authors: juan valle et al reviewed by : scott berry date posted: june 2009
DESCRIPTION
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 - PowerPoint PPT PresentationTRANSCRIPT
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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
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R
Gem 1000 mg/m2
D1,8,15 q 28d
24 weeks (6 cycles)
Cisplatin 25 mg/m2 + Gem 1000 mg/m2
D1,8 q 21d
24 weeks (8 cycles)
LocallyAdvanced/Metastatic
CholangioCAGall Bladder CA
Periampullary CA
N=410
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RESULTS
Gem Gem/Cis p-value
Response Rate (%) 16% 26% p=0.25
PFS (median,
mos) 6.5 8.4 P=0.003
OS
(median, mos)
8.3 11.7 P=0.002
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Adverse events: Grade 3-4
Toxicity by patient Gem Cis/Gem
% %
White blood cells 11.0% 15.1%
Platelets 8.0% 8.2%
Haemoglobin 3.7% 6.3%
Neutrophils 17.9% 22.6%
Infection + neutropaenia 7.5% 10.2%
Infection - neutropaenia 8.6% 6.4%
Bilirubin 13.1% 10.7%
ALT 18.1% 9.6%
AST 11.4% 8.2%
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Adverse events: Grade 3-4
Toxicity by patient Gem (n, %)Cis/Gem (n,
%)
Anorexia 2.5% 1.9%
Lethargy 16.6% 18.6%
Nausea 3.1% 3.2%
Renal function 1.2% 1.9%
Vomiting 3.0% 5.1%
Constipation 1.8% 1.3%
Diarrhoea 2.5% 4.5%
Dyspnoea 1.2% 3.2%
Pedal oedema 3.1% 2.6%
Pain 7.5% 9.0%
Any grade ≥3 events 65.5% 64.2%
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STUDY COMMENTARY
• First demonstration of survival benefit in advanced biliary cancer
•Statistically and Clinically significant improvement
• Benefit gained with no clinically significant added toxicity
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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