Manager, Pharmacoepidemiology Daiichi Sankyo, Inc. Rutgers University Morris Plains, United States
Background: Colorectal cancer (CRC) is the third most common cancer diagnosed in the United States, excluding skin cancers. It is important to evaluate adverse events (AEs) associated with treatments for CRC to ensure that the benefits outweigh potential risks.
Objectives: The primary objectives of this systematic literature review and meta-analysis were to evaluate the frequency of the five most frequently reported AEs of any grade in phase III clinical trials of patients with CRC overall and identify the five most frequently reported severe AEs (following the Common Terminology Criteria for Adverse Events [CTCAE] grade ≥3) from phase III clinical trials of patients with CRC overall.
Methods: Literature searches were performed to review articles published between January 1, 2012, and February 1, 2022, using ClinicalTrials.gov, PubMed, Citeline’s TrialTrove, EBM Reviews - Cochrane Central Register of Controlled Trials, EBM Reviews - Cochrane Clinical Answers, BIOSIS Previews, Northern Light Life Sciences Conference Abstracts, Embase, and Ovid MEDLINE. Studies in adult patients in phase III clinical trials who were diagnosed with CRC (colon, rectal, and colorectal cancers) were included. Meta-analysis was conducted using random effects models. The risk of bias was evaluated using the Cochrane risk-of-bias tool. All methodology was documented according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
Results: Twenty-two articles were included. The most frequent any grade AEs overall were neuropathy peripheral (55.8%), hemoglobin abnormal (51.4%), neutrophil count abnormal (43.5%), rash (35.8%), and neutropenia (35.0%). The most frequent grade ≥3 AEs overall were neutropenia (27.3%), neutrophil count abnormal (21.1%), hyperbilirubinemia (16.5%), neurotoxicity (11.0%), and hypertension (9.9%).
Conclusions: The most commonly reported AEs in patients with CRC varied based on treatment regimen, drug class, and metastatic status. This review provides a general interpretation of the most common AEs in treatments for patients with CRC, which may help inform treatment decisions.
