Real‐World Data of Second‐Line Amrubicin Monotherapy in Patients With Extensive‐Stage Small Cell Lung Cancer Who Received First‐Line Chemoimmunotherapy or Chemotherapy: A Multicenter Retrospective Study
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2026
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| author | Kei Sonehara Toshiharu Tsutsui Shuhei Nozawa Toshihiko Agatsuma Manabu Yamamoto Akemi Matsuo Masanori Nakanishi Tomoshige Chiaki Akane Kato Takashige Miyahara Tsutomu Hachiya Shintaro Kanda Taro Hirabayashi Katsuya Yanagisawa Taisuke Araki Kazunari Tateishi Masayuki Hanaoka |
| author_facet | Kei Sonehara Toshiharu Tsutsui Shuhei Nozawa Toshihiko Agatsuma Manabu Yamamoto Akemi Matsuo Masanori Nakanishi Tomoshige Chiaki Akane Kato Takashige Miyahara Tsutomu Hachiya Shintaro Kanda Taro Hirabayashi Katsuya Yanagisawa Taisuke Araki Kazunari Tateishi Masayuki Hanaoka Kei Sonehara Toshiharu Tsutsui Shuhei Nozawa Toshihiko Agatsuma Manabu Yamamoto Akemi Matsuo Masanori Nakanishi Tomoshige Chiaki Akane Kato Takashige Miyahara Tsutomu Hachiya Shintaro Kanda Taro Hirabayashi Katsuya Yanagisawa Taisuke Araki Kazunari Tateishi Masayuki Hanaoka |
| collection | Wiley Open Access |
| contents | Real‐World Data of Second‐Line Amrubicin Monotherapy in Patients With Extensive‐Stage Small Cell Lung Cancer Who Received First‐Line Chemoimmunotherapy or Chemotherapy: A Multicenter Retrospective Study Kei Sonehara Toshiharu Tsutsui Shuhei Nozawa Toshihiko Agatsuma Manabu Yamamoto Akemi Matsuo Masanori Nakanishi Tomoshige Chiaki Akane Kato Takashige Miyahara Tsutomu Hachiya Shintaro Kanda Taro Hirabayashi Katsuya Yanagisawa Taisuke Araki Kazunari Tateishi Masayuki Hanaoka Cancer Medicine ABSTRACT Background Chemoimmunotherapy is widely used as the first‐line treatment for extensive‐stage small cell lung cancer (ES‐SCLC), but treatment options for second‐line have not changed. Amrubicin monotherapy is used as the standard treatment for relapsed SCLC, but since chemoimmunotherapy became an additional indication for ES‐SCLC, the efficacy and safety of second‐line amrubicin have not been sufficiently investigated. Methods We enrolled a total of 131 relapsed SCLC patients who received second‐line amrubicin at eleven institutions in Japan between August 2019 and June 2023. We retrospectively examined the efficacy and safety of second‐line amrubicin monotherapy. Results Twenty‐five (19.1%) and 106 patients (80.9%) had sensitive and refractory relapse, respectively. 51 (38.9%) and 80 (61.1%) patients received first‐line chemoimmunotherapy and first‐line chemotherapy, respectively. The median progression‐free survival (PFS) and overall survival (OS) were 3.6 months (95% confidence interval [CI], 3.1–4.1 months) and 7.9 months (95% CI, 6.7–9.1 months), respectively. The median PFS and OS were significantly longer in the sensitive group compared with the refractory group (PFS: 6.4 vs. 3.5 months, p = 0.008, OS: 9.4 vs. 6.4 months, p = 0.021, respectively). Treatment‐related adverse events were as follows: Grade 4 neutropenia in 51 patients (38.9%), grade 3 or higher febrile neutropenia in 18 patients (13.7%), and all grade interstitial lung disease in 13 patients (9.9%). Treatment‐related death was 1 patient (0.8%). Conclusion Second‐line amrubicin monotherapy for relapsed SCLC may be useful and well‐tolerated as a treatment option after first‐line chemoimmunotherapy or chemotherapy. 10.1002/cam4.71982 http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| doi_str_mv | 10.1002/cam4.71982 |
