Phase II study of weekly irinotecan plus capecitabine for chemotherapy‐naive patients with advanced nonsmall cell lung carcinoma

BACKGROUND A Phase II study was conducted to evaluate the efficacy and toxicity of an irinotecan plus capecitabine combination, a new nonplatinum regimen, in chemonaive patients with advanced nonsmall cell lung carcinoma (NSCLC). METHODS Between July 2003 and April 2004, 53 patients with a histologically confirmed diagnosis of NSCLC were enrolled. All but 5 patients were male, 52 (98%) had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1, 39 (74%) had AJCC Stage IV disease, and the median age was 61 years. Treatment consisted of intravenous irinotecan at a dose of 90 mg/m2 on Days 1 and 8 and oral capecitabine at a dose of 1000 mg/m2 twice daily on Days 1–14 of each 21‐day cycle, given up to 12 cycles. RESULTS Of 53 patients enrolled, 22 achieved objective tumor responses (all partial responses) for an overall response rate of 41.5% (95% confidence interval [95% CI], 28.2–54.8%). After a median follow‐up of 17.4 months, the median survival was 14.6 months with a 1‐year survival rate of 60.1% (95% CI, 46.9–73.4%) and a median progression‐free survival of 5.1 months. Treatment was very well tolerated, with only 10% of patients experiencing NCI‐CTC Grade 3 or 4 toxicities. The most common toxicities were hand–foot syndrome and diarrhea. In multiple logistic regression analysis for overall response, only the stage predicted for significantly better response (P = 0.04). Squamous cell carcinoma was marginally predictive for better response (P = 0.08). CONCLUSIONS The irinotecan plus capecitabine regimen demonstrated an antitumor activity that is favorably comparable with other commonly used cisplatin‐based regimens. Given the mild toxicity profile and favorable survival outcome, this nonplatinum regimen warrants further evaluation in a randomized trial. Cancer 2005. © 2005 American Cancer Society. A Phase II study was conducted to evaluate the efficacy and toxicity of an irinotecan plus capecitabine combination, a new nonplatinum regimen, in chemonaive patients with advanced nonsmall cell lung carcinoma.