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. Cisplatin 25 mg/m2 + 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 Gem Gem/Cis 16% 26% p=0.25 6.5 8.4 P=0.003 8.3 11.7 P=0.002
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

4. 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%

5. 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%
Vomiting
3.0%
5.1%
Constipation
1.8%
1.3%
Diarrhoea
4.5%
Dyspnoea
Pedal oedema
2.6%
Pain
7.5%
9.0%
Any grade ≥3 events
65.5%
64.2%

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