Irinotecan and docetaxel as first-line chemotherapy in patients with stage IIIB/IV non-small cell lung cancer

Abstract

7246 Background: Cisplatin-based chemotherapy is considered the standard first line for patients (pts) with non-small cell lung cancer (NSCLC). Non-platinum combinations have been developing with the goal to decrease toxicity and obtain similar or better results. Irinotecan has demonstrated activity in NSCLC as single agent and in combination. Docetaxel is active in NSCLC. Methods: We designed a Phase II trial to examine the activity and toxicity of this combination as first line chemotherapy for patients with stage IIIB/IV NSCLC. The doses and schedule were based on a phase I trial done by Masuda (J Clin Oncol 2000,18:2996–3003); and included: docetaxel 50mg/m2 on day 2, and irinotecan 50mg/m2on days 1,8,and 15 of a 28-day cycle. We planned to enroll 41 pts, but the trial was closed after evaluation of the first 14 due to the low response rate. Results: We enrolled 10 males and 4 females, with a median age of 59 years (range, 42–71). Twelve patients (86%) with stage IV and two with stage IIIB.Four patients (29%) had an ECOG performance status of 0, and the remaining ten (72%) had an ECOG performance status of 1. A total of 44 cycles of chemotherapy were delivered. The analysis of the first 14 patients showed only 1 partial response (7%) and no complete responses. However, five patients experienced stable disease (36%) for a clinical benefit of 43%. The median survival time was 11 months and the 1-year survival was 43%. This combination was well tolerated with only few grade 3/4 toxicities: 3 cases of neutropenia (21%), 1 case of anemia (7%), and no cases of diarrhea. Maybe the chemotherapy schedule that we choose was not the most appropriate, however the ORR reported by Masuda was 37% with the same schedule. Other phase I studies done by Adjei or Murren (Oncol 1999 and 2001) have recommended different schedules. A phase II trial of docetaxel plus cisplatin or irinotecan in advanced NSCLC showed that response rates and survival were not statistically different. (Satouchi, ASCO 2001). Conclusions: This chemotherapy combination has a favorable toxicity profile, however the schedule and the doses delivered may not be the most appropriate for the first line therapy of NSCLC. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis Aventis