Upfront FOLFOXIRI+bevacizumab followed by fluoropyrimidin and bevacizumab maintenance in patients with molecularly unselected metastatic colorectal cancer

British Journal of Cancer
Alexander SteinCarsten Bokemeyer

Abstract

The addition of bevacizumab (BEV) to standard doublet chemotherapy improves outcomes compared with chemotherapy alone in patients with metastatic colorectal cancer (mCRC). The OPAL study examined the effect of BEV+FOLFOXIRI followed by 5FU/LV and BEV maintenance on progression-free survival (PFS) in patients with previously untreated unresectable mCRC. Eligible patients had histologically confirmed mCRC, ECOG performance status ⩽1 and were 18-70 years old. Patients received up to 12 cycles of FOLFOXIRI+BEV q2w (induction phase) followed by up to ⩽40 cycles of 5FU/LV+BEV q2w (maintenance phase). Median PFS was the primary end point; secondary end points included response, OS, secondary resection rate, safety and prognostic value of pharmacogenetic profiling. Ninety-seven patients were enrolled. Of these, 90 received study medication and formed the safety population: 64 males; median age 58 (range 28-71) years; ECOG performance status 0/1 in 54%/46% patients; and liver only disease in 35 patients. Relative dose intensities were 79-85% for all four drugs. The incidence of adverse events (AEs) was as previously reported and there were no new safety signals. In total, 87 serious AEs occurred in 39 patients (43%). Median PFS was 11.1...Continue Reading

References

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Citations

Feb 7, 2016·Critical Reviews in Oncology/hematology·Yu SunakawaHeinz-Josef Lenz
Feb 11, 2016·Annals of Oncology : Official Journal of the European Society for Medical Oncology·C CremoliniA Falcone
Jul 7, 2016·Annals of Oncology : Official Journal of the European Society for Medical Oncology·E Van CutsemD Arnold
Jul 24, 2020·Oncology and Therapy·Riccardo GiampieriRossana Berardi
Mar 20, 2019·Expert Opinion on Biological Therapy·Pilar García-AlfonsoAriadna Lloansí
Nov 21, 2017·Annals of Oncology : Official Journal of the European Society for Medical Oncology·T YoshinoJ-Y Douillard

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Clinical Trials Mentioned

NCT00940303

Software Mentioned

OPAL

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