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.

• Authors: Katsuyuki Hotta, Nagio Takigawa, Katsuyuki Kiura, Masahiro Tabata, Shigeki Umemura, Atsuko Ogino, Akiko Uchida, Akihiro Bessho, Yoshihiko Segawa, Tetsu Shinkai, Naoyuki Nogami, Shingo Harita, Niro Okimoto, Hiroshi Ueoka, Mitsune Tanimoto
• Journal: Anticancer research (Anticancer Res) 2005 May-Jun Vol. 25 Issue 3c Pg. 2429-34 ISSN: 0250-7005 [Print] Greece
• PMID: 16080470 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Journal Article)

Chemical References

• Anthracyclines
• Irinotecan
• amrubicin
• Camptothecin

Topics

• Aged
• Anthracyclines (administration & dosage, adverse effects)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Camptothecin (administration & dosage, adverse effects, analogs & derivatives)
• Carcinoma, Non-Small-Cell Lung (drug therapy)
• Female
• Hematologic Diseases (chemically induced)
• Humans
• Hyponatremia (chemically induced)
• Irinotecan
• Lung Neoplasms (drug therapy)
• Male
• Middle Aged