دورية أكاديمية
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.
| العنوان: | 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. |
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| المؤلفون: | van der Kruijssen DEW; Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht., Elias SG; Department of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht., van de Ven PM; Department of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht., van Rooijen KL; Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht., Lam-Boer J'; Department of Surgery, Radboud University Medical Center, Nijmegen; Department of Surgery, Netherlands Cancer Institute, Amsterdam., Mol L; Clinical Research Department, Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht., Punt CJA; Department of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht., Sommeijer DW; Department of Medical Oncology, Amsterdam University Medical Center, Amsterdam; Department of Medical Oncology, Flevo Hospital, Almere., Tanis PJ; Department of Surgery, Amsterdam University Medical Center, Amsterdam; Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands., Nielsen JD; Department of Surgery, Aalborg University Hospital, Aalborg, Denmark., Yilmaz MK; Department of Medical Oncology, Aalborg University Hospital, Aalborg, Denmark., van Riel JMGH; Department of Medical Oncology, Elisabeth-TweeSteden Hospital, Tilburg., Wasowiz-Kemps DK; Department of Surgery, Elisabeth-TweeSteden Hospital, Tilburg., Loosveld OJL; Department of Medical Oncology, Amphia Hospital, Breda., van der Schelling GP; Department of Surgery, Amphia Hospital, Breda., de Groot JWB; Department of Medical Oncology, Isala Hospital, Zwolle, The Netherlands., van Westreenen HL; Department of Surgery, Isala Hospital, Zwolle, The Netherlands., Jakobsen HL; Department of Surgery, Herlev and Gentofte Hospital, Herlev, Denmark., Fromm AL; Department of Medical Oncology, Herlev and Gentofte Hospital, Herlev, Denmark., Hamberg P; Department of Medical Oncology, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands., Verseveld M; Department of Surgery, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands., Jaensch C; Department of Surgery, Regional Hospital Gødstrup, Herning, Denmark., Liposits GI; Department of Medical Oncology, Regional Hospital Gødstrup, Herning, Denmark., van Duijvendijk P; Department of Surgery, Gelre Hospital, Apeldoorn., Oulad Hadj J; Department of Medical Oncology, Gelre Hospital, Apeldoorn., van der Hoeven JAB; Department of Surgery, Albert Schweitzer Hospital, Dordrecht, The Netherlands., Trajkovic M; Department of Medical Oncology, Albert Schweitzer Hospital, Dordrecht, The Netherlands., de Wilt JHW; Department of Surgery, Radboud University Medical Center, Nijmegen., Koopman M; Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht. Electronic address: M.Koopman-6@umcutrecht.nl. |
| مؤلفون مشاركون: | CAIRO4 Working Group |
| المصدر: | Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2024 Sep; Vol. 35 (9), pp. 769-779. Date of Electronic Publication: 2024 Jun 07. |
| نوع المنشور: | Journal Article; Clinical Trial, Phase III; Randomized Controlled Trial; Multicenter Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: England NLM ID: 9007735 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1569-8041 (Electronic) Linking ISSN: 09237534 NLM ISO Abbreviation: Ann Oncol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2020- : London : Elsevier Original Publication: Dordrecht ; Boston : Kluwer Academic Publishers, c1990- |
| مواضيع طبية MeSH: | Colorectal Neoplasms*/pathology , Colorectal Neoplasms*/drug therapy , Colorectal Neoplasms*/surgery , Colorectal Neoplasms*/mortality , Antineoplastic Combined Chemotherapy Protocols*/therapeutic use, Humans ; Male ; Female ; Aged ; Middle Aged ; Denmark/epidemiology ; Netherlands/epidemiology ; Bevacizumab/administration & dosage ; Bevacizumab/therapeutic use ; Neoplasms, Multiple Primary/surgery ; Neoplasms, Multiple Primary/pathology ; Neoplasms, Multiple Primary/drug therapy ; Neoplasms, Multiple Primary/mortality ; Aged, 80 and over ; Adult ; Neoplasm Metastasis ; Survival Rate |
| مستخلص: | 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. (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.) |
| فهرسة مساهمة: | Investigator: J Vincent, Department of Medical Oncology, Elkerliek Hospital, Helmond, The Netherlands.; JA Wegdam, Department of Surgery, Elkerliek Hospital, Helmond, The Netherlands.; BCM Haberkorn, Department of Medical Oncology, Maasstad Hospital, Rotterdam, The Netherlands.; E van der Harst, Department of Surgery, Maasstad Hospital, Rotterdam, The Netherlands.; MP Hendriks, Department of Medical Oncology, Northwest Clinics Alkmaar, Alkmaar, The Netherlands.; WHH Schreurs, Department of Surgery, Northwest Clinics Alkmaar, Alkmaar, The Netherlands.; HA Cense, Department of Surgery, Rode Kruis Hospital, Beverwijk, The Netherlands.; RC Rietbroek, Department of Medical Oncology, Rode Kruis Hospital, Beverwijk, The Netherlands.; MJ de Gier, Department of Medical Oncology, IJselland Hospital, Capelle aan den IJssel, The Netherlands.; EA van Breugel, Department of Surgery, Dijklander Hospital, Hoorn, The Netherlands.; AI de Vos, Department of Medical Oncology, Dijklander Hospital, Hoorn, The