Primary Tumor Resection Before Systemic Therapy in Patients With Colon Cancer and Unresectable Metastases: Combined Results of the SYNCHRONOUS and CCRe-IV Trials

Author:

Rahbari Nuh N.1ORCID,Biondo Sebastiano2,Frago Ricardo2ORCID,Feißt Manuel3,Kreisler Esther2,Rossion Inga4,Serrano Monica2ORCID,Jäger Dirk5,Lehmann Monika6,Sommer Florian7ORCID,Dignass Axel8ORCID,Bolling Claus8ORCID,Vogel Ilka9,Bork Ulrich10,Büchler Markus W.11,Folprecht Gunnar12ORCID,Kieser Meinhard3,Lordick Florian13,Weitz Jürgen1014,Paty P.B.,Hermann R.,Schmoor C.

Affiliation:

1. Department of Surgery, Ulm University hospital, Ulm, Germany

2. Department of General and Digestive Surgery—Colorectal Unit, Bellvitge University Hospital, University of Barcelona and IDIBELL, Barcelona, Spain

3. Institute of Medical Biometry, University of Heidelberg, Heidelberg, Germany

4. The Study Center of the German Society of Surgery (SDGC), University of Heidelberg, Heidelberg, Germany

5. Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg, Germany

6. Coordination Centre for Clinical Trials (KKS), University Hospital Heidelberg, Heidelberg, Germany

7. Department of General, Visceral and Transplantation Surgery, University Hospital Augsburg, Augsburg, Germany

8. Department of Medicine I, Agaplesion Markus Hospital, Goethe-University, Frankfurt am Main, Germany

9. Department of Surgery, Community Hospital Kiel, Kiel, Germany

10. Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany

11. Department of General, Visceral and Transplantation Surgery, Medical Faculty Heidelberg, University Hospital Heidelberg, Heidelberg, Germany

12. Department of Medicine I, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany

13. Department of Oncology, Gastroenterology, Hepatology, and Pulmonology, Comprehensive Cancer Center Central Germany (CCCG), University of Leipzig Medical Center, Leipzig, Germany

14. National Center for Tumor Diseases (NCT/UCC), Dresden, Germany

Abstract

PURPOSE Chemotherapy is established as primary treatment in patients with stage IV colorectal cancer and unresectable metastases. Data from nonrandomized clinical trials have fueled persistent uncertainty if primary tumor resection (PTR) before chemotherapy prolongs survival. We investigated the prognostic value of PTR in patients with newly diagnosed stage IV colon cancer who were not amenable to curative treatment. PATIENTS AND METHODS Patients enrolled in the multicenter, randomized SYNCHRONOUS and CCRe-IV trials were included in the analysis. Patients with colon cancer with synchronous unresectable metastases were randomly assigned at 100 sites in Austria, Germany, and Spain to undergo PTR or up-front chemotherapy (No PTR group). The chemotherapy regimen was left at discretion of the local team. Patients with tumor-related symptoms, inability to tolerate surgery and/or systemic chemotherapy, and history of another cancer were excluded. The primary end point was overall survival (OS), and the analyses were performed with intention-to-treat. RESULTS A total of 393 patients were randomly assigned to undergo PTR (n = 187) or no PTR (n = 206) between November 2011 and March 2017. Chemotherapy was not administered to 6.4% in the No PTR group and 24.1% in the PTR group. The median follow-up time was 36.7 months (95% CI, 36.6 to 37.3). The median OS was 16.7 months (95% CI, 13.2 to 19.2) in the PTR group and 18.6 months (95% CI, 16.2 to 22.3) in the No PTR group ( P = .191). Comparable OS between the study groups was further confirmed on multivariate analysis (hazard ratio, 0.944 [95% CI, 0.738 to 1.209], P = .65) and across all subgroups. Patients with serious adverse events were more common in the No PTR group (10.2% v 18.0%; P = .027). CONCLUSION Among patients with colon cancer and synchronous unresectable metastases, PTR before systemic chemotherapy was not associated with prolonged OS.

Publisher

American Society of Clinical Oncology (ASCO)

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