RT Journal Article
SR Electronic
T1 Phase I Study of Irinotecan and Amrubicin in Patients with Advanced Non-Small-Cell Lung Cancer
JF Anticancer Research
JO Anticancer Res
FD International Institute of Anticancer Research
SP 2429
OP 2434
VO 25
IS 3C
A1 KATSUYUKI HOTTA
A1 NAGIO TAKIGAWA
A1 KATSUYUKI KIURA
A1 MASAHIRO TABATA
A1 SHIGEKI UMEMURA
A1 ATSUKO OGINO
A1 AKIKO UCHIDA
A1 AKIHIRO BESSHO
A1 YOSHIHIKO SEGAWA
A1 TETSU SHINKAI
A1 NAOYUKI NOGAMI
A1 SHINGO HARITA
A1 NIRO OKIMOTO
A1 HIROSHI UEOKA
A1 MITSUNE TANIMOTO
YR 2005
UL http://ar.iiarjournals.org/content/25/3C/2429.abstract
AB 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.