NSABP Protocol C-08 Ming He MD

Stage II or III resected colon cancer NSABP C-08 Randomize Oxaliplatinum Leucovorin 5-FU Repeat every 2 weeks x 6 months Bevacizumab on Day 1 of every chemotherapy cycle, then continued every 2 weeks for a total of 1 year Oxaliplatinum Leucovorin 5-FU Repeat every 2 weeks x 6 months

Prognostic Factors in Stage II Colon Cancer Obstructing tumor Perforated tumor Lymphatic or vascular invasion Poorly differentiated histology

NSABP C-08: Group A 14-day cycle 46-hour infusion 5-fluorouracil 400 mg/m2 5-fluorouracil 2400 mg/m2 Oxaliplatinum 85 mg/m2 + Leucovorin 400 mg/m2

NSABP C-08: Group B 14-day cycle 46-hour infusion 5-fluorouracil 400 mg/m2 5-fluorouracil 2400 mg/m2 Oxaliplatinum 85 mg/m2 + Leucovorin 400 mg/m2 Bevacizumab 5 mg/kg

Selected Adverse Events in Relation to Bevcizumab Table 4. Selected Adverse Events. Hurwitz, H. et al. N Engl J Med 2004;350:2335-2342

Adverse Events in Relation to Bevacizumab Increased risk of post operative bleeding and wound healing complications while receiving Bevacizumab Immediate and long term effect on fertility and pregnancy unknown Teratogenic in animal studies

Patient Eligibility Randomization occurs beginning post operative Day 29 and ending post operative Day 50 Adenocarcinoma En bloc curative resection Distal extent of tumor must be at least 12cm from anal verge Blood pressure of less than or equal to 150/90

Exclusions Significant bleeding within 6 months Non healing wound Active GI ulcers Surgery, open biopsy, trauma within 28 days Minor procedure within 7 days Any previous CNS ischemia Peripheral or visceral arterial ischemia within 6 months