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Schmoll, Hans-Joachim; Mann, Julia; Meinert, Fabian; Garlipp, Benjamin; Borchert, Kersten; Vogel, Arndt; Goekkurt, Eray; Kaiser, Ulrich; Hoeffkes, Heinz-Gert; Rüssel, Jörn; Kanzler, Stephan; Edelmann, Thomas; Forstbauer, Helmut; Göhler, Thomas; Hannig, Carla; Hildebrandt, Bert; Roll, Carsten; Bokemeyer, Carsten; Steighardt, Jörg; Cygon, Franziska; Ibach, Stefan; Stein, Alexander; Tintelnot, Joseph

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

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  • Media type: E-Article
  • Title: Efficacy and quality of life for FOLFOX/bevacizumab +/− irinotecan in first-line metastatic colorectal cancer—final results of the AIO CHARTA trial
  • Contributor: Schmoll, Hans-Joachim; Mann, Julia; Meinert, Fabian; Garlipp, Benjamin; Borchert, Kersten; Vogel, Arndt; Goekkurt, Eray; Kaiser, Ulrich; Hoeffkes, Heinz-Gert; Rüssel, Jörn; Kanzler, Stephan; Edelmann, Thomas; Forstbauer, Helmut; Göhler, Thomas; Hannig, Carla; Hildebrandt, Bert; Roll, Carsten; Bokemeyer, Carsten; Steighardt, Jörg; Cygon, Franziska; Ibach, Stefan; Stein, Alexander; Tintelnot, Joseph
  • imprint: Springer Science and Business Media LLC, 2024
  • Published in: British Journal of Cancer
  • Language: English
  • DOI: 10.1038/s41416-023-02496-4
  • ISSN: 0007-0920; 1532-1827
  • Keywords: Cancer Research ; Oncology
  • Origination:
  • Footnote:
  • Description: <jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Results</jats:title> <jats:p>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% (<jats:italic>P</jats:italic> = 0.21) and median PFS was 10.3 vs. 12 months (HR 0.83; <jats:italic>P</jats:italic> = 0.17). The PFS was (11.4 vs. 12.9 months; HR 0.83; <jats:italic>P</jats:italic> = 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; <jats:italic>P</jats:italic> = 0.14). The addition of irinotecan did not diminish QoL.</jats:p> </jats:sec><jats:sec> <jats:title>Conclusion</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Trial registration</jats:title> <jats:p>The trial was registered as NCT01321957.</jats:p> </jats:sec>