TY - JOUR
T1 - A phase II study of S-1 and cisplatin with concurrent thoracic radiotherapy followed by durvalumab for unresectable, locally advanced non-small-cell lung cancer in Japan (SAMURAI study)
AU - Tanzawa, Shigeru
AU - Ushijima, Sunao
AU - Shibata, Kazuhiko
AU - Shibayama, Takuo
AU - Bessho, Akihiro
AU - Kaira, Kyoichi
AU - Misumi, Toshihiro
AU - Shiraishi, Kenshiro
AU - Matsutani, Noriyuki
AU - Tanaka, Hisashi
AU - Inaba, Megumi
AU - Haruyama, Terunobu
AU - Nakamura, Junya
AU - Kishikawa, Takayuki
AU - Nakashima, Masanao
AU - Iwasa, Keiichi
AU - Fujiwara, Keiichi
AU - Kohyama, Tadashi
AU - Kuyama, Shoichi
AU - Miyazawa, Naoki
AU - Nakamura, Tomomi
AU - Miyawaki, Hiroshi
AU - Ishida, Hiroo
AU - Oda, Naohiro
AU - Ishikawa, Nobuhisa
AU - Morinaga, Ryotaro
AU - Kusaka, Kei
AU - Fujimoto, Nobukazu
AU - Yokoyama, Toshihide
AU - Gemba, Kenichi
AU - Tsuda, Takeshi
AU - Nakagawa, Hideyuki
AU - Ono, Hirotaka
AU - Shimizu, Tetsuo
AU - Nakamura, Morio
AU - Kusumoto, Sojiro
AU - Hayashi, Ryuji
AU - Shirasaki, Hiroki
AU - Ochi, Nobuaki
AU - Aoe, Keisuke
AU - Kanaji, Nobuhiro
AU - Kashiwabara, Kosuke
AU - Inoue, Hiroshi
AU - Seki, Nobuhiko
N1 - Publisher Copyright:
© The Author(s), 2021.
PY - 2021
Y1 - 2021
N2 - Background: Based on the results of the PACIFIC study, chemoradiotherapy followed by 1-year consolidation therapy with durvalumab was established as the standard of care for unresectable, locally advanced non-small-cell lung cancer (LA-NSCLC). However, some topics not foreseen in that design can be explored, including progression-free survival (PFS) and overall survival (OS) after the start of chemoradiotherapy, the proportion of patients who proceeded to consolidation therapy with durvalumab, and the optimal chemotherapeutic regimens. In Japan, the combination regimen of S-1 + cisplatin (SP), for which the results of multiple clinical studies have suggested a good balance of efficacy and tolerability, is frequently selected in clinical settings. However, the efficacy and safety of consolidation therapy with durvalumab following this SP regimen have not been evaluated. We therefore planned a multicenter, prospective, single-arm, phase II study. Methods: In treatment-naïve LA-NSCLC, two cycles of combination chemotherapy with S-1 (80–120 mg/body, Days 1–14) + cisplatin (60 mg/m2, Day 1) will be administered at an interval of 4 weeks, with concurrent thoracic radiotherapy (60 Gy). Responders will then receive durvalumab every 2 weeks for up to 1 year. The primary endpoint is 1-year PFS rate. Discussion: Compared with the conventional standard regimen in Japan, the SP regimen is expected to be associated with lower incidences of pneumonitis, esophagitis, and febrile neutropenia, which complicate the initiation of consolidation therapy with durvalumab, and have higher antitumor efficacy during chemoradiotherapy. Therefore, SP-based chemoradiotherapy is expected to be successfully followed by consolidation therapy with durvalumab in more patients, resulting in prolonged PFS and OS. Toxicity and efficacy results of the SP regimen in this study will also provide information important to the future establishment of the concurrent combination of chemoradiotherapy and durvalumab. Trial registration: Japan Registry of Clinical Trials, jRCTs031190127, registered 1 November 2019, https://jrct.niph.go.jp/latest-detail/jRCTs031190127
AB - Background: Based on the results of the PACIFIC study, chemoradiotherapy followed by 1-year consolidation therapy with durvalumab was established as the standard of care for unresectable, locally advanced non-small-cell lung cancer (LA-NSCLC). However, some topics not foreseen in that design can be explored, including progression-free survival (PFS) and overall survival (OS) after the start of chemoradiotherapy, the proportion of patients who proceeded to consolidation therapy with durvalumab, and the optimal chemotherapeutic regimens. In Japan, the combination regimen of S-1 + cisplatin (SP), for which the results of multiple clinical studies have suggested a good balance of efficacy and tolerability, is frequently selected in clinical settings. However, the efficacy and safety of consolidation therapy with durvalumab following this SP regimen have not been evaluated. We therefore planned a multicenter, prospective, single-arm, phase II study. Methods: In treatment-naïve LA-NSCLC, two cycles of combination chemotherapy with S-1 (80–120 mg/body, Days 1–14) + cisplatin (60 mg/m2, Day 1) will be administered at an interval of 4 weeks, with concurrent thoracic radiotherapy (60 Gy). Responders will then receive durvalumab every 2 weeks for up to 1 year. The primary endpoint is 1-year PFS rate. Discussion: Compared with the conventional standard regimen in Japan, the SP regimen is expected to be associated with lower incidences of pneumonitis, esophagitis, and febrile neutropenia, which complicate the initiation of consolidation therapy with durvalumab, and have higher antitumor efficacy during chemoradiotherapy. Therefore, SP-based chemoradiotherapy is expected to be successfully followed by consolidation therapy with durvalumab in more patients, resulting in prolonged PFS and OS. Toxicity and efficacy results of the SP regimen in this study will also provide information important to the future establishment of the concurrent combination of chemoradiotherapy and durvalumab. Trial registration: Japan Registry of Clinical Trials, jRCTs031190127, registered 1 November 2019, https://jrct.niph.go.jp/latest-detail/jRCTs031190127
KW - S-1
KW - chemoradiotherapy
KW - cisplatin
KW - durvalumab
KW - non-small-cell lung cancer
UR - http://www.scopus.com/inward/record.url?scp=85101856969&partnerID=8YFLogxK
U2 - 10.1177/1758835921998588
DO - 10.1177/1758835921998588
M3 - 学術論文
C2 - 33717228
AN - SCOPUS:85101856969
SN - 1758-8340
VL - 13
JO - Therapeutic Advances in Medical Oncology
JF - Therapeutic Advances in Medical Oncology
ER -