Dataset Information

Clinical benefit analysis of PD-1 inhibitors in patients with advanced, recurrent or metastatic cervical cancer: a meta-analysis and systematic review.

ABSTRACT:

Purpose

This study aims to comprehensively evaluate the efficacy and safety of programmed cell death protein-1 (PD-1) in patients with advanced, recurrent, or metastatic cervical cancer (ARMCC) and identify the population that may benefit the most.

Methods

We conducted a search of PubMed, EMBASE, and the Cochrane Collaboration Library from their inception to September 2023. We extracted and analyzed the results related to the efficacy and safety of PD-1 in patients with ARMCC. The primary endpoints included the overall objective response rate (ORR) and adverse events (AEs), while the secondary endpoints encompassed the 1-year overall survival (OS) rate, 1-year progression-free survival (PFS) rate, as well as OS and PFS. We used a random effects model to conduct a meta-analysis on single-group rates, and the Mantel-Haenszel method was utilized to compare the ORR and the incidence of AEs.

Results

Our study included a total of 21 trials involving 2,097 patients. The ORR of the combination of PD-1 inhibitors with chemotherapy was 56.36%, the combination of PD-1 inhibitors with anti-angiogenic agents was 38.72%, the combination of PD-1 inhibitors with Cytotoxic T-lymphocyte antigen 4 inhibitors was 25.60%, and PD-1 inhibitor monotherapy was 15.99%. The subgroup analysis showed that the group of patients with squamous cell carcinoma (SCC) exhibited a significantly higher ORR compared to the non-SCC group in patients who received PD-1 inhibitors combined with other anti-tumor drugs (Odds Ratio =2.43, P=0.002). Additionally, the group of patients with a programmed death-ligand 1 combined positive score (PD-L1 CPS) ≥1 exhibited a significantly higher ORR compared to the PD-L1 CPS <1 group in patients who received PD-1 inhibitor monotherapy (OR=4.14, P=0.02). PD-1 inhibitor monotherapy or PD-1 inhibitors combined with chemotherapy did not significantly increase the incidence of all grades of adverse events (Relative Risk=0.99, p=0.788) or the incidence of serious adverse events (RR=0.99, p=0.788) compared to chemotherapy alone.

Conclusion

PD-1 inhibitors demonstrate outstanding efficacy in the treatment of patients with ARMCC. Patients with SCC may benefit more from treatments including PD-1 inhibitors in combination with other anti-tumor drugs, and PD-L1 CPS ≥1 can be considered a favorable indicator of immune therapy response. Importantly, the use of PD-1 inhibitor monotherapy or PD-1 inhibitors in combination with chemotherapy did not lead to an increased incidence of AEs compared with chemotherapy alone, indicting safety during treatment.

Systematic review registration

PROSPERO (CRD42023457945).

SUBMITTER: Wang YZ

PROVIDER: S-EPMC10847356 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Clinical benefit analysis of PD-1 inhibitors in patients with advanced, recurrent or metastatic cervical cancer: a meta-analysis and systematic review.

Wang Yun-Zi YZ Wang Ji-Sheng JS Du Jiang J Tang Xue-Li XL Xiao Jing-Ping JP

Frontiers in immunology 20240124

<h4>Purpose</h4>This study aims to comprehensively evaluate the efficacy and safety of programmed cell death protein-1 (PD-1) in patients with advanced, recurrent, or metastatic cervical cancer (ARMCC) and identify the population that may benefit the most.<h4>Methods</h4>We conducted a search of PubMed, EMBASE, and the Cochrane Collaboration Library from their inception to September 2023. We extracted and analyzed the results related to the efficacy and safety of PD-1 in patients with ARMCC. The ...[more]

