N/A N=274

A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)

BRAF V600E Mutation Positive · Metastatic Colorectal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT04317599 ↗

Enrolled (actual)

274

Serious AEs

15.7%

Results posted

Jul 2024

Primary outcome: Primary: Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients — 17; 6; 10; 1 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Non interventional (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pierre Fabre Medicament
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients	17; 6; 10; 1; 72; 11	—
PRIMARY Duration of Treatment for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients	6.04	—
PRIMARY Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients	80; 30; 24; 13; 13; 21	—
SECONDARY Demographic and Clinical Characteristics	0; 3; 4; 8; 1; 7	—
SECONDARY Progression-free Survival (PFS)	5.98	—
SECONDARY Overall Survival (OS)	12.68	—
SECONDARY Overall Response Rate (ORR)	37.1	—
SECONDARY Time to Treatment Cessation	4.83	—
SECONDARY Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients	244; 11; 62; 140; 21; 1	—
SECONDARY Description of BRAF Mutation Testing Timing in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients	0.6; 6.1	—

Summary

The presence of a BRAFV600E mutation is considered a marker of poor prognosis in patients with mCRC, and findings from clinical trials have largely remained inconclusive regarding the efficacy of first line treatments for BRAF-mutant mCRC patients. In the absence of targeted/specific treatment for BRAF-mutant mCRC, treatment practices can vary based on local practices and guidelines. There is, therefore, an unmet need to document the current practices for first-line treatment of BRAF-mutant mCRC, and their effectiveness and safety in a real-world setting. This real-world, multicenter non-interventional study (NIS) will describe the treatment patterns, effectiveness and safety of current treatment regimens in BRAFV600E mutant mCRC patients in Europe, with the aim to put the clinical study findings of the ongoing Phase 2, single-arm, open label trial (ANCHOR) into context of the current treatment landscape excluding investigational therapies. Additionally, the NIS output may be used to support future health technology assessment submissions and publications.

Eligibility Criteria

Inclusion Criteria

Diagnosis of histologically or cytologically confirmed CRC that is metastatic and unresectable
Presence of BRAFV600E mutation in tumor tissue, as confirmed by a local assay
Initiated first-line treatment with drugs registered for mCRC in the respective country at the time of treatment between January 1st, 2016 and December 31st, 2018 (both days inclusive)
Provision of informed consent or non-opposition to the patient (or next of kin, if applicable) for the use of data, according to local regulations

Exclusion Criteria

Patients will be excluded from the study if they fulfil any of the following criteria:

Patients with another concomitant cancer at the time of diagnosis*
Patients participating in interventional trials on investigational drugs at the time of initiation of first-line treatment
Except for non-metastatic non-melanoma skin cancers, or in situ or benign neoplasms; a cancer will be considered concomitant if it occurs within 5 years of mCRC diagnosis.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04317599). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.