Netherlands.; RPM Brosens, Department of Medical Oncology, Het Van Weel-Bethesda Hospital, Dirksland, The Netherlands.; PG Doornebosch, Department of Surgery, Het Van Weel-Bethesda Hospital, Dirksland, The Netherlands.; FE de Jongh, Department of Surgery, IJselland Hospital Capelle aan den IJssel, The Netherlands.; WJ Vles, Department of Medical Oncology, Ikazia Hospital, Rotterdam, The Netherlands.; MO den Boer, Department of Medical Oncology, Laurentius Hospital, Roermond, The Netherlands.; JWA Leijtens, Department of Surgery, Laurentius Hospital Roermond, Roermond, The Netherlands.; AJH Gelderblom, Department of Medical Oncology, Leiden Univeristy Medical Center, Leiden, The Netherlands.; KCMJ Peeters, Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.; BC Kuenen, Department of Medical Oncology, Martini Hospital, Groningen, The Netherlands.; BB Pultrum, Department of Surgery, Martini Hospital, Groningen, The Netherlands.; JM van Dodewaard-de Jong, Department of Medical Oncology, Meander Medical Center, Amersfoort, The Netherlands.; ECJ Consten, Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands; Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands.; AJY van de Wouw, Department of Medical Oncology, Viecuri Medical Center, Venlo, The Netherlands.; JLM Konsten, Department of Surgery, VieCuri Medical Center, Venlo, The Netherlands.; R Hoekstra, Department of Medical Oncology, Ziekenhuisgroep Twente, Almelo, The Netherlands.; MF Lutke Holzik, Department of Surgery, Ziekenhuisgroep Twente, Almelo, The Netherlands.; AH Vos, Department of Medical Oncology, Bernhoven, Uden, The Netherlands.; MJ van Hoogstraten, Department of Surgery, Bernhoven, Uden, The Netherlands.; NH Schlesinger, Department of Surgery, Bispebjerg Hospital, Copenhagen, Denmark.; GJ Creemers, Department of Medical Oncology, Catharina Hospital, Eindhoven, The Netherlands.; IHJT de Hingh, Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands.; ML Kjær, Department of Surgery, Hvidovre Hospital, Hvidovre, Denmark.; LN Petersen, Department of Medical Oncology, Rigshospitalet, Copenhagen, Denmark.; M Seiersen, Department of Surgery, Roskilde Hospital, Roskilde, Denmark.; R Altaf, Department of Medical Oncology, Roskilde Hospital, Roskilde, Denmark.; H van Cruijsen, Department of Medical Oncology, Antonius Hospital Sneek, Sneek, The Netherlands.; DA Hess, Department of Surgery, Antonius Hospital Sneek, Sneek, The Netherlands.; LL van Leeuwen-Snoeks, Department of Medical Oncology, Diakonessenhuis, Utrecht, The Netherlands.; A Pronk, Department of Surgery, Diakonessenhuis, Utrecht, The Netherlands.; CIM Baeten, Department of Surgery, Groene Hart Hospital, Gouda, The Netherlands.; WM van der Deure, Department of Medical Oncology, Groene Hart Hospital, Gouda, The Netherlands.; K Bosscha, Department of Surgery, Jeroen Bosch Hospital, Den Bosch, The Netherlands.; H Schut, Department of Medical Oncology, Jeroen Bosch Hospital, Den Bosch, The Netherlands.; WKG Leclercq, Department of Surgery, Máxima Medical Center, Veldhoven, The Netherlands.; LHJ Simkens, Department of Medical Oncology, Máxima Medical Center, Veldhoven, The Netherlands.; K Reijnders, Department of Surgery, Slingeland Hospital, Doetinchem, The Netherlands.; K van Arkel, Department of Medical Oncology, Slingeland Hospital, Slingeland Hospital, Doetinchem, The Netherlands.; WMUH van Grevenstein, Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.; AWH van de Ven, Department of Surgery, Flevo hospital, Almere, The Netherlands.; RJCLM Vuylsteke, Department of Surgery, Spaarne Gasthuis, Haarlem, The Netherlands.; P Kuijer, Department of Medical Oncology, Spaarne Gasthuis, Haarlem, The Netherlands.; SD Bakker, Department of Medical Oncology, Zaans Medical Center, Noord-Holland, The Netherlands.; H Goei, Department of Surgery, Zaans Medical Center, Noord-Holland, The Netherlands.; HH Helgason, Department of Medical Oncology, Haaglanden Medical Center, Den Haag, The Netherlands.; GJD van Acker, Department of Surgery, Haaglanden Medical Center, Den Haag, The Netherlands.; M Temizkan, Department of Medical Oncology, Hospital St. Jansdal, Harderwijk, The Netherlands.; MWA van Tilburg, Department of Surgery, Hospital St. Jansdal, Harderwijk, The Netherlands.; MF Gerhards, Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.; ED Kerver, Department of Medical Oncology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.; E Gootjes, Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.; P Nieboer, Department of Medical Oncology, Wilhelmina Hospital Assen, Assen, The Netherlands.; WA Bleeker, Department of Surgery, Wilhelmina Hospital Assen, Assen, the Netherlands.; GR Bleeker, Department of Research and Development, Netherlands Comprehensive Cancer Organisation (IKNL). Keywords: metastatic colorectal cancer; primary tumor resection; systemic therapy |
| سلسلة جزيئية: | ClinicalTrials.gov NCT01606098 |
| المشرفين على المادة: | 2S9ZZM9Q9V (Bevacizumab) |
| تواريخ الأحداث: | Date Created: 20240609 Date Completed: 20240830 Latest Revision: 20240905 |
| رمز التحديث: | 20240906 |
| DOI: | 10.1016/j.annonc.2024.06.001 |
| PMID: | 38852675 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1569-8041 |
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| DOI: | 10.1016/j.annonc.2024.06.001 |