Mencoboni Manlio, Ceppi Marcello, Bruzzone Marco, Taveggia Paola, Cavo Alessia, Scordamaglia Francesca, Gualco Marina, Filiberti Rosa Angela
SSD Oncologia Ospedale Villa Scassi, ASL 3 Genovese, 16149 Genova, Italy.
Clinical Epidemiology, IRCCS Ospedale Policlinico San Martino, 16132 Genova, Italy.
Cancers (Basel). 2021 Mar 19;13(6):1388. doi: 10.3390/cancers13061388.
Immunotherapy based on anti PD-1/PD-L1 inhibitors is the new standard of advanced non-small cell lung cancers. Pembrolizumab, nivolumab and atezolizumab are used in clinical practice. The strict eligibility criteria of clinical trials do not allow researchers to fully represent treatment effects in the patients that will ultimately use these drugs. We performed a systematic review and a meta-analysis to evaluate the effectiveness and safety of these drugs, and more generally of ICIs, as second-line therapy in NSCLC patients in real world practice. MEDLINE, PubMed, Scopus and Web of Science were searched to include original studies published between January 2015 and April 2020. A total of 32 studies was included in the meta-analysis. The overall radiological response rate (ORR), disease control rate (DCR), median progression-free survival (PFS) and overall survival (OS) were 21%, 52%, 3.35 months and 9.98 months, respectively. The results did not change when analysis was adjusted for Eastern Cooperative Oncology Group performance status (ECOG PS) and age. A unitary increase in the percent of patients with liver and CNS metastases reduced the occurrence of DCR by 7% ( < 0.001) and the median PFS by 2% ( = 0.010), respectively. The meta-analysis showed that the efficacy and safety of immunotherapy in everyday practice is comparable to that in clinical trials.
基于抗PD-1/PD-L1抑制剂的免疫疗法是晚期非小细胞肺癌的新标准。帕博利珠单抗、纳武利尤单抗和阿替利珠单抗已应用于临床实践。临床试验严格的入选标准使研究人员无法全面展现这些药物在最终使用它们的患者中的治疗效果。我们进行了一项系统评价和荟萃分析，以评估这些药物以及更广泛的免疫检查点抑制剂（ICI）作为非小细胞肺癌患者二线治疗在现实世界中的有效性和安全性。检索了MEDLINE、PubMed、Scopus和科学网，纳入2015年1月至2020年4月发表的原始研究。共有32项研究纳入荟萃分析。总体放射学缓解率（ORR）、疾病控制率（DCR）、中位无进展生存期（PFS）和总生存期（OS）分别为21%、52%、3.35个月和9.98个月。根据东部肿瘤协作组体能状态（ECOG PS）和年龄进行分析调整后，结果未发生变化。肝转移和中枢神经系统转移患者百分比每增加一个单位，DCR发生率分别降低7%（P<0.001），中位PFS降低2%（P=0.010）。荟萃分析表明，免疫疗法在日常实践中的疗效和安全性与临床试验中的相当。
