R Fietkau1, R Grützmann2, U A Wittel3, R S Croner4, L Jacobasch5, U P Neumann6, A Reinacher-Schick7, D Imhoff8, S Boeck9, L Keilholz10, H Oettle11, W M Hohenberger2, H Golcher2, W O Bechstein12, W Uhl13, A Pirkl14, W Adler15, S Semrau16, S Rutzner16, M Ghadimi17, D Lubgan16. 1. Department of Radiation Oncology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany. rainer.fietkau@uk-erlangen.de. 2. Department of Surgery, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany. 3. Department for General- and Visceral Surgery, Medical Center and Faculty of Medicine, University of Freiburg, Freiburg, Germany. 4. Department of Surgery, University Hospital Magdeburg, Magdeburg, Germany. 5. Private practice, Hematology/Oncology, Dresden, Germany. 6. Department of Surgery, University Hospital RWTH Aachen, Aachen, Germany. 7. Department for Hematology, Oncology and Palliative Care, St Josef-Hospital, Ruhr-University Bochum, Bochum, Germany. 8. Department of Radiation Oncology, Universitätsklinikum Frankfurt, Frankfurt, Germany. 9. Department of Medical Oncology and Comprehensive Cancer Centre, Klinikum Grosshadern, Ludwig-Maximilians-University of Munich, Munich, Germany. 10. Department of Radiotherapy, Clinical Center Bayreuth, Bayreuth, Germany. 11. Outpatient Department Hematology/Oncology, Friedrichshafen, Germany. 12. Department of General and Visceral Surgery, Frankfurt University Hospital and Clinics, Frankfurt, Germany. 13. Department of Surgery, St. Josef Hospital, Ruhr-University Bochum, Bochum, Germany. 14. Medical Centre for Information and Communication Technology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany. 15. Department of Medical Informatics, Biometry and Epidemiology, University of Erlangen-Nürnberg, Waldstraße 6, 91054, Erlangen, Germany. 16. Department of Radiation Oncology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany. 17. Department of General, Visceral and Pediatric Surgery, Medical Center, Georg-August-University Göttingen, Göttingen, Germany.
Abstract
PURPOSE:Chemotherapy with or without radiotherapy is the standard in patients with initially nonmetastatic unresectable pancreatic cancer. Additional surgery is in discussion. The CONKO-007 multicenter randomized trial examines the value of radiotherapy. Our interim analysis showed a significant effect of surgery, which may be relevant to clinical practice. METHODS:One hundred eighty patients receivedinduction chemotherapy (gemcitabine or FOLFIRINOX). Patients without tumor progression were randomized to either chemotherapy alone or to concurrent chemoradiotherapy. At the end of therapy, a panel of five independent pancreatic surgeons judged the resectability of the tumor. RESULTS: Following induction chemotherapy, 126/180 patients (70.0%) were randomized to further treatment. Following study treatment, 36/126 patients (28.5%) underwent surgery; (R0: 25/126 [19.8%]; R1/R2/Rx [n = 11/126; 6.1%]). Disease-free survival (DFS) and overall survival (OS) were significantly better for patients with R0 resected tumors (median DFS and OS: 16.6 months and 26.5 months, respectively) than for nonoperated patients (median DFS and OS: 11.9 months and 16.5 months, respectively; p = 0.003). In the 25 patients with R0 resected tumors before treatment, only 6/113 (5.3%) of the recommendations of the panel surgeons recommended R0 resectability, compared with 17/48 (35.4%) after treatment (p < 0.001). CONCLUSION: Tumor resectability of pancreatic cancer staged as unresectable at primary diagnosis should be reassessed after neoadjuvant treatment. The patient should undergo surgery if a resectability is reached, as this significantly improves their prognosis.
RCT Entities:
PURPOSE: Chemotherapy with or without radiotherapy is the standard in patients with initially nonmetastatic unresectable pancreatic cancer. Additional surgery is in discussion. The CONKO-007 multicenter randomized trial examines the value of radiotherapy. Our interim analysis showed a significant effect of surgery, which may be relevant to clinical practice. METHODS: One hundred eighty patients received induction chemotherapy (gemcitabine or FOLFIRINOX). Patients without tumor progression were randomized to either chemotherapy alone or to concurrent chemoradiotherapy. At the end of therapy, a panel of five independent pancreatic surgeons judged the resectability of the tumor. RESULTS: Following induction chemotherapy, 126/180 patients (70.0%) were randomized to further treatment. Following study treatment, 36/126 patients (28.5%) underwent surgery; (R0: 25/126 [19.8%]; R1/R2/Rx [n = 11/126; 6.1%]). Disease-free survival (DFS) and overall survival (OS) were significantly better for patients with R0 resected tumors (median DFS and OS: 16.6 months and 26.5 months, respectively) than for nonoperated patients (median DFS and OS: 11.9 months and 16.5 months, respectively; p = 0.003). In the 25 patients with R0 resected tumors before treatment, only 6/113 (5.3%) of the recommendations of the panel surgeons recommended R0 resectability, compared with 17/48 (35.4%) after treatment (p < 0.001). CONCLUSION:Tumor resectability of pancreatic cancer staged as unresectable at primary diagnosis should be reassessed after neoadjuvant treatment. The patient should undergo surgery if a resectability is reached, as this significantly improves their prognosis.
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