Background/Aims: First line palliative chemotherapy (CT1) improves survival and quality of life in advanced biliary cancer (ABC). There is no randomised evidence to support second line chemotherapy (CT2) in ABC. We reviewed the experience of CT2 in ABC at four NSW cancer centres.

Methods: We performed a retrospective review of all patients who received one or more lines of chemotherapy for advanced biliary tract cancer at the Wollongong, Sutherland, St George and Prince of Wales cancer centres between 2008 and 2012. Cox proportional hazard models were developed to determine the impact of clinicopathologic variables on overall survival (OS) from time of progression on CT1.

Results: We identified 73 patients who received palliative chemotherapy for advanced biliary cancer. The most common regimen in CT1 was gemcitabine/cisplatin (69% of patients), with a disease control rate (DCR) of 61.6% and a median progression free survival (PFS) of 4.2 months. 25 (34%) patients received CT2 and 7 (10%) patients had 3 lines of chemotherapy. Patients with a good ECOG performance status after progression on first line chemotherapy were more likely to receive CT2. The most common regimens for CT2 were fluorouracil combinations (eg FOLFOX or ECF; 36%), gemcitabine/platin doublet (28%) and fluorouracil monotherapy (24%). The mean PFS for CT2 was 3.2 months (95% CI 1.5 – 4.9) with a DCR of 36%. Median OS for patients who received CT2 was 12.3 months (compared to 2.6 months in patients who did not receive CT2). Statistically significant variables for OS in the multivariate analysis were ECOG performance status at CT2 (p<0.0001), presence of metastatic disease at CT2 (p=0.0001), and lines of chemotherapy (p=0.048).

Conclusion: Second-line chemotherapy is feasible in a subset of patients with ABC. Further prospective studies are required to confirm benefits to survival and quality of life, and identify optimal chemotherapeutic regimens.