18175 Background: The goals of chemoradiotherapy in non-small cell lung cancer (NSCLC) with stage III disease are to achieve local control, for which radiotherapy plays the main role, and eradicate occult distant metastases by chemotherapy. Systemic progression remains a significant cause of morbidity and mortality in these patients. Japanese trials showed that the combination of uracil and tegafur (UFT) improves survival in patients with early NSCLC. The Brazilian National Cancer Institute (INCA) conducted a phase II trial to evaluate the use of adjuvant UFT in patients with IIIB NSCLC treated with sequential chemoradiation. Methods: The eligibility requirements were stage IIIB NSCLC, an ECOG performance status 0 or 1 and normal end organ function. Patients were treated with induction chemotherapy with cisplatin (100 mg/m2 - days 1 and 29) and vinblastine (5 mg/m2/week for 5 weeks) followed by 60 Gy of thoracic radiotherapy. Two weeks after the end of radiotherapy they started a fixed UFT oral dose (400 mg/day), administered continuously for one year if no progression was detected in this interval. Results: Between May 1999 and October 2003, 22 patients were enrolled; 15 were male (68.2%); 65% were white (no patients had oriental ethnicity); 11 were adenocarcinoma (50%), 9 squamous cell (40.9%); the median age was 55.5 years (range: 45–74 years). UFT’s toxicity was manageable with 13.6% of grades 3 and 4 toxicities (mainly fatigue, diarrhea, nausea and vomiting). Two patients discontinue UFT due to limiting toxicity (1 patient due to diarrhea and 1 due to nausea and fatigue). Median time on UFT was 5 months (range: 0.5–12 months). Median follow-up was 13.5 months (range: 6–77 months) and five patients are still alive. The median overall survival (OS) was 14 months (95% CI: 10.6–17.3) and the median progression-free survival was 8 months (95% CI: 3.4–12.5). Conclusions: UFT in this fixed dose schedule was well tolerated, but our results are almost identical to the Dillman′s original report with sequential chemotherapy and radiotherapy in stage IIIB NSCLC (13.7 months OS). Despite our limited sample size these data may suggest that adjuvant UFT do not add any benefit to sequential chemoradiation in this non-oriental population. No significant financial relationships to disclose.
Randomized Phase II Trial of Sequential Chemotherapy in Advanced Non-Small Cell Lung Cancer (SWOG 9806)