Adjuvant Capecitabine Prolongs Survival in Biliary Tract Cancer
Study results suggest that capecitabine should be incorporated into standard care for biliary tract cancer.
|The following article features coverage from the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. Click here to read more of Cancer Therapy Advisor's conference coverage.|
Adjuvant capecitabine prolongs overall survival (OS) among patients with biliary tract cancer (BTC), according to a study that will be presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.1
The outcomes of BTC remain poor, with a 5-year survival of under 10%. The purpose of the BILCAP trial (ClinicalTrials.gov Identifier: NCT00363584) was to evaluate the efficacy of capecitabine after radical surgery.
The BILCAP trial randomly assigned 447 patients with macroscopically resected BTC — cholangiocarcinoma (CCA) or gallbladder cancer — to receive 8 cycles of capecitabine or observation.
Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. The median age at baseline was 63, and the primary tumor site was intrahepatic in 19%, hilar in 28%, extrahepatic CCA in 35%, or muscle-invasive gallbladder in 18%.
Capecitabine prolonged OS with a median of 51.1 months (95% CI, 34.6-59.1) compared with 36.4 months (95% CI, 29.7-44.5) with observation (hazard ratio [HR], 0.81; 95% CI, 0.63-1.04; P = .097), though this finding was not significant.
An analysis of patients who received capecitabine per protocol — without early discontinuation — demonstrated significantly improved OS with capecitabine (53 vs 36 months; HR, 0.75; 95% CI, 0.58-0.97; P = .028).
The most common grade 3 to 4 adverse events among patients who receive capecitabine were plantar palmar erythema (20.7%), fatigue (7.5%), and diarrhea (7.5%).
RELATED: GEMOX Does Not Improve Relapse-free Survival in Biliary Tract Cancer
According to the investigators, these data suggest that “capecitabine should become the standard of care for patients following curative resection of BTC.”
Read more of Cancer Therapy Advisor's coverage of the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting by visiting the conference page.
- Primrose JN, Fox R, Palmer DH, et al. Adjuvant capecitabine for biliary tract cancer: the BILCAP randomized study. J Clin Oncol. 2017;34(suppl; abstr 4006).