Abstract 648P
Background
In advanced non-small-cell lung cancer (NSCLC) without driver oncogene, immune checkpoint inhibitors (ICIs) plus platinum-based chemotherapy (Chemo-ICIs) is a standard treatment. However, the efficacy and safety of Chemo-ICIs in patients with poor ECOG PS (≥2) have not been established.
Methods
In this retrospective cohort study (16 centers in Japan), 424 were diagnosed with stage IV driver oncogene negative NSCLC with ECOG PS 2, between January 2016 and December 2020. We mainly compared Chemo-ICIs with Chemo regarding their efficacy and safety. Propensity score matching (PSM) method was used to adjust patients’ backgrounds (52 matched pairs from each group).
Results
Among 424 patients: median [range] age was 71 [24-94] years; 157 (37%) were ≥75 years; 311 (73.3%) were male; 121 (28.5%) had a PD-L1 tumor proportion score ≥50%; 56 (13.2%) received Chemo-ICIs, 117 (27.6%) Chemo, 78 (18.4%) ICIs monotherapy, 54 (12.7%) single agent chemotherapy and 119 (28.1%) best supportive care. Median progression free survival (PFS) was 5.7 months in the Chemo-ICIs group and 2.6 months in the Chemo group (hazard ratio [HR]: 0.53; p = 0.0014), and 5.7 months and 2.6 months (HR: 0.53; p = 0.0076), respectively, after PSM. Median overall survival (OS) was 8.0 months in the Chemo-ICIs group and 6.3 months in the Chemo group (HR: 0.75; p = 0.13), and 8.0 months and 7.1 months (HR: 0.80; p = 0.33), respectively, after PSM. The response rate was higher in Chemo-ICIs than in Chemo (42.9% versus 21.4%; p = 0.0033). The overall adverse events (≥grade3) were comparable in the two groups (50.0% versus 43.6%; p = 0.43).
Conclusions
This study found that adding ICIs to Chemo significantly improved PFS in patients with ECOG PS 2. Additionally, there was no significant difference in the frequency of grade (≥3) adverse events.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
T. Shukuya: Financial Interests, Personal and Institutional, Speaker’s Bureau: AstraZeneca, Chugai pharmaceutical, Boehringer Ingelheim, MSD, Novartis; Financial Interests, Personal and Institutional, Local PI: AstraZeneca, Chugai pharmaceutical, MSD, Novartis; Financial Interests, Personal and Institutional, Research Funding: Chugai pharmaceutical, Boehringer Ingelheim; Financial Interests, Personal, Speaker’s Bureau: Eli Lilly, Ono Pharmaceutical, Merck, Takeda pharmaceutical, Pfizer, Daiichi Sankyo pharmaceutical, Taiho pharmaceutical, Bristol Myers Squibb, Eisai, Nippon Kayaku, Amgen. D. Fujimoto: Financial Interests, Personal, Funding: PRiME-R; Financial Interests, Personal, Research Funding: AstraZeneca KK, Boehringer Ingelheim Japan Inc., Chugai Pharmaceutical Co., Ltd.; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca KK, Ono Pharmaceutical Co Ltd, Bristol Myers Squibb Co Ltd, Taiho Pharmaceutical Co Ltd, Chugai Pharmaceutical Co Ltd, Merck Sharp & Dohme KK, Boehringer Ingelheim Japan Inc, Eli Lilly Japan KK, Novartis Pharma K.K, Kyowa Kirin Co. Ltd, Janssen Pharmaceutical KK, Daiichi Sankyo Co., Ltd, Takeda Pharmaceutical Co.,Ltd. H. Ohtsu: Non-Financial Interests, Personal, Member of Board of Directors: NPO Japan Clinical Research Support Unit; Financial Interests, Personal, Stocks or ownership: Statcom Company Limited. Y. Toi: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical, Bristol Myers Squibb, MSD, Chugai Pharmaceutical Co., AstraZeneca, Taiho Pharmaceutical Co. T. Yokoyama: Financial Interests, Institutional, Research Funding: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, MSD, Parexel