Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial
Preoperative chemoradiotherapy may improve the radical resection rate for resectable or borderline resectable pancreatic cancer, but the overall benefit is unproven. In this randomized phase III trial in 16 centers, patients with resectable or borderline resectable pancreatic cancer were randomly as...
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| Published in | Journal of clinical oncology Vol. 38; no. 16; pp. 1763 - 1773 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
American Society of Clinical Oncology
01.06.2020
|
| Subjects | |
| Online Access | Get full text |
| ISSN | 0732-183X 1527-7755 1527-7755 |
| DOI | 10.1200/JCO.19.02274 |
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| Abstract | Preoperative chemoradiotherapy may improve the radical resection rate for resectable or borderline resectable pancreatic cancer, but the overall benefit is unproven.
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 × 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.
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;
= .096). The resection rate was 61% and 72% (
= .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 (
< .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
19.8 months;
029). The proportion of patients who suffered serious adverse events was 52% versus 41% (
096).
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. |
|---|---|
| AbstractList | Preoperative chemoradiotherapy may improve the radical resection rate for resectable or borderline resectable pancreatic cancer, but the overall benefit is unproven.
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 × 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.
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;
= .096). The resection rate was 61% and 72% (
= .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 (
< .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
19.8 months;
029). The proportion of patients who suffered serious adverse events was 52% versus 41% (
096).
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. Preoperative chemoradiotherapy may improve the radical resection rate for resectable or borderline resectable pancreatic cancer, but the overall benefit is unproven.PURPOSEPreoperative chemoradiotherapy may improve the radical resection rate for resectable or borderline resectable pancreatic cancer, but the overall benefit is unproven.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 × 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.PATIENTS AND METHODSIn 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 × 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.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).RESULTSBetween 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).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.CONCLUSIONPreoperative 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. Preoperative chemoradiotherapy may improve the radical resection rate for resectable or borderline resectable pancreatic cancer, but the overall benefit is unproven. |
| Author | Zwinderman, Aeilko H. Versteijne, Eva Besselink, Marc G. Wilmink, Johanna W. Punt, Cornelis J. Paardekooper, Gabriel M.R.M. Busch, Olivier R. van Dam, Ronald M. Neelis, Karen J. Patijn, Gijs A. Kerver, Emile D. Suker, Mustafa Eskens, Ferry A.L.M. Groothuis, Karin Nuyttens, Joost Buijsen, Jeroen Festen, Sebastiaan Akkermans-Vogelaar, Janine M. de Vos-Geelen, Judith Bonsing, Bert A. de Groot, Jan Willem B. de Hingh, Ignace H. van Hooft, Jeanin E. Creemers, Geert-Jan M. van Eijck, Casper H. Groot Koerkamp, Bas Homs, Marjolein Y.V. van Tienhoven, Geertjan van der Sangen, Maurice J.C. Luelmo, Saskia A.C. |
| Author_xml | – sequence: 1 givenname: Eva surname: Versteijne fullname: Versteijne, Eva organization: Department of Radiation Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands – sequence: 2 givenname: Mustafa surname: Suker fullname: Suker, Mustafa organization: Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands – sequence: 3 givenname: Karin surname: Groothuis fullname: Groothuis, Karin organization: Clinical Research Department, Comprehensive Cancer Organisation the Netherlands (IKNL), Nijmegen, the Netherlands – sequence: 4 givenname: Janine M. surname: Akkermans-Vogelaar fullname: Akkermans-Vogelaar, Janine M. organization: Clinical Research Department, Comprehensive Cancer Organisation the Netherlands (IKNL), Nijmegen, the Netherlands – sequence: 5 givenname: Marc G. surname: Besselink fullname: Besselink, Marc