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KMID : 1011320180100010024
Journal of Pharmacoepidemiology and Risk Management
2018 Volume.10 No. 1 p.24 ~ p.31
A Comparison of the Frequency of Adverse Events during Parallel Treatment of Bevacizumab with 5-FU Based Chemotherapy for Metastatic Colorectal Cancer Patients
Beom Jin-Seon

Seol Mi-Jin
Park Mi-Seon
Ahn Hyo-Cho
Jeon So-Yeon
Park Seoung-Ju
Kim Ju-Sin
Abstract
Objective: The aim of this study was review the incidence of adverse events in patients receiving additional Bevacizumab concurrent chemotherapy versus 5-FU based regimen for the treatment of patients with metastatic colorectal cancer, and review the cases of discontinuation of Bevacizumab during parallel treatment.

Methods: We retrospectively studied with Electronic Medical Record of the metastatic colorectal cancer patients who treated chemotherapy at CNUH from January 1, 2016 to December 31, 2016. We analyzed comparisons of the incidence of hematologic adverse events, non-hematologic adverse events, and gastrointestinal adverse events between FOLFIRI, FOLFOX group and additional Bevacizumab group, reviewed the incidence of Bevacizumab-specific adverse events and the discontinuation of Bevacizumab.

Results: Among the 100 patients (5-FU based group: 38 vs. parallel group: 62) who treated chemotherapy, the incidence of adverse events were 325 cases (5-FU based group: 92 vs. parallel group: 233). Hematologic adverse events occurred in 7 cases in the 5-FU based group and 19 cases in the bevacizumab group. In non-hematologic adverse events, there were 21 cases and 43 cases, the incidence of fever in parallel group were higher than the single-group (21.0% (13) vs. 5.3% (2), p=0.043). Gastrointestinal adverse events were in 59 cases in the single-group and in 123 cases in the parallel group. Other adverse effects were 2 cases in the single-group and 24 cases in the parallel group. Bevacizumab-specific adverse events were bleeding 14 cases (22.6%, p=0.025), hypertension 4 cases (6.5%), proteinuria 4 cases (6.5%) and thromboembolism 2 cases (3.2%), and the discontinuation of Bevacizumab was 30 cases.

Conclusion: The incidence of adverse events in the Bevacizumab group was higher than in the 5-FU based group. Bevacizumab-specific adverse events may lead to serious reactions. Therefore it is necessary to make counselling, including education and prevention remedy for major adverse events in patients receiving chemotherapy with Bevacizumab to reduce anxiety and improve quality of life.
KEYWORD
Adverse events, Metastatic colorectal cancer, 5-FU based regimen, Bevacizumab, Patient counseling for education
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