Recently, a group of researchers designed a phase II, single-arm clinical trial to evaluate the use of Ramucirumab in the treatment of advanced biliary tract cancer patients. Ramucirumab is a monoclonal antibody targeting vascular endothelial growth factor receptor 2 (VEGFR-2). The researchers enrolled patients with ECOG performance status 0-1 who were previously treated with gemcitabine-based chemotherapy. The researchers assessed progression-free survival (PFS), overall survival (OS), overall response rate (ORR), disease control rate (DCR), and toxicity.
Sixty-one eligible patients were enrolled in this study and treated with Ramucirumab 8 mg/kg intravenously on day 1 of a 14-day cycle. Two dose reductions were allowed but not less than 5 mg/kg. Patients continued treatment until the disease progressed or the patient developed intolerable toxicity.
The trial analysis showed:
- 9.5 months median OS with a 58% median 6-month OS rate and 32% median 6 months PFS rate.
- One patient achieved partial response, 26 patients had stable disease, and 25 had disease progression.
- The majority of toxicities were grade 1 or 2.
- Grade 3 hypertension occurred in 13 patients, and grade 3 proteinuria and pulmonary embolism occurred in only one patient.
- Grade 4 gastrointestinal bleeding occurred in only one patient.
In conclusion, Ramucirumab is well tolerable and may result in clinical benefits for previously treated patients. A future, randomized, controlled clinical trial is needed to better assess the clinical impact of Ramucirumab as a monotherapy or in combination with other treatment approaches.
Reham Abdel-Wahab is the Cholangiocarcinoma Foundation's Director of Research and Chief Scientific Officer. She completed five years of postdoctoral fellowships at the Gastrointestinal Medical Oncology Department at MD Anderson Cancer Center in Houston, Texas. Her research interest is primarily in the field of Hepatobiliary Cancers.