International, Takeda; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Bristol Myers Squibb, Chugai Pharmaceutical, Eli Lilly, Merck Biopharma, MSD, Nippon Kayaku, Novartis, Ono Pharmaceutical, Pfizer, Takeda. T. Kato: Financial Interests, Personal, Advisory Board, speaker: Pfizer; Financial Interests, Personal, Advisory Board, speaker, consultancy: Merck Biopharma, MSD, AstraZeneca; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Invited Speaker: Ono, Novartis, Eli Lilly, Bristol Meyers Squibb, Boehringer Ingelheim, Amgen; Financial Interests, Personal, Other, consultancy: Takeda, Daiichi Sankyo; Financial Interests, Personal, Other, consultancy, speaker: Chugai; Financial Interests, Personal, Full or part-time Employment, Family member: Eli Lilly; Financial Interests, Institutional, Local PI: AbbVie, Amgen, Bayer, BeiGene, Blueprint Medicines, Chugai, Daiichi Sankyo, Eli Lilly, Gilead, GSK, Haihe Biopharma, Janssen, MSD, Merck Biophama, Novartis, Pfizer, Regeneron, Takeda, BMS, Arrivent; Financial Interests, Personal and Institutional, Steering Committee Member, Local PI: AstraZeneca; Financial Interests, Personal, Steering Committee Member: Roche. T. Yamaguchi: Financial Interests, Personal, Invited Speaker: AstraZeneca, Ono Pharmaceutical, Chugai Pharmaceutical, MSD, Bristol Meyers Squibb, Taiho Pharmaceutical, Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Daiichi Sankyo. S. Miura: Financial Interests, Personal, Speaker’s Bureau: Chugai Pharmaceutical, Taiho Pharmaceutical, Pfizer, Eli Lilly, Boehringer-Ingelheim Japan, Ono Pharmaceutical, AstraZeneca, Novartis, MSD, Bristol Myers Squibb, Kyowa Hakko Kirin, Daiichi Sankyo, Nippon Kayaku, Amgen, Merck, Takeda Pharmaceutical, Eisai. M. Tachihara: Financial Interests, Personal, Invited Speaker: Eli Lilly Japan K.K., Chugai Pharmaceutical Co.,Ltd, AstraZeneca K.K, MSD K.K., Ono Pharmaceutical Co.,Ltd., Bristol Myers Squibb Co. Ltd., Nippon Boehringer Ingelheim Co.,Ltd., Pfizer Japan Inc., Daiichi Sankyo, Janssen Pharmaceutical K.K., Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd.; Financial Interests, Institutional, Research Grant: AstraZeneca K.K., Eli Lilly Japan K.K., Chugai Pharmaceutical Co.,Ltd. Y. Sato: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai Pharmaceutical, MSD, Ono Pharmaceutical, Novartis, Pfizer, Taiho Pharmaceutical, Nippon Kayaku, Bristol Myers Squibb, Eli Lilly, Takeda, Kyowa Kirin, Daiichi Sankyo, Boehringer Ingelheim. S. Ikeda: Financial Interests, Personal, Advisory Board: AstraZeneca, Chugai, Ono, Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai, Ono, Bristol Myers Squibb, Taiho, Eli Lilly, Pfizer, Boehringer Ingelheim, Takeda, MSD; Financial Interests, Personal, Research Grant: AstraZeneca, Chugai. N. Yamamoto: Financial Interests, Personal, Invited Speaker: MSD K.K, AstraZeneca, Ono Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical CO., LTD., Chugai Pharmaceutical CO., LTD., Eli Lilly Japan K.K., Novartis, Pfizer Inc., Amgen Inc., MercK biopharma; Financial Interests, Personal, Advisory Board: AstraZeneca, Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical CO., LTD., Chugai Pharmaceutical CO., LTD., Eli Lilly Japan K.K., Novartis; Financial Interests, Institutional, Research Grant: MSD K.K; Financial Interests, Institutional, Local PI: AstraZeneca, Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical CO., LTD., Amgen Inc., Janssen Pharmaceutical K.K., Novartis, Eisai, Eli Lilly Japan; Financial Interests, Institutional, Funding: Daiichi Sankyo Co., Ltd., Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical