R0 resection following chemo (radio)therapy improves survival of primary inoperable pancreatic cancer patients. Interim

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ORIGINAL ARTICLE

R0 resection following chemo (radio)therapy improves survival of primary inoperable pancreatic cancer patients. Interim results of the German randomized CONKO-007± trial 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. Semrau1 · S. Rutzner1 · M. Ghadimi16 · D. Lubgan1 Received: 18 June 2020 / Accepted: 11 August 2020 © The Author(s) 2020

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 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.

R. Fietkau and R. Grützmann contributed equally to this work as first author. M. Ghadimi and D. Lubgan contributed equally to this work as last author. Availability of data and material: ±CONKO-007, official title: Chemoradiation following induction chemotherapy in locally advanced, unresectable pancreatic cancer—a randomised phase 3 trial: chemoradiation following induction chemotherapy compared with chemotherapy alone (EudraCT: 2009-014476-21, NCT01827553) Code availability: Not applicable

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

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Department of Medical Oncology and Comprehensive Cancer Centre, Klinikum Grosshadern, Ludwig-Maximilians-University of Munich, Munich, Germany

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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

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Medical Centre for Information and Communication Technology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany

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Department of Medical Informatics, Biometry and Epidemiology, University of Erlangen-Nürnberg, Waldstraße 6, 91054 Erlangen, Germany

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Department of General, Visceral and Pediatric Surgery, Medical Center, Georg-August-University Göttingen, Göttingen, Germany

 Prof. Dr. R. Fietkau

[email protected] 1

Department of Radiation Oncology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany

2

Department of Sur