MOSAIC

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Slide 1: 

MOSAIC Trial: Final results of the study: 6 years overall survival ( OS) and 5 year updated DFS

Introduction : 

Introduction To determine whether the improved efficacy observed with oxaliplatin in the metastatic setting translates into benefits in stage II or III colon cancer In mCRC (stage IV), Oxaliplatin with FL have shown improved efficacy compared with FL alone Andre, et.al, conducted a large international phase III clinical trial in stage II or III colon cancer (Multicenter International Study of Oxaliplatin/5-Fluorouracil/ Leucovorin in the Adjuvant Treatment of Colon Cancer [MOSAIC])

Slide 3: 

Patients randomly assigned N = 2,246 FOLFOX4 (n = 1,123) FU+ Leucovorin +Oxaliplatin LV5FU2 (n = 1,123) FU+ Leucovorin Study design Primary end point: Disease free survival Secondary end point: Overall survival

Slide 4: 

Disease-free survival 20% reduction in the risk of relapse in favor of FOLFOX4

Slide 5: 

Overall survival 16% reduction in the risk of death in favor of FOLFOX4 Median time from relapse to death was 21 months in FOLFOX4 group and 24 months in LV5FU2 group

Safety : 

Safety The frequency of grade 3 peripheral sensory neuropathy among patients in the FOLFOX4 group declined during the follow-up period Grade 3 peripheral sensory neuropathy is 12.5% during treatment and reduce to 0.7% after 48 weeks of treatment

Conclusion : 

Conclusion The significant DFS and OS benefits observed with the addition of Oxaliplatin to FL 6-year OS and 5-year DFS shows statistical significance and clinical relevance in FOLFOX4 arm among stage III patients Adjuvant Oxaliplatin plus FU and LV shows benefit after surgery for patients undergoing treatment with a curative intent for stage III colon cancer

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