Lung cancer (Amsterdam, Netherlands) · 2026
Phase I study of amrubicin plus cisplatin and concurrent accelerated hyperfractionated thoracic radiotherapy for limited-stage small cell lung cancer.
СтатьяКлиническое исследование I фазыНазвание и аннотация: Перевод пока не подготовлен
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Akagi Kazumasa, Taniguchi Hirokazu, Fukuda Minoru, Yamazaki Takuya, Takao Daisuke, Tagawa Ryuta, Hayashi Fumiko, Ogata Ryosuke, Ono Sawana, Tomono Hiromi, Suyama Takayuki, Honda Noritaka, Umeyama Yasuhiro, Dotsu Yosuke, Matsuo Midori, Gyotoku Hiroshi, Senju Hiroaki, Takemoto Shinnosuke, Soda Hiroshi, Mizowaki Takashi, Ikeda Takaya, Nagashima Seiji, Tasaki Yutaro, Nakamura Daisuke, Komiya Kazutoshi, Nakatomi Katsumi, Sasaki Eisuke, Hirakawa Koichi, Toya Ryo, Ashizawa Kazuto, Mukae Hiroshi
Аннотация
BACKGROUND: Etoposide plus cisplatin (EP) with concurrent accelerated hyperfractionated thoracic radiotherapy (AHTRT) remains the standard treatment for unresectable limited-stage (LS) small cell lung cancer (SCLC)) for over two decades. Our previous study demonstrated that amrubicin plus cisplatin (AP) with once-daily thoracic radiotherapy (50 Gy per 25 fractions) for LS-SCLC prolonged overall survival (OS) to 39.5 months with manageable toxicities. To enhance therapeutic efficacy, this study aimed to assess the feasibility of AP combined with AHTRT for LS-SCLC.
METHODS: Treatment-naïve patients aged 20-75 years with LS-SCLC, performance status 0-1, and adequate organ function were enrolled. Chemotherapy consisted of cisplatin 60 mg/m2/day (day 1) and amrubicin (days 1-3), administered concurrently with AHTRT (1.5 Gy/time, twice daily, 45 Gy in total). The initial amrubicin dose was set to 25 mg/m2 and increased to 35 mg/m2 from the second cycle.
RESULTS: Nine patients were enrolled in this study. Dose-limiting toxicities included Grade 3 febrile neutropenia and Grade 3 hypokalemia. The recommended and maximum tolerated dose of amrubicin was 25 mg/m2. The overall response rate was 100%, with both median progression-free survival and OS not reached. The 5-year OS rate was 64.8%.
CONCLUSION: AP combined with AHTRT from the first chemotherapy cycle was well tolerated at the recommended amrubicin dose of 25 mg/m2. This regimen demonstrated promising efficacy and may represent a potential therapeutic option for LS-SCLC.
METHODS: Treatment-naïve patients aged 20-75 years with LS-SCLC, performance status 0-1, and adequate organ function were enrolled. Chemotherapy consisted of cisplatin 60 mg/m2/day (day 1) and amrubicin (days 1-3), administered concurrently with AHTRT (1.5 Gy/time, twice daily, 45 Gy in total). The initial amrubicin dose was set to 25 mg/m2 and increased to 35 mg/m2 from the second cycle.
RESULTS: Nine patients were enrolled in this study. Dose-limiting toxicities included Grade 3 febrile neutropenia and Grade 3 hypokalemia. The recommended and maximum tolerated dose of amrubicin was 25 mg/m2. The overall response rate was 100%, with both median progression-free survival and OS not reached. The 5-year OS rate was 64.8%.
CONCLUSION: AP combined with AHTRT from the first chemotherapy cycle was well tolerated at the recommended amrubicin dose of 25 mg/m2. This regimen demonstrated promising efficacy and may represent a potential therapeutic option for LS-SCLC.