Thyroid disorders as predictors of cemiplimab efficacy in recurrent/metastatic cervical cancer: real-world evidence from Poland
IntroductionImmune 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 evidenc...
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Frontiers Media S.A.
2025-06-01
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| Series: | Frontiers in Immunology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fimmu.2025.1604826/full |
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| author | Renata Pacholczak-Madej Renata Pacholczak-Madej Maja Lisik-Habib Radosław Mądry Monika Szarszewska Zuzanna Borysiewicz Katarzyna Gabalewicz Ewa Iwańska Wiktor Szatkowski Mirosława Puskulluoglu Jerzy Jakubowicz Paweł Blecharz |
| author_facet | Renata Pacholczak-Madej Renata Pacholczak-Madej Maja Lisik-Habib Radosław Mądry Monika Szarszewska Zuzanna Borysiewicz Katarzyna Gabalewicz Ewa Iwańska Wiktor Szatkowski Mirosława Puskulluoglu Jerzy Jakubowicz Paweł Blecharz |
| author_sort | Renata Pacholczak-Madej |
| collection | DOAJ |
| description | IntroductionImmune 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.MethodsWe 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.ResultsAfter 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.ConclusionsIr-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. |
| format | Article |
| id | doaj-art-fee07211f4e04d8dab3527dd72e2fd93 |
| institution | OA Journals |
| issn | 1664-3224 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Immunology |
| spelling | doaj-art-fee07211f4e04d8dab3527dd72e2fd932025-08-20T02:09:28ZengFrontiers Media S.A.Frontiers in Immunology1664-32242025-06-011610.3389/fimmu.2025.16048261604826Thyroid disorders as predictors of cemiplimab efficacy in recurrent/metastatic cervical cancer: real-world evidence from PolandRenata Pacholczak-Madej0Renata Pacholczak-Madej1Maja Lisik-Habib2Radosław Mądry3Monika Szarszewska4Zuzanna Borysiewicz5Katarzyna Gabalewicz6Ewa Iwańska7Wiktor Szatkowski8Mirosława Puskulluoglu9Jerzy Jakubowicz10Paweł Blecharz11Department of Gynecological Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, PolandDepartment of Anatomy, Jagiellonian University, Medical College, Krakow, PolandDepartment of Proliferative Diseases, Copernicus Memorial Hospital in Lodz Comprehensive Cancer Center and Traumatology, Łódź, PolandKlinika Ginekologii Onkologicznej Uniwersytetu Medycznego w Poznaniu, Poznan, PolandKlinika Ginekologii Onkologicznej Uniwersytetu Medycznego w Poznaniu, Poznan, PolandDepartment of Oncology and Chemotherapy, Provincial Integrated Hospital, Elbląg, PolandLower Silesian Oncology, Pulmonology and Hematology Center, Wrocław, PolandDepartment of Gynecological Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, PolandDepartment of Gynecological Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, PolandDepartment of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, PolandDepartment of Gynecological Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, PolandDepartment of Gynecological Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, PolandIntroductionImmune 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.MethodsWe 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.ResultsAfter 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.ConclusionsIr-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.https://www.frontiersin.org/articles/10.3389/fimmu.2025.1604826/fullcemiplimabuterine cervical neoplasmsthyroid diseasesimmune checkpoint inhibitorsimmune-related adverse events |
| spellingShingle | Renata Pacholczak-Madej Renata Pacholczak-Madej Maja Lisik-Habib Radosław Mądry Monika Szarszewska Zuzanna Borysiewicz Katarzyna Gabalewicz Ewa Iwańska Wiktor Szatkowski Mirosława Puskulluoglu Jerzy Jakubowicz Paweł Blecharz Thyroid disorders as predictors of cemiplimab efficacy in recurrent/metastatic cervical cancer: real-world evidence from Poland Frontiers in Immunology cemiplimab uterine cervical neoplasms thyroid diseases immune checkpoint inhibitors immune-related adverse events |
| title | Thyroid disorders as predictors of cemiplimab efficacy in recurrent/metastatic cervical cancer: real-world evidence from Poland |
| title_full | Thyroid disorders as predictors of cemiplimab efficacy in recurrent/metastatic cervical cancer: real-world evidence from Poland |
| title_fullStr | Thyroid disorders as predictors of cemiplimab efficacy in recurrent/metastatic cervical cancer: real-world evidence from Poland |
| title_full_unstemmed | Thyroid disorders as predictors of cemiplimab efficacy in recurrent/metastatic cervical cancer: real-world evidence from Poland |
| title_short | Thyroid disorders as predictors of cemiplimab efficacy in recurrent/metastatic cervical cancer: real-world evidence from Poland |
| title_sort | thyroid disorders as predictors of cemiplimab efficacy in recurrent metastatic cervical cancer real world evidence from poland |
| topic | cemiplimab uterine cervical neoplasms thyroid diseases immune checkpoint inhibitors immune-related adverse events |
| url | https://www.frontiersin.org/articles/10.3389/fimmu.2025.1604826/full |
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