500P - The effectiveness and safety of durvalumab after chemoradiotherapy for locoregional recurrence of completely resected non-small cell lung cancer: Real-world, multicenter, observational study (NEJ056)

Background

There is no standard therapeutic strategy for locoregional recurrence of non-small cell lung cancer (NSCLC) after complete resection. We evaluated the effectiveness and safety of chemoradiotherapy (CRT) followed by durvalumab compared with CRT alone in patients with this disease.

Methods

We retrospectively collected the data of patients with NSCLC diagnosed with locoregional recurrence after complete resection and subsequently underwent concurrent CRT followed by durvalumab (CRT-D group) or CRT (CRT group) initiated between January 1, 2016 and December 31, 2020. In CRT group, radiotherapy must have been completed by April 30, 2018 to exclude patients who underwent CRT alone after durvalumab approval. Inverse probability treatment weighting (IPTW) was used for survival analysis to adjust baseline characteristics between two groups. The primary outcome was progression-free survival (PFS) from the time of CRT initiation.

Results

Among the 196 patients included, 121 patients were in the CRT-D group and 75 patients were in the CRT group; median age 67/68 years; male 64.5%/70.7%; smoker 75.2%/81.3%; PS 0-1 98.3%/100%; Adenocarcinoma 69.4%/72.0%; EGFR mutation 21.5%/23.9%; in patients with known PD-L1 status, PD-L1 ≥50%; 31.9%/36.1%, 1-49%; 40.2%/41.6%, <1%; 27.8%/22.2%. IPTW-adjusted median PFS and OS showed significant improvements with CRT-D group vs CRT group (Table). Grade 3 or 4 adverse events occurred in 48.8% during CRT and 10.7% after the start of durvalumab maintenance in the CRT-D group, and 57.3% in the CRT group; Any-grade pneumonitis occurred in 9.9%, 63.6% and 41.3%, respectively. Table: 500P

Conclusions

In our study, PFS and OS in the CRT-D group was significantly longer than in the CRT group. CRT followed by durvalumab is one of the promising treatment strategies for locoregional recurrence of NSCLC after complete resection.

Clinical trial identification

Trial protocol number: 022-0079 release date: September 29, 2022.

Editorial acknowledgement

Legal entity responsible for the study

North East Japan Study Group.

Funding

AstraZeneca.

Disclosure

H. Horinouchi: Financial Interests, Personal, Invited Speaker: AstraZeneca, Eli Lilly, BMS/Ono, Merck Sharp & Dohme, Roche/Chugai, Novartis, Pfizer, Boehringer Ingelheim, Kyowa-Kirin, Nihon Kayaku, AbbVie; Financial Interests, Personal, Advisory Board: AstraZeneca, Eli Lilly, BMS/Ono, Merck Sharp & Dohme, Roche/Chugai, Amgen, Nihon Kayaku; Financial Interests, Personal, Steering Committee Member: Roche/Chugai; Financial Interests, Institutional, Research Grant: Roche/Chugai, Merck Sharp & Dohme, Daiichi Sankyo, Ono pharmaceutical, AstraZeneca; Financial Interests, Institutional, Local PI: AbbVie. M. Furuta: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical, AstraZeneca. I. Yokota: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical Co, AstraZeneca; Financial Interests, Personal, Research Grant: KAKENHI, AMED, Health, Labour and Welfare Policy Research Grants; Financial Interests, Personal, Research Funding: Nihon Medi-Physics. T. Yamaguchi: Financial Interests, Personal, Invited Speaker: AstraZeneca, Ono Pharmaceutical, Chugai Pharmaceutical, MSD, Bristol-Myers Squibbb. S. Itoh: Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb K.K., AstraZeneca K.K, Amgen K.K., Chugai Pharmaceutical Co., Ltd., Pfizer Japan Inc. A. Iwashima: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai Pharmaceutical Co., Boehringer Ingelheim, Bristol Myers Squibb, Takeda Pharmaceutical Co., Novartis, GSK K.K., Sanofi, FUJIFILM Toyama Chemical Co., Ltd., Asahi Kasei Pharma Corporation. Y. Kawashima: Financial Interests, Personal, Invited Speaker, lecture fee: Taiho Pharmaceutical, Chugai Pharmaceutical Co, Eli Lilly and Company, AstraZeneca, Life Technologies Japan Ltd, Kyowa Kirin Co., Ltd. H. Tanaka: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical Co. Ltd, Bristol Myers Squibb, AstraZeneca, Chugai Pharmaceutical Co, Boehringer Ingelheim Japan Inc, Pfizer Japan Inc, Pharmaceutical, Eli Lilly. H. Yokouchi: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Local PI: AstraZeneca, Bristol Myers Squibb, Sanofi, Takeda Pharmaceutical Company Limited, Chugai Pharmaceutical Company Limited, Daiichi Sankyo Company Limited. K. Miura: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical, Taiho Pharmaceutical, AstraZeneca. T. Kamoshida: Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim. T. Kato: Financial Interests, Personal, Invited Speaker: Johnson & Johnson K.K., Otsuka Pharmaceutical Co., Ltd., AstraZeneca, Nippon Kayaku Co., Ltd., Chugai Pharmaceutical Co., Ltd., CSL Behring K.K., Bristol Myers Squibb K.K., Daiichi Sankyo Co., TERUMO Corporation, Japan Blood Products Organization. K. Kobayashi: Financial Interests, Personal, Invited Speaker: Daiichi Sankyo Co., AstraZeneca, Takeda Pharmaceutical Co. H. Asahina: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical, AstraZeneca, MSD, Ono Pharmaceutical, Kyowahakko Kirin, Eli Lilly, Merck; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Research Grant: AstraZeneca. All other authors have declared no conflicts of interest.