Lung and Esophageal Cancer Clinic, Chonnam National University Hwasun Hospital, 322 Seoyang-ro, Hwasun-eup, Jeonnam, 519-809, Republic of Korea.
Cancer Chemother Pharmacol. 2013 Dec;72(6):1247-54. doi: 10.1007/s00280-013-2308-5. Epub 2013 Oct 5.
Concurrent chemoradiotherapy (CCRT) is recommended for the management of patients with unresectable non-small cell lung cancer (NSCLC). This prospective study aimed to compare the efficacy of concurrently delivered cisplatin doublets with paclitaxel, or docetaxel, or gemcitabine.
The main eligibility criteria consisted of previously untreated stage IIIB NSCLC. The subjects were randomized into three arms: paclitaxel 45 mg/m(2)/week (TP), docetaxel 20 mg/m(2)/week (DP), and gemcitabine 350 mg/m(2)/week (GP) in addition to cisplatin 20 mg/m(2)/week. Three-dimensional conformal radiotherapy was given once daily, weekly 5 fractions and the total prescription dose was 60-66 Gy. The primary endpoint was response rate, and the secondary endpoints were survival and toxicity.
A total of 101 patients were recruited into this trial of whom 93 (TP: 33, DP: 29, GP: 31) patients were treated with CCRT from March 2005 to July 2007. Similar response rates were observed across arms: TP: 63.6 %, DP: 72.4 %, GP: 61.3 % (p = 0.679). There was no statistically significant difference of median survival (TP: 27.3, DP: 27.6, GP: 16.5 months, p = 0.771). In subgroup analysis, a survival benefit of consolidation chemotherapy was not seen, but leucopenia (63.2 %) and neutropenia (68.4 %) more than grade 3 were significantly high in DP arm. The grade ≥3 radiation esophagitis was more frequent in the GP arm (22.6 %, p = 0.163).
Among the three arms, no statistically significant difference in response rate, survival, and toxicity was observed. However, clinically significant radiation toxicity was more frequent in the GP arm.
对于不能手术的非小细胞肺癌（NSCLC）患者，推荐采用同步放化疗（CCRT）。本前瞻性研究旨在比较同时给予顺铂双联药物（紫杉醇、多西他赛或吉西他滨）的疗效。
主要入选标准为未经治疗的 IIIB 期 NSCLC。将受试者随机分为三组：紫杉醇 45 mg/m²/周（TP 组）、多西他赛 20 mg/m²/周（DP 组）和吉西他滨 350 mg/m²/周（GP 组），联合顺铂 20 mg/m²/周。三维适形放疗，每周 5 次，总处方剂量为 60-66 Gy。主要终点为缓解率，次要终点为生存和毒性。
本试验共纳入 101 例患者，其中 93 例（TP 组 33 例，DP 组 29 例，GP 组 31 例）于 2005 年 3 月至 2007 年 7 月接受 CCRT。各组缓解率相似：TP 组 63.6%，DP 组 72.4%，GP 组 61.3%（p = 0.679）。中位生存时间无统计学差异（TP 组 27.3 个月，DP 组 27.6 个月，GP 组 16.5 个月，p = 0.771）。亚组分析显示，巩固化疗并未带来生存获益，但 DP 组 3 级以上白细胞减少（63.2%）和中性粒细胞减少（68.4%）更为常见。GP 组≥3 级放射性食管炎更常见（22.6%，p = 0.163）。
三组间缓解率、生存和毒性无统计学差异。然而，GP 组的放射性毒性更明显。
