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Reviewer: Dr Phil Bedard Date posted: June 21, 2007

Oxaliplatin/5FU/LV in adjuvant colon cancer: Updated efficacy results of the MOSAIC trial, including survival, with a median follow-up of six years Authors: Gramont et al. Reviewer: Dr Phil Bedard Date posted: June 21, 2007. Background. MOSAIC trial Primary endpoint = DFS

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Reviewer: Dr Phil Bedard Date posted: June 21, 2007

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  1. Oxaliplatin/5FU/LV in adjuvant colon cancer: Updated efficacy results of the MOSAIC trial, including survival, with a median follow-up of six years Authors: Gramont et al. Reviewer: Dr Phil Bedard Date posted: June 21, 2007

  2. Background • MOSAIC trial • Primary endpoint = DFS • Advantage in 3-yr and 5-yr DFS for FOLFOX4 compared with LV5FU2 in Stage II or III colon cancer • Secondary endpoint = OS, safety

  3. Study Design FOLFOX4 Leucovorin 200mg/m2 IV over 2 hours 5-FU 400mg/m2 IV over 2 hours, then 600mg/m2 continuous IV infusion over 22 hours days 1 and 2 Oxaliplatin 85mg/m2 IV N=1123 Patients with resected Stage II or Stage III colon cancer N=2246 LV5FU2 Leucovorin 200mg/m2 IV over 2 hours 5-FU 400mg/m2 IV over 2 hours, then 600mg/m2 continuous IV infusion over 22 hours days 1 and 2 N=1123

  4. Results: 6-yr OS High-risk stage II- defined as at least one of the following: T4, tumor perforation, bowel obstruction, poorly differentiated tumor, venous invasion , <10 lymph nodes examined 5 Yr DFS HR 0.74 (0.52-1.06) 5 yr DFS 82.1 % (FOLFOX 4 vs 74.9% LV5FU2)

  5. Results • Incidence of peripheral neuropathy at 4 years in FOLFOX 4 arm • Grade 1: 12.0% • Grade 2: 2.8% • Grade 3: 0.7%

  6. Study Commentary • There is an OS benefit for Stage III patients with FOLFOX4 • DFS but no OS survival benefit in high risk stage II patients • There may not have been power to detect a survival benefit in this subset of patients • ? Meta analysis possible with patients from NSABP C07 • Although there is evidence of recovery from peripheral neuropathy, • 15% of patients had neuropathy at 4 years • < 1 % have grade 3 neuropathy at 4 yrs

  7. Bottom Line for Canadian Medical Oncologists • Adjuvant FOLFOX4 improves DFS and OS in resected stage III colon cancer • ? Role of FOLFOX4 in high risk stage II • There is no role for FOLFOX4 in low-risk stage II colon cancer • Patients should be warned about the risk of persistent neuropathy with oxaliplatin

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