TY - JOUR
T1 - Neoadjuvant Chemoradiotherapy Versus Upfront Surgery for Resectable and Borderline Resectable Pancreatic Cancer
T2 - Long-Term Results of the Dutch Randomized PREOPANC Trial
AU - Versteijne, Eva
AU - van Dam, Jacob L.
AU - Suker, Mustafa
AU - Janssen, Quisette P.
AU - Groothuis, Karin
AU - Akkermans-Vogelaar, Janine M.
AU - Besselink, Marc G.
AU - Bonsing, Bert A.
AU - Buijsen, Jeroen
AU - Busch, Olivier R.
AU - Creemers, Geert-Jan M.
AU - van Dam, Ronald M.
AU - Eskens, Ferry A. L. M.
AU - Festen, Sebastiaan
AU - de Groot, Jan Willem B.
AU - Groot Koerkamp, Bas
AU - de Hingh, Ignace H.
AU - Homs, Marjolein Y. V.
AU - van Hooft, Jeanin E.
AU - Kerver, Emile D.
AU - Luelmo, Saskia A. C.
AU - Neelis, Karen J.
AU - Nuyttens, Joost
AU - Paardekooper, Gabriel M. R. M.
AU - Patijn, Gijs A.
AU - van der Sangen, Maurice J. C.
AU - de Vos-Geelen, Judith
AU - Wilmink, Johanna W.
AU - Zwinderman, Aeilko H.
AU - Punt, Cornelis J.
AU - van Tienhoven, Geertjan
AU - van Eijck, Casper H. J.
N1 - Publisher Copyright:
© 2022 American Society of Clinical Oncology.
PY - 2022/4/10
Y1 - 2022/4/10
N2 - PURPOSEThe benefit of neoadjuvant chemoradiotherapy in resectable and borderline resectable pancreatic cancer remains controversial. Initial results of the PREOPANC trial failed to demonstrate a statistically significant overall survival (OS) benefit. The long-term results are reported.METHODSIn this multicenter, phase III trial, patients with resectable and borderline resectable pancreatic cancer were randomly assigned (1:1) to neoadjuvant chemoradiotherapy or upfront surgery in 16 Dutch centers. Neoadjuvant chemoradiotherapy consisted of three cycles of gemcitabine combined with 36 Gy radiotherapy in 15 fractions during the second cycle. After restaging, patients underwent surgery followed by four cycles of adjuvant gemcitabine. Patients in the upfront surgery group underwent surgery followed by six cycles of adjuvant gemcitabine. The primary outcome was OS by intention-to-treat. No safety data were collected beyond the initial report of the trial.RESULTSBetween April 24, 2013, and July 25, 2017, 246 eligible patients were randomly assigned to neoadjuvant chemoradiotherapy (n = 119) and upfront surgery (n = 127). At a median follow-up of 59 months, the OS was better in the neoadjuvant chemoradiotherapy group than in the upfront surgery group (hazard ratio, 0.73; 95% CI, 0.56 to 0.96; P =.025). Although the difference in median survival was only 1.4 months (15.7 months v 14.3 months), the 5-year OS rate was 20.5% (95% CI, 14.2 to 29.8) with neoadjuvant chemoradiotherapy and 6.5% (95% CI, 3.1 to 13.7) with upfront surgery. The effect of neoadjuvant chemoradiotherapy was consistent across the prespecified subgroups, including resectable and borderline resectable pancreatic cancer.CONCLUSIONNeoadjuvant gemcitabine-based chemoradiotherapy followed by surgery and adjuvant gemcitabine improves OS compared with upfront surgery and adjuvant gemcitabine in resectable and borderline resectable pancreatic cancer.
AB - PURPOSEThe benefit of neoadjuvant chemoradiotherapy in resectable and borderline resectable pancreatic cancer remains controversial. Initial results of the PREOPANC trial failed to demonstrate a statistically significant overall survival (OS) benefit. The long-term results are reported.METHODSIn this multicenter, phase III trial, patients with resectable and borderline resectable pancreatic cancer were randomly assigned (1:1) to neoadjuvant chemoradiotherapy or upfront surgery in 16 Dutch centers. Neoadjuvant chemoradiotherapy consisted of three cycles of gemcitabine combined with 36 Gy radiotherapy in 15 fractions during the second cycle. After restaging, patients underwent surgery followed by four cycles of adjuvant gemcitabine. Patients in the upfront surgery group underwent surgery followed by six cycles of adjuvant gemcitabine. The primary outcome was OS by intention-to-treat. No safety data were collected beyond the initial report of the trial.RESULTSBetween April 24, 2013, and July 25, 2017, 246 eligible patients were randomly assigned to neoadjuvant chemoradiotherapy (n = 119) and upfront surgery (n = 127). At a median follow-up of 59 months, the OS was better in the neoadjuvant chemoradiotherapy group than in the upfront surgery group (hazard ratio, 0.73; 95% CI, 0.56 to 0.96; P =.025). Although the difference in median survival was only 1.4 months (15.7 months v 14.3 months), the 5-year OS rate was 20.5% (95% CI, 14.2 to 29.8) with neoadjuvant chemoradiotherapy and 6.5% (95% CI, 3.1 to 13.7) with upfront surgery. The effect of neoadjuvant chemoradiotherapy was consistent across the prespecified subgroups, including resectable and borderline resectable pancreatic cancer.CONCLUSIONNeoadjuvant gemcitabine-based chemoradiotherapy followed by surgery and adjuvant gemcitabine improves OS compared with upfront surgery and adjuvant gemcitabine in resectable and borderline resectable pancreatic cancer.
UR - https://www.scopus.com/pages/publications/85125798289
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85125798289&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/35084987
U2 - 10.1200/JCO.21.02233
DO - 10.1200/JCO.21.02233
M3 - Article
C2 - 35084987
SN - 0732-183X
VL - 40
SP - 1220
EP - 1230
JO - Journal of clinical oncology
JF - Journal of clinical oncology
IS - 11
ER -
SDG 3 Good Health and Well-being