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Uracil/Tegafur Plus Cisplatin with Concurrent Radiotherapy for Locally Advanced Non-Small-Cell Lung Cancer

A Multi-institutional Phase II Trial

¹ Department of Thoracic Oncology, National Kyusyu Cancer Center, Fukuoka, Japan; ² Department of Internal Medicine, Sendai Kohsei Hospital, Miyagi, Japan; ³ Fourth Department of Internal Medicine, Nippon Medical School, Tokyo, Japan; ⁴ Division of Respiratory Diseases, Kumamoto Regional Medical Center, Kumamoto, Japan; ⁵ Department of Respiratory Medicine, Takeda General Hospital, Fukushima, Japan; ⁶ Department of Respiratory Oncology and Molecular Medicine, Institute of Development, Aging and Cancer, Tohoku University, Miyagi, Japan; ⁷ Department of Respiratory Medicine, Asou Iizuka Hospital, Fukuoka, Japan; ⁸ Department of Respiratory Medicine, Iwaki Kyoritsu Hospital, Fukushima; and ⁹ The Tokyo Cooperative Oncology Group, Tokyo, Japan

Purpose: To evaluate the efficacy and toxicity of a novel combination treatment using concurrent radiotherapy with cisplatin plus UFT, which is comprised of uracil and tegafur, in locally advanced non-small cell lung cancer (NSCLC) patients.

Experimental Design: In this Phase II trial, patients with unresectable stage III NSCLC were treated with the oral administration of UFT (400 mg/m²/d tegafur) on days 1–14 and days 29–42 whereas 80 mg/m² cisplatin was administered i.v. on days 8 and 36. Radiotherapy, with a total dose of 60 Gy, was delivered in 30 fractions from day 1.

Results: Seventy patients were enrolled and eligible, as follows: 57 males/13 females; mean age 61 ranging from 36 to 74; performance status 0/1:45/25; stage IIIA/IIIB, 14/56. A complete response was observed in two patients and a partial response in 54 patients, and the overall response rate was 81% (95% confidence interval; 70–89%). The median survival, the 1- and 2-year survival rates were 16.5 months, 67% and 33%, respectively. Grade 3/4 leukopenia occurred in 14%/1% of the patients. Grades 3 non-hematological toxicities were only reported in three patients with nausea, two with esophagitis and one with pneumonitis whereas no grade 4 non-hematological toxicity was observed.

Conclusions: UFT plus cisplatin with concurrent radiotherapy is considered to be a feasible and effective treatment for locally advanced NSCLC patients. Additional study of this concurrent chemoradiotherapy is warranted.