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Background

The Combination of Bevacizumab (Bev) with capecitabine/irinotecan (CapIri/Bev) or capecitabine/oxaliplatin (CapOx/Bev) is highly active in advanced colorectal cancer (ACRC): A randomized phase II study of the AIO Colorectal Study Group (AIO trial 0604).

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Background

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  1. The Combination of Bevacizumab (Bev) with capecitabine/irinotecan (CapIri/Bev) or capecitabine/oxaliplatin (CapOx/Bev) is highly active in advanced colorectal cancer (ACRC): A randomized phase II study of the AIO Colorectal Study Group (AIO trial 0604) A. Reinacher-Schick1, S. Kubicka2, W. Freier3, D. Arnold4, G. Dietrich5, M. Geißler6, S. Hegewisch-Becker7, U. Graeven8, H.-J. Schmoll4 and W. Schmiegel1, Ruhr University Bochum1, University Hannover2, Center of Oncology Hildesheim3, Martin-Luther-University Halle-Wittenberg4, Hospital Bietigheim, Bietigheim-Bissingen5, Community Hospital Esslingen6, Center of Oncology Eppendorf, Hamburg7, Maria Hilf Hospital Mönchengladbach8, Germany

  2. Background • Addition of Bevacizumab to 5FU/FA/irinotecan1 and 5FU/FA/oxaliplatin2,3 improves progression free survival (PFS) in advanced CRC (aCRC) • Efficacy of Capecitabine/Oxaliplatin (CapOx) is similar to 5-FU/FA/Oxaliplatin • Data on Capecitabine/Irinotecan (CapIri) combinations remains controversial, due to toxicity 4-7 1 Hurwitz, N Engl J Med 2004; 2 Giantonio, JCO 2007; 3 Saltz, JCO 2008; 4 Fuchs, JCO 2007; 5 Köhne, Ann Oncol 2008; 6 Grothey, ASCO 2003; 7 Koopman, Lancet 2007

  3. Aim To investigate whether bevacizumab in combination with CapOx or CapIri is effective for patients with aCRC

  4. Study Design Open-label, multicenter, randomized phase II study Primary endpoint: Rate of pts. without disease progression at 6 months: Exclude insufficient activity (defined as rate < 60%) Secondary endpoints: Overall survival, toxicity, resectability of liver/lung mets.

  5. Main eligibility criteria - written informed consent - histologically proven aCRC, measurable lesion (RECIST) - Age > 18 years - ECOG performance status < 2 - Adequate haematological, renal and hepatic function - no previous systemic immunotherapy or chemotherapy (except (neo)adjuvant therapy for non-metastatic disease > 6 months) - history of thrombosis or severe bleeding < 6 months, bleeding diathesis, therapeutic anticoagulation - proteinuria < +1 by dipstick urin analysis

  6. Treatment protocol • Arm A: d 1 d 15 • Oxaliplatin • 130mg/m2, 120min i.v. • Bevacizumab • 7,5 mg/kg i.v. • Capecitabine • 1000mg/m2 p.o., 2x daily • Arm B: (*) • Irinotecan • 200mg/m2, 30min i.v. • Bevacizumab • 7,5 mg/kg i.v. • Capecitabine • 800mg/m2 p.o., 2x daily • q 3wks • note dose reduction of CapIri compared to previous trials for safety reasons

  7. observed expected Patient accrual

  8. Baseline characteristics (n=247)

  9. Treatment characteristics (n=247)

  10. Reasons for end of treatment, EOT (n=222) *end of treatment information available for n=222 pts.

  11. CTC V. 3.0 Grade 3 and 4 Toxicities (n=247)

  12. AEs of special interest (n=247)

  13. Best overall response* (n=247) *ITT, RECIST criteria, investigator‘s assessment; **not evaluated/not available

  14. PFS rate after 6 months: Primary endpoint

  15. Progression free survival (PFS) - ITT analysis rate without progression months

  16. Overall survival (OS) - ITT analysis Survival rate months

  17. Conclusion • Both regimens, CapOx/Bev and CapIri/Bev, • are highly active in aCRC. • The dose reduction of CapIri/Bev may lead to a favourable toxicity profile compared to previous capecitabine/irinotecan trials seemingly without compromising efficacy • The CapIri/Bev arm - compared to the CapOx/Bev arm - seems to be associated with higher cycle numbers and a tendency towards longer PFS

  18. Acknowledgements • We would like to thank • - the patients and their families • the co-investigators • the study nurses and data monitors • Roche Pharma AG and Sanofi-Aventis for financial support

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