Phase 1 study of amrubicin plus cisplating and concurrent accelerated hyperfractionated thoracic radiotherapy for limited-stage small cell lung cancer

A phase 1 trial at Nagasaki University Hospital (Japan) evaluated the combination of amrubicin plus cisplatin (AP) with concurrent accelerated hyperfractionated thoracic radiotherapy (AHTRT; 45 Gy in fractions of 1.5 Gy twice daily) for limited-stage small cell lung cancer (LS-SCLC). The trial included 9 patients aged 20-75 years with LS-SCLC, performance status 0-1, and adequate organ function. Chemotherapy consisted of cisplatin 60 mg/m² on day 1 plus amrubicin 25 mg/m² on days 1-3 in the first cycle; increasing to 35 mg/m² from the second cycle. Dose-limiting toxicities included grade 3 febrile neutropenia and grade 3 hypokalemia. The maximum tolerated dose of amrubicin was 25 mg/m². The overall response rate was 100%. Median progression-free survival and overall survival were not reached; five-year overall survival rate was 64.8%. The authors conclude that AP combined with AHTRT had promising efficacy and may represent a potential therapeutic option for LS-SCLC.