A multi-center retrospective analysis of survival benefits of chemotherapy for unresectable biliary tract cancer.

BACKGROUND

This study examined the effect of five systemic chemotherapy regimens on survival in patients with unresectable biliary tract cancer (BTC) as compared with the best supportive care (BSC).

METHODS

This study retrospectively reviewed data from 413 consecutive patients with BTC who were seen at any of nine central hospitals in Japan between April 2000 and March 2003. Patients were eligible if they had intra- or extrahepatic cholangiocarcinoma or gallbladder cancer with no prior chemotherapy. Hazard ratios of treatment regimens were estimated using the Cox proportional hazard model and the propensity score method.

RESULTS

Three-hundred and four patients were enrolled: 125 (41.1%) received BSC and 179 (58.9%) took chemotherapy. Of those who received chemotherapy, 58 (19.1%) took gemcitabine (GEM), 45 (14.5%) took a cisplatin (CDDP)-based regimen, 30 (9.9%) took a 5-fluorouracil (5-FU)-based regimen, 27 (8.9%) took 5-FU + doxorubicin + mitomycin (FAM) and 20 (6.6%) took S-1. The response rate was 8.4% (n = 15). The CDDP-based regimen was associated with a high frequency of toxicity symptoms. The adjusted hazard ratio for GEM in the Cox regression was 0.53 (95% CI 0.34-0.82) and the hazard ratio for the CDDP-based regimen was 0.49 (95% CI 0.36-0.99).

CONCLUSION

Chemotherapy with GEM may benefit patients with BTC.