TY - JOUR
T1 - Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer
T2 - 54th Annual Meeting of the American-Society-of-Clinical-Oncology (ASCO)
AU - Versteijne, Eva
AU - Suker, Mustafa
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 - Koerkamp, Bas Groot
AU - de Hingh, Ignace H.
AU - Homs, Marjolein Y.
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 Eijck, Casper H.
AU - van Tienhoven, Geertjan
AU - Dutch Pancreatic Canc Grp
N1 - Funding Information:
Supported by the Dutch Cancer Society (KWF) (UVA 2012-5696), which funded the data management (central and local) and onsite monitoring of the trial. The Dutch Cancer Society (KWF) did not influence the design or analysis of the study. We thank all patients who participated in the trial and relatives for their support. In addition to the authors, we thank the following coworkers in the PREOPANC trial; A. Bel (Amsterdam UMC, Amsterdam), R.J. Bennink (Amsterdam UMC, Amsterdam), J.C. Beukema (University Medical Center Groningen [UMCG], Groningen), M. Bijlsma (Amsterdam UMC, Amsterdam), T. Bisseling (Radboud UMC, Nijmegen), D. Boerma (St Antonius Hospital, Nieuwegein), T.L. Bollen (St Antonius Hospital, Nieuwegein), K. Bosscha (Jeroen Bosch Hospital, Den Bosch), M. Bruno (Erasmus MC, Rotterdam), A.M. Bruynzeel (Amsterdam UMC, Amsterdam), F. Dijk (Amsterdam UMC, Amsterdam), J. Erdmann (Amsterdam UMC, Amsterdam), G. Franssen (Erasmus MC, Rotterdam), H. van Goor (Radboud UMC, Nijmegen), J. Hagoort (Erasmus MC, Rotterdam), E. van der Harst (Maasstad Hospital, Maasstad), K. Haustermans (UZ Leuven, Leuven), E.M. Hendriksen (Medisch Spectrum Twente [MST], Enschede), K. van der Hoeven (Radboud UMC, Nijmegen), G.A.P. Hospers (UMCG, Groningen), M.C.C.M. Hulshof (Amsterdam UMC, Amsterdam), C. Hurkmans (Catharina Hospital, Eindhoven), M.P. van Intven (UMC Utrecht [UMCU], Utrecht), J.M. Jansen (OLVG, Amsterdam), K.P. de Jong (UMCG, Groningen), G. Kazemier (Amsterdam UMC, Amsterdam), J. Klaasse (UMCG, Groningen), B.M. van der Kolk (Radboud UMC, Nijmegen), M. Koopman (UMCU, Utrecht), M.C.J.C. Legdeur (MST, Enschede), M.S. Liem (MST, Enschede), M. Los (St Antonius Hospital, Nieuwegein), I.Q. Molenaar (UMCU, Utrecht), S.S.K.S. Phoa (Amsterdam UMC, Amsterdam), A.C. Poen (Isala Oncology Center, Zwolle), J.F.M. Pruijt (Jeroen Bosch Hospital, Den Bosch), S. Radema (Radboud UMC, Nijmegen), T. Rozema (Verbeeten Instituut, Tilburg), H. Rutten (Radboud UMC, Nijmegen), H.C. van Santvoort (St Antonius Hospital, Nieuwegein), C.H. Scharloo-Karels (Amsterdam UMC, Amsterdam), G.P. van der Schelling (Amphia Hospital, Breda), T. Seerden (Amphia Hospital, Breda), M.W.T. Tanck (Erasmus MC, Rotterdam), A. J. ten Tije (Amphia Hospital, Breda), R. Timmer (St Antonius Hospital, Nieuwegein), N. G. Venneman (MST, Enschede), and L. Welling (Leiden UMC, Leiden).
Funding Information:
Supported by the Dutch Cancer Society (KWF) (UVA 2012-5696), which funded the data management (central and local) and onsite monitoring of the trial. The Dutch Cancer Society (KWF) did not influence the design or analysis of the study.
