Efficacy, safety, and patient-reported outcome of immune checkpoint inhibitor in gynecologic cancers: A systematic review and meta-analysis of randomized controlled trials

• Published in: PloS one 2024-08, Vol.19 (8), p.e0307800
• Main Authors: Kusuma, Fitriyadi, Glenardi, Glenardi, Mangkuliguna, Ghea, Winarto, Hariyono, Purwoto, Gatot, Utami, Tofan Widya, Anggraeni, Tricia Dewi
• Format: Article
• Language: English
• Subjects: Adverse events; Analysis; Cancer; Cancer patients; Care and treatment; Cervical cancer; Clinical trials; Effectiveness; Endometrial cancer; Female; Genital Neoplasms, Female - drug therapy; Genital Neoplasms, Female - immunology; Gynecological cancer; Humans; Immune checkpoint inhibitors; Immune Checkpoint Inhibitors - adverse effects; Immune Checkpoint Inhibitors - therapeutic use; Malignancy; Medicine and Health Sciences; Meta-analysis; Oncology, Experimental; Ovarian cancer; Patient outcomes; Patient Reported Outcome Measures; Pemetrexed; Physical Sciences; Quality of Life; Randomized Controlled Trials as Topic; Research and Analysis Methods; Survival; Treatment Outcome; Uterine cancer
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0307800

Over the past decades, immune checkpoint inhibitors (ICIs) have shown dramatic efficacy in improving survival rates in multiple malignancies. Recently, gynecological cancer patients also showed to respond favorably to ICI treatment. This study aimed to evaluate the efficacy, safety, and patient-reported outcomes of ICI therapy in gynecological cancers. We conducted a systematic review and meta-analysis by retrieving literature from multiple electronic databases, such as MEDLINE, ScienceDirect, EBSCO, ProQuest, and Google Scholar. The protocol used in this study has been registered in PROSPERO (CRD42022369529). We included a total of 12 trials involving 8 therapies and 8,034 patients. ICI group demonstrated a longer OS (HR: 0.807; 95% CI: 0.719, 0.907; p = 0.000) and greater PFS improvement (HR: 0.809; 95% CI: 0.673, 0.973; p = 0.024) compared to the control group. There was no significant difference in the incidence of treatment-related adverse events [RR: 0.968; 95%CI: 0.936, 1.001; p = 0.061], but a higher incidence of immune-related adverse events (IRAEs) was observed in the ICI group (RR: 3.093; 95%CI: 1.933, 4.798; p = 0.000). Although the mean changes of QOL score from baseline was not significantly different between both groups (SMD: 0.048; 95% CI: -0.106, 0.202; p = 0.542), the time to definitive QOL deterioration was longer in the ICI group (HR: 0.508; 95% CI: 0.461, 0.560; p = 0.000). Despite having a higher incidence of IRAE, ICI was shown to improve survival rates and QOL of patients. Thus, it should be considered as a new standard of care for gynecologic cancers, especially in advanced stages.