BRIEF RESEARCH REPORT article
Front. Immunol.
Sec. Cancer Immunity and Immunotherapy
Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1604826
This article is part of the Research TopicImmunological Aspects and Immunotherapy in Gynecologic CancersView all 14 articles
Thyroid disorders as predictors of cemiplimab efficacy in recurrent/metastatic cervical cancer: real-world evidence from Poland
Provisionally accepted
Renata Pacholczak-Madej1*
Maja Lisik-Habib2Radosław Mądry3Monika Szarszewska3Zuzanna Borysiewicz4Katarzyna Gabalewicz5Ewa Iwańska1Wiktor Szatkowski1
Miroslawa Puskulluoglu1Jerzy Jakubowicz1Paweł Blecharz1- 1Maria Skłodowska-Curie National Institute of Oncology, Kraków, Poland
- 2Copernicus Memorial Hospital, Łódź, Łódź, Poland
- 3Poznan University of Medical Sciences, Poznań, Greater Poland, Poland
- 4Department of Oncology and Chemotherapy, Provincial Integrated Hospital, Elbląg, Poland
- 5Lower Silesian Oncology Center, Wrocław, Silesian, Poland
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Introduction: Immune checkpoint inhibitors have improved survival in patients with recurrent or metastatic cervical cancer (r/mCC), yet reliable predictors of treatment efficacy remain undefined. Immune-related adverse events (irAEs) have been suggested as potential predictors of response, but evidence in cervical cancer is limited.Methods: We conducted an ambispective, multicenter observational study of 37 patients with r/mCC treated with cemiplimab within Poland's national rescue access program. Baseline characteristics, treatment outcomes, and irAEs were analyzed. Survival outcomes were estimated using the Kaplan-Meier method and compared using Cox proportional hazards models. A p-value of <0.05 was considered statistically significant.Results: After a median follow-up of 9.2 months, 17 episodes of irAEs were reported in 40.5% of patients (n=15), with thyroid disorders being the most common (n=11, 64.7%). Patients who developed ir-thyroid disorders had significantly longer progression-free survival (hazard ratio [HR]=0.2; 95% confidence interval [CI]: 0.07-0.6, p=0.004) and overall survival (HR=0.2; 95% CI: 0.05-0.9; p=0.04) compared to those without such events. Moreover, the objective response rate was notably higher in this group (45.5% versus 11.5%, p=0.04). Most irAEs were mild and manageable, with a median time to onset of two months after cemiplimab initiation.Conclusions: Ir-thyroid disorders may indicate enhanced immune activation and represent a potential surrogate of cemiplimab efficacy in r/mCC, although validation in larger cohorts is required.
Keywords: Cemiplimab, Uterine Cervical Neoplasms, Thyroid Diseases, immune checkpoint inhibitors, Immune-related adverse events
Received: 02 Apr 2025; Accepted: 05 Jun 2025.
Copyright: © 2025 Pacholczak-Madej, Lisik-Habib, Mądry, Szarszewska, Borysiewicz, Gabalewicz, Iwańska, Szatkowski, Puskulluoglu, Jakubowicz and Blecharz. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Renata Pacholczak-Madej, Maria Skłodowska-Curie National Institute of Oncology, Kraków, Poland
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