Experience of gemcitabine plus oxaliplatin chemotherapy in patients with advanced biliary tract carcinoma.

BACKGROUNDS

The combination gemcitabine-oxaliplatin (GEMOX) is frequently used in patients with advanced biliary tract carcinoma (BTC). However, this is only based on phase II studies performed in selected patients.We assessed the efficacy and safety of the GEMOX regimen in non-selected patients with advanced BTC.

METHODS

All consecutive patients with advanced BTC received the GEMOX regimen in a setting outside a study: gemcitabine 1,000 mg/m(2) on day 1, and oxaliplatin 100 mg/m(2) on day 2, treatment repeated every 2 weeks until progression or unacceptable toxicity.

RESULTS

Forty-four patients were enrolled.

EFFICACY

1 complete and 6 partial responses (objective response rate = 16.3%), 18 tumour stabilizations (41.9%, disease control rate = 58.1%), median progression-free survival was 5.0 months and median overall survival was 11.0 months.

TOXICITY

grade 3 neuropathy in 4 patients, grade 3 asthenia in 5 patients.

CONCLUSION

The GEMOX combination was well tolerated, with a modest activity in non-selected patients with advanced BTC. This regimen should be compared to the new standard gemcitabine-cisplatin combination.