Publisher Copyright:
© 2020 by American Society of Clinical Oncology
PY - 2020/6/1
Y1 - 2020/6/1
N2 - PURPOSE Preoperative chemoradiotherapy may improve the radical resection rate for resectable or borderline resectable pancreatic cancer, but the overall benefit is unproven.PATIENTS AND METHODS In this randomized phase III trial in 16 centers, patients with resectable or borderline resectable pancreatic cancer were randomly assigned to receive preoperative chemoradiotherapy, which consisted of 3 courses of gemcitabine, the second combined with 15 x 2.4 Gy radiotherapy, followed by surgery and 4 courses of adjuvant gemcitabine or to immediate surgery and 6 courses of adjuvant gemcitabine. The primary end point was overall survival by intention to treat.RESULTS Between April 2013 and July 2017, 246 eligible patients were randomly assigned; 119 were assigned to preoperative chemoradiotherapy and 127 to immediate surgery. Median overall survival by intention to treat was 16.0 months with preoperative chemoradiotherapy and 14.3 months with immediate surgery (hazard ratio, 0.78; 95% CI, 0.58 to 1.05; P = .096). The resection rate was 61% and 72% (P = .058). The R0 resection rate was 71% (51 of 72) in patients who received preoperative chemoradiotherapy and 40% (37 of 92) in patients assigned to immediate surgery (P <.001). Preoperative chemoradiotherapy was associated with significantly better disease-free survival and locoregional failure-free interval as well as with significantly lower rates of pathologic lymph nodes, perineural invasion, and venous invasion. Survival analysis of patients who underwent tumor resection and started adjuvant chemotherapy showed improved survival with preoperative chemoradiotherapy (35.2 v 19.8 months; P = .029). The proportion of patients who suffered serious adverse events was 52% versus 41% (P = .096).CONCLUSION Preoperative chemoradiotherapy for resectable or borderline resectable pancreatic cancer did not show a significant overall survival benefit. Although the outcomes of the secondary end points and predefined subgroup analyses suggest an advantage of the neoadjuvant approach, additional evidence is required.
AB - PURPOSE Preoperative chemoradiotherapy may improve the radical resection rate for resectable or borderline resectable pancreatic cancer, but the overall benefit is unproven.PATIENTS AND METHODS In this randomized phase III trial in 16 centers, patients with resectable or borderline resectable pancreatic cancer were randomly assigned to receive preoperative chemoradiotherapy, which consisted of 3 courses of gemcitabine, the second combined with 15 x 2.4 Gy radiotherapy, followed by surgery and 4 courses of adjuvant gemcitabine or to immediate surgery and 6 courses of adjuvant gemcitabine. The primary end point was overall survival by intention to treat.RESULTS Between April 2013 and July 2017, 246 eligible patients were randomly assigned; 119 were assigned to preoperative chemoradiotherapy and 127 to immediate surgery. Median overall survival by intention to treat was 16.0 months with preoperative chemoradiotherapy and 14.3 months with immediate surgery (hazard ratio, 0.78; 95% CI, 0.58 to 1.05; P = .096). The resection rate was 61% and 72% (P = .058). The R0 resection rate was 71% (51 of 72) in patients who received preoperative chemoradiotherapy and 40% (37 of 92) in patients assigned to immediate surgery (P <.001). Preoperative chemoradiotherapy was associated with significantly better disease-free survival and locoregional failure-free interval as well as with significantly lower rates of pathologic lymph nodes, perineural invasion, and venous invasion. Survival analysis of patients who underwent tumor resection and started adjuvant chemotherapy showed improved survival with preoperative chemoradiotherapy (35.2 v 19.8 months; P = .029). The proportion of patients who suffered serious adverse events was 52% versus 41% (P = .096).CONCLUSION Preoperative chemoradiotherapy for resectable or borderline resectable pancreatic cancer did not show a significant overall survival benefit. Although the outcomes of the secondary end points and predefined subgroup analyses suggest an advantage of the neoadjuvant approach, additional evidence is required.
KW - FULL-DOSE GEMCITABINE
KW - NEOADJUVANT CHEMORADIATION
KW - ADJUVANT CHEMOTHERAPY
KW - DUCTAL ADENOCARCINOMA
KW - CONCURRENT RADIATION
KW - OPEN-LABEL
KW - THERAPY
KW - MULTICENTER
KW - FOLFIRINOX
KW - SURVIVAL
U2 - 10.1200/JCO.19.02274
DO - 10.1200/JCO.19.02274
M3 - Article
C2 - 32105518
SN - 0732-183X
VL - 38
SP - 1763
EP - 1773
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 16
Y2 - 1 June 2018 through 5 June 2018
ER -