A multi-center randomized phase II clinical study of bevacizumab plus irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) compared with FOLFIRI alone as second-line treatment for Chinese patients with metastatic colorectal cancer

Abstract

Bevacizumab is an anti-VEGF human monoclonal antibody suitable for chemotherapy for patients with metastatic colorectal cancer (mCRC). This study investigated the efficacy and safety of using bevacizumab plus irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) as second-line chemotherapy option for patients with mCRC in China. Patients with mCRC, who had been previously treated with oxaliplatin-based chemotherapy, but not bevacizumab, were randomly assigned to two groups to receive bevacizumab plus FOLFIRI (FOLFIRI-B) or FOLFIRI alone. In FOLFIRI-B group, patients were given 10 mg/kg bevacizumab plus FOLFIRI every 2 weeks. The primary endpoints were response rates and survival rates. Between June 2010 and May 2014, 65 patients were assigned to FOLFIRI-B group and 77 to FOLFIRI alone group. The median progression-free survivals were 8.5 months (95 % CI 5.8-10.5 months) for FOLFIRI-B and 5.1 months (95 % CI 2.7-9.8 months) for FOLFIRI alone; median overall survivals were 15.2 months (95 % CI 11.8-19.4 months) for FOLFIRI-B and 11.3 months (95 % CI 6.7-16.5 months) for FOLFIRI alone. Incidence rates of grade 3 and 4 adverse events were observed and comparable between FOLFIRI-B and FOLFIRI alone groups. Chinese patients with mCRC treated with second-line chemotherapy of FOLFIRI-B had better survivals than those patients treated with FOLFIRI alone.

Surrogate Endpoints in Second-Line Trials of Targeted Agents in Metastatic Colorectal Cancer: A Literature-Based Systematic Review and Meta-Analysis

“…A total of 7,571 patients were enrolled in these trials, and the median number of enrolled patients was 197 (range, 75 to 1,226). The primary endpoint was PFS in 12 trials (60%) [11-15,18,19, 21-24,30], OS in six trials (30%) [16,20,26-29] and ORR in one trial (5%) [17]. In one trial (5%), PFS and OS were co-primary endpoints [25].…”

Correlation of genetic polymorphism of vascular endothelial growth factor gene with susceptibility to lung cancer

“…[17][18][19] VEGF and its receptors are frequently overexpressed in human tumors and inhibition of angiogenesis with bevacizumab, a monoclonal antibody that selectively binds to VEGF has shown promising clinical efficacy. [20][21][22][23][24] Multiple studies have shown that high VEGF expression in tumor or in serum is an indicator of prognosis of non-small cell lung cancer and response to anti-angiogenesis. 25,26 As such, VEGF SNP has been extensively investigated for its role in predicting cancer susceptibility, progression and anti-VEGF therapeutic response in subjects with tumors.…”

Clinical significance of epithelial–mesenchymal transition typing of circulating tumour cells in colorectal cancer

“…The adverse outcomes associated with late diagnosis in most patients are due to distant metastasis, lymphatic dissemination and recurrence . The combination of cytotoxic chemotherapy and targeted drugs has improved the overall survival (OS) of patients with advanced CRC by nearly 30 months . However, the systemic outcomes in some patients have been unsatisfactory and, in addition to the adverse effects of chemotherapy, have considerably reduced their quality of life .…”