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Treatment 6 cycles of: Doxorubicin 60 mg/m 2 IV* Day 1 in 21-day cycles Sorafenib 400 mg po bid

Final Results From a Phase II, Randomized, Double-blind Study of Sorafenib Plus Doxorubicin Versus Placebo Plus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma. Authors: Abou-Alfa GK, Johnson P, Knox J, Davidenko I, Lacava J, Leung T, Mori A, Leberre M-A, Voliotis D, & Saltz LB

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Treatment 6 cycles of: Doxorubicin 60 mg/m 2 IV* Day 1 in 21-day cycles Sorafenib 400 mg po bid

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  1. Final Results From a Phase II, Randomized, Double-blind Study of Sorafenib Plus Doxorubicin Versus Placebo Plus Doxorubicin in Patients With Advanced HepatocellularCarcinoma Authors: Abou-Alfa GK, Johnson P, Knox J, Davidenko I, Lacava J, Leung T, Mori A, Leberre M-A, Voliotis D, & Saltz LB Date posted: October 22, 2007

  2. Randomized Phase II Study N= 96 Primary Outcome: TTP • Treatment 6 cycles of: • Doxorubicin 60 mg/m2 IV* Day 1 in 21-day cycles • Sorafenib 400 mg po bid ThenSorafenib 400 mg po bid R * In approved circumstances , doxorubicin doses of up to 450 mg/m2 allowed • Treatment 6 cycles of: • Doxorubicin 60 mg/m2 IV* Day 1 in 21-day cycles • Placebo 2 tablets po bid ThenPlacebo 2 tablets po bid • Advanced • Hepatocellular CA • ECOG 0-2 • Child’s Pugh A • No Previous • Chemoembolization

  3. RESULTS - Demographics

  4. RESULTS • Considering the interim results of the Phase III SHARP trial(sorafenib vs placebo), an Independent Data Monitoring Committee (DMC) performed an interim analysis in January 2007 • “DMC would advise the sponsor to consider discontinuation of this Phase II trial”

  5. RESULTS

  6. TOXICITY

  7. STUDY COMMENTARY • This randomized phase II trial demonstrated a statistically and clinically significant survival benefit for adriamycin and sorafenib vs adriamycin and placebo • Coupled with the SHARP trial (Sorafenib vs Placebo - Llovet, ASCO 2007) supports growing body of evidence for sorafenib in HCC • Larger trials necessary to determine optimal role of adriamycin/sorafenib in HCC

  8. BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS • Sorafenib and adriamycin and sorafenib as a single agent could be considered for use in patients with HCC who are candidates for systemic therapy • Cost and reimbursement of sorafenib may limit its widespread use in Canada

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