CO., LTD., Sanofi. K. Takahashi: Non-Financial Interests, Personal, Officer: Chairman of the Board of Directors, The Japanese Respiratory Society; Financial Interests, Institutional, Research Funding: Chugai pharmaceutical, Ono pharmaceutical, MSD; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim, Chugai pharmaceutical, KYORIN Pharmaceutical, Nippon Kayaku, Taiho pharmaceutical; Non-Financial Interests, Personal, Speaker, Consultant, Advisor: Amgen, Eli Lilly, Merck, Novartis Pharma, Taiho pharmaceutical, Teijin Pharma ; Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, BioMerieux Japan Ltd., Boehringer Ingelheim, Bristol Myers Squibb, Chugai pharmaceutical, Daiichi Sankyo pharmaceutical, KYORIN Pharmaceutical, MSD, Nippon Kayaku, Ono pharmaceutical, Pfizer, Takeda pharmaceutical. H. Hayashi: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical Co. Ltd., Bristol Myers Squibb Co. Ltd, AstraZeneca K.K, Boehringer Ingelheim Japan Inc., Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo K.K, Eli Lilly Japan K.K, Merck Biopharma Co. Ltd, MSD K.K., Novartis Pharmaceuticals K.K, Pfizer, Takeda Pharmaceutical Co. Ltd; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb Co. Ltd, Eli Lilly Japan K.K, Pfizer, AstraZeneca K.K, Daiichi Sankyo Co.Ltd; Financial Interests, Personal, Royalties, Currently no provided: Sysmex; Financial Interests, Personal, Steering Committee Member: Janssen Pharmaceutical K.K., GSK plc., Daiichi Sankyo, Inc.; Financial Interests, Institutional, Local PI: IQVIA Services JAPAN K.K, Syneos Health Clinical K.K., EPS Corporation., Nippon Kayaku Co.,Ltd., Takeda Pharmaceutical Co.,Ltd., MSD K.K., Amgen Inc., Taiho Pharmaceutical Co.,Ltd., Bristol Myers Squibb Company, Janssen Pharmaceutical K.K., CMIC CO., Ltd., Pfizer R&D Japan G.K., Labcorp Development Japan K.K., Kobayashi Pharmaceutical Co., Ltd., Pfizer Japan Inc., AbbVie Inc., A2 Healthcare Corp., Eli Lilly Japan K.K., Medpace Japan KK, EPS International Co.,Ltd,., Covance Japan Inc., EP-CRSU CO., LTD., GSK K.K., Sanofi K.K., Chugai Pharmaceutical Co.,Ltd., Nippon Boehringer Ingelheim Co.,Ltd., PRA Health Sciences Inc., Astellas Pharma Inc., Ascent Development Services, AstraZeneca K.K., Daiichi Sankyo Co., Ltd., Novartis Pharma K.K., Merck Biopharma Co., Ltd, Mochida Pharmaceutical Co., Ltd., Japan Clinical Research Operations; Financial Interests, Institutional, Research Grant: Japanese Gastric Cancer Association, Clinical Research Support Center Kyushu, Japan Clinical Caner Research Organization, Ono Pharmaceutical Co.,Ltd., Medical Research Support, Eisai Co., Ltd, Shionogi & Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co.,Ltd., Nippon Boehringer Ingelheim Co.,Ltd., Bayer Yakuhin, Ltd, Kyowa Kirin Co.,Ltd.; Financial Interests, Institutional, Funding: SRL Medisearch Inc., Eisai Inc., Thoracic Oncology Research Group(TORG), West Japan Oncology Group (WJOG), Comprehensive Support Project for Oncological Research of Breast Cancer (CSPOR-BC), Mebix, Inc.; Non-Financial Interests, Personal, Member: West Japan Oncology Group, Japanese Society of Medical Oncology. I. Okamoto: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical, Boehringer Ingelheim, AstraZeneca, Bristol Myers Squibb, Takeda Pharmaceutical, Daiichi Sankyo, MSD, Pfizer, Taiho Pharmaceutical, Novartis; Financial Interests, Institutional, Local PI: Chugai Pharmaceutical, Boehringer Ingelheim, AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, GSK, MSD, Taiho Pharmaceutical, Novartis. All other authors have declared no conflicts of interest.