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The VEGF-A monoclonal antibody bevacizumab is currently recommended for first-line treatment of all metastatic colorectal cancer (mCRC) patients. Cost-benefit ratio and side-effects however necessitate patient selection. A large retrospective yet nonrandomized study showed that patients with loss of chromosome 18q11.2-q12.1 in the tumor and treated with bevacizumab have 3 months improved median progression-free (PFS) and overall survival (OS) benefit compared to patients without this loss and/or treatment modality. Implementation for loss of chromosome 18q11.2-q12.1 as a marker in clinical practice mandates evidence in a randomized controlled trial for bevacizumab. Of the trials with randomization of chemotherapy vs chemotherapy with bevacizumab, the AGITG-MAX trial was the only one with tumor materials available. Chromosome 18q11.2-q12.1 copy number status was measured for 256 AGITG-MAX trial patients and correlated with PFS according to a predefined analysis plan with marker-treatment interaction as the primary end-point. Chromosome 18q11.2-q12.1 losses were detected in 71% of patients (181/256) characteristic for mCRC. Consistent with the nonrandomized study, significant PFS benefit of bevacizumab was observed in patients with chromosome 18q11.2-q12.1 loss (P = .009), and not in patients without 18q loss (P = .67). Although significance for marker-treatment interaction was not reached (P interaction = .28), hazard ratio and 95% confidence interval of this randomized cohort (HR interaction = 0.72; 95% CI = 0.39-1.32) shows striking overlap with the nonrandomized study cohorts (HR interaction = 0.41; 95% CI = 0.32-0.8) supported by a nonsignificant Cochrane χ 2 test (P = .11) for heterogeneity. We conclude that post hoc analysis of the AGITG-MAX RCT provides supportive evidence for chromosome 18q11.2-q12.1 as a predictive marker for bevacizumab in mCRC patients.

Titel:	Predictive value of chromosome 18q11.2-q12.1 loss for benefit from bevacizumab in metastatic colorectal cancer: A post hoc analysis of the randomized phase III-trial AGITG-MAX.
Autor/in / Beteiligte Person:	van Dijk E ; van Werkhoven E ; Asher, R ; Mooi, JK ; Espinoza, D ; van Essen HF ; van Tinteren H ; van Grieken NCT ; Punt, CJA ; Tebbutt, NC ; Ylstra, B
Link:	Full Text Finder (Volltext)
Zeitschrift:	International journal of cancer, Jg. 151 (2022-10-01), Heft 7, S. 1166-1174
Veröffentlichung:	1995- : New York, NY : Wiley-Liss ; <i>Original Publication</i>: 1966-1984 : Genève : International Union Against Cancer, 2022
Medientyp:	academicJournal
ISSN:	1097-0215 (electronic)
DOI:	10.1002/ijc.34061
Schlagwort:	Antineoplastic Combined Chemotherapy Protocols therapeutic use Bevacizumab therapeutic use Chromosome Deletion Chromosomes Disease-Free Survival Fluorouracil therapeutic use Humans Retrospective Studies Colonic Neoplasms genetics Colorectal Neoplasms drug therapy Colorectal Neoplasms genetics Colorectal Neoplasms pathology Rectal Neoplasms drug therapy
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Language: English [Int J Cancer] 2022 Oct 01; Vol. 151 (7), pp. 1166-1174. <i>Date of Electronic Publication: </i>2022 May 23. MeSH Terms: Colonic Neoplasms* / genetics ; Colorectal Neoplasms* / drug therapy ; Colorectal Neoplasms* / genetics ; Colorectal Neoplasms* / pathology ; Rectal Neoplasms* / drug therapy ; Antineoplastic Combined Chemotherapy Protocols / therapeutic use ; Bevacizumab / therapeutic use ; Chromosome Deletion ; Chromosomes ; Disease-Free Survival ; Fluorouracil / therapeutic use ; Humans ; Retrospective Studies References: Bioinformatics. 