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




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).


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.


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).


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.