TY - JOUR T1 - Phase I Study of Irinotecan and Amrubicin in Patients with Advanced Non-Small-Cell Lung Cancer JF - Anticancer Research JO - Anticancer Res SP - 2429 LP - 2434 VL - 25 IS - 3C AU - KATSUYUKI HOTTA AU - NAGIO TAKIGAWA AU - KATSUYUKI KIURA AU - MASAHIRO TABATA AU - SHIGEKI UMEMURA AU - ATSUKO OGINO AU - AKIKO UCHIDA AU - AKIHIRO BESSHO AU - YOSHIHIKO SEGAWA AU - TETSU SHINKAI AU - NAOYUKI NOGAMI AU - SHINGO HARITA AU - NIRO OKIMOTO AU - HIROSHI UEOKA AU - MITSUNE TANIMOTO Y1 - 2005/05/01 UR - http://ar.iiarjournals.org/content/25/3C/2429.abstract N2 - Background: Combination chemotherapy of irinotecan and amrubicin for advanced non-small cell lung cancer (NSCLC) has not been fully evaluated. To determine the maximum-tolerated dose (MTD), a phase I study in patients with advanced NSCLC was conducted. Materials and Methods: Patients with stage IIIB/IV NSCLC were enrolled in this study. Both patients with and without prior chemotherapy were also eligible. The drugs were administered on days 1 and 8, every 3 weeks. The starting doses of irinotecan and amrubicin were 60 and 35 mg/m2, respectively. Results: Nineteen patients received a total of 53 courses. Grade 4 neutropenia was observed in 23% of courses. Anaemia and thrombocytopenia were generally mild. Grade 3 febrile neutropenia occurred in 5 courses. Other grade 3 or greater non-haematological toxicities were observed in only 4 out of 52 courses (grade 3 infection and hyponatremia). The maximum-tolerated doses (MTDs) of irinotecan and amrubicin were 100 and 45 mg/m2, respectively. Objective response was obtained in 2 patients (10.5%), who had received prior chemotherapy. Conclusion: This combination was well tolerated, but produced only a modest anti-tumour effect for advanced NSCLC. Further investigation into the role of this regimen as a salvage chemotherapy may be warranted in relapsed patients. ER -