Efficacy and safety of VEGFR inhibitors versus standard chemotherapy in Chinese patients with metastatic liver cancer: Results of a preliminary clinical trial

Purpose: To evaluate efficacy and safety of vandetanib with and without standard chemotherapy in Chinese patients with metastatic liver cancer. Methods: Patients with confirmed diagnosis of metastatic liver cancer were randomized to receive vandetanib (300 mg per day in 28 days cycle) intravenously or standard chemotherapy (FOLFOX4) plus best supportive care. Efficacy measures such as overall survival (OS), objective response rate (ORR), and progression-free survival (PFS) were assessed after study drug treatment. Safety of vandetanib and FOLFOX4 was also assessed. Survival time with respect to disease progression was also assessed. Results: Vandetanib + standard chemotherapy-based regimens showed significantly higher OS benefit when compared to vandetanib and chemotherapy alone. Objective response rate (ORR) was also favorable among the patients treated with combination therapy when compared with monotherapy. A similar trend was noted for PFS; treatment with vandetanib + chemotherapy showed significantly longer PFS when compared to vandetanib and chemotherapy alone, respectively. Trial results demonstrated that vandetanib as a monotherapy or in combination with standard chemotherapy appears to be safe. Conclusion: The results of this trial may aid clinicians to select appropriate therapeutic intervention for patients with metastatic liver cancer.