A Phase Ii Study Of 3-Week Scheduling Of Irinotecan (I) In Combination With Cisplatin (P) (Revised-Ip) In Patients With Stage Iiib Or Iv Non-Small Cell Lung Cancer (Nsclc).

7284 Background: A phase III study performed in Japan revealed the efficacy of combination therapy with I plus P given every 4 weeks (IP regimen) in patients with advanced NSCLC (Negoro et al. Br J Cancer 88:335–41, 2003). However, in that study there were considerable delays in treatment with or dose omissions of I because of leukopenia and/or diarrhea, and the dose intensity (DI) of I was only 30 mg/m2/week (range: 11.7–46.1) in contrast to the planned DI of 45 mg/m2/week. We therefore conducted a phase II study of revised-IP as a novel regimen to evaluate its response rate, safety and DI as measures of its feasibility in patients with advanced NSCLC. Methods: Eligible patients included those with histological or cytological diagnosis of NSCLC; no previous chemotherapy; age less than 75 years; and ECOG performance status of 0–1. Patients were treated intravenously with I 60 mg/m2 on days 1 and 8 and P 60 mg/m2 on day 1 every 3 weeks. Results: Of 28 patients enrolled, one patient did not receive the treatment and 27 were evaluable for response and toxicity. Baseline characteristics of the evaluable patients were as follows: median age of 63 (range 38–72); male/female, 19/8; PS 0/1, 11/16. The response rate was 30% (8 PRs) and the DI of I was 33.3 mg/m2/week (range: 9.3–40.0). The median number of cycles administered was 4 (range: 1–6). The major toxicities observed were leukopenia (grade 3: 26%, 4: 0%) and diarrhea (grade 3: 22%, 4: 0%). Other toxicities were generally mild. Conclusions: The revised-IP regimen is more feasible than the IP regimen, and its efficacy is equivalent to those of other regimens widely used. Further use of the revised-IP regimen will confirm that this regimen is useful in the treatment of advanced NSCLC. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Daiichi Pharmaceutical Co., Ltd.; Yakult Honsha Co., Ltd.