PMID- 32417680 OWN - NLM STAT- MEDLINE DCOM- 20210621 LR - 20210621 IS - 1872-8332 (Electronic) IS - 0169-5002 (Linking) VI - 145 DP - 2020 Jul TI - ECOG performance status >/=2 as a prognostic factor in patients with advanced non small cell lung cancer treated with immune checkpoint inhibitors-A systematic review and meta-analysis of real world data. PG - 95-104 LID - S0169-5002(20)30398-6 [pii] LID - 10.1016/j.lungcan.2020.04.027 [doi] AB - OBJECTIVES: ICIs have been approved and are routinely administered regardless of performance status (PS), despite randomized clinical trials of ICIs alone or combined with chemotherapy or target therapy enrolled patients with ECOG PS 0 or 1, while patients with ECOG PS 2 or more were excluded. MATERIALS AND METHODS: We carried out a meta-analysis of available clinical studies exploring the prognostic impact of PS >/= 2 on Overall Survival (OS), Progression Free Survival (PFS) or Overall Response Rate (ORR) in patients with non small cell lung cancer (NSCLC) treated with immunotherapy (any line). RESULTS: We reviewed 19 studies, comprising 3600 NSCLC patients, 757 of whom with ECOG PS > 1 (average 21.0%, range 6.0-48.6%). In the overall population PS >/= 2 resulted in worse OS, PFS and ORR (OS pooled hazard ratio of 2.72; 95% CI: 2.03-3.63; I(2) 72.70%, p < 0.001; PFS pooled hazard ratio of 2.39; 95% CI 1.81-3.15, p < 0.0001; I(2) 73.03%; ORR pooled odds ratio 0.25; 95% CI 0.11-0.56, p 0.001; I(2) 0.00%). CONCLUSION: ECOG PS >/= 2 retains an important prognostic validity in patients treated with ICI similar, in terms of effect size, to that reported for chemotherapy in NSCLC. The high level of heterogeneity for OS and PFS analysis (but not for ORR), not completely explained by the different proportion of ECOG 3-4 patients (ranging from 0% to 50% of the PS >/= 2 population), could be the result of both patient heterogeneity within the PS 2 population and the subjectivity of ECOG PS assessment. Whether poorer PS is also a predictor of lower immunotherapy efficacy remains still to be demonstrated. CI - Copyright (c) 2020 Elsevier B.V. All rights reserved. FAU - Dall'Olio, Filippo G AU - Dall'Olio FG AD - Sant'Orsola Malpighi Teaching Hospital - University of Bologna, Medical Oncology Unit, Bologna, Italy. Electronic address: filippogdallolio@gmail.com. FAU - Maggio, Ilaria AU - Maggio I AD - Sant'Orsola Malpighi Teaching Hospital - University of Bologna, Medical Oncology Unit, Bologna, Italy. FAU - Massucci, Maria AU - Massucci M AD - Sant'Orsola Malpighi Teaching Hospital - University of Bologna, Medical Oncology Unit, Bologna, Italy. FAU - Mollica, Veronica AU - Mollica V AD - Sant'Orsola Malpighi Teaching Hospital - University of Bologna, Medical Oncology Unit, Bologna, Italy. FAU - Fragomeno, Benedetta AU - Fragomeno B AD - Sant'Orsola Malpighi Teaching Hospital - University of Bologna, Medical Oncology Unit, Bologna, Italy. FAU - Ardizzoni, Andrea AU - Ardizzoni A AD - Sant'Orsola Malpighi Teaching Hospital - University of Bologna, Medical Oncology Unit, Bologna, Italy. LA - eng PT - Journal Article PT - Meta-Analysis PT - Systematic Review DEP - 20200506 PL - Ireland TA - Lung Cancer JT - Lung cancer (Amsterdam, Netherlands) JID - 8800805 RN - 0 (Immune Checkpoint Inhibitors) SB - IM MH - *Carcinoma, Non-Small-Cell Lung/diagnosis/drug therapy MH - Humans MH - Immune Checkpoint Inhibitors MH - Immunotherapy MH - *Lung Neoplasms/diagnosis/drug therapy MH - Prognosis OTO - NOTNLM OT - Atezolizumab OT - Carcinoma OT - Frail elderly OT - Humans OT - Immunologic factors OT - Immunotherapy OT - Lung neoplasms OT - Nivolumab OT - Non-small-cell lung OT - Pembrolizumab OT - Prognosis COIS- Declaration of Competing Interest The other authors have no conflict of interest to declare. EDAT- 2020/05/18 06:00 MHDA- 2021/06/22 06:00 CRDT- 2020/05/18 06:00 PHST- 2019/12/03 00:00 [received] PHST- 2020/04/05 00:00 [revised] PHST- 2020/04/21 00:00 [accepted] PHST- 2020/05/18 06:00 [pubmed] PHST- 2021/06/22 06:00 [medline] PHST- 2020/05/18 06:00 [entrez] AID - S0169-5002(20)30398-6 [pii] AID - 10.1016/j.lungcan.2020.04.027 [doi] PST - ppublish SO - Lung Cancer. 2020 Jul;145:95-104. doi: 10.1016/j.lungcan.2020.04.027. Epub 2020 May 6.