Oncological outcome and immune-checkpoint-blockade-induced toxicities in patients with cervical cancer – a Norwegian real-world cohort

Authors

  • Katharina Bischof Department of Surgical Oncology, Section for Gynaecological Oncology, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway ;Institute of Clinical Medicine, Department of Cancer Immunology, Faculty of Medicine, University of Oslo, Oslo, Norway https://orcid.org/0000-0001-6099-2118
  • Keira Matallah Fredriksen Department of Surgical Oncology, Section for Gynaecological Oncology, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway; Department of Clinical and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway
  • Margrethe Bjørnstad Department of Surgical Oncology, Section for Research and Clinical Studies, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway
  • Mari Bunkholt Elstrand Department of Surgical Oncology, Section for Gynaecological Oncology, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway
  • Brynhildur Eyjolfsdottir Department of Surgical Oncology, Section for Gynaecological Oncology, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway
  • Alda Birgisdottir Department of Surgical Oncology, Section for Gynaecological Oncology, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway
  • Elisabeth Lillo Department of Surgical Oncology, Section for Gynaecological Oncology, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway
  • Guro Aune Department of Clinical and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway; Department of Gynaecological Oncology, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway
  • Kristina Lindemann Department of Surgical Oncology, Section for Gynaecological Oncology, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway; Department of Surgical Oncology, Section for Research and Clinical Studies, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway

DOI:

https://doi.org/10.2340/1651-226X.2026.45737

Keywords:

Uterine Cervical Neoplasms, Gynecologic Cancer, Immune Checkpoint Inhibitors, Real-World data

Abstract

Background and purpose: The introduction of immune checkpoint inhibitors (ICIs) into the treatment of patients with metastatic or recurrent cervical cancer has been shown to significantly prolong survival. In this study, we examined the clinical outcomes and tolerability of treatment with ICIs in patients with metastatic or recurrent cervical cancer in a real-world setting in Norway.
Patient/material and methods: This retrospective cohort study included patients treated with an ICI in combination with chemotherapy or as single agent at Oslo University Hospital between 2016 and 2024. The primary oncological endpoint was progression-free survival (PFS). Secondary endpoints include overall survival (OS) as well as tolerability.
Results: We included 57 patients with a median age of 53 years and a median follow-up of 15.2 months. Thirty-five patients were treated with an ICI in combination with chemotherapy (cohort 1), and or an ICI alone (n = 22) (cohort 2). Forty-six patients (81%) were treated for recurrent disease. In cohort 1, the median PFS was 12.4 months (95% CI: 9.0–15.7), and the median OS was 27.5 months (95% CI: 18.0–37.1). In cohort 2, the median PFS was 3.7 months (95% CI: 2.4–5.0), and the median OS was 9.3 months (95% CI: 4.3–14.4). Nine patients (16%) discontinued treatment due to toxicity.
Interpretation: Our real-world data on the use of ICIs alone or in combination showed antitumour efficacy comparable to that reported in clinical studies in patients with advanced or recurrent cervical cancer. Our discontinuation rate highlights that toxicity management and mitigation are paramount when novel drugs are introduced in clinical algorithms.

Downloads

Download data is not yet available.

References

World Health Organization. Cervical cancer [Internet]. Geneva: WHO; [cited 2026 Jan 16]. Available from: https://www.who.int/news-room/fact-sheets/detail/cervical-cancer

Cancer Registry of Norway, Norwegian Institute of Public Health. Cancer in Norway 2024 – cancer incidence, mortality, survival and prevalence in Norway. Oslo: Cancer Registry of Norway; 2025.

Chung HC, Ros W, Delord JP, Perets R, Italiano A, Shapira-Frommer R et al. Efficacy and safety of pembrolizumab in previously treated advanced cervical cancer: results from the phase II KEYNOTE-158 study. J Clin Oncol. 2019; 37:1470–8. DOI: https://doi.org/10.1200/JCO.18.01265

Monk BJ, Colombo N, Tewari KS, Dubot C, Caceres MV, Hasegawa K, et al. First-line pembrolizumab + chemotherapy versus placebo + chemotherapy for persistent, recurrent, or metastatic cervical cancer: final overall survival results of KEYNOTE-826. J Clin Oncol. 2023;41(36):5505–11. DOI: https://doi.org/10.1200/JCO.23.00914

Tewari KS, Monk BJ, Vergote I, Miller A, de Melo AC, Kim HS, et al. Survival with cemiplimab in recurrent cervical cancer. N Engl J Med. 2022;386:544–55. DOI: https://doi.org/10.1056/NEJMoa2112187

