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. 2022 Aug 16;14(16):3953.
doi: 10.3390/cancers14163953.

Efficacy and Safety of Amrubicin in Small Cell Carcinoma Previously Treated with Immune Checkpoint Inhibitors and Chemotherapy

Tadashi Nishimura  1   2 , Hajime Fujimoto  2 , Takumi Fujiwara  2   3 , Kentaro Ito  4 , Atsushi Fujiwara  5 , Hisamichi Yuda  6 , Hidetoshi Itani  7 , Masahiro Naito  1 , Shuji Kodama  5 , Akihiko Yagi  6 , Valeria Fridman D'Alessandro  8 , Taro Yasuma  8 , Kazuki Furuhashi  2 , Haruko Saiki  2 , Tomohito Okano  2 , Atsushi Tomaru  2 , Motoaki Tanigawa  7 , Corina N D'Alessandro-Gabazza  8 , Esteban C Gabazza  8 , Masamichi Yoshida  5 , Osamu Hataji  4 , Hidenori Ibata  1 , Tetsu Kobayashi  2
Affiliations

Efficacy and Safety of Amrubicin in Small Cell Carcinoma Previously Treated with Immune Checkpoint Inhibitors and Chemotherapy

Tadashi Nishimura et al. Cancers (Basel). .

Abstract

Adding an immune checkpoint inhibitor to chemotherapy to treat extensive-stage small cell lung cancer is effective. However, there are no reports of an effective second-line treatment in patients previously treated with chemotherapy and immune checkpoint inhibitors as a first-line treatment. Here, we assessed the efficacy and safety of amrubicin as a second-line treatment for extensive-stage small cell lung cancer after chemotherapy and immune checkpoint inhibitor combination therapy. The study enrolled 150 patients with extensive-stage small cell lung cancer. The efficacy and the incidence of adverse events were compared between patients previously treated with immune checkpoint inhibitors and patients without previous immune checkpoint inhibitor treatment. One hundred and twenty-three patients were eligible. There was no difference in objective response rate, time-to-treatment failure, progression-free survival, and overall survival between both groups. The incidence of adverse events was similar in both treatment groups. Pretreatment with immune checkpoint inhibitors was not associated with an increase in amrubicin-related adverse events. This study shows that the efficacy of amrubicin in extensive-stage small cell lung cancer remains unchanged irrespective of previous treatment with immune checkpoint inhibitors. Amrubicin-related adverse events did not increase in patients previously treated with immune checkpoint inhibitors.

Keywords: amrubicin; immune checkpoint inhibitor; small cell lung cancer.

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Conflict of interest statement

The authors declare no conflict of interest regarding the work reported in this study. The following authors declared a conflict of interest unrelated to the present work: K.I. reported receiving lecture fees from Eli Lilly, Boehringer Ingelheim, Takeda Pharmaceutical, Chugai Pharmaceutical, AstraZeneca, Pfizer, Merk Sharp & Dohme (MSD), Ono Pharmaceutical, and Taiho Pharmaceutical. O.H. reported grants from AbbVie, AstraZeneca, Boehringer Ingelheim, Byer, Chugai Pharmaceutical, Eli Lilly, Fukuda Denshi, GlaxoSmithKline, Insmed, Janssen Pharmaceutical, Kyorin Pharmaceutical, Merk Sharp & Dohme (MSD), Novartis, Ono Pharmaceutical, Sanofi and Takeda Pharmaceutical, and lecture fees from AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Fukuda Denshi, GlaxoSmithKline, Kyorin Pharmaceutical, Merck Biopharma, Merk Sharp & Dohme (MSD), Meiji Seika Pharma, Mitsubishi Tanabe Pharma, Nippon Kayaku, Nippon Chemiphar, Novartis, Ono Pharmaceutical, Sanofi, Takeda Pharmaceutical, Taiho Pharmaceutical, and Boehringer Ingelheim. E.C.G. reported receiving funding from Takeda Foundation. T.K. reported receiving grants from Chugai Pharma, Taiho Pharma, Eli Lilly, Boehringer Ingelheim, and Daiichi-Sankyo, and lecture fees from AstraZeneca.

Figures

Figure 1
Figure 1
Study flow chart. The patients were divided into immune checkpoint inhibitor (ICI)-treated and ICI-untreated groups.
Figure 2
Figure 2
Kaplan–Meier curves of (a) time-to-treatment failure, (b) progression-free survival, and (c) overall survival. CI: confidence interval; ICI: immune checkpoint inhibitor; MST: median survival time; NA: not assessed; PFS: progression-free survival; TTF: time-to-treatment failure.
See this image and copyright information in PMC

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