0 98

Cited 92 times in

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

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 
Citation
 ANNALS OF SURGERY, Vol.268(2) : 215-222, 2018 
Journal Title
 ANNALS OF SURGERY 
ISSN
 0003-4932 
Issue Date
2018
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.
Full Text
http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&AN=00000658-201808000-00005&LSLINK=80&D=ovft
DOI
10.1097/SLA.0000000000002705
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Radiation Oncology (방사선종양학교실) > 1. Journal Papers
Yonsei Authors
Park, Joon Seong(박준성) ORCID logo https://orcid.org/0000-0001-8048-9990
Yoon, Dong Sup(윤동섭) ORCID logo https://orcid.org/0000-0001-6444-9606
Lee, Ik Jae(이익재) ORCID logo https://orcid.org/0000-0001-7165-3373
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/169786
사서에게 알리기
  feedback

qrcode

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

Browse

Links