Upfront resection versus no resection of the primary tumor in patients with synchronous metastatic colorectal cancer:the randomized phase III CAIRO4 study conducted by the Dutch Colorectal Cancer Group and the Danish Colorectal Cancer Group

Verfasser:	van der Kruijssen, D. E. W. Elias, S. G. van de Ven, P. M. van Rooijen, K. L. Lam-Boer, J. ’t Mol, L. Punt, C. J. A. Sommeijer, D. W. Tanis, P. J. Nielsen, J. D. Yilmaz, M. K. van Riel, J. M. G. H. Wasowiz-Kemps, D. K. Loosveld, O. J. L. van der Schelling, G. P. de Groot, J. W. B. van Westreenen, H. L. Jakobsen, H. L. Fromm, A. L. Hamberg, P. Verseveld, M. Jaensch, C. Liposits, G. I. van Duijvendijk, P. Oulad Hadj, J. van der Hoeven, J. A. B. Trajkovic, M. de Wilt, J. H. W. Koopman, M. Vincent, Jeroen Wegdam, Johannes A. Haberkorn, Brigitte C. M. van der Harst, Erwin Hendriks, Mathijs P. Schreurs, W. H. Hermien Cense, Huib A. Rietbroek, Ron C. de Gier, Marie-José van Breugel, Edwin A. de Vos, Aad I. Brosens, Rebecca P. M. Doornebosch, P. G. de Jongh, Felix E. Vles, Wouter J. den Boer, Marien O. Leijtens, Jeroen W. A. Gelderblom, A. J. Hans Peeters, Koen C. M. J. Kuenen, Bart C. Pultrum, Bareld B. van Dodewaard-de Jong, Joyce M. Consten, Esther C. J. van de Wouw, A. J. Yes Konsten, J. L. M. Hoekstra, R. Lutke Holzik, Martijn F. Vos, Allert H. van Hoogstraten, M. J. Schlesinger, Nis H. Creemers, Geert-Jan de Hingh, Ignace H. J. T. Kjær, Monica L. Petersen, Lone N. Seiersen, Michael Altaf, Rahim van Cruijsen, Hester Hess, Daniël A. van Leeuwen-Snoeks, Lobke L. Pronk, Apollo Baeten, Coen I. M. van der Deure, Wendy M. Bosscha, Koop Schut, Heidi Leclercq, W. K. G. Simkens, L. H. J. Reijnders, Koen van Arkel, Kees van Grevenstein, W. M. U. Helma van de Ven, Anthony W. H. Vuylsteke, Ronald J. C. L. M. Kuijer, Philomeen Bakker, Sandra D. Goei, Hauwy Helgason, Helgi H. van Acker, Gijs J. D. Temizkan, Mehmet van Tilburg, Marc W. A. Gerhards, Michael F. Kerver, E. D. Gootjes, Elske Nieboer, Peter Bleeker, Wim A. Bleeker, G. R.
Dokumenttyp:	Artikel
Erscheinungsdatum:	2024
Reihe/Periodikum:	van der Kruijssen , D E W , Elias , S G , van de Ven , P M , van Rooijen , K L , Lam-Boer , J , Mol , L , Punt , C J A , Sommeijer , D W , Tanis , P J , Nielsen , J D , Yilmaz , M K , van Riel , J M G H , Wasowiz-Kemps , D K , Loosveld , O J L , van der Schelling , G P , de Groot , J W B , van Westreenen , H L , Jakobsen , H L , Fromm , A L , Hamberg , P , Verseveld , M , Jaensch , C , Liposits , G I , van Duijvendijk , P , Oulad Hadj , J , van der Hoeven , J A B , Trajkovic , M , de Wilt , J H W , Koopman , M , Vincent , J , Wegdam , J A , Haberkorn , B C M , van der Harst , E , Hendriks , M P , Schreurs , W H H , Cense , H A , Rietbroek , R C , de Gier , M-J , van Breugel , E A , de Vos , A I , Brosens , R P M , Doornebosch , P G , de Jongh , F E , Vles , W J , den Boer , M O , Leijtens , J W A , Gelderblom , A J H , Peeters , K C M J , Kuenen , B C , Pultrum , B B , van Dodewaard-de Jong , J M , Consten , E C J , van de Wouw , A J Y , Konsten , J L M , Hoekstra , R , Lutke Holzik , M F , Vos , A H , van Hoogstraten , M J , Schlesinger , N H , Creemers , G-J , de Hingh , I H J T , Kjær , M L , Petersen , L N , Seiersen , M , Altaf , R , van Cruijsen , H , Hess , D A , van Leeuwen-Snoeks , L L , Pronk , A , Baeten , C I M , van der Deure , W M , Bosscha , K , Schut , H , Leclercq , W K G , Simkens , L H J , Reijnders , K , van Arkel , K , van Grevenstein , W M U H , van de Ven , A W H , Vuylsteke , R J C L M , Kuijer , P , Bakker , S D , Goei , H , Helgason , H H , van Acker , G J D , Temizkan , M , van Tilburg , M W A , Gerhards , M F , Kerver , E D , Gootjes , E , Nieboer , P , Bleeker , W A & Bleeker , G R 2024 , ' Upfront resection versus no resection of the primary tumor in patients with synchronous metastatic colorectal cancer : the randomized phase III CAIRO4 study conducted by the Dutch Colorectal Cancer Group and the Danish Colorectal Cancer Group ' , Annals of Oncology . https://doi.org/10.1016/j.annonc.2024.06.001
Sprache:	Englisch
Permalink:	https://search.fid-benelux.de/Record/base-29048439
Datenquelle:	BASE; Originalkatalog
Powered By:	BASE
Link(s) :	https://research.vumc.nl/en/publications/f8b5083f-8e1a-4ab9-9d2b-38d1523065f4

Background: Upfront primary tumor resection (PTR) has been associated with longer overall survival (OS) in patients with synchronous unresectable metastatic colorectal cancer (mCRC) in retrospective analyses. The aim of the CAIRO4 study was to investigate whether the addition of upfront PTR to systemic therapy resulted in a survival benefit in patients with synchronous mCRC without severe symptoms of their primary tumor. Patients and methods: This randomized phase III trial was conducted in 45 hospitals in The Netherlands and Denmark. Eligibility criteria included previously untreated mCRC, unresectable metastases, and no severe symptoms of the primary tumor. Patients were randomized (1 : 1) to upfront PTR followed by systemic therapy or systemic therapy without upfront PTR. Systemic therapy consisted of first-line fluoropyrimidine-based chemotherapy with bevacizumab in both arms. Primary endpoint was OS in the intention-to-treat population. The study was registered at ClinicalTrials.gov, NCT01606098. Results: Between August 2012 and February 2021, 206 patients were randomized. In the intention-to-treat analysis, 204 patients were included (n = 103 without upfront PTR, n = 101 with upfront PTR) of whom 116 were men (57%) with median age of 65 years (interquartile range 59-71 years). Median follow-up was 69.4 months. Median OS in the arm without upfront PTR was 18.3 months (95% confidence interval 16.0-22.2 months) compared with 20.1 months (95% confidence interval 17.0-25.1 months) in the upfront PTR arm (P = 0.32). The number of grade 3-4 events was 71 (72%) in the arm without upfront PTR and 61 (65%) in the upfront PTR arm (P = 0.33). Three deaths (3%) possibly related to treatment were reported in the arm without upfront PTR and four (4%) in the upfront PTR arm. Conclusions: Addition of upfront PTR to palliative systemic therapy in patients with synchronous mCRC without severe symptoms of the primary tumor does not result in a survival benefit. This practice should no longer be considered standard of care.