Polintan Edgar Theodore, Canicula Stephanie Krystel, Catahay Jesus Alfonso, Lo Kevin Bryan, Villalona-Calero Miguel, Loong Herbert Ho-Fung
Faculty of Medicine and Surgery, University of Santo Tomas, Blk 15, Lot 13, Brgy. Dagatan, Mt. Malarayat Golf and Residential Estate, Lipa, Batangas, 4217, Philippines.
Faculty of Medicine and Surgery, University of Santo Tomas, Manila, Philippines.
Ther Adv Med Oncol. 2022 Nov 15;14:17588359221137429. doi: 10.1177/17588359221137429. eCollection 2022.
To investigate whether Adjunctive PD-1 inhibitors have improved clinical outcomes compared to chemotherapy alone in platinum-pretreated and platinum-naive recurrent or metastatic nasopharyngeal carcinoma (R/M NPCA).
The study involved a literature search from PubMed, Cochrane CENTRAL, and Google Scholar for randomized clinical trials (RCTs) on the use of PD-1 inhibitors chemotherapy alone in patients with R/M NPCA. Bias was assessed using Cochrane collaboration's risk of bias tool. Overall Survival (OS) was examined as the primary endpoint. Secondary endpoints were Progression-Free Survival (PFS), Objective Response Rate, Disease Control Rate (DCR), Duration of Response, and Serious/Grade ⩾3 Adverse Events. Outcomes were measured with either Mean Difference, Risk ratio (RR), or Hazard ratios (HRs) at 95% confidence interval.
Four RCTs were included in the meta-analysis and systematic review. OS for the monotherapy subgroup was a HR of 0.87 [0.67, 1.13] ( = 0.30) while the combination subgroup had 0.64 [0.45, 0.90] ( = 0.01). The monotherapy subgroup exhibited significantly worse outcomes in PFS (HR 1.31 [1.01, 1.68]) ( = 0.04) and DCR (RR 1.52 [1.12, 2.05]) ( = 0.007) but no significant difference in other outcomes. For combination therapy, a statistically significant benefit can be seen in all outcomes except DCR (RR 0.62 [0.38, 1.01]) ( = 0.06) which was a non-significant benefit favoring PD-1 inhibitors.
Combination PD-1 inhibitor + chemotherapy followed by maintenance PD-1 inhibitor therapy is superior to chemotherapy alone in the first-line treatment of R/M NPCA, implying a potential benefit with the use of PD-1 inhibitors + chemotherapy with maintenance PD-1 inhibitors as first-line in R/M NPCA compared to standard chemotherapy alone.
探讨在铂类预处理和未接受过铂类治疗的复发或转移性鼻咽癌(R/M NPCA)患者中,辅助性程序性死亡受体1(PD-1)抑制剂与单纯化疗相比是否能改善临床结局。
本研究通过检索PubMed、Cochrane CENTRAL和谷歌学术,查找关于在R/M NPCA患者中使用PD-1抑制剂联合单纯化疗的随机临床试验(RCT)。使用Cochrane协作网的偏倚风险工具评估偏倚。将总生存期(OS)作为主要终点进行研究。次要终点包括无进展生存期(PFS)、客观缓解率、疾病控制率(DCR)、缓解持续时间以及严重/≥3级不良事件。结局指标采用95%置信区间的平均差、风险比(RR)或风险比(HR)进行测量。
四项RCT纳入了荟萃分析和系统评价。单药治疗亚组的OS的HR为0.87[0.67, 1.13](P = 0.30),而联合治疗亚组为0.64[0.45, 0.90](P = 0.01)。单药治疗亚组在PFS(HR 1.31[1.01, 1.68])(P = 0.04)和DCR(RR 1.52[1.12, 2.05])(P = 0.007)方面的结局明显更差,但在其他结局方面无显著差异。对于联合治疗,除DCR(RR 0.62[0.38, 1.01])(P = 0.06)外,在所有结局方面均有统计学意义的获益,DCR虽有有利于PD-1抑制剂的非显著获益。
在R/M NPCA的一线治疗中,联合使用PD-1抑制剂+化疗后序贯维持PD-1抑制剂治疗优于单纯化疗,这意味着与单纯标准化疗相比,在R/M NPCA中使用PD-1抑制剂+化疗并序贯维持PD-1抑制剂作为一线治疗可能具有潜在益处。