Gemcitabine and capecitabine for advanced biliary cancer.

BACKGROUND

Gemcitabine with capecitabine (gem-cap) is an established regimen for advanced biliary cancer (ABC) supported by our previously reported phase II trial. Here, we provide our updated experience.

METHODS

Single institution, retrospective study from 2005 to 2015 of ABC treated with gem-cap.

RESULTS

A total of 372 patients with ABC were identified, of whom 227 (61.0%) were treated with chemotherapy. 153 patients (67.4%) received gem-cap, of which 129 (56.8%) received it in the first line. Thirty two point six percent (42/129) were locally advanced, 67.4% (87/129) had metastatic disease, and 18.6% (24/129) received it as adjuvant therapy. Disease sites included 48.8% [63] intrahepatic cholangiocarcinoma (IHCC), 24.0% [31] extrahepatic cholangiocarcinoma (EHCC) and 27.1% [35] gallbladder carcinoma (GBC). Median follow-up was 49.7 months (mo). The median PFS and OS were 8.0 mo [95% confidence intervals (CI): 6.0-9.3] and 13.0 mo (95% CI: 10.7-17.4), respectively. Overall, 53.5% (69/129) experienced a grade 3/4 toxicity. The most common (35.7%) was a hematologic toxicity (neutropenia or thrombocytopenia) followed by infection (25.6%).

CONCLUSIONS

Gem-cap provides similar survival outcomes to gemcitabine/cisplatin based on historical comparison to the ABC-2 trial (median PFS =8.0 mo and OS =11.7 mo). Gem-cap may offer the advantage of fewer adverse events compared to the levels reported in ABC-2 (grade 3/4 events 70.7%).