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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