Efficacy and quality of life for FOLFOX/bevacizumab +/- irinotecan in first-line metastatic colorectal cancer-final results of the AIO CHARTA trial.

Autor: Schmoll HJ; Clinic for Internal Medicine IV-Hematology/Oncology, University Clinic, Martin-Luther-University, Halle-Wittenberg, Germany., Mann J; Department of Medicine, Hematology and BMT with section Pneumology, University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Meinert F; Clinic for Internal Medicine IV-Hematology/Oncology, University Clinic, Martin-Luther-University, Halle-Wittenberg, Germany., Garlipp B; Department for Surgery, Oberhavel Kliniken Oranienburg, Oranienburg, Germany., Borchert K; Clinic for Oncology/Hematology Klinikum Magdeburg, Magdeburg, Germany., Vogel A; Clinic for Gastroenterology, Medical University Hannover, Hannover, Germany., Goekkurt E; Department of Medicine, Hematology and BMT with section Pneumology, University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Kaiser U; Clinic for Hematology/Oncology, St. Bernward Krankenhaus, Hildesheim, Germany., Hoeffkes HG; Tumorclinic, Klinikum Fulda, Fulda, Germany., Rüssel J; Clinic for Internal Medicine IV-Hematology/Oncology, University Clinic, Martin-Luther-University, Halle-Wittenberg, Germany., Kanzler S; Medical Clinic II, Leopoldina Clinic Schweinfurt, Schweinfurt, Germany., Edelmann T; Oncological Practice Schkeuditz, Schkeuditz, Germany., Forstbauer H; Oncological Practice Rheinsieg, Bonn, Germany., Göhler T; Oncological Center Dresden, Dresden, Germany., Hannig C; Oncological Practice Bottrop, Bottrop, Germany., Hildebrandt B; Clinic for Gastroenterology, Hematology and Medical Oncology, Klinikum Barnim, Eberswalde, Germany., Roll C; Clinic for Oncology/Hematology Klinikum Magdeburg, Magdeburg, Germany., Bokemeyer C; Department of Medicine, Hematology and BMT with section Pneumology, University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Steighardt J; Coordination Center for Clinical Trials Halle, Medical Faculty, Martin-Luther-University, Halle-Wittenberg, Germany., Cygon F; Clinic for Internal Medicine IV-Hematology/Oncology, University Clinic, Martin-Luther-University, Halle-Wittenberg, Germany., Ibach S; X-act Cologne Clinical Research GmbH, Köln, Germany., Stein A; Department of Medicine, Hematology and BMT with section Pneumology, University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Tintelnot J; Department of Medicine, Hematology and BMT with section Pneumology, University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. j.tintelnot@uke.de.
Jazyk: angličtina
Zdroj: British journal of cancer [Br J Cancer] 2024 Feb; Vol. 130 (2), pp. 233-241. Date of Electronic Publication: 2023 Nov 23.
DOI: 10.1038/s41416-023-02496-4
Abstrakt: Background: FOLFOXIRI plus bevacizumab has demonstrated benefits for metastatic colorectal cancer (mCRC) patients. However, challenges arise in its clinical implementation due to expected side effects and a lack of stratification criteria.
Methods: The AIO "CHARTA" trial randomised mCRC patients into clinical Group 1 (potentially resectable), 2 (unresectable/risk of rapid progression), or 3 (asymptomatic). They received FOLFOX/bevacizumab +/- irinotecan. The primary endpoint was the 9-month progression-free survival rate (PFSR@9). Secondary endpoints included efficacy in stratified groups, QoL, PFS, OS, ORR, secondary resection rate, and toxicity.
Results: The addition of irinotecan to FOLFOX/bevacizumab increased PFSR@9 from 56 to 67%, meeting the primary endpoint. The objective response rate was 61% vs. 69% (P = 0.21) and median PFS was 10.3 vs. 12 months (HR 0.83; P = 0.17). The PFS was (11.4 vs. 12.9 months; HR 0.83; P = 0.46) in potentially resectable patients, with a secondary resection rate of 37% vs. 51%. Moreover, Group 3 (asymptomatic) patients had a PFS of 11.1 vs. 16.1 months (HR 0.6; P = 0.14). The addition of irinotecan did not diminish QoL.
Conclusion: The CHARTA trial, along with other studies, confirms the efficacy and tolerability of FOLFOXIRI/bevacizumab as a first-line treatment for mCRC. Importantly, clinical stratification may lead to its implementation.
Trial Registration: The trial was registered as NCT01321957.
(© 2023. The Author(s).)
Databáze: MEDLINE
Externí odkaz: