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Bruce J. Giantonio, Paul J. Catalano, Peter J. O’Dwyer, Neal J. Meropol, and Al B. Benson III.

Impact of Bevacizumab Dose Reduction on Clinical Outcomes for Patients Treated on the Eastern Cooperative Oncology Group’s Study E3200. Bruce J. Giantonio, Paul J. Catalano, Peter J. O’Dwyer, Neal J. Meropol, and Al B. Benson III.

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Bruce J. Giantonio, Paul J. Catalano, Peter J. O’Dwyer, Neal J. Meropol, and Al B. Benson III.

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  1. Impact of Bevacizumab Dose Reduction on Clinical Outcomes for Patients Treated on the Eastern Cooperative Oncology Group’s Study E3200. Bruce J. Giantonio, Paul J. Catalano, Peter J. O’Dwyer, Neal J. Meropol, and Al B. Benson III. University of Pennsylvania, Philadelphia, PA, Dana-Farber Cancer Institute, Boston, MA Fox Chase Cancer Center, Philadelphia, PA, Northwestern University, Chicago, IL

  2. Bevacizumab dose reduction/discontinuation criteria Dose reductions of bevacizumab to 5mg/kg were permitted for the following: • Hypertension, bleeding, and thrombosis  Grade 2, • Proteinuria of < 2 grams/24 hours that resolved to < 0.5 grams/24 hrs, • Liver function test abnormalities  grade 3 that resolved to  Grade 1. Discontinuation of bevacizumab was required for: • any of the above events that occurred at a grade in excess of that which didn’t meet criteria for reduction, or • that did not resolve to the specified grade required for continuation. Note, the occurrence of Grade 3 thrombosis (defined as requiring anticoagulation) required discontinuation of bevacizumab Giantonio ASCO 06

  3. Methods 1. Data on the application of dose reduction and discontinuation were obtained from a post study survey of institutions for all study participants who were treated with bevacizumab. 2. Median overall survival, median progression free survival, and hazard ratios were computed for patients who either had their bevacizumab discontinued (provided at least one cycle was administered), dose reduced, or dose reduced followed by discontinuation. Giantonio ASCO 06

  4. E3200: Study Design • Stratification factors: • ECOG PS: 0 vs 1, 2 • Prior XRT FOLFOX4 + Bevacizumab (10 mg/kg, q 2 weeks) PD Previously treated metastatic CRC PD FOLFOX4 Bevacizumab (10mg/kg, q 2 wks) PD Giantonio ASCO 06

  5. Dose Modification/Reduction Survey Giantonio ASCO 06

  6. Survey Response Demographics Giantonio ASCO 06

  7. Survey Responses Giantonio ASCO 06

  8. Dose Reductions by Toxicity Giantonio ASCO 06

  9. Discontinuations by Toxicity Giantonio ASCO 06

  10. Outcomes by reduction/discontinuation of bevacizumab Giantonio ASCO 06

  11. Conclusions • Study specified dose reduction and/or discontinuation of bevacizumab was performed for adverse events in 56% and 38% of patients treated in Arms A and C who responded to the questionnaire. • Hypertension and proteinuria were the most common reasons for bevacizumab dose reduction or discontinuation. • Overall survival and progression free survival were not compromised for patients who underwent dose reductions or discontinuation of bevacizumab. • Randomized clinical trials will be required to determine the optimal dose of bevacizumab used in combination with chemotherapy for the treatment of colorectal cancer. Giantonio ASCO 06

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