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Updated: Aug 16, 2026
Endobronchial Ultrasound-guided Intratumoral Injection of Cisplatin for the Treatment of Isolated Mediastinal Recurrence of Lung Cancer
Published on: February 12, 2017
Phase I study of irinotecan and amrubicin in patients with advanced non-small-cell lung cancer
Katsuyuki Hotta1, Nagio Takigawa, Katsuyuki Kiura
1Department of Medicine II, Okayama University Medical School, 2-5-1, Shikata-cho, Okayama, 700-8558, Japan. khotta@md.okayama-u.ac.jp
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.