| format | Artículo Open Access |
| id | wiley_oa_10_1002_cam4_71982 |
| institution | Wiley Open Access |
| license_str_mv | http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| publishDate | 2026 |
| publisher | Wiley |
| record_format | wiley_oa |
| spellingShingle | Real‐World Data of Second‐Line Amrubicin Monotherapy in Patients With Extensive‐Stage Small Cell Lung Cancer Who Received First‐Line Chemoimmunotherapy or Chemotherapy: A Multicenter Retrospective Study Kei Sonehara Toshiharu Tsutsui Shuhei Nozawa Toshihiko Agatsuma Manabu Yamamoto Akemi Matsuo Masanori Nakanishi Tomoshige Chiaki Akane Kato Takashige Miyahara Tsutomu Hachiya Shintaro Kanda Taro Hirabayashi Katsuya Yanagisawa Taisuke Araki Kazunari Tateishi Masayuki Hanaoka Cancer Medicine Real‐World Data of Second‐Line Amrubicin Monotherapy in Patients With Extensive‐Stage Small Cell Lung Cancer Who Received First‐Line Chemoimmunotherapy or Chemotherapy: A Multicenter Retrospective Study Kei Sonehara Toshiharu Tsutsui Shuhei Nozawa Toshihiko Agatsuma Manabu Yamamoto Akemi Matsuo Masanori Nakanishi Tomoshige Chiaki Akane Kato Takashige Miyahara Tsutomu Hachiya Shintaro Kanda Taro Hirabayashi Katsuya Yanagisawa Taisuke Araki Kazunari Tateishi Masayuki Hanaoka Cancer Medicine ABSTRACT Background Chemoimmunotherapy is widely used as the first‐line treatment for extensive‐stage small cell lung cancer (ES‐SCLC), but treatment options for second‐line have not changed. Amrubicin monotherapy is used as the standard treatment for relapsed SCLC, but since chemoimmunotherapy became an additional indication for ES‐SCLC, the efficacy and safety of second‐line amrubicin have not been sufficiently investigated. Methods We enrolled a total of 131 relapsed SCLC patients who received second‐line amrubicin at eleven institutions in Japan between August 2019 and June 2023. We retrospectively examined the efficacy and safety of second‐line amrubicin monotherapy. Results Twenty‐five (19.1%) and 106 patients (80.9%) had sensitive and refractory relapse, respectively. 51 (38.9%) and 80 (61.1%) patients received first‐line chemoimmunotherapy and first‐line chemotherapy, respectively. The median progression‐free survival (PFS) and overall survival (OS) were 3.6 months (95% confidence interval [CI], 3.1–4.1 months) and 7.9 months (95% CI, 6.7–9.1 months), respectively. The median PFS and OS were significantly longer in the sensitive group compared with the refractory group (PFS: 6.4 vs. 3.5 months, p = 0.008, OS: 9.4 vs. 6.4 months, p = 0.021, respectively). Treatment‐related adverse events were as follows: Grade 4 neutropenia in 51 patients (38.9%), grade 3 or higher febrile neutropenia in 18 patients (13.7%), and all grade interstitial lung disease in 13 patients (9.9%). Treatment‐related death was 1 patient (0.8%). Conclusion Second‐line amrubicin monotherapy for relapsed SCLC may be useful and well‐tolerated as a treatment option after first‐line chemoimmunotherapy or chemotherapy. 10.1002/cam4.71982 http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| title | Real‐World Data of Second‐Line Amrubicin Monotherapy in Patients With Extensive‐Stage Small Cell Lung Cancer Who Received First‐Line Chemoimmunotherapy or Chemotherapy: A Multicenter Retrospective Study |
| topic | Cancer Medicine |
| url | https://onlinelibrary.wiley.com/doi/10.1002/cam4.71982 |