Phase I study of irinotecan and amrubicin in patients with advanced non-small-cell lung cancer.

Abstract:

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.

journal_name

Anticancer Res

journal_title

Anticancer research

authors

Hotta K,Takigawa N,Kiura K,Tabata M,Umemura S,Ogino A,Uchida A,Bessho A,Segawa Y,Shinkai T,Nogami N,Harita S,Okimoto N,Ueoka H,Tanimoto M

subject

Has Abstract

pub_date

2005-05-01 00:00:00

pages

2429-34

issue

3c

eissn

0250-7005

issn

1791-7530

journal_volume

25

pub_type

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