Okanin A, Gladieff L, Martínez-García J, Villacampa G, Takekuma M, De Giorgi U, et al. Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent, or recurrent cervical cancer (BEATcc): a randomised, open-label, phase 3 trial. Lancet. 2024;403:31–43. DOI: https://doi.org/10.1016/S0140-6736(23)02405-4

Choi MC, Kim YM, Lee JW, Lee YJ, Suh DH, Lee SJ, et al. Real-world experience of pembrolizumab monotherapy in patients with recurrent or persistent cervical cancer: a Korean Multi-Center Retrospective Study (KGOG1041). Cancers (Basel). 2020;12:3188. DOI: https://doi.org/10.3390/cancers12113188

Furuya RL, Boak K, Mullen MM, Wang D, Massad LS. Real-world outcomes after pembrolizumab treatment for cervical cancer: results from a university setting. Gynecol Oncol Rep. 2025;60:101921. DOI: https://doi.org/10.1016/j.gore.2025.101921

Tuninetti V, Virano E, Salutari V, Ricotti A, Pisano C, Ducceschi M, et al. Real-life efficacy and safety of cemiplimab in advanced cervical cancer from a nominal use program in Italy: the MITO 44 study. Eur J Can. 2024;203:114039. DOI: https://doi.org/10.1016/j.ejca.2024.114039

U.S. Department of Health and Human Services, National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 quick reference (5×7) [Internet]. 2017. [cited 2026 Feb 1]. Available from: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcae_v5_quick_reference_5x7.pdf

Haanen J, Obeid M, Spain L, Carbonnel F, Wang Y, Robert C, et al. Management of toxicities from immunotherapy: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann Oncol. 2022;33:1217–38. DOI: https://doi.org/10.1016/j.annonc.2022.10.001

Chaudhary N, Raju K, Sheela SR, Sakalecha AK, Manjunath GN. Programmed death ligand (PD L1) expression in invasive squamous cell carcinoma of the uterine cervix: a cross sectional observational study. Cancer Res Stat Treat. 2022;5:461 7. DOI: https://doi.org/10.4103/crst.crst_98_22

Tewari KS, Sill MW, Long HJ, Penson RT, Huang H, Ramondetta LM, et al. Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med. 2014;370(8):734–43. DOI: https://doi.org/10.1056/NEJMoa1309748

Tewari KS, Sill MW, Penson RT, Huang H, Ramondetta LM, Landrum LM, et al. Bevacizumab for advanced cervical cancer: final overall survival and adverse event analysis of a randomised, controlled, open-label, phase 3 trial (Gynecologic Oncology Group 240). Lancet. 2017;390(10103):1654–63. DOI: https://doi.org/10.1016/S0140-6736(17)31607-0

Schneider BJ, Naidoo J, Santomasso BD, Lacchetti C, Adkins S, Anadkat M, et al. Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: ASCO guideline update. JCO. 2021;39:4073–126. DOI: https://doi.org/10.1200/JCO.21.01440

De Giorgi U, Mansi L, Martinez-Garcia J, Villacampa Javierre G, Takekuma M, Lindemann K, et al. Efficacy according to PD-L1 status in the BEATcc (ENGOT-Cx10/GEICO 68-C/JGOG1084/GOG-3030) randomised phase III trial of first-line atezolizumab (atezo), chemotherapy (CT) and bevacizumab (bev) for metastatic, persistent or recurrent cervical cancer (R/M CC). ESMO 2025:Abstract 100. DOI: https://doi.org/10.1016/j.esmoop.2025.105140

Marth C, Landoni F, Mahner S, McCormack M, Gonzalez-Martin A, Colombo N, et al. Cervical cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017;28(Suppl 4):iv72–8. DOI: https://doi.org/10.1093/annonc/mdx220

Van den Heuvel M, van der Noort V, ter Heine R. Low dose versus standard dose pembrolizumab for treatment of stage IV non-small cell lung carcinoma: results of the pre-planned interim analysis of the NVALT-30 clinical trial. ASCO 2024:Abstract 1258 MO. DOI: https://doi.org/10.1016/j.annonc.2024.08.1315

Additional Files

Published

2026-06-01

How to Cite

Bischof , K., Fredriksen, K. M., Bjørnstad, M., Elstrand, M. B., Eyjolfsdottir, B., Birgisdottir, A., … Lindemann, K. (2026). Oncological outcome and immune-checkpoint-blockade-induced toxicities in patients with cervical cancer – a Norwegian real-world cohort. Acta Oncologica, 65, 518–524. https://doi.org/10.2340/1651-226X.2026.45737