Subject(s)
B7-H1 Antigen , Biomarkers, Tumor , Carcinoma, Non-Small-Cell Lung , Lung Neoplasms , Humans , Carcinoma, Non-Small-Cell Lung/pathology , Carcinoma, Non-Small-Cell Lung/drug therapy , Carcinoma, Non-Small-Cell Lung/mortality , Carcinoma, Non-Small-Cell Lung/genetics , Lung Neoplasms/pathology , Lung Neoplasms/mortality , B7-H1 Antigen/antagonists & inhibitors , Biomarkers, Tumor/genetics , Prognosis , Immune Checkpoint Inhibitors/therapeutic useABSTRACT
OBJECTIVES: To evaluate the efficacy and safety of immune checkpoint inhibitor (ICI) combination therapy in the first-line treatment for recurrent or metastatic squamous cell carcinoma of the head and neck (R/M-SCCHN). METHODS: We conducted a meta-analysis between ICI combination therapy and standard of care (SOC) treatment (chemotherapy with or without cetuximab) in R/M-SCCHN based on randomized controlled trials (RCTs). The outcomes were overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and adverse events (AEs). RESULTS: Five RCTs involving 2576 patients were included in the analysis. Compared with SOC, PD-1 inhibitor plus chemotherapy significantly improved OS (hazard ratio [HR], 0.73, 95 % CI 0.62-0.87, p = 0.0004), PFS (HR, 0.65, 95 % CI 0.43-0.99, p = 0.04) and ORR (risk ratio [RR], 1.10; 95 % CI 1.01-1.19, p = 0.02) of patients, while double-agent immunotherapy could not improve either the outcome of OS, PFS, or ORR (all p > 0.05). In safety analyses, combination immunotherapy showed similar risks of grade 3 or higher treatment-related AEs (RR, 0.79, 95 % CI 0.56-1.11, P = 0.17) and treatment-related deaths (RR, 1.16, 95 % CI 0.65-2.07, P = 0.63) compared to SOC. CONCLUSIONS: Compared with SOC, PD-1 inhibitor plus chemotherapy enhanced OS, PFS, and ORR in the first-line treatment for patients with R/M-SCCHN, but double-agent immunotherapy showed no more benefit for these patients.
Subject(s)
Head and Neck Neoplasms , Lung Neoplasms , Humans , Squamous Cell Carcinoma of Head and Neck/drug therapy , Immune Checkpoint Inhibitors/therapeutic use , Cetuximab , Combined Modality Therapy , Head and Neck Neoplasms/drug therapy , Lung Neoplasms/drug therapy , Antineoplastic Combined Chemotherapy Protocols/therapeutic useABSTRACT
PURPOSE: To evaluate the efficacy and safety of programmed cell death-1/programmed cell death-ligand 1 inhibitor monotherapy compared to the standard of care in the first-line setting for recurrent or metastatic head and neck squamous cell carcinoma. MATERIALS AND METHODS: The PubMed, Embase, and Cochrane Library databases were searched for relevant randomized controlled trials. The clinical outcomes of overall survival, progression-free survival, objective response rates, and grade 3 or higher adverse events were analyzed using Stata SE 15 software with a significance level set to 0.05. RESULTS: We identified four randomized controlled trials (1 nivolumab, 2 pembrolizumab, and 1 durvalumab), including a total of 2474 patients. The results of the meta-analysis showed pooled hazard ratios of overall and progression-free survival for programmed cell death-1/programmed cell death-ligand 1 inhibitor monotherapy of 0.82 (95% CI: 0.73-0.91, p < 0.001) and 0.96 (95%CI: 0.84-1.07, p < 0.001) and pooled odds ratios of objective response rates and grade 3 or higher adverse events of 1.04 (95%CI: 0.46-2.37; p = 0.926) and 0.28 (95%CI: 0.22-0.35, p < 0.001), respectively. Subgroup analysis showed that inhibitors for both programmed cell death-1 (nivolumab and pembrolizumab) and programmed cell death-ligand 1 (durvalumab) were associated with significantly longer overall survival (HR = 0.80, 95% CI: 0.70-0.90, p < 0.001 and HR = 0.88, 95%CI: 0.70-1.06, p < 0.001, respectively). CONCLUSIONS: Programmed cell death-1/programmed cell death-ligand 1 inhibitor monotherapy showed more clinical benefit versus the standard of care in patients with recurrent or metastatic head and neck squamous cell carcinoma, with an acceptable safety profile.
Subject(s)
Head and Neck Neoplasms , Programmed Cell Death 1 Receptor , Head and Neck Neoplasms/drug therapy , Humans , Immune Checkpoint Inhibitors , Nivolumab/therapeutic use , Squamous Cell Carcinoma of Head and Neck/drug therapyABSTRACT
BACKGROUND: Cisplatin-based concurrent chemoradiotherapy is a standard of care for locally advanced nasopharyngeal carcinoma (NPC), and weekly and triweekly cisplatin are both alternative regimens based on the results of squamous cell carcinoma of the head and neck. However, there is a lack of direct evidence on the efficacy and safety of weekly versus triweekly cisplatin concurrent with radiotherapy in NPC alone. This meta-analysis aimed to identify which regimen is more superior between weekly and triweekly cisplatin in patients with NPC treated with concurrent chemoradiotherapy. METHODS: The PubMed, Embase, and Cochrane Library were searched for eligible literatures. Clinical outcome measures including 1-year overall survival (OS), 3-year OS, 5-year OS, 5-year loco-regional failure-free survival, 5-year distant metastasis-free survial and the most common 3 grade or higher acute toxicities (hematological toxicity, mucositis and nausea and vomiting) were analyzed by RevMan 5.4 software; significance level was 0.05. RESULTS: Seven clinical controlled studies with 1795 patients were included in the meta-analysis. There were no significant differences between weekly and triweekly cisplatin in 1-year OS, 3-year OS, 5-year OS, 5-year loco-regional failure-free survival, and 5-year distant metastasis-free survial) (all Pâ >â .05). Grade 3 or higher mucositis and nausea and vomiting showed similar between the 2 arms. However, grade 3 or higher hematological toxicity of weekly cisplatin was significantly higher than that of triweekly cisplatin (1.55; 95% CI, 1.22-1.98, Pâ =â .0004). CONCLUSIONS: Weekly cisplatin resulted in similar survival benifit as triweekly cisplatin, but with higher hematological toxicity.