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First efficacy and safety results from XELOX-1

XELOX placebo N=350. FOLFOX4 placebo N=351. XELOX bevacizumabN=350. FOLFOX4 bevacizumabN=350. XELOX N=317. FOLFOX4 N=317. Initial 2-arm open-label study (N=634). Protocol amended to 2x2 placebo-controlled design after bevacizumab phase III data1 became available (N=1401). Recruitmen

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First efficacy and safety results from XELOX-1

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    1. First efficacy and safety results from XELOX-1/NO16966, a randomised 2x2 factorial phase III trial of XELOX vs FOLFOX4 + bevacizumab or placebo in first-line metastatic colorectal cancer Professor Jim Cassidy Cancer Research UK Department of Oncology, University of Glasgow On behalf of the XELOX-1/NO16966 investigators

    2. NO16966 study design

    3. Study drugs

    4. Study objectives Main endpoint = progression-free survival (PFS) Two primary objectives XELOX is non-inferior to FOLFOX Non-inferiority concluded if upper limit of 97.5% CI = 1.23 Bevacizumab + chemotherapy* is superior to placebo + chemotherapy Superiority concluded if p = 0.025

    5. Study populations ITT (intent-to-treat) = all randomised* used for the bevacizumab superiority analyses EPP (eligible patient population) = ITT minus major protocol violators and patients not receiving at least one dose of study drug used for the XELOX non-inferiority analyses due to health authority requirements Safety population = all patients receiving at least one dose of the respective study drug

    6. Baseline characteristics

    7. XELOX non-inferiority question

    8. PFS XELOX non-inferiority: primary objective met based on ITT

    9. PFS XELOX non-inferiority: primary objective met based on EPP

    10. PFS non-inferiority subgroup analysis

    11. Safety profile: FOLFOX vs XELOX

    12. Bevacizumab superiority question

    13. PFS chemotherapy + bevacizumab superiority: primary objective met

    14. PFS chemotherapy + bevacizumab superiority: XELOX and FOLFOX subgroups

    15. PFS superiority subgroup analysis

    16. Hypothesis: FOLFOX + placebo patients with prior adjuvant therapy have better baseline prognosis

    17. Safety profile: chemotherapy + placebo or bevacizumab

    18. Comparison of treatment duration and PFS in AVF2107 vs NO16966

    19. Comparison of treatment duration and PFS in AVF2107 vs NO16966

    20. Conclusions XELOX XELOX is non-inferior to FOLFOX XELOX and FOLFOX safety profiles are balanced XELOX offers the advantage of oral fluoropyrimidine administration XELOX is a good alternative to FOLFOX

    21. Conclusions Bevacizumab 1st evidence from 1st line CRC phase III trial that bevacizumab adds clinically meaningful statistically superior benefit to oxaliplatin-based chemotherapy Safety profile overall in line with previous trial experience in colorectal cancer The outcome of this trial adds to the large body of evidence supporting the use of bevacizumab in combination with standard 1st line chemotherapy

    22. Thank you to… The patients participating in this trial and their families The investigators The study nurses and site coordinators The study management team at Roche

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