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Valle JW et al. ASCO 2009; Abstract 4503. (Oral Presentation)

Gemcitabine With or Without Cisplatin in Patients with Advanced or Metastatic Biliary Tract Cancer (ABC): Results of a Multicentre, Randomized Phase III Trial (The UK ABC-02 Trial). Valle JW et al. ASCO 2009; Abstract 4503. (Oral Presentation). Introduction.

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Valle JW et al. ASCO 2009; Abstract 4503. (Oral Presentation)

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  1. Gemcitabine With or Without Cisplatin in Patients with Advanced or Metastatic Biliary Tract Cancer (ABC): Results of a Multicentre, Randomized Phase III Trial (The UK ABC-02 Trial) Valle JW et al. ASCO 2009; Abstract 4503. (Oral Presentation)

  2. Introduction • Biliary tract cancers (BTC: cholangiocarcinoma, gall bladder cancer, ampullary cancer) are rare, lethal cancers with rising incidence • Cholangiocarcinoma, the most common BTC, accounts for 3% of all GI cancers globally (Vauthey Sem Liver Dis 1994) • 5-year survival: 5-10% • No standard of care exists for BTC • Few underpowered phase III chemotherapy studies • Small phase II studies, mostly 5-FU or gemcitabine-based • ABC-01: Randomized Phase II study (N = 86) - Cisplatin (Cis)/Gemcitabine (Gem) appeared superior to Gem (GI Cancers Symposium 2006;Abstract 98) • 6-mos PFS: 57.1% vs 47.7% • Median TTP: 8.0 mos vs 4.0 mos • ORR: 24% vs 15% • Tumor control rate: 76% vs 58% • Current study objectives: • Prospectively evaluate the activity and safety of Cis/Gem vs Gem in patients with advanced or metastatic BTC in a large, multicenter phase III study Source: Valle JW et al. ASCO 2009; Abstract 4503.

  3. ABC-02: Phase III Multicenter Study (N = 410*) Gemcitabine 1,000 mg/m2 D1, 8, 15 q28 days 24 weeks (6 cycles) Primary site: Gallbladder/bile duct/ampulla 37%/58%/5% R Gemcitabine 1,000 mg/m2 Cisplatin 25 mg/m2 D1, 8 q21 days 24 weeks (8 cycles) Primary site: Gallbladder/bile duct/ampulla 36%/60%/4% *Includes 86 patients from ABC-01 Upon disease progression, management will be at clinician’s discretion (mostly best supportive care) Source: Valle JW et al. ASCO 2009; Abstract 4503.

  4. Grade 3/4 Adverse Events Source: Valle JW et al. ASCO 2009; Abstract 4503.

  5. Additional Grade 3/4 Adverse Events Source: Valle JW et al. ASCO 2009; Abstract 4503.

  6. Radiologic Response:Investigator-Assessed *Patients not required to have measurable disease at study entry and some patients still in follow-up Source: Valle JW et al. ASCO 2009; Abstract 4503.

  7. Progression-Free Survival: Intention-to-Treat 1.00 0.75 0.50 0.25 0.00 Progression-free survival GemcitabineGemcitabine + Cisplatin 0 100 200 300 400 500 600 700 800 900 1000 Follow up time (days) Source: With permission from Valle JW. ASCO 2009; Abstract 4503.

  8. Overall Survival: Intention-to-Treat 1.00 0.75 0.50 0.25 0.00 Survival GemcitabineGemcitabine + Cisplatin 0 100 200 300 400 500 600 700 800 900 1000 Follow up time (days) Source: With permission from Valle JW. ASCO 2009; Abstract 4503.

  9. Summary and Conclusions • Cis/Gem significantly improves OS and PFS compared to Gem • Median OS: 11.7 mos vs 8.3 mos • Reduced risk of death by 30% (HR = 0.70, p = 0.002) • Median PFS: 8.4 mos vs 6.5 mos • Reduced risk of disease progression by 28% (HR = 0.72, p = 0.003) • First demonstration of a survival benefit in advanced BTC • Benefit gained without additional clinically significant toxicity • Lethargy is the most common Grade 3/4 AE in both arms: Cis/Gem (18.6%) and Gem (16.6%) • Slight excess of Grade 3/4 neutropenia with Cis/Gem vs Cis: 22.6% vs 17.9%, respectively • Therapy withdrawal due to toxicity: Cis/Gem n=8, Gem n=11 • Cis/Gem is recommended as a worldwide standard of care and should serve as the backbone of future studies Source: Valle JW et al. ASCO 2009; Abstract 4503.

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