- 作者：Shunichi Sugawara ; Makoto Maemondo ; Motoko Tachihara ; Akira Inoue ; Osamu Ishimoto ; Tomohiro Sakakibara ; Kazuhiro Usui ; Hiroshi Watanabe ; Nobumichi Matsubara ; Kana Watanabe ; Kenya Kanazawa ; Takashi Ishida ; Yasuo Saijo ; Toshihiro Nukiwa ; North Japan Lung Cancer Study Group
- 关键词：UFT ; Vinorelbine ; Cisplatin ; Chemoradiotherapy ; Locally advanced ; Non-small-cell lung cancer ; Randomized phase II trial
- 刊名：Lung Cancer
- 出版年：2013
- 出版时间：July, 2013
- 年：2013
- 卷：81
- 期：1
- 页码：91-96
- 全文大小：573 K
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/m2 UFT on days 1-14 and 29-42 and 80 mg/m2 cisplatin on days 8 and 36) or NP (20 mg/m2 vinorelbine on days 1, 8, 29, and 36 and 80 mg/m2 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.