Phase II study of irinotecan and ifosfamide in patients with advanced non-small cell lung cancer.
OBJECTIVE
This phase II study was conducted to investigate the efficacy and safety of irinotecan (CPT-11) and ifosfamide as first-line chemotherapy for advanced non-small cell lung cancer (NSCLC).


METHODS
Eligibility criteria included histologically or cytologically confirmed NSCLC (stage IIIb or IV), no prior treatment, and measurable or evaluable disease. CPT-11 (80 mg/m(2)) was administered intravenously on days 1, 8, and 15, while ifosfamide (1.5 g/m(2)) was given on days 1 through 3 every 4 weeks.


RESULTS
Forty-four patients (31 men) with a median age of 65 years (range 43-75) and a median ECOG performance status of 1 (range 0-2) were enrolled. The response rate was 29.5% [95% CI: 16.7-45.2%], with 13 partial responses. The median survival was 12.5 months, the median time to progression was 5.3 months, and the 1 and 2-year survival rates were 52.3 and 11.3%, respectively. Toxicity was generally mild; WHO grade 3-4 neutropenia was recorded in 38.6% of the patients, grade 3 diarrhea in 6.8%, and grade 3-4 nausea/vomiting in 0%.


CONCLUSIONS
CPT-11 combined with ifosfamide demonstrated anti-tumor activity in advanced NSCLC, with response and survival rates similar to those of cisplatin-based chemotherapy but with a more favorable toxicity profile.
Ichiki
Masao
M
First Department of Internal Medicine, Kurume University School of Medicine, Kurume, Japan. ichiki@med.kurume-u.ac.jp
Rikimaru
Toru
T
Gohara
Rumi
R
Koga
Takeharu
T
Kawayama
Tomotaka
T
Matunami
Michiya
M
Oshita
Yuichi
Y
Kamimura
Tomoko
T
Aizawa
Hisamichi
H
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D016896:Treatment Outcome
D000077146:Irinotecan; D007069:Ifosfamide; D002166:Camptothecin