TY - JOUR
T1 - Phase II study of IRInotecan treatment after COmbined chemo-immunotherapy for extensive-stage small cell lung cancer
T2 - Protocol of IRICO study
AU - Tomono, Hiromi
AU - Taniguchi, Hirokazu
AU - Fukuda, Minoru
AU - Ikeda, Takaya
AU - Nagashima, Seiji
AU - Akagi, Kazumasa
AU - Ono, Sawana
AU - Umeyama, Yasuhiro
AU - Shimada, Midori
AU - Gyotoku, Hiroshi
AU - Takemoto, Shinnosuke
AU - Hisamatsu, Yasushi
AU - Morinaga, Ryotaro
AU - Tagawa, Ryuta
AU - Ogata, Ryosuke
AU - Dotsu, Yosuke
AU - Senju, Hiroaki
AU - Soda, Hiroshi
AU - Nakatomi, Katsumi
AU - Hayashi, Fumiko
AU - Sugasaki, Nanae
AU - Kinoshita, Akitoshi
AU - Mukae, Hiroshi
N1 - Publisher Copyright:
© 2023 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd.
PY - 2023/10
Y1 - 2023/10
N2 - Introduction: Combined treatment using anti-programmed death-ligand 1 antibody (anti-PD-L1) and platinum-etoposide is the current standard first-line treatment for patients with extensive-stage (ES) small cell lung cancer (SCLC). However, the best treatment for relapsed ES-SCLC after the first-line treatment remains unclear. There are some approved chemotherapeutic agents that can be used against ES-SCLC, and treatment with irinotecan is well established as both a monotherapy and a combined therapy, in combination with platinum. Therefore, we conduct a phase II study with irinotecan in the second- or later-line setting for patients with ES-SCLC who have been previously treated with combined treatment. Methods: Our study will enroll total 30 patients who are diagnosed with ES-SCLC and have experienced disease progression after the combined treatment. Patients will receive irinotecan on days 1, 8, and 15, which will be repeated every 4 weeks. Doses of irinotecan (100/80/60 mg/m2) will be determined according to the type of UGT1A1 gene polymorphism, and the treatment will be discontinued following disease progression, intolerance, withdrawal of patient consent, and based on the investigator's decision. The primary endpoint of the study is the response rate, and the secondary endpoints are overall survival, progression-free survival, and safety. Discussion: Since the present first-line treatment has been changed to the combined treatment, the second- or later-line treatment should be re-evaluated for patients with relapsed SCLC. Irinotecan is a major chemotherapeutic agent used for SCLC. This study demonstrates and re-evaluates the clinical benefits of irinotecan after combined treatment with anti-PD-L1 and platinum-etoposide for patients with ES-SCLC. Registration details: This study was registered in the Japan Registry of Clinical Trials (no. jRCT s071210090) on November 4, 2021.
AB - Introduction: Combined treatment using anti-programmed death-ligand 1 antibody (anti-PD-L1) and platinum-etoposide is the current standard first-line treatment for patients with extensive-stage (ES) small cell lung cancer (SCLC). However, the best treatment for relapsed ES-SCLC after the first-line treatment remains unclear. There are some approved chemotherapeutic agents that can be used against ES-SCLC, and treatment with irinotecan is well established as both a monotherapy and a combined therapy, in combination with platinum. Therefore, we conduct a phase II study with irinotecan in the second- or later-line setting for patients with ES-SCLC who have been previously treated with combined treatment. Methods: Our study will enroll total 30 patients who are diagnosed with ES-SCLC and have experienced disease progression after the combined treatment. Patients will receive irinotecan on days 1, 8, and 15, which will be repeated every 4 weeks. Doses of irinotecan (100/80/60 mg/m2) will be determined according to the type of UGT1A1 gene polymorphism, and the treatment will be discontinued following disease progression, intolerance, withdrawal of patient consent, and based on the investigator's decision. The primary endpoint of the study is the response rate, and the secondary endpoints are overall survival, progression-free survival, and safety. Discussion: Since the present first-line treatment has been changed to the combined treatment, the second- or later-line treatment should be re-evaluated for patients with relapsed SCLC. Irinotecan is a major chemotherapeutic agent used for SCLC. This study demonstrates and re-evaluates the clinical benefits of irinotecan after combined treatment with anti-PD-L1 and platinum-etoposide for patients with ES-SCLC. Registration details: This study was registered in the Japan Registry of Clinical Trials (no. jRCT s071210090) on November 4, 2021.
KW - combined chemo-immunotherapy
KW - irinotecan
KW - small cell lung cancer
UR - http://www.scopus.com/inward/record.url?scp=85169897503&partnerID=8YFLogxK
U2 - 10.1111/1759-7714.15097
DO - 10.1111/1759-7714.15097
M3 - Article
C2 - 37675546
AN - SCOPUS:85169897503
SN - 1759-7706
VL - 14
SP - 2890
EP - 2894
JO - Thoracic Cancer
JF - Thoracic Cancer
IS - 28
ER -