Phase II Study of Cisplatin with Irinotecan as Induction Chemotherapy Followed by Chemoradiotherapy for Unresectable Stage III Non-small Cell Lung Cancer

Background/Aim: We evaluated the anti-tumor activity and safety of cisplatin with irinotecan (IP) induction chemotherapy followed by chemoradiotherapy with etoposide/cisplatin (EP). Patients and Methods: Induction chemotherapy consisted of irinotecan i.v. and cisplatin i.v. and was administered on day 1 and day 8 of each cycle. Patients underwent two cycles of chemotherapy with a 3-week interval. In the absence of progressive disease, 66 Gy radiation was administered concurrently with etoposide on days 1 to 5 and 29 to 33, as well as with cisplatin on day 1, 8, 29, and 36. Results: Twenty patients were enrolled between July 2007 and December 2009. This study was closed prematurely due to lack of efficacy in induction chemotherapy. The overall response rate was 45% [95% confidence interval (CI), 25 to 65%], which did not meet the upper limit for first stage rejection of the treatment. The rates of 3-year progression-free survival and overall survival were 17.1% (95% CI, 0 to 36.8%) and 25% (95% CI, 0.2 to 49.8%), respectively. The primary toxicities included neutropenia, diarrhea and fatigue. Conclusion: This study failed to demonstrate a benefit for induction chemotherapy which was characterized by suboptimal antitumor activity and was poorly tolerated, with excess treatment-related toxicity.