New Treatment Option Available for Advanced Biliary Tract Cancers

Capecitabine plus oxaliplatin (XELOX) proved noninferior to gemcitabine plus oxaliplatin (GEMOX) in patients with biliary tract cancer, according to the results of a study published in the Annals of Oncology.

In this open-label randomized phase III trial, patients with metastatic biliary tract cancer were assigned randomly to receive either GEMOX (n = 114) or XELOX (n = 108) as first-line treatment, given every 3 weeks, for a total of 8 cycles.

“Our findings suggest that XELOX may be an effective alternative in the first-line treatment of advanced [biliary tract cancers],” said the investigators.

The median progression-free survival (PFS) was 5.3 months in the GEMOX group and 5.8 months in the XELOX group. The 6-month PFS rate was 44.5% for the GEMOX group and 46.7% for the XELOX group.

No difference in objective response (P = .171) and median overall survival (P = .131) between the groups was observed. Neutropenia and thrombocytopenia were the most common grade 3/4 adverse events, and no patient died secondary to treatment. The XELOX group had fewer hospital visits vs the GEMOX group (P < .001).

The sole curative treatment for biliary tract cancer is surgical resection, but even with this procedure, many patients experience recurrence. Limited research supports the use of chemotherapy in patients with advanced biliary tract cancers, with gemcitabine plus platinum-based regimens being considered the standard first-line treatment. GEMOX has demonstrated antitumor activity and a favorable toxicity profile in advanced biliary tract cancers and has been used as the reference arm in recent phase II and III trials.

XELOX is the standard treatment for gastric cancer, colorectal cancer, and other gastrointestinal tumors, with a phase II trial for biliary tract cancers also reporting that XELOX had modest activity and tolerable toxicity.

“This study provides another alternative to gemcitabine and platinum-based therapy,” said Milind Javle, MD, professor of gastrointestinal medical oncology at the University of Texas MD Anderson Cancer Center in Houston.

However, he noted that no survival benefit was seen with XELOX and that the current findings are “unlikely to change standards unless patients are intolerant to gemcitabine,” contrary to suggestions made by the authors.