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ECCO ESMO 2011 GI Cancer Updates TAS102 and BSC vs. Placebo and BSC

ECCO ESMO 2011 GI Cancer Updates TAS102 and BSC vs. Placebo and BSC. Reviewer: Dr. Scott Berry Date posted: October 2011.

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ECCO ESMO 2011 GI Cancer Updates TAS102 and BSC vs. Placebo and BSC

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  1. ECCO ESMO 2011 GI Cancer UpdatesTAS102 and BSC vs. Placebo and BSC Reviewer: Dr. Scott Berry Date posted: October 2011

  2. A multicenter, randomized, double-blind, phase II study of TAS-102 plus best supportive care (BSC) versus Placebo plus BSC in patients with chemotherapy-refractory metastatic colorectal cancer (10040030 study)Presenter: Y. Kuboki (The Cancer Institute Hospital of JFCR, Tokyo, Japan)

  3. Background • TAS-102 is a new oral anticancer agent that combines trifluorothymidine and thymidine phosphorylase inhibitor at a molar ratio of 1:0.5 • trifluorothymidine inhibits thymidylate synthase and DNA synthesis • thymidine phosphorylase inhibitor prevents the degradation of trifluorothymidine

  4. TAS-102+BSC vs P+BSC N= 169 Primary Outcome: Overall Survival n=112 TAS-102+BSC 70mg/m2b.i.d q4wks (d 1-5, 8-12) R 2:1 • Patient Population • 2 or more prior regimens • Refractory/Intolerant of: • fluoropyrimidine • irinotecan • oxaliplatin • ECOG PS 0-2 n=57 Placebo + BSC

  5. Prior Chemotherapy

  6. RESULTS

  7. Major Adverse Events (Grade 3/4) There were no treatment related deaths

  8. Post-Treatment

  9. STUDY COMMENTARY • Interesting subset analysis based on the KRAS status of the patients’ tumours: • KRAS WT OS HR = 0.70 • KRAS MUT OS HR = 0.44 • However: • ? Biologic rationale • Needs to be validated in future trials • Given that this study was done solely in Japan – would be good to have clinical data from a broader patient population

  10. BOTTOM LINE FOR MEDICAL ONCOLOGISTS • We are seeing more treatment refractory patients like the patients in this trial that are fit for further therapy – especially patients with KRAS Mutant tumours • This randomized phase II trial of this novel agent demonstrated a statistically and clinically significant improvement in OS in this group of patients • However a larger, confirmatory phase III trial is needed before it could be considered a standard of care

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