Wada H, Hitomi S, Teramatsu T
Department of Chest Disease Research Institute, Kyoto University, Kyoto, Japan.
J Clin Oncol. 1996 Apr;14(4):1048-54. doi: 10.1200/JCO.1996.14.4.1048.
We performed a study to determine whether postoperative mild chemotherapy to maintain the patient's quality of life (QOL) and immunoactivity could also prolong survival.
From December 1985 to July 1988, 323 patients with completely resected primary non-small-cell lung cancer (stage I to III) were enrolled. The subjects were randomized into three treatment groups, as follows: cisplatin (CDDP) 50 mg/m2 body surface, vindesine (VDS) 2 to 3 mg/kg body weight for three courses, and 1-year oral administration of tegafur (FT) plus uracil (UFT) 400 mg/kg body weight (CVUft group, 115 patients); 1-year oral administration of UFT 400 mg/kg body weight (Uft group, 108 patients); or surgical treatment only (control group, 100 patients).
The overall 5-year survival rates were 60.6% for the CVUft group and 64.1% for the Uft group versus 49.0% for the control group. The results of statistical testing were P = .053 (log-rank test) and P = .044 (generalized Wilcoxon test) among the three groups, P = .083 (log-rank) and P = .074 (Wilcoxon) between the CVUft and the control groups, and P = .022 (log-rank) and P = .019 (Wilcoxon) between the Uft and the control groups, which indicates higher survival rates in the CVUft and the Uft groups compared with the control group. A multivariate statistical analysis on prognostic factors using Cox's proportional hazards model was performed with the following results: P = .037, hazards ratio = 0.64 with a 95% confidence interval (CI) of 0.42 to 0.97 (control v CVUft group); and P = .009, hazards ratio = 0.55 with a 95% CI of 0.36 to 0.86 (control v Uft group).
Significantly favorable results were obtained in the CVUft and Uft groups compared with surgery alone. These data showed significant prognostic advantages in the postoperative adjuvant chemotherapy groups.
我们开展了一项研究，以确定术后进行温和化疗以维持患者生活质量（QOL）和免疫活性是否也能延长生存期。
1985年12月至1988年7月，纳入323例原发性非小细胞肺癌完全切除患者（Ⅰ至Ⅲ期）。将受试者随机分为三个治疗组，如下：顺铂（CDDP）50mg/m²体表面积、长春地辛（VDS）2至3mg/kg体重，共三个疗程，以及口服替加氟（FT）加尿嘧啶（UFT）400mg/kg体重1年（CVUft组，115例患者）；口服UFT 400mg/kg体重1年（Uft组，108例患者）；或仅接受手术治疗（对照组，100例患者）。
CVUft组的总体5年生存率为60.6%，Uft组为64.1%，而对照组为49.0%。三组间统计学检验结果为P = 0.053（对数秩检验）和P = 0.044（广义威尔科克森检验），CVUft组与对照组之间为P = 0.083（对数秩）和P = 0.074（威尔科克森），Uft组与对照组之间为P = 0.022（对数秩）和P = 0.019（威尔科克森），这表明CVUft组和Uft组的生存率高于对照组。使用Cox比例风险模型对预后因素进行多变量统计分析得到以下结果：P = 0.037，风险比 = 0.64，95%置信区间（CI）为0.42至0.97（对照组对比CVUft组）；P = 0.009，风险比 = 0.55，95%CI为0.36至0.86（对照组对比Uft组）。
与单纯手术相比CVUft组和Uft组取得了显著更好的结果。这些数据显示术后辅助化疗组具有显著的预后优势。