PMID: 38327524

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Project description:BackgroundThe combination of immunotherapy and chemotherapy has demonstrated an enhancement in progression-free survival (PFS) for individuals with advanced and metastatic triple-negative breast cancer (TNBC) when compared to the use of chemotherapy alone. Nevertheless, the extent to which different subgroups of metastatic TNBC patients experience this benefit remains uncertain.ObjectivesOur objective was to conduct subgroup analyses to more precisely identify the factors influencing these outcomes.Materials and methodsThe PubMed database was searched until Dec 2023 for studies that compared PD-1 checkpoint inhibitors plus chemotherapy (ICT) with chemotherapy (CT) alone. The primary outcome of interest was progression-free survival (PFS). Review Manager (RevMan) version 5.4. was used for the data analysis.ResultsFour randomized controlled trials (RCTs) comprising 2468 advanced and metastatic TNBC were included in this systematic review and meta-analysis. PFS surge with combined therapy was observed in White (HR 0.80 [0.70, 0.91], p = 0.0007) and Asian ethnicities (HR 0.73 [0.58, 0.93], p = 0.01) but not in Blacks (HR 0.72 [0.42, 1.24], p = 0.24). Overall, patients with distant metastasis demonstrated to derive the PFS benefit from additional immunotherapy (HR 0.87 [0.77, 0.99], p = 0.03); however, metastasis to individual distant site was associated with failure to achieve any treatment difference (Bone: HR 0.79 [0.41, 1.52], p = 0.49; Lung: HR 0.85 [0.70, 1.04], p = 0.11; Liver: HR 0.80 [0.64, 1.01], p = 0.06). While number of metastases > 3 also showed to impact the PFS advantage (HR 0.89 [0.69, 1.16], p = 0.39). While patients, regardless of prior chemotherapy, experienced a notable enhancement in PFS with ICT (Overall: HR 0.79 [0.71, 0.88], p < 0.0001; Yes: HR 0.87 [0.76, 1.00], p = 0.05; No: HR 0.67 [0.56, 0.80], p < 0.00001), those previously exposed to chemotherapy exhibited a significantly smaller PFS advantage compared to those without prior chemotherapy, as evidenced by a significant subgroup difference (Test for subgroup difference: P = 0.02, I2 = 82.2%). Patients lacking PD-L1 expression also failed to achieve any additional benefit from immunotherapy (PD-L1-: HR 0.95 [0.81, 1.12]; p = 0.54; PD-L1+: HR 0.73 [0.64, 0.85], p < 0.0001). Age, ECOG status, and presentation with de novo metastasis/recurrent shown no impact on IT-associated PFS advantage.ConclusionsPatient- and treatment- related factors such as ethnicity, distant metastases, number of metastases (> 3), previous exposure to chemotherapy and PD-L1 expression, seem to influence or restrict the advantage in progression-free survival associated with the addition of immunotherapy to chemotherapy, as opposed to chemotherapy alone, in patients with advanced and metastatic TNBC. Larger studies are warranted to validate these outcomes.

Project description:BackgroundImmunotherapy for colorectal cancer has developed rapidly in the past decade. Many high-quality clinical trials examining the application of PD-1/PD-L1 inhibitors in patients with metastatic colorectal cancer (mCRC) have been conducted in recent years. However, the clinical benefits, including the efficacy and safety of these treatments against mCRC, remain controversial. Hence, we conducted this meta-analysis on the clinical benefits of PD-1/PD-L1 inhibitors in patients with mCRC.MethodsWe searched online databases including MEDLINE, Embase, Cochrane Library, and Web of Science, from inception to January 4, 2021. The outcomes related to efficacy and safety were extracted and analyzed. Subgroup analyses were conducted according to the categories of dMMR-MSI-H (tumors with mismatch repair deficiency and high levels of microsatellite instability) ≥ 5% vs. dMMR-MSI-H < 5%, monotherapy vs. combination therapy, PD-1 inhibitors vs. PD-L1 inhibitors, and nivolumab vs. pembrolizumab.ResultsFourteen studies including 1129 subjects were included in our systematic review. The overall complete response (CR), partial response (PR), stable disease (SD), and progression of disease (PD) rates were 0.01 (95% CI 0.00-0.04), 0.04 (95% CI 0.05-0.26), 0.27 (95% CI 0.22-0.32), and 0.44 (95% CI 0.30-0.58), respectively. The overall objective response rate (ORR) and disease control rate (DCR) were 0.16 (95%CI 0.06-0.31) and 0.50 (95%CI 0.35-0.65), respectively. The overall rate of adverse events (AEs) and severe adverse responses (SAEs) were 0.84 (95% CI 0.72-0.92) and 0.30 (95% CI 0.20-0.41), respectively. The ORRs of the dMMR-MSI-H ≥ 5% and dMMR-MSI-H < 5% subgroups were 0.40 (95% CI 0.30-0.51) and 0.04 (95% CI 0.00-0.09), respectively.ConclusionsPD-1/PD-L1 inhibitors produced encouraging clinical benefits including the response rate in the treatment of dMMR-MSI-H mCRC. They actually have been influenced by the present state of mCRC therapy including pMMR-MSI-L mCRC. Nevertheless, additional multi-center prospective studies are still expected.Trial registrationWe have registered this study in the International Prospective Register of Systematic Reviews (PROSPERO), and the registration number is CRD42021249601 .

Dataset Information

Clinical benefit analysis of PD-1 inhibitors in patients with advanced, recurrent or metastatic cervical cancer: a meta-analysis and systematic review.

Purpose

Methods

Results

Conclusion

Systematic review registration

Publications

Clinical benefit analysis of PD-1 inhibitors in patients with advanced, recurrent or metastatic cervical cancer: a meta-analysis and systematic review.

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