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Efficacy and Safety of PD-1/PD-L1 Inhibitor as Single-Agent Immunotherapy in Endometrial Cancer: A Systematic Review
Mohd Nazzary Mamat Yusof1, Kah Teik Chew1, Abdul Muzhill Hannaan Abdul Hafizz1
1Gynaecologic-Oncology Unit, Department of Obstetrics and Gynaecology, Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia, Cheras, Kuala Lumpur 56000, Malaysia.
Abstract:
The programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) pathway plays a crucial role in the immune escape mechanism and growth of cancer cells in endometrial cancer (EC). Clinical trials investigating PD-1/PD-L1 inhibitor have shown promising results in other cancers, but their efficacy in EC still remains uncertain. Therefore, this meta-analysis aims to provide an updated and robust analysis of the effectiveness and safety of PD-1/PDL1 inhibitor as single-agent immunotherapy in EC, focusing on the objective response rate (ORR), disease control rate (DCR), and adverse events (AEs). This meta-analysis utilized STATA version 17 and RevMan version 5.4 software to pool the results of relevant studies. Five studies conducted between 2017 and 2022, comprising a total of 480 EC patients enrolled for PD-1/PD-L1 inhibitor immunotherapy met the inclusion criteria. The pooled proportion of EC patients who achieved ORR through PD-1/PD-L1 inhibitor treatment was 26.0% (95% CI: 16.0-36.0%; p < 0.05). Subgroup analysis based on mismatch repair (MMR) status showed an ORR of 44.0% (95% CI: 38.0-50.0%; p = 0.32) for the deficient mismatch repair (dMMR) group and 8.0% (95% CI: 0.0-16.0%; p = 0.07) for the proficient mismatch repair (pMMR) group. Pooled proportion analysis by DCR demonstrated an odds ratio (OR) of 41.0% (95% CI: 36.0-46.0%, p = 0.83) for patients undergoing PD-1/PD-L1 inhibitor treatment. Subgroup analysis based on MMR status revealed DCR of 54.0% (95% CI: 47.0-62.0%; p = 0.83) for the dMMR group, and 31.0% (95% CI: 25.0-39.0%; p = 0.14) for the pMMR group. The efficacy of PD-1/PD-L1 inhibitors was significantly higher in the dMMR group compared to the pMMR group, in terms of both ORR (OR = 6.30; 95% CI = 3.60-11.03; p < 0.05) and DCR (OR = 2.57; 95% CI = 1.66-3.99; p < 0.05). In terms of safety issues, the pooled proportion of patients experiencing at least one adverse event was 69.0% (95% CI: 65.0-73.0%; p > 0.05), with grade three or higher AEs occurring in 16.0% of cases (95% CI: 12.0-19.0%; p > 0.05). Based on the subgroup analysis of MMR status, PD-1/PD-L1 inhibitor immunotherapy showed significantly better efficacy among dMMR patients. These findings suggest that patients with dMMR status may be more suitable for this treatment approach. However, further research on PD-1/PD-L1 inhibitor immunotherapy strategies is needed to fully explore their potential and improve treatment outcomes in EC.
Insights
Programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) inhibitors show moderate effectiveness in endometrial cancer (EC), with significantly higher response rates in deficient mismatch repair (dMMR) patients. Adverse events were common but manageable.
Area of Science:
- Oncology
- Immunotherapy
- Cancer Research
Background:
- The PD-1/PD-L1 pathway is implicated in immune evasion and tumor growth in endometrial cancer (EC).
- While PD-1/PD-L1 inhibitors show promise in other cancers, their efficacy in EC requires further evaluation.
- Understanding treatment response based on molecular subtypes, such as mismatch repair (MMR) status, is crucial for personalized therapy.
Purpose of the Study:
- To conduct a meta-analysis evaluating the effectiveness and safety of PD-1/PD-L1 inhibitors as monotherapy in endometrial cancer.
- To determine the objective response rate (ORR), disease control rate (DCR), and adverse events (AEs) associated with this treatment.
- To investigate the impact of MMR status on treatment outcomes in EC patients receiving PD-1/PD-L1 inhibitors.
Main Methods:
- A meta-analysis was performed using data from five studies (2017-2022) involving 480 EC patients treated with PD-1/PD-L1 inhibitors.
- STATA version 17 and RevMan version 5.4 software were utilized for data pooling and analysis.
- Outcomes assessed included ORR, DCR, and AEs, with subgroup analyses conducted based on MMR status (dMMR vs. pMMR).
Main Results:
- The overall objective response rate (ORR) for EC patients treated with PD-1/PD-L1 inhibitors was 26.0%.
- Patients with deficient mismatch repair (dMMR) exhibited significantly higher ORR (44.0%) and DCR (54.0%) compared to proficient mismatch repair (pMMR) patients (ORR: 8.0%, DCR: 31.0%).
- The pooled incidence of any adverse event was 69.0%, with 16.0% experiencing grade three or higher events.
Conclusions:
- PD-1/PD-L1 inhibitor monotherapy demonstrates a notable objective response rate in endometrial cancer patients.
- Treatment efficacy, measured by ORR and DCR, is significantly superior in patients with dMMR status.
- While generally well-tolerated, adverse events are common, necessitating careful monitoring. dMMR status is a key predictive biomarker for PD-1/PD-L1 inhibitor therapy in EC.
