Docetaxel + Cisplatin vs. Mitomycin, Vindesine + Cisplatin with Concurrent Thoracic Radiation Therapy for Locally Advanced NSCLC
CHICAGO—A long-term follow up on a Phase 3 study for locally advanced non-small cell lung cancer (NSCLC) showed that docetaxel and cisplatin (DP) chemotherapy with concurrent thoracic radiation therapy (TRT) vs. mitomycin, vindesine, and cisplatin (MVP) therapy seemed more efficacious during early period, however the benefit disappeared later, investigators report from the American Society of Clinical Oncology's 11th Annual Meeting.
Katsuyuki Kiura MD, PhD and colleagues from the Okayama Lung Cancer Study Group; Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan, state that although overall survival (OS) and progression-free survival (PFS) tended to be longer in the DP arm than in the MVP arm, there was no significant difference in the first report from ASCO 2008. The study took place between July 2000 and July 2005, when 200 patients were randomly assigned to DP or MVP treatment arms. Chemotherapy consisted of docetaxel 40mg/m2 and cisplatin 40mg/m2 on Days 1, 8, 29, and 36 in the DP arm and mitomycin 8mg/m2 on Days 1 and 29, vindesine 3mg/m2 on Days 1, 8, 29, and 36, and cisplatin 80mg/m2 on Days 1 and 29 in the MVP arm. Thoracic radiation therapy began on Day 1 at a dose of 60Gy (2Gy per fraction). Overall survival and PFS were calculated using the Kaplan-Meier method. Early-period weighted log rank tests were applied for the primary endpoint, OS in two years.
The patient characteristics were defined as below. See Table 1. Median follow up time was 6.4 years in December 2010. The OS was in favor to the DP arm (P=0.042 by an early-period weighted log rank test). The PFS was also greater in the DP arm than in the MVP arm (P=0.032). See Tables 2 and 3. The favorable outcomes were mostly derived from the early observation period. Median PFS (2.1 years) and OS time (2.2 years) were favorable in the DP arm compared with 1.6 years and 1.9 years, respectively, in the MVP arm, although there were no significant differences. When restricted with young patients (<65 years old), 30.6% (15/49) in the DP arm and 17.3% (9/52) in the MVP arm survived more than 5 years.
Dr. Kiura et al. conclude that DP chemotherapy with concurrent TRT had better efficacy for the early period, however, the benefit came to disappear in the long-term follow-up at 2 years or later. DP treatment, however, may improve the cure rate in young patients (<65 years) with good performance status.