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Authors: Juan Valle et al Reviewed by : Scott Berry Date posted: June 2009

UK ABC-02 trial: Gemcitabine with or without cisplatin in patients (pts) with advanced or metastatic biliary tract cancer (ABC): Results of a multicenter, randomized phase III trial. Authors: Juan Valle et al Reviewed by : Scott Berry Date posted: June 2009. Gem 1000 mg/m 2 D1,8,15 q 28d

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Authors: Juan Valle et al Reviewed by : Scott Berry Date posted: June 2009

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  1. UK ABC-02 trial: Gemcitabine with or without cisplatin in patients (pts) with advanced or metastatic biliary tract cancer (ABC): Results of a multicenter, randomized phase III trial. Authors: Juan Valle et al Reviewed by : Scott Berry Date posted: June 2009

  2. Gem 1000 mg/m2 D1,8,15 q 28d 24 weeks (6 cycles) N=410 R Cisplatin 25 mg/m2 + Gem 1000 mg/m2 D1,8 q 21d 24 weeks (8 cycles) Locally Advanced/ Metastatic CholangioCA Gall Bladder CA Periampullary CA

  3. RESULTS

  4. Adverse events: Grade 3-4

  5. Adverse events: Grade 3-4

  6. STUDY COMMENTARY • First demonstration of survival benefit in advanced biliary cancer • Statistically and Clinically significant improvement • Benefit gained with no clinically significant added toxicity

  7. BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS • Important trial that demonstrated a clinically significant survival benefit with an inexpensive and easily available agent • The control arm of NCIC BI.1 (Gem vs Gem / Capecitabine) will need to be re-considered given the results of this trial

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