Multicenter prospective observational post-approval study of safety and efficacy of bevacizumab (Avegra®, BIOCAD) in patients with metastatic colorectal cancer in real world practice: APOLLON-11 and SOYUZ-APOLLON

Abstract

Aim. To evaluate the safety and efficacy of long-term continuous use of Avegra BIOCAD (international nonproprietary name INN: bevacizumab) as a targeted therapy in patients with metastatic colorectal cancer in real-world practice. Materials and methods. The paper presents the interim results of a multicenter prospective observational post-approval study of the safety and efficacy of Avegra BIOCAD (INN: bevacizumab) combined with chemotherapy in patients with metastatic colorectal cancer. Inclusion criteria: histology verified diagnosis of metastatic colorectal cancer; therapy with bevacizumab (by JSC BIOCAD, Russia) to all patients included in the study, as part of real-world clinical practice, at a dose of 5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks in combination with standard cytotoxic regimens (FOLFOX 6, XELOX, etc.). The main safety criteria are the incidence of adverse reactions to bevacizumab and the rate of treatment withdrawal due to the development of adverse reactions to bevacizumab. Additional criteria are objective response rate (complete and partial response to therapy), disease control rate (ORR and stable disease), and rate of disease progression. Results. At the time of the interim analysis, 441 patients with metastatic colorectal cancer in 28 research centers of the Russian Federation (Moscow, Saint Petersburg and regional clinics) were included in the study. Median age of patients is 62 (2887) years. Patients had an ECOG performance status of 01, with a median follow-up of 7.3 months. After the therapy, the disease control rate was 79.5%. The median PFS was 8 months (95% CI 7.04 to 9.00). The median OS was not reached. Toxicity associated with bevacizumab manifested predominantly as arterial hypertension (3%), diarrhea (1,1%) and asthenia (0.9%). Nine (2.1%) SARs were observed; three (0.6%) of them (COVID-19, intestinal obstruction, multiple organ failure) resulted in mortality. The obtained results are well consistent with the previously known bevacizumab safety profile characteristics. Conclusion. The interim analysis results confirm the favorable safety profile and high efficacy of Avegra BIOCAD (INN: bevacizumab) combined with standard cytotoxic regimens (FOLFOX, XELOX, etc.) as first-line therapy in patients with metastatic colorectal cancer. The real-world data for ORR and PFS are comparable with clinical trials results. At the time of the interim analysis publication, the study is ongoing. Final conclusions on the safety and efficacy of bevacizumab (by JSC BIOCAD, Russia), will be made after the study is completed.