Department of Surgery, Seoul National University Hospital, Seoul, Republic of Korea.
Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Ann Surg. 2018 Aug;268(2):215-222. doi: 10.1097/SLA.0000000000002705.
This study was performed to determine whether neoadjuvant treatment increases survival in patients with BRPC.
Despite many promising retrospective data on the effect of neoadjuvant treatment for borderline resectable pancreatic cancer (BRPC), no high-level evidence exists to support the role of such treatment.
This phase 2/3 multicenter randomized controlled trial was designed to enroll 110 patients with BRPC who were randomly assigned to gemcitabine-based neoadjuvant chemoradiation treatment (54 Gray external beam radiation) followed by surgery or upfront surgery followed by chemoradiation treatment from four large-volume centers in Korea. The primary endpoint was the 2-year survival rate (2-YSR). Interim analysis was planned at the time of 50% case enrollment.
After excluding the patients who withdrew consent (n = 8) from the 58 enrolled patients, 27 patients were allocated to neoadjuvant treatment and 23 to upfront surgery groups. The overall 2-YSR was 34.0% with a median survival of 16 months. In the intention-to-treat analysis, the 2-YSR and median survival were significantly better in the neoadjuvant chemoradiation than the upfront surgery group [40.7%, 21 months vs 26.1%, 12 months, hazard ratio 1.495 (95% confidence interval 0.66-3.36), P = 0.028]. R0 resection rate was also significantly higher in the neoadjuvant chemoradiation group than upfront surgery (n = 14, 51.8% vs n = 6, 26.1%, P = 0.004). The safety monitoring committee decided on early termination of the study on the basis of the statistical significance of neoadjuvant treatment efficacy.
This is the first prospective randomized controlled trial on the oncological benefits of neoadjuvant treatment in BRPC. Compared to upfront surgery, neoadjuvant chemoradiation provides oncological benefits in patients with BRPC.
本研究旨在确定新辅助治疗是否能提高 BRPC 患者的生存率。
尽管有许多有前途的回顾性数据表明新辅助治疗对交界可切除胰腺癌（BRPC）有效，但目前尚无高级别的证据支持这种治疗方法。
本 2/3 期多中心随机对照试验设计招募了 110 例 BRPC 患者，将其随机分为接受吉西他滨为基础的新辅助放化疗（54 戈瑞外照射）联合手术或直接手术联合化疗的两组，该试验在韩国的四个大容量中心进行。主要终点是 2 年生存率（2-YSR）。计划在病例入组达到 50%时进行中期分析。
在排除了 58 名入组患者中 8 名因撤回同意而退出的患者后，27 名患者被分配到新辅助治疗组，23 名患者被分配到直接手术组。总的 2-YSR 为 34.0%，中位生存期为 16 个月。在意向治疗分析中，新辅助放化疗组的 2-YSR 和中位生存期明显优于直接手术组[40.7%，21 个月 vs 26.1%，12 个月，风险比 1.495（95%置信区间 0.66-3.36），P = 0.028]。新辅助放化疗组的 R0 切除率也明显高于直接手术组（n = 14，51.8% vs n = 6，26.1%，P = 0.004）。根据新辅助治疗疗效的统计学意义，安全性监测委员会决定提前终止该研究。
这是首个关于 BRPC 新辅助治疗在肿瘤学方面获益的前瞻性随机对照试验。与直接手术相比，新辅助放化疗可为 BRPC 患者带来肿瘤学获益。
