Yuri Tasaka1, Takayuki Honda1, Naoki Nishiyama2, Toshiharu Tsutsui3, Hiroaki Saito4, Haruna Watabe5, Kazuhiro Shimaya6, Akifumi Mochizuki7, Shun Tsuyuki8, Tatsuo Kawahara1, Rie Sakakibara1, Takahiro Mitsumura1, Tsukasa Okamoto1, Masayoshi Kobayashi2, Tomoshige Chiaki9, Takaaki Yamashita10, Yoshikazu Tsukada7, Reiko Taki11, Yasuto Jin6, Hiroyuki Sakashita5, Ichirou Natsume5, Kazuhito Saitou4, Yoshihiro Miyashita3, Yasunari Miyazaki12. 1. Department of Respiratory Medicine, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan. 2. Department of Respiratory Medicine, Tokyo Metropolitan Bokutoh Hospital, 4-23-15 Koutoubashi, Sumida-ku, Tokyo 130-8575, Japan. 3. Department of Respiratory Medicine, Yamanashi Prefectural Central Hospital, 1‑1‑1 Fujimi, Kofu‑shi, Yamanashi 400‑8506, Japan. 4. Department of Respiratory Medicine, TsuchiuraKyodo General Hospital, 4‑1‑1 Otsuno, Tsuchiura‑shi, Ibaraki 300‑0028, Japan. 5. Department of Chemotherapy, Yokosuka Kyosai Hospital, 1‑16 Yonegahama‑dori, Yokosuka‑shi, Kanagawa 238‑8558, Japan. 6. Department of Respiratory Medicine, Hiratsuka Kyosai Hospital, 9‑11 Oiwake, Hiratsuka‑shi, Kanagawa 254‑8502, Japan. 7. Department of Respiratory Medicine, Soka Municipal Hospital, 2‑21‑1 Soka, Soka‑shi, Saitama 340‑8560, Japan. 8. Department of Respiratory Medicine, Kudanzaka Hospital, 1-6-12 Kudanminami, Chiyoda-ku, Tokyo 102-0074, Japan. 9. Department of Respiratory Medicine, Hokushin General Hospital, 1‑5‑63 Nishi, Nakano‑shi, Nagano 383‑8505, Japan. 10. Department of Respiratory Medicine, Japan Agricultural Cooperatives Toride Medical Center, 2‑1‑1 Hongo, Toride‑shi, Ibaraki 302‑0022, Japan. 11. Department of Respiratory Medicine, Japanese Red Cross Musashino Hospital, 1‑26‑1 Kyonancho, Musashino‑shi, Tokyo 180‑8610, Japan. 12. Department of Respiratory Medicine, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan. Electronic address: miyazaki.pilm@tmd.ac.jp.
Abstract
OBJECTIVES: The efficacy of immune checkpoint inhibitors (ICIs) in non-small-cell lung cancer (NSCLC) patients with pre-existing interstitial lung disease (ILD) is unclear. MATERIALS AND METHODS: Retrospective medical data from advanced or recurrent NSCLC patients who were treated with nivolumab or pembrolizumab at ten institutions in Japan between January 2016 and September 2018 were analyzed. Eligible patients were divided into two groups according to the presence of pre-existing ILD. RESULTS: A total of 461 NSCLC patients were enrolled, 412 without ILD (Non-ILD group) and 49 with ILD (ILD group). The response rate (RR) and disease control rate (DCR) of the ILD group were not inferior to those of the Non-ILD group [RR: 49.0 % (24/49) vs. 30.1 % (124/412), P < 0.01 and DCR: 69.4 % (34/49) vs. 51.2 % (211/412), P = 0.016, respectively]. Non-inferior outcomes were also observed with respect to progression-free survival (PFS) and overall survival (OS) (median PFS: 5.9 months vs. 3.5 months, P = 0.14 and median OS: 27.8 months vs. 25.2 months, P = 0.74 in the ILD and Non-ILD groups, respectively). Among immune-related adverse effects (irAEs), checkpoint inhibitor pneumonitis (CIP) was more frequently observed among NSCLC patients in the ILD group [30.6 % (15/49) vs. 9.5 % (39/412), P < 0.01]. The frequency of irAEs other than CIP and infusion reactions was not significantly different between the ILD group and the Non-ILD group. CONCLUSION: These results suggest that the clinical outcomes of ICIs are not significantly affected by pre-existing ILD despite the increased frequency of CIP. NSCLC patients with ILD are therefore probable candidates for ICIs.
OBJECTIVES: The efficacy of immune checkpoint inhibitors (ICIs) in non-small-cell lung cancer (NSCLC) patients with pre-existing interstitial lung disease (ILD) is unclear. MATERIALS AND METHODS: Retrospective medical data from advanced or recurrent NSCLCpatients who were treated with nivolumab or pembrolizumab at ten institutions in Japan between January 2016 and September 2018 were analyzed. Eligible patients were divided into two groups according to the presence of pre-existing ILD. RESULTS: A total of 461 NSCLCpatients were enrolled, 412 without ILD (Non-ILD group) and 49 with ILD (ILD group). The response rate (RR) and disease control rate (DCR) of the ILD group were not inferior to those of the Non-ILD group [RR: 49.0 % (24/49) vs. 30.1 % (124/412), P < 0.01 and DCR: 69.4 % (34/49) vs. 51.2 % (211/412), P = 0.016, respectively]. Non-inferior outcomes were also observed with respect to progression-free survival (PFS) and overall survival (OS) (median PFS: 5.9 months vs. 3.5 months, P = 0.14 and median OS: 27.8 months vs. 25.2 months, P = 0.74 in the ILD and Non-ILD groups, respectively). Among immune-related adverse effects (irAEs), checkpoint inhibitor pneumonitis (CIP) was more frequently observed among NSCLCpatients in the ILD group [30.6 % (15/49) vs. 9.5 % (39/412), P < 0.01]. The frequency of irAEs other than CIP and infusion reactions was not significantly different between the ILD group and the Non-ILD group. CONCLUSION: These results suggest that the clinical outcomes of ICIs are not significantly affected by pre-existing ILD despite the increased frequency of CIP. NSCLCpatients with ILD are therefore probable candidates for ICIs.
Authors: Namrata Kewalramani; Carlos Machahua; Venerino Poletti; Jacques Cadranel; Athol U Wells; Manuela Funke-Chambour Journal: ERJ Open Res Date: 2022-06-20