In an Indian phase II trial (BEER BTC) reported in the Journal of Clinical Oncology, Ramaswamy et al found that maintenance therapy with bevacizumab/erlotinib improved progression-free survival vs active surveillance in patients with advanced biliary tract cancers who had at least stable disease after gemcitabine-based chemotherapy.
As stated by the investigators, “Patients with chemotherapy-responsive advanced biliary tract cancers are usually observed after 6 months of gemcitabine-based therapy. There is limited prospective evidence for maintenance strategies after chemotherapy.”
Study Details
In the open-label trial, 98 patients from two centers in India with at least stable disease after 6 months of gemcitabine-based chemotherapy were randomly assigned between May 2021 and November 2022 to receive maintenance with bevacizumab at 5 mg/kg every 21 days plus erlotinib at 100 mg once daily (n = 49) or active surveillance (n = 49); treatment continued until disease progression or unacceptable toxicity. Most patients (80%) had gallbladder cancer. The primary endpoint of the study was investigator-assessed progression-free survival.
Key Findings
Median follow-up was 13.4 months. Median progression-free survival was 5.3 months (95% confidence [CI] = 3.53–7.04 months) in the bevacizumab/erlotinib group vs 3.1 months (95% CI = 2.47–3.64 months) in the active surveillance group (hazard ratio = 0.51, 95% CI = 0.33–0.74, P = .0013). Rates at 6 months were 44.3% vs 21.9%, respectively. Objective response was observed in 2.1% and stable disease in 35.4% of the patients in the active surveillance group, compared with rates of 15.5% and 46.7% in the bevacizumab/erlotinib group.
No grade 4 or 5 adverse events were observed. The most common adverse events of any grade were acneiform rash (26%), fatigue (12%), and fever (12%) in the bevacizumab/erlotinib group, and fatigue (14%) and diarrhea (6%) in the active surveillance group. Grade 3 class-specific adverse events in the bevacizumab/erlotinib group included acneiform rash (2%) and oral stomatitis (2%) with erlotinib and bleeding (2%) with bevacizumab.
The investigators concluded, “The combination of bevacizumab and erlotinib as switch maintenance improves progression-free survival with an acceptable safety profile compared with active surveillance in patients with advanced biliary tract cancers in this phase II study. The trial moves on to [a] phase III component to evaluate improvement in overall survival.”
Vikas Ostwal, MD, of the Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Lupin Limited and Intas Pharmaceuticals Limited. For full disclosures of the study authors, visit ascopubs.org.
