TY - JOUR
T1 - Efficacy and quality of life for FOLFOX/bevacizumab +/− irinotecan in first-line metastatic colorectal cancer—final results of the AIO CHARTA trial
AU - Schmoll, Hans Joachim
AU - Mann, Julia
AU - Meinert, Fabian
AU - Garlipp, Benjamin
AU - Borchert, Kersten
AU - Vogel, Arndt
AU - Goekkurt, Eray
AU - Kaiser, Ulrich
AU - Hoeffkes, Heinz Gert
AU - Rüssel, Jörn
AU - Kanzler, Stephan
AU - Edelmann, Thomas
AU - Forstbauer, Helmut
AU - Göhler, Thomas
AU - Hannig, Carla
AU - Hildebrandt, Bert
AU - Roll, Carsten
AU - Bokemeyer, Carsten
AU - Steighardt, Jörg
AU - Cygon, Franziska
AU - Ibach, Stefan
AU - Stein, Alexander
AU - Tintelnot, Joseph
N1 - Publisher Copyright:
© 2023, The Author(s).
PY - 2024/2/10
Y1 - 2024/2/10
N2 - 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.
AB - 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.
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U2 - 10.1038/s41416-023-02496-4
DO - 10.1038/s41416-023-02496-4
M3 - Article
C2 - 37996507
AN - SCOPUS:85177691426
SN - 0007-0920
VL - 130
SP - 233
EP - 241
JO - British Journal of Cancer
JF - British Journal of Cancer
IS - 2
ER -