Jin-Young Jang1, Youngmin Han1, Hongeun Lee1, Sun-Whe Kim1, Wooil Kwon1, Kyung-Hun Lee2, Do-Youn Oh2, Eui Kyu Chie3, Jeong Min Lee4, Jin Seok Heo5, Joon Oh Park6, Do Hoon Lim7, Seong Hyun Kim8, Sang Jae Park9, Woo Jin Lee9, Young Hwan Koh9, Joon Seong Park10, Dong Sup Yoon10, Ik Jae Lee11, Seong Ho Choi5. 1. Department of Surgery, Seoul National University Hospital, Seoul, Republic of Korea. 2. Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea. 3. Department of Radiation Oncology, Seoul National University Hospital, Seoul, Republic of Korea. 4. Department of Radiology, Seoul National University Hospital, Seoul, Republic of Korea. 5. Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 6. Department of Internal Medicine Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 7. Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 8. Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 9. Center for Liver Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea. 10. Department of Surgery, Gangnam Severance Hospital, Yonsei University Health System, Seoul, Republic of Korea. 11. Department of Radiation Oncology, Yonsei University Health System, Seoul, Republic of Korea.
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.
RCT Entities:
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.
Authors: A J Hyde; R Nassabein; A AlShareef; D Armstrong; S Babak; S Berry; D Bossé; E Chen; B Colwell; C Essery; R Goel; R Goodwin; S Gray; N Hammad; A Jeyakuymar; D Jonker; P Karanicolas; N Lamond; R Letourneau; J Michael; N Patil; E Powell; R Ramjeesingh; W Saliba; R Singh; S Snow; T Stuckless; S Tadros; M Tehfé; M Thana; M Thirlwell; M Vickers; K Virik; S Welch; T Asmis Journal: Curr Oncol Date: 2019-10-01 Impact factor: 3.677
Authors: Eva Versteijne; Mustafa Suker; Karin Groothuis; Janine M Akkermans-Vogelaar; Marc G Besselink; Bert A Bonsing; Jeroen Buijsen; Olivier R Busch; Geert-Jan M Creemers; Ronald M van Dam; Ferry A L M Eskens; Sebastiaan Festen; Jan Willem B de Groot; Bas Groot Koerkamp; Ignace H de Hingh; Marjolein Y V Homs; Jeanin E van Hooft; Emile D Kerver; Saskia A C Luelmo; Karen J Neelis; Joost Nuyttens; Gabriel M R M Paardekooper; Gijs A Patijn; Maurice J C van der Sangen; Judith de Vos-Geelen; Johanna W Wilmink; Aeilko H Zwinderman; Cornelis J Punt; Casper H van Eijck; Geertjan van Tienhoven Journal: J Clin Oncol Date: 2020-02-27 Impact factor: 44.544
Authors: Quisette P Janssen; Stefan Buettner; Mustafa Suker; Berend R Beumer; Pietro Addeo; Philippe Bachellier; Nathan Bahary; Tanios Bekaii-Saab; Maria A Bali; Marc G Besselink; Brian A Boone; Ian Chau; Stephen Clarke; Mary Dillhoff; Bassel F El-Rayes; Jessica M Frakes; Derek Grose; Peter J Hosein; Nigel B Jamieson; Ammar A Javed; Khurum Khan; Kyu-Pyo Kim; Song Cheol Kim; Sunhee S Kim; Andrew H Ko; Jill Lacy; Georgios A Margonis; Martin D McCarter; Colin J McKay; Eric A Mellon; Sing Yu Moorcraft; Ken-Ichi Okada; Alessandro Paniccia; Parag J Parikh; Niek A Peters; Hans Rabl; Jaswinder Samra; Christoph Tinchon; Geertjan van Tienhoven; Eran van Veldhuisen; Andrea Wang-Gillam; Matthew J Weiss; Johanna W Wilmink; Hiroki Yamaue; Marjolein Y V Homs; Casper H J van Eijck; Matthew H G Katz; Bas Groot Koerkamp Journal: J Natl Cancer Inst Date: 2019-08-01 Impact factor: 13.506