Rechallenge of BRAF +/- MEK Inhibitors Following an Adverse Event in Patients With Cancer (BRAFREC)

Caen University Hospital

Status: Unknown

Conditions: Cancer

Treatments: Drug: BRAF inhibitor

Study type: Observational

Funder types: Other

Identifiers

NCT05080361

BRAFREC

Details and patient eligibility

About

Very little data are published on the safety of a rechallenge with a BRAF inhibitor or combination of BRAF and MEK inhibitor (BRAFi and MEKi) after an adverse event (AE). This study aimed at identifying the recurrence rate of the same AE after a BRAFi +/- MEKi rechallenge in patients with cancer and the factors associated to the recurrence.

Full description

This is an observational, cross-sectional, pharmacovigilance cohort study. AEs were extracted from safety reports from the World Health Organization database VigiBase®, to evaluate the safety of a rechallenge with a BRAF inhibitor or combination of BRAF and MEK inhibitor (BRAFi and MEKi) after an adverse event (AE) in patients with cancer.

Enrollment: 16,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All consecutive AE cases associated with BRAFi and MEKi therapy. Combination therapy cases, where BRAFi were concurrently reported with MEKi will be identified, as well as the combination therapy regimen (V+C, D+T, E+B). We will not study MEKi monotherapy cases

Exclusion criteria

• MEKi monotherapy cases
• Cases concurrently reporting on immune checkpoint inhibitor therapies

Trial design

16,000 participants in 1 patient group

Reports of adverse events associated with the use of BRAF +/- MEK inhibitors

Description:

Reports of adverse event (individual case safety reports) from Vigibase, the World Health Organization pharmacovigilance database related to the use of BRAF +/- MEK inhibitors from inception (1986) until March, 1, 2021 will be extracted. Cases concurrently reporting on immune checkpoint inhibitor therapies will be excluded.

Treatment:

Drug: BRAF inhibitor