2009 Jul 15;25(14):1754-60. (PMID: 19451168) ; N Engl J Med. 2004 Jun 3;350(23):2335-42. (PMID: 15175435) ; Eur J Cancer. 2019 Jan;106:37-44. (PMID: 30476731) ; Clin Colorectal Cancer. 2019 Jun;18(2):141-148. (PMID: 30713134) ; Sci Rep. 2020 Jun 17;10(1):9778. (PMID: 32555399) ; Nucleic Acids Res. 2021 Dec 2;49(21):12007-12016. (PMID: 34230973) ; Acta Oncol. 2020 Apr;59(4):395-403. (PMID: 32048563) ; Clin Pharmacol Ther. 2015 Jul;98(1):34-46. (PMID: 25868461) ; Cancer Treat Rev. 2021 Jun;97:102202. (PMID: 33838596) ; J Clin Oncol. 2011 Jul 1;29(19):2675-82. (PMID: 21646616) ; Am J Clin Oncol. 1982 Dec;5(6):649-55. (PMID: 7165009) ; Clin Cancer Res. 2018 Sep 15;24(18):4365-4370. (PMID: 29743182) ; Nat Rev Clin Oncol. 2021 Aug;18(8):506-525. (PMID: 33864051) ; Nat Med. 2015 Nov;21(11):1350-6. (PMID: 26457759) ; J Clin Oncol. 2012 Feb 20;30(6):608-15. (PMID: 22253466) ; Ann Oncol. 2018 Nov 1;29(11):2240-2246. (PMID: 30247524) ; J Clin Oncol. 2010 Jul 1;28(19):3191-8. (PMID: 20516443) ; Oncotarget. 2017 Jun 27;8(26):42949-42961. (PMID: 28487489) ; JAMA. 2011 Feb 2;305(5):487-94. (PMID: 21285426) ; Genome Res. 2014 Dec;24(12):2022-32. (PMID: 25236618) ; Nat Commun. 2018 Oct 5;9(1):4112. (PMID: 30291241) ; Eur J Cancer. 2019 Mar;109:175-182. (PMID: 30735919) ; J Clin Oncol. 2013 Mar 20;31(9):1219-30. (PMID: 23401453) ; Clin Cancer Res. 2013 Jun 1;19(11):2824-7. (PMID: 23549876) ; Nucleosides Nucleotides Nucleic Acids. 2006;25(9-11):1001-7. (PMID: 17065054) ; Stat Med. 2000 Feb 29;19(4):441-52. (PMID: 10694729) ; J Clin Oncol. 2015 Jan 1;33(1):22-8. (PMID: 25385741) ; J Clin Oncol. 2018 Jul 10;36(20):2052-2060. (PMID: 29792754) ; BMC Bioinformatics. 2016 Jul 25;17 Suppl 7:239. (PMID: 27454357) ; J Clin Oncol. 2015 Nov 10;33(32):3838-9. (PMID: 26304897) ; JAMA Oncol. 2019 Feb 1;5(2):236-242. (PMID: 30489611) ; Digestion. 2016;94(3):129-137. (PMID: 27756074) ; Clin Colorectal Cancer. 2018 Mar;17(1):58-64. (PMID: 29157662) ; BMC Cancer. 2016 Aug 24;16:677. (PMID: 27558497) ; Nat Rev Clin Oncol. 2009 Aug;6(8):465-77. (PMID: 19581909) ; Nature. 2012 Jul 18;487(7407):330-7. (PMID: 22810696) ; Nat Commun. 2014 Nov 14;5:5457. (PMID: 25394515) ; Am Health Drug Benefits. 2013 Sep;6(8):469-78. (PMID: 24991376) ; Ann Oncol. 2016 Aug;27(8):1386-422. (PMID: 27380959) ; Bioinformatics. 2009 May 1;25(9):1099-104. (PMID: 19276148) ; Acta Oncol. 2012 Sep;51(7):890-6. (PMID: 22974094) ; Int J Cancer. 2022 Oct 1;151(7):1166-1174. (PMID: 35489024) ; J Clin Oncol. 2009 Sep 20;27(27):4591-8. (PMID: 19704056) ; Sci Rep. 2017 Jul 31;7(1):6882. (PMID: 28761069) ; J Clin Oncol. 2021 Mar 1;39(7):861-862. (PMID: 33439690) ; N Engl J Med. 2009 Feb 5;360(6):563-72. (PMID: 19196673) ; Bioinformatics. 2007 Mar 15;23(6):657-63. (PMID: 17234643) ; J Clin Oncol. 2008 Apr 20;26(12):2013-9. (PMID: 18421054) ; Bioinformatics. 2007 Apr 1;23(7):892-4. (PMID: 17267432) ; Clin Transl Med. 2021 Apr;11(4):e401. (PMID: 33931971) Contributed Indexing: Keywords: anti-VEGF monoclonal antibody; bevacizumab; chromosome 18q; metastatic colorectal cancer; predictive biomarker; randomized controlled trial Substance Nomenclature: 2S9ZZM9Q9V (Bevacizumab) ; U3P01618RT (Fluorouracil) Entry Date(s): Date Created: 20220430 Date Completed: 20220812 Latest Revision: 20221015 Update Code: 20240513 PubMed Central ID: PMC9545440

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Predictive value of chromosome 18q11.2-q12.1 loss for benefit from bevacizumab in metastatic colorectal cancer: A post hoc analysis of the randomized phase III-trial AGITG-MAX.