G. organization: Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands – sequence: 6 givenname: Bert A. surname: Bonsing fullname: Bonsing, Bert A. organization: Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands – sequence: 7 givenname: Jeroen surname: Buijsen fullname: Buijsen, Jeroen organization: Department of Radiation Oncology (MAASTRO), GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands – sequence: 8 givenname: Olivier R. surname: Busch fullname: Busch, Olivier R. organization: Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands – sequence: 9 givenname: Geert-Jan M. surname: Creemers fullname: Creemers, Geert-Jan M. organization: Department of Medical Oncology, Catharina Hospital, Eindhoven, the Netherlands – sequence: 10 givenname: Ronald M. surname: van Dam fullname: van Dam, Ronald M. organization: Department of Surgery, Division of Hepato-Pancreato-Biliary & Oncology, European Surgery Center Aachen Maastricht, Maastricht UMC+, Maastricht, the Netherlands – sequence: 11 givenname: Ferry A.L.M. surname: Eskens fullname: Eskens, Ferry A.L.M. organization: Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands – sequence: 12 givenname: Sebastiaan surname: Festen fullname: Festen, Sebastiaan organization: Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands – sequence: 13 givenname: Jan Willem B. surname: de Groot fullname: de Groot, Jan Willem B. organization: Department of Medical Oncology, Isala Oncology Centre, Zwolle, the Netherlands – sequence: 14 givenname: Bas surname: Groot Koerkamp fullname: Groot Koerkamp, Bas organization: Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands – sequence: 15 givenname: Ignace H. surname: de Hingh fullname: de Hingh, Ignace H. organization: Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands – sequence: 16 givenname: Marjolein Y.V. surname: Homs fullname: Homs, Marjolein Y.V. organization: Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands – sequence: 17 givenname: Jeanin E. surname: van Hooft fullname: van Hooft, Jeanin E. organization: Department of Gastroenterology and Hepatology, Cancer Centre Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands – sequence: 18 givenname: Emile D. surname: Kerver fullname: Kerver, Emile D. organization: Department of Medical Oncology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands – sequence: 19 givenname: Saskia A.C. surname: Luelmo fullname: Luelmo, Saskia A.C. organization: Department of Medical Oncology, Leiden University Medical Center, Leiden, the Netherlands – sequence: 20 givenname: Karen J. surname: Neelis fullname: Neelis, Karen J. organization: Department of Radiation Oncology, Leiden University Medical Center, Leiden, the Netherlands – sequence: 21 givenname: Joost surname: Nuyttens fullname: Nuyttens, Joost organization: Department of Radiation Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands – sequence: 22 givenname: Gabriel M.R.M. surname: Paardekooper fullname: Paardekooper, Gabriel M.R.M. organization: Department of Radiation Oncology, Isala Oncology Center, Zwolle, the Netherlands – sequence: 23 givenname: Gijs A. surname: Patijn fullname: Patijn, Gijs A. organization: Department of Surgery, Isala Oncology Center, Zwolle, the Netherlands – sequence: 24 givenname: Maurice J.C. surname: van der Sangen fullname: van der Sangen, Maurice J.C. organization: Department of Radiation Oncology, Catharina Hospital, Eindhoven, the Netherlands – sequence: 25 givenname: Judith surname: de Vos-Geelen fullname: de Vos-Geelen, Judith organization: Department of Internal Medicine, Division of Medical Oncology, GROW School for Oncology and Developmental Biology, Maastricht UMC+, Maastricht, the Netherlands – sequence: 26 givenname: Johanna W. surname: Wilmink fullname: Wilmink, Johanna W. organization: Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands – sequence: 27 givenname: Aeilko H. surname: Zwinderman fullname: Zwinderman, Aeilko H. organization: Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands – sequence: 28 givenname: Cornelis J. surname: Punt fullname: Punt, Cornelis J. organization: Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands – sequence: 29 givenname: Casper H. surname: van Eijck fullname: van Eijck, Casper H. organization: Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands – sequence: 30 givenname: Geertjan surname: van Tienhoven fullname: van Tienhoven, Geertjan organization: Department of Radiation Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/32105518$$D View this record in MEDLINE/PubMed |
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