Yasuda Hiroyasu, Yamaya Mutsuo, Nakayama Katsutoshi, Sasaki Takahiko, Ebihara Satoru, Kanda Akio, Asada Masanori, Inoue Daisuke, Suzuki Tomoko, Okazaki Tatsuma, Takahashi Hidenori, Yoshida Motoki, Kaneta Tomohiro, Ishizawa Kota, Yamanda Shinsuke, Tomita Naoki, Yamasaki Miyako, Kikuchi Akiko, Kubo Hiroshi, Sasaki Hidetada
Department of Geriatric and Respiratory Medicine, Tohoku University School of Medicine, Seiryo-machi, Aoba-ku, Sendai, Japan.
J Clin Oncol. 2006 Feb 1;24(4):688-94. doi: 10.1200/JCO.2005.04.0436.
To investigate the efficacy and safety of nitroglycerin plus vinorelbine and cisplatin in patients with previously untreated stage IIIB/IV non-small-cell lung cancer (NSCLC) as the experimental arm for the next phase III trial.
One hundred twenty patients with stage IIIB/IV NSCLC were randomly assigned to vinorelbine 25 mg/m2 on days 1 and 8 and cisplatin 80 mg/m2 on day 1, with transdermally applied nitroglycerin (25 mg/patient daily for 5 days; arm A) or with placebo patch (arm B) every 3 weeks for a maximum of four cycles in a double-blind and controlled trial. Primary efficacy end points were the best confirmed response rate and time to disease progression (TTP).
The response rate in arm A (72%; 43 of 60 patients) was significantly higher than that for patients in arm B (42%; 25 of 60 patients; P < .001). Median TTP in arm A was longer than that in arm B (327 v 185 days). No severe adverse effect was recognized for either arm. The rate of grade 1 to 2 headache in arm A (30%; 18 of 60 patients) was significantly higher than that in arm B (2%; one of 60 patients; P < .001, chi(2) test).
Use of nitroglycerin combined with vinorelbine and cisplatin may improve overall response and TTP in patients with stage IIIB/IV NSCLC. The arm A regimen is being evaluated in a large phase III trial.
研究硝酸甘油联合长春瑞滨和顺铂用于既往未治疗的ⅢB/Ⅳ期非小细胞肺癌（NSCLC）患者的疗效和安全性，作为下一阶段Ⅲ期试验的试验组。
120例ⅢB/Ⅳ期NSCLC患者被随机分为两组，试验组（A组）在第1天和第8天给予长春瑞滨25mg/m²，第1天给予顺铂80mg/m²，同时每3周经皮应用硝酸甘油（25mg/患者，每日1次，共5天）；对照组（B组）每3周经皮应用安慰剂贴剂，均进行双盲对照试验，最多进行4个周期。主要疗效终点为最佳确认缓解率和疾病进展时间（TTP）。
A组的缓解率（72%；60例患者中的43例）显著高于B组患者（42%；60例患者中的25例；P<.001）。A组的中位TTP长于B组（327天对185天）。两组均未发现严重不良反应。A组1至2级头痛发生率（30%；60例患者中的18例）显著高于B组（2%；60例患者中的1例；P<.001，卡方检验）。
硝酸甘油联合长春瑞滨和顺铂可提高ⅢB/Ⅳ期NSCLC患者的总体缓解率和TTP。A组方案正在一项大型Ⅲ期试验中进行评估。
