UFT after sequential chemo and radiotherapy in patients with stage IIIB non-small cell lung cancer (NSCLC)

Abstract

7294 Background:Chemotherapy added to radiotherapy decreases systemic progression in patients with locally advanced NSCLC. However,distant failure remains a significant cause of morbidity and mortality in these patients. Randomized studies from Japan showed that UFT improves survival in patients (pts) with early NSCLC. The reduction in systemic relapsed is due to its effect on the micrometastatic disease.We conducted a phase II study to evaluate the effect of UFT on the systemic progression of pts with stage IIIB NSCLC. Methods:Patients with stage IIIB NSCLC were included. Pts had ECOG performance status (PS) 0 or 1 and normal end organ function.Pts were treated with induction chemotherapy with two cycles of cisplatin (100mg/m2 days 1 and 29) and vinblastine (5mg/m2/week for 5 weeks) followed by 60Gy of thoracic radiotherapy. Two weeks after the completion of radiotherapy they were started on a fixed dose of 400mg/day of UFT, administered continuously for one year. Results:Between May 1999 and October 2003 twenty four pts were included. Patient's characteristics: 15 male (62%), 10 adenocarcinoma and 10 squamous cell, 4 pts had NSCLC not otherwise classified, median age was 55 years, all pts had PS of 1. Only one pt was not a former or current smoker. Toxicity of the chemo/radiotherapy phase of the study was compatible with published literature with no toxic deaths. Toxicity of UFT was minimal. The most common side effect was fatigue. Median time on UFT was 6 months.In 6 pts (50%) the first clinical sign of progression was local, and in the other 6 patients it was systemic (2 brain). Five pts (21%) completed 12 months on UFT and 5 are on treatment. With a median follow-up of 12 months the median survival was 14 months. The actuarial 1,2 and 3-year survivals were 52, 35 and 25%, respectively. Conclusions:UFT in this fixed dose schedule was very well tolerated. However our results are almost identical to the published literature with sequential chemo and radiotherapy in stage IIIB NSCLC. This finding suggests that UFT may have little effect on the control of micrometastatic disease in pts with locally advanced NSCLC. Local control remains a critical issue in stage IIIB patients. No significant financial relationships to disclose.