The prognosis for patients with biliary tract cancer is poor, and no standard palliative care has been defined. Now Austrian researchers report that adding cetuximab to gemcitabine and oxaliplatin (GEMOX) for patients with advanced biliary tract cancer results in a high overall response rate and good disease control and is well tolerated.
These findings, published online in The Lancet Oncology, indicate a promising first-line palliative care treatment for biliary tract cancers, and are the first to suggest a therapy that increases the chances of potentially curative secondary resection.
This prospective phase 2 study by Birgit Gruenberger, MD, Barmherzige Brueder Hospital, Vienna, Austria, and colleagues included patients with advanced or metastatic biliary tract cancer who were not eligible for surgery. Patients received infusions of cetuximab 500 mg/m2 on day 1, gemcitabine 1000 mg/m2 on day 1, and oxailiplatin 100 mg/m2 on day 2 for 12 cycles.
Of the 30 patients enrolled in the study, 19 (63%) had a response (tumor shrinkage of at least 30%), including three (10%) with a complete response and 16 (53%) with a partial response. The other patients had stable or progressive disease, giving an overall disease control rate of 80%. Nine patients underwent secondary surgical resection after major response to therapy.
The nine patients who had secondary surgery survived without disease progression for three times longer than those who did not have surgery (median, 21.2 months versus 6.8 months). More than 80% of the patients who had secondary surgery were still alive after 30 months of follow-up. Overall survival was 11.6 months in those ineligible for secondary surgery.
The combination regimen was well tolerated, although doses were reduced in 13 patients because of side effects. Most patients experienced cetuximab-related acneiform rash; response to treatment was best in those with the most severe rash. Other common adverse effects were nausea, anaemia, and peripheral neuropathy.
Large, randomized studies of cetuximab plus GEMOX are warranted on the basis of these findings, the authors conclude.