Oncological Benefits of Neoadjuvant Chemoradiation With Gemcitabine Versus Upfront Surgery in Patients With Borderline Resectable Pancreatic Cancer: A Prospective, Randomized, Open-label, Multicenter Phase 2/3 Trial. Issue 2 (August 2018)

• Record Type: Journal Article
• Authors: Jang, Jin-Young; Han, Youngmin; Lee, Hongeun; Kim, Sun-Whe; Kwon, Wooil; Lee, Kyung-Hun; Oh, Do-Youn; Chie, Eui Kyu; Lee, Jeong Min; Heo, Jin Seok; Park, Joon Oh; Lim, Do Hoon; Kim, Seong Hyun; Park, Sang Jae; Lee, Woo Jin; Koh, Young Hwan; Park, Joon Seong; Yoon, Dong Sup; Lee, Ik Jae; Choi, Seong Ho
• Is Part Of: Annals of surgery. Volume 268:Issue 2(2018:Aug.)
• Publication Date: 2018-08
• Subjects: borderline resectable pancreatic cancer -- gemcitabine -- neoadjuvant chemoradiation -- upfront surgery; Surgery -- Periodicals; 617.005
• DOI: 10.1097/SLA.0000000000002705
• Languages: English
• ISSNs: 0003-4932

Abstract

Abstract : Objective: This study was performed to determine whether neoadjuvant treatment increases survival in patients with BRPC. Summary Background Data: 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. Methods: 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. Results: 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. Conclusion: 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.