Clinical efficacy and safety evaluation of immune checkpoint inhibitors combined with chemoradiotherapy in the treatment of advanced cervical cancer: An 80-case prospective cohort study
Abstract
Objective: To investigate the clinical efficacy and safety of immune checkpoint inhibitors combined with chemoradiotherapy in the treatment of advanced cervical cancer. Methods: A total of 80 patients with advanced cervical cancer admitted to our hospital from January 2022 to December 2023 were randomly divided into a combination therapy group (pembrolizumab + chemoradiotherapy, 40 cases) and a control group (chemoradiotherapy alone, 40 cases). The objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and adverse reactions were compared between the two groups. Results: The ORR of the combination therapy group was 75.0% (30/40), significantly higher than 55.0% (22/40) in the control group (P = 0.043). The median PFS was 12.5 months vs. 9.0 months (P = 0.022), and the median OS was 24.0 months vs. 18.0 months (P = 0.027). There was no significant difference in the incidence of grade 3 and above adverse reactions between the two groups (40.0% vs. 35.0%, P = 0.546), but immune-related adverse reactions in the combination therapy group (such as hypothyroidism 12.5%, rash 10.0%) were more common, mostly grade 1–2. Conclusion: Immune checkpoint inhibitors combined with chemoradiotherapy can improve the efficacy of advanced cervical cancer, prolong survival, and have controllable safety, providing a new treatment option for patients.
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References
1. Frenel JS, Le Tourneau C, O’Neil B, et al. Safety and Efficacy of Pembrolizumab in Advanced, Programmed Death Ligand 1–Positive Cervical Cancer: Results From the Phase Ib KEYNOTE-028 Trial. Journal of Clinical Oncology. 2017; 35(36): 4035-4041. doi: 10.1200/jco.2017.74.5471
2. Musunuru HB, Pifer PM, Mohindra P, et al. Advances in management of locally advanced cervical cancer. Indian Journal of Medical Research. 2021; 154(2): 248-261.
3. Rodrigues M, Vanoni G, Loap P, et al. Nivolumab plus chemoradiotherapy in locally-advanced cervical cancer: the NICOL phase 1 trial. Nature Communications. 2023; 14(1). doi: 10.1038/s41467-023-39383-8
4. Chen J, Han Y, Hu Y, et al. Neoadjuvant camrelizumab plus chemotherapy for locally advanced cervical cancer. BMJ Open. 2023; 13(5): e067767. doi: 10.1136/bmjopen-2022-067767
5. Grau JF, Farinas-Madrid L, Garcia-Duran C, et al. Advances in immunotherapy in cervical cancer. International Journal of Gynecological Cancer. 2023; 33(3): 403-413. doi: 10.1136/ijgc-2022-003758
6. Gao XS, Boere IA, van Beekhuizen HJ, et al. Acute and long-term toxicity in patients undergoing induction chemotherapy followed by thermoradiotherapy for advanced cervical cancer. International Journal of Hyperthermia. 2022; 39(1): 1440-1448. doi: 10.1080/02656736.2022.2146213
7. Lee SY, Lee NR, Cho DH, et al. Treatment outcome analysis of chemotherapy combined with modulated electro-hyperthermia compared with chemotherapy alone for recurrent cervical cancer, following irradiation. Oncology Letters. 2017; 14(1): 73-78. doi: 10.3892/ol.2017.6117
8. Jiang P, Wei S, Bai Y, et al. The Efficacy of Volumetric Modulated Arc Therapy Combined With Chemotherapy, Brachytherapy, and Local Hyperthermia on Patients with Locally Advanced Cervical Cancer: A Retrospective Study. Technology in Cancer Research & Treatment. 2023; 22. doi: 10.1177/15330338231185013
9. Yea JW, Park JW, Oh SA, et al. Chemoradiotherapy with hyperthermia versus chemoradiotherapy alone in locally advanced cervical cancer: a systematic review and meta-analysis. International Journal of Hyperthermia. 2021; 38(1): 1333-1340. doi: 10.1080/02656736.2021.1973584
10. Li Z, Deng J, Sun J, et al. Hyperthermia Targeting the Tumor Microenvironment Facilitates Immune Checkpoint Inhibitors. Frontiers in Immunology. 2020; 11. doi: 10.3389/fimmu.2020.595207
11. Nishikawa A, Suzuki Y, Kaneko M, et al. Combination of magnetic hyperthermia and immunomodulators to drive complete tumor regression of poorly immunogenic melanoma. Cancer Immunology, Immunotherapy. 2022; 72(6): 1493-1504. doi: 10.1007/s00262-022-03345-8
12. Li T, Hu Z, Song F, et al. Photonic Hyperthermia Synergizes with Immune‐Activators to Augment Tumor‐Localized Immunotherapy. Small Methods. 2023; 7(5). doi: 10.1002/smtd.202300116
13. Li R, Zheng Q, Deng Q, et al. A Dual Functional Drug Delivery System that Combines Photothermal Therapy and Immunotherapy to Treat Tumors. Molecular Pharmaceutics. 2022; 19(5): 1449-1457. doi: 10.1021/acs.molpharmaceut.1c00999
14. Wang X, Liu G, Chen S, et al. Combination therapy with PD-1 blockade and radiofrequency ablation for recurrent hepatocellular carcinoma: a propensity score matching analysis. International Journal of Hyperthermia. 2021; 38(1): 1519-1528. doi: 10.1080/02656736.2021.1991011
15. Kwon S, Jung S, Baek SH. Combination Therapy of Radiation and Hyperthermia, Focusing on the Synergistic Anti-Cancer Effects and Research Trends. Antioxidants. 2023; 12(4): 924. doi: 10.3390/antiox12040924
16. Liu P, Ye M, Wu Y, et al. Hyperthermia combined with immune checkpoint inhibitor therapy: Synergistic sensitization and clinical outcomes. Cancer Medicine. 2022; 12(3): 3201-3221. doi: 10.1002/cam4.5085