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


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.


CONCLUSIONS
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.
Hotta
Katsuyuki
K
Department of Medicine II, Okayama University Medical School, 2-5-1, Shikata-cho, Okayama, 700-8558, Japan. khotta@md.okayama-u.ac.jp
Takigawa
Nagio
N
Kiura
Katsuyuki
K
Tabata
Masahiro
M
Umemura
Shigeki
S
Ogino
Atsuko
A
Uchida
Akiko
A
Bessho
Akihiro
A
Segawa
Yoshihiko
Y
Shinkai
Tetsu
T
Nogami
Naoyuki
N
Harita
Shingo
S
Okimoto
Niro
N
Ueoka
Hiroshi
H
Tanimoto
Mitsune
M
D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D007010:Hyponatremia / Q000139:chemically induced; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged
D018943:Anthracyclines; D000077146:Irinotecan; C055866:amrubicin; D002166:Camptothecin