Paula Ghaneh1,2, Jorg Kleeff2, Christopher M Halloran2, Michael Raraty2, Richard Jackson1, James Melling2, Owain Jones2, Daniel H Palmer1, Trevor F Cox1, Chloe J Smith1, Derek A O'Reilly3, Jakob R Izbicki4, Andrew G Scarfe5, Juan W Valle6, Alexander C McDonald7, Ross Carter8, Niall C Tebbutt9, David Goldstein10, Robert Padbury11, Jennifer Shannon12, Christos Dervenis13, Bengt Glimelius14, Mark Deakin15, Alan Anthoney16, Markus M Lerch17, Julia Mayerle17, Attila Oláh18, Charlotte L Rawcliffe1, Fiona Campbell19, Oliver Strobel20, Markus W Büchler20, John P Neoptolemos1,2. 1. Liverpool Cancer Research U.K. Cancer Trials Unit, University of Liverpool, Liverpool, United Kingdom University of Liverpool, Liverpool, UK. 2. The Department of Surgery, Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK. 3. Department of Surgery, Manchester Royal Infirmary, Manchester, UK. 4. Department of Surgery, University of Hamburg Medical institutions UKE, Hamburg, Germany. 5. Department of Oncology Division of Medical Oncology 2228 Cross Cancer Institute and University of Alberta, Canada. 6. Department of Medical Oncology , The Christie, Manchester, UK. 7. Department of Medical Oncology, The Beatson West of Scotland Cancer Centre, Glasgow, Scotland, UK. 8. Department of Surgery, Glasgow Royal Infirmary, Glasgow, Scotland, UK. 9. Department of Medical Oncology, Austin Health, Melbourne, Australia. 10. Department of Medical Oncology, Prince of Wales hospital and Clinical School University of New South Wales, Australia. 11. Department of Surgery, Flinders Medical Centre, Adelaide, South Australia. 12. Department of Medical Oncology, Nepean Cancer Centre and University of Sydney, Australia. 13. Department of Surgery, The Agia Olga Hospital, Athens, Greece. 14. Department of Immunology, Genetics and Pathology, Experimental and Clinical Oncology, Uppsala Clinical Research Center, Uppsala, Sweden. 15. Department of Surgery, University Hospital, North Staffordshire, UK. 16. Division of Oncology at the University of Leeds, St James's University Hospital, Leeds, UK. 17. Department of Medicine A, University Medicine Greifswald, Greifswald, Germany. 18. Department of Surgery, The Petz Aladar Hospital, Gyor, Hungary. 19. Department of Pathology, The Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK. 20. The Department of Surgery, University of Heidelberg, Heidelberg, Germany.
Abstract
OBJECTIVE AND BACKGROUND:Local and distant disease recurrence are frequently observed following pancreatic cancer resection, but an improved understanding of resection margin assessment is required to aid tailored therapies. METHODS: Analyses were carried out to assess the association between clinical characteristics and margin involvement as well as the effects of individual margin involvement on site of recurrence and overall and recurrence-free survival using individual patient data from the European Study Group for Pancreatic Cancer (ESPAC)-3 randomized controlled trial. RESULTS: There were 1151 patients, of whom 505 (43.9%) had an R1 resection. The median and 95% confidence interval (CI) overall survival was 24.9 (22.9-27.2) months for 646 (56.1%) patients with resection margin negative (R0 >1 mm) tumors, 25.4 (21.6-30.4) months for 146 (12.7%) patients with R1<1 mm positive resection margins, and 18.7 (17.2-21.1) months for 359 (31.2%) patients with R1-direct positive margins (P < 0.001). In multivariable analysis, overall R1-direct tumor margins, poor tumor differentiation, positive lymph node status, WHO performancestatus ≥1, maximum tumor size, and R1-directposterior resection margin were all independently significantly associated with reduced overall and recurrence-free survival. Competing risks analysis showed that overall R1-direct positive resection margin status, positive lymph node status, WHO performance status 1, and R1-directpositive superior mesenteric/medial margin resection status were all significantly associated with local recurrence. CONCLUSIONS: R1-direct resections were associated with significantly reduced overall and recurrence-free survival following pancreatic cancer resection. Resection margin involvement was also associated with an increased risk for local recurrence.
RCT Entities:
OBJECTIVE AND BACKGROUND: Local and distant disease recurrence are frequently observed following pancreatic cancer resection, but an improved understanding of resection margin assessment is required to aid tailored therapies. METHODS: Analyses were carried out to assess the association between clinical characteristics and margin involvement as well as the effects of individual margin involvement on site of recurrence and overall and recurrence-free survival using individual patient data from the European Study Group for Pancreatic Cancer (ESPAC)-3 randomized controlled trial. RESULTS: There were 1151 patients, of whom 505 (43.9%) had an R1 resection. The median and 95% confidence interval (CI) overall survival was 24.9 (22.9-27.2) months for 646 (56.1%) patients with resection margin negative (R0 >1 mm) tumors, 25.4 (21.6-30.4) months for 146 (12.7%) patients with R1<1 mm positive resection margins, and 18.7 (17.2-21.1) months for 359 (31.2%) patients with R1-direct positive margins (P < 0.001). In multivariable analysis, overall R1-direct tumor margins, poor tumor differentiation, positive lymph node status, WHO performance status ≥1, maximum tumor size, and R1-direct posterior resection margin were all independently significantly associated with reduced overall and recurrence-free survival. Competing risks analysis showed that overall R1-direct positive resection margin status, positive lymph node status, WHO performance status 1, and R1-direct positive superior mesenteric/medial margin resection status were all significantly associated with local recurrence. CONCLUSIONS: R1-direct resections were associated with significantly reduced overall and recurrence-free survival following pancreatic cancer resection. Resection margin involvement was also associated with an increased risk for local recurrence.
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