Omer Fatih Olmez
1,
Fatih Selcukbiricik
2,
Taner Korkmaz
3,
Ismail Erturk
9,
Irem Bilgetekin
6,
Serkan Celik
10,
Alper Turkel
11,
Ali Alkan
12,
Abdullah Sakin
1,
Orcun Can
3,
Meral Gunaldi
13,
Ece Esin
14 and
Ozcan Yildiz
1add
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1
Department of Medical Oncology, Faculty of Medicine, İstanbul Medipol University, 34214 Istanbul, Türkiye
2
Department of Medical Oncology, Koc University Hospital, 34010 Istanbul, Türkiye
3
Department of Medical Oncology, Faculty of Medicine, Mehmet Ali Aydınlar Acıbadem University, 34752 Istanbul, Türkiye
4
Department of Medical Oncology, Faculty of Medicine, Ordu University Training and Research Hospital, 52200 Ordu, Türkiye
5
Department of Medical Oncology, Ozel Ortadogu Hospital, 67055 Adana, Türkiye
6
Medical Oncology Unit, Memorial Ankara Hospital, 06520 Ankara, Türkiye
7
Department of Medical Oncology, Faculty of Medicine, Altınbas University, 34147 Istanbul, Türkiye
8
Department of Medical Oncology, Faculty of Medicine, Ankara University, 06100 Ankara, Türkiye
9
Ministry of Health Gülhane Training and Research Hospital, 06010 Ankara, Türkiye
10
Department of Medical Oncology, Yeditepe University, 34755 Istanbul, Türkiye
11
Department of Medical Oncology, Abdurrahman Yurtaslan Ankara Oncology Research and Training Hospital, 06200 Ankara, Türkiye
12
Department of Medical Oncology, School of Medicine, Mugla Sıtkı Kocman University, 48000 Mugla, Türkiye
13
Department of Medical Oncology, Faculty of Medicine, Aydın University, 34295 Istanbul, Türkiye
14
Department of Medical Oncology, Bayındır Hospital, 06250 Ankara, Türkiye
*
Author to whom correspondence should be addressed.
Cancers 2024, 16(19), 3389; https://doi.org/10.3390/cancers16193389
Submission received: 19 August 2024
/
Revised: 26 September 2024
/
Accepted: 27 September 2024
/
Published: 3 October 2024
(This article belongs to the Section Clinical Research of Cancer)
Simple Summary
This study investigates the real-world efficacy and safety of combining pembrolizumab, a novel immunotherapy agent, with chemotherapy in early-stage triple-negative breast cancer treatment. We specifically aimed to validate clinical trial results in routine practice. A total of 108 Turkish patients receiving neoadjuvant therapy were examined. The combined regimen demonstrated high efficacy, with 64% of patients achieving pathological complete response, and exhibited generally favorable safety profiles with predominantly mild adverse events. These findings support the use of this combination as a standard treatment for this aggressive breast cancer subtype. However, the results underscore the need for further research to identify optimal patient selection criteria, which can inform oncologists’ decision-making and potentially enhance outcomes for patients with triple-negative breast cancer.
Abstract
Abstract: Background/Objectives: Following the results of the phase 3 KEYNOTE-522 trial, the U.S. Food and Drug Administration approved pembrolizumab, a humanized IgG4 kappa monoclonal antibody, in combination with neoadjuvant chemotherapy as a new standard of care for high-risk early-stage triple-negative breast cancer (TNBC). This retrospective, multicenter study in Türkiye assessed the real-world efficacy and safety of neoadjuvant pembrolizumab combined with chemotherapy in early-stage TNBC. Methods: The study included 108 patients treated between 2021 and 2023 across 14 oncology centers. Three distinct neoadjuvant regimens incorporating pembrolizumab were administered at the discretion of the treating physicians. The primary outcomes were the pathological complete response (pCR) rate after neoadjuvant therapy and the 2-year event-free survival (EFS) and overall survival (OS) rates. Results: The observed pCR rate was 63.9%, closely mirroring the 64.8% reported in the KEYNOTE-522 trial. At the two-year mark, the EFS rate was 87.2% and the OS rate was 92.3%. Multivariable analysis identified pCR as the sole independent predictor of both EFS and OS. The safety profile was consistent with previous clinical trial data, with most adverse events being of grade 1−2 in severity. Conclusions: These findings provide valuable real-world confirmation of the efficacy and safety of neoadjuvant pembrolizumab–chemotherapy in early-stage TNBC, complementing evidence from randomized trials.
