TY - JOUR
T1 - First-line immunotherapy in advanced non-small-cell lung cancer patients with ECOG performance status 2
T2 - results of an International Expert Panel Meeting by the Italian Association of Thoracic Oncology
AU - Gridelli, C.
AU - Peters, S.
AU - Mok, T.
AU - Forde, P. M.
AU - Reck, M.
AU - Attili, I.
AU - de Marinis, F.
N1 - Funding Information:
This work was supported by Associazione Italiana di Oncologia Toracica (AIOT) (no grant number). CG received honoraria as speaker bureau or advisory board member or as consultant from MSD, BMS, Roche, AstraZeneca, Novartis, Pfizer, Menarini, Boehringer, Karyopharm and Eli Lilly. SP reports personal fees for speaking or attending advisory boards, and has participated in investigation in trials for Amgen, AstraZeneca, Boehringer-Ingelheim, Bristol Myers Squibb, Clovis, F. Hoffmann-La Roche, Illumina, Merck Sharp & Dohme, Merck Serono, Novartis and Pfizer; and personal fees for speaking or attending advisory boards for AbbVie, Bayer, Biocartis, Bioinvent, Daiichi Sankyo, Debiopharm, ecancer, Foundation Medicine, Janssen, Lilly, Medscape, Merrimack, Pharma Mar, Regeneron, Sanofi, Seattle Genetics and Takeda (all fees to institution). TM reported receiving personal fees, grants or other fees from AbbVie, ACEA Pharma, Alpha Biopharma Co Ltd, Amgen, Amoy Diagnostics Co Ltd, AstraZeneca, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Blueprint Medicines Corporation, CStone Pharmaceuticals, Daiichi Sankyo, Eisai, Fishawack Facilitate Ltd, geneDecode, Gritstone Oncology Inc, Guardant Health, Hengrui Therapeutics, Ignyta Inc, IQVIA, Incyte Corporation, InMed Medical Communication, Janssen, Lilly, Loxo-Oncology, Lunit Inc, MD Health (Brazil), Medscape/WebMD, Merck Serono, Merck Sharp & Dohme, Mirati Therapeutics Inc, MORE Health, Novartis, OrigiMed, PeerVoice, Physicians' Education Resource, Permanyer SL, Pfizer Inc, PrIME Oncology, Puma Technology Inc, Research to Practice, Roche, Sanofi-Aventis R&D, Takeda, Touch Medical Media, Virtus Medical Group, Yuhan Corporation, AstraZeneca PLC, Hutchison Chi-Med, Sanomics Ltd, Clovis Oncology, SFJ Pharmaceuticals, Xcovery, Curio Science, Inivata, Berry Oncology, G1 Therapeutics Inc and Aurora. PMF received honoraria or consulting fees from Amgen, AstraZeneca, Bristol Myers Squibb, Novartis, Janssen, Iteos, Flame, Sanofi, Genentech, F-Star, G1 therapeutics and Surface Oncology; and research funding from AstraZeneca, BMS, Kyowa, Corvus and Novartis. MR reports honoraria for consultancy and lecture roles from Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Lilly, Merck, Mirati, Merck Sharp & Dohme, Novartis and Pfizer. FdM received honoraria or consulting fees from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer, Novartis, Takeda, Xcovery and Roche. IA has declared no conflicts of interest.
Funding Information:
This work was supported by Associazione Italiana di Oncologia Toracica (AIOT) (no grant number).
Publisher Copyright:
© 2021 The Authors
PY - 2022/2
Y1 - 2022/2
N2 - Background: Immunotherapy represents the standard of care in the first-line treatment of advanced non-small-cell lung cancer (NSCLC), either as monotherapy in high programmed death-ligand 1 (PD-L1)-positive tumors (≥50%) or in combination with platinum-based chemotherapy regardless of PD-L1 status. However, most pivotal clinical trials of immune checkpoint inhibitors (ICIs) did not include patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2. Hence, a consensus is lacking on the safety and efficacy of ICIs in this specific subgroup of patients. Materials and methods: A virtual International Expert Panel took place in July 2021 with the aim of reviewing the available evidence on the use of ICIs in NSCLC patients with ECOG PS 2, both in clinical practice and in a research setting. Results: All panelists expressed concern about the applicability of currently available PS scales to evaluate patients for ICI treatment. The panelists agreed that, though limited, the available data support the safety of single-agent immunotherapy in PS 2 NSCLC patients, whereas concern was raised on the safety of ICI combinations, mainly related to chemotherapy and/or anti-cytotoxic T-lymphocyte-associated antigen 4 toxicity. On the basis of reviewed data, ICI efficacy may be speculated in PS 2 NSCLC patients; however, PS 2 remains a negative prognostic category as compared to PS 0-1 in patients treated with ICI, as it is for chemotherapy. The panelists defined high, medium and low priorities in clinical research. High priority was attributed to the inclusion of PS 2 patients in prospective clinical trials and the specific evaluation of combined ICI treatments with attenuated chemotherapy doses. Conclusions: Based on the current evidence, the panelists outlined the major limitations affecting PS 2 patients with NSCLC and reached common considerations on the feasibility, safety and effectiveness of ICI monotherapy and ICI combinations in the first-line setting.
AB - Background: Immunotherapy represents the standard of care in the first-line treatment of advanced non-small-cell lung cancer (NSCLC), either as monotherapy in high programmed death-ligand 1 (PD-L1)-positive tumors (≥50%) or in combination with platinum-based chemotherapy regardless of PD-L1 status. However, most pivotal clinical trials of immune checkpoint inhibitors (ICIs) did not include patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2. Hence, a consensus is lacking on the safety and efficacy of ICIs in this specific subgroup of patients. Materials and methods: A virtual International Expert Panel took place in July 2021 with the aim of reviewing the available evidence on the use of ICIs in NSCLC patients with ECOG PS 2, both in clinical practice and in a research setting. Results: All panelists expressed concern about the applicability of currently available PS scales to evaluate patients for ICI treatment. The panelists agreed that, though limited, the available data support the safety of single-agent immunotherapy in PS 2 NSCLC patients, whereas concern was raised on the safety of ICI combinations, mainly related to chemotherapy and/or anti-cytotoxic T-lymphocyte-associated antigen 4 toxicity. On the basis of reviewed data, ICI efficacy may be speculated in PS 2 NSCLC patients; however, PS 2 remains a negative prognostic category as compared to PS 0-1 in patients treated with ICI, as it is for chemotherapy. The panelists defined high, medium and low priorities in clinical research. High priority was attributed to the inclusion of PS 2 patients in prospective clinical trials and the specific evaluation of combined ICI treatments with attenuated chemotherapy doses. Conclusions: Based on the current evidence, the panelists outlined the major limitations affecting PS 2 patients with NSCLC and reached common considerations on the feasibility, safety and effectiveness of ICI monotherapy and ICI combinations in the first-line setting.
KW - NSCLC
KW - consensus
KW - immune checkpoint inhibitors
KW - performance status 2
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U2 - 10.1016/j.esmoop.2021.100355
DO - 10.1016/j.esmoop.2021.100355
M3 - Review article
C2 - 34922299
AN - SCOPUS:85121270939
SN - 2059-7029
VL - 7
JO - ESMO Open
JF - ESMO Open
IS - 1
M1 - 100355
ER -