Retrospective analysis data suggest that second-line chemotherapy of capecitabine and cisplatin combination therapy was associated with modest efficacy in patients with advanced biliary tract cancer.
There are limited data relating to the efficacy and safety of second-line chemotherapy for patients with advanced biliary tract cancer (BTC). Hence, a retrospective analysis was conducted to assess the efficacy and safety of the capecitabine (Xeloda) and cisplatin combination as second-line chemotherapy in patients with advanced BTC, the results of which were presented at the American Society of Clinical Oncology (ASCO) 2020 Gastrointestinal Cancers Symposium.
The analysis included patients with advanced BTC who received second-line capecitabine and cisplatin following progression on gemcitabine platinum first-line chemotherapy between March 2014 and December 2018. Capecitabine was administered orally at a dose of 1000 mg/m2 twice a day for 14 days, followed by a 1 week off period. Cisplatin 60 mg/m2 was infused over 1 hour on day 1, every 3 weeks.
A total of 40 patients were included in the analysis. In the analysis population, 16 (40%) patients were female, the median age was 67.5 years (range, 59.75-73 years), 30 (75%) patients had Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and the majority had undergone surgery (70%). In terms of primary tumor site, 8 (20%) patients had intrahepatic disease, 16 (40%) had extrahepatic disease, and 16 (40%) had gallbladder disease. Twenty-three (57.5%) patients presented with metastatic disease, 17 (42.5%) patients with recurrent disease after curative surgery, and 1 with locally advanced unresectable disease. The mean number of chemotherapy cycles received was 3.3 ± 2.0.
Objective response rate was achieved by 5 (12.5%) patients. Disease stabilization was achieved by 10 (25%) patients for a clinical benefit rate of 37.5%. From the beginning of the capecitabine and cisplatin chemotherapy, median PFS was 2.8 months (95% confidence interval [CI], 1.1-9.27) and median OS was 7 months (95% CI, 1.6-18.6). In multivariate analysis using stepwise Cox proportional hazards regression modeling, cancer antigen 19-9 was identified to be a prognostic marker for OS (hazard ratio, 2.33; P = .04).
Most common grade 3/4 AEs included neutropenia (17.5%), anemia (7.5%), hand-foot syndrome (7.5%), nausea and vomiting (5%), peripheral neuropathy (5%), and mucositis (2.5%). There were no treatment-related deaths.
Based on these results, the investigators concluded that capecitabine and cisplatin combination therapy showed modest efficacy as second-line chemotherapy for advanced BTC.
Source: Shin K, et al. J Clin Oncol. 2020;38(4_suppl). Abstract 543.