NRG 肿瘤学/RTOG 0848 辅助化疗问题-Erlotinib+Gemcitabine 治疗切除的胰头癌：一项 II 期随机临床试验。
Results of the NRG Oncology/RTOG 0848 Adjuvant Chemotherapy Question-Erlotinib+Gemcitabine for Resected Cancer of the Pancreatic Head: A Phase II Randomized Clinical Trial.
机构信息
Rush University Medical Center, Chicago, IL.
NRG Oncology Statistics and Data Management Center.
出版信息
Am J Clin Oncol. 2020 Mar;43(3):173-179. doi: 10.1097/COC.0000000000000633.
PURPOSE
NRG/RTOG 0848 was designed to determine whether adjuvant radiation with fluoropyrimidine sensitization improved survival following gemcitabine-based adjuvant chemotherapy for patients with resected pancreatic head adenocarcinoma. In step 1 of this protocol, patients were randomized to adjuvant gemcitabine versus the combination of gemcitabine and erlotinib. This manuscript reports the final analysis of these step 1 data.
METHODS
Eligibility-within 10 weeks of curative intent pancreaticoduodenectomy with postoperative CA19-9<180. Gemcitabine arm-6 cycles of gemcitabine. Gemcitabine+erlotinib arm-gemcitabine and erlotinib 100 mg/d. Two hundred deaths provided 90% power (1-sided α=0.15) to detect the hypothesized OS signal (hazard ratio=0.72) in favor of the arm 2.
RESULTS
From November 17, 2009 to February 28, 2014, 163 patients were randomized and evaluable for arm 1 and 159 for arm 2. Median age was 63 (39 to 86) years. CA19-9 ≤90 in 93%. Arm 1: 32 patients (20%) grade 4 and 2 (1%) grade 5 adverse events; arm 2, 27 (17%) grade 4 and 3 (2%) grade 5. GI adverse events, arm 1: 22% grade ≥3 and arm 2: 28%, (P=0.22). The median follow-up (surviving patients) was 42.5 months (min-max: <1 to 75). With 203 deaths, the median and 3-year OS (95% confidence interval) are 29.9 months (21.7, 33.4) and 39% (30, 45) for arm 1 and 28.1 months (20.7, 30.9) and 39% (31, 47) for arm 2 (log-rank P=0.62). Hazard ratio (95% confidence interval) comparing OS of arm 2 to arm 1 is 1.04 (0.79, 1.38).
CONCLUSIONS
The addition of adjuvant erlotinib to gemcitabine did not provide a signal for increased OS in this trial.
目的
NRG/RTOG0848 旨在确定在接受吉西他滨辅助化疗的胰腺头腺癌患者中，氟嘧啶增敏辅助放疗是否能提高生存。在该方案的第 1 步中，患者被随机分配接受辅助吉西他滨或吉西他滨联合厄洛替尼治疗。本手稿报告了这些第 1 步数据的最终分析。
方法
在有治愈意图的胰十二指肠切除术后 10 周内，术后 CA19-9<180。吉西他滨组-6 个周期的吉西他滨。吉西他滨+厄洛替尼组-吉西他滨和厄洛替尼 100mg/d。200 例死亡提供了 90%的效力（单侧α=0.15）来检测假设的 OS 信号（危险比=0.72）有利于臂 2。
结果
从 2009 年 11 月 17 日至 2014 年 2 月 28 日，163 名患者被随机分配到臂 1 组，159 名患者被分配到臂 2 组。中位年龄为 63（39 至 86）岁。CA19-9≤90 占 93%。臂 1：32 名患者（20%）为 4 级，2 名患者（1%）为 5 级；臂 2 组：27 名患者（17%）为 4 级，3 名患者（2%）为 5 级。胃肠道不良事件，臂 1：22%≥3 级，臂 2：28%，（P=0.22）。中位随访（存活患者）为 42.5 个月（最短-最长：<1 至 75）。在 203 例死亡中，中位和 3 年 OS（95%置信区间）分别为 29.9 个月（21.7，33.4）和 39%（30，45），臂 1 和 28.1 个月（20.7，30.9）和 39%（31，47），臂 2（对数秩 P=0.62）。与臂 1 相比，臂 2 的 OS 风险比（95%置信区间）为 1.04（0.79，1.38）。
结论
在这项试验中，吉西他滨联合辅助厄洛替尼并不能提供增加 OS 的信号。
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