• Jin-Young Jang, Youngmin Han, Hongeun Lee, Sun-Whe Kim, Wooil Kwon, Kyung-Hun Lee, Do-Youn Oh, Eui Kyu Chie, Jeong Min Lee, Jin Seok Heo, Joon Oh Park, LimDo HoonDHDepartment of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea., Seong Hyun Kim, Sang Jae Park, Woo Jin Lee, Young Hwan Koh, Joon Seong Park, Dong Sup Yoon, Ik Jae Lee, and Seong Ho Choi.
• Department of Surgery, Seoul National University Hospital, Seoul, Republic of Korea.
• Ann. Surg. 2018 Aug 1; 268 (2): 215222215-222.

ObjectiveThis study was performed to determine whether neoadjuvant treatment increases survival in patients with BRPC.Summary Background DataDespite 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.MethodsThis 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.ResultsAfter 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.ConclusionThis 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.

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