Aim
To determine the clinical benefit response (CBR), time to tumor progression (TTP), overall survival, and effect on quality
of life (QOL) of gemcitabine and capecitabine in patients with advanced biliary cancer.
Methods
Gemcitabine (1000 mg/m2 IV over 30 minutes on days 1 and 8) and capecitabine (650 mg/m2 orally twice daily for 14 days) were administered and repeated every 21 days. All patients completed the European Organization
for Research and Treatment of Cancer Core Quality of Life Questionnaire and Pancreatic Cancer Module (EORTC QLQ-C30-PAN 26)
questionnaire on day 1 of each cycle. Cumulative QOL scores were calculated. The two-stage design required 17 patients to
evaluate the confirmed response at nine weeks.
Results
Twelve patients with a median age of 54 years were enrolled. A median of eight cycles per patient were completed. With a median
follow-up of 18.2 months, the CBR (two partial response and five stable disease) was 58% [95% confidence interval (CI) 28–85%].
Four out of seven patients with CBR had no decline in QOL with chemotherapy. The probability of survival at one year was 0.58.
Median TTP and overall survival were 9.0 and 14.0 months, respectively. Nine patients had grade 3 or 4 toxicities. There were
no treatment-related deaths.
Conclusions
Gemcitabine and capecitabine at this dose and schedule are well tolerated and effective and may offer clinical benefit and
maintain QOL in patients with advanced biliary cancer. This regimen merits further investigation in the neoadjuvant setting.
Keywords Biliary tract cancer - Capecitabine - Gemcitabine - Quality of life (QOL) - Chemotherapy