Randomized phase II trial of uracil/tegafur and cisplatin versus vinorelbine and cisplatin with concurrent thoracic radiotherapy for locally advanced unresectable stage III non-small-cell lung cancer: NJLCG 0601.

Abstract Introduction The optimal chemotherapy with thoracic radiotherapy (TRT) for locally advanced non-small-cell lung cancer (NSCLC) remains to be established. This randomized phase II study of concurrent chemoradiotherapy was conducted to compare uracil/tegafur (UFT) and cisplatin with vinorelbine and cisplatin for stage III NSCLC. Patients and methods Patients with unresectable stage III NSCLC were randomized to receive UP (400 mg/m 2 UFT on days 1–14 and 29–42 and 80 mg/m 2 cisplatin on days 8 and 36) or NP (20 mg/m 2 vinorelbine on days 1, 8, 29, and 36 and 80 mg/m 2 cisplatin on days 1 and 29). TRT began on day 1 (total 60 Gy in 30 fractions). Results Of 70 enrolled patients, 66 were evaluable for efficacy and safety. The overall response rates were 80% (95% CI: 67–93%) and 71% (95% CI: 55–87%) for the UP arm and the NP arm. With a median follow-up of 20.2 months, the progression-free survival and median survival time were 8.8 and 26.9 months in the UP arm, and 6.8 and 21.7 months in the NP arm. The 2-/3-year survival rates were 51.0/34.3% and 46.9/33.4% for the UP arm and the NP arm, respectively. Grade 3/4 neutropenia occurred in 20% and 58% of patients in the UP and NP arms, respectively. Conclusion Combined with concurrent TRT, the UP arm achieved better efficacy and safety compared with the NP arm, suggesting it to be a promising candidate as a standard regimen for locally advanced NSCLC. Further evaluation of the UP arm is warranted.