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.
This retrospective, multi-center longitudinal study on BRAFV600E mutant mCRC patients will be conducted in Europe to characterize the first-line treatment patterns. All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between January 1st, 2016 and December 31st, 2018 (both days inclusive) with drugs registered for mCRC in respective country will be eligible to participate. The study will not provide or recommend any treatment or procedure; all decisions regarding treatment are made at the sole discretion of the treating physician in accordance with their usual practices and all eligible patients will be considered for enrollment. The target countries for patient enrollment will include Germany, France, Italy, United Kingdom, Spain, Belgium, Austria and the Netherlands. Approximately 300 adult patients (≥18 years) from a mix of academic and non-academic sites (up to 65 sites) will be enrolled.
Study Type
OBSERVATIONAL
Enrollment
274
All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country
Barmherzige Brüder Krankenhaus St. Veit/Glan.
Saint Veit/Glan, Austria
Medizinische Universität Wien
Vienna, Austria
Imelda VZW
Bonheiden, Belgium
AZ Klina
Brasschaat, Belgium
UZ Leuven
Leuven, Belgium
CHC MontLégia
Liège, Belgium
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
First-line SACT treatment patterns in BRAFV600E mutant mCRC patients described by agent or combination of agents received
Time frame: time from treatment initiation (for mCRC) up to 31 December 2020
Duration of Treatment for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
First-line SACT treatment patterns in BRAFV600E mutant mCRC patients described by Duration of Treatment
Time frame: time from treatment initiation (for mCRC) up to 31 December 2020
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch in mCRC first-line SACT treatment in BRAFV600E mutant mCRC patients.
Time frame: time from treatment initiation (for mCRC) up to 31 December 2020
Demographic and Clinical Characteristics
Description of the demographic and clinical profile of patients at the time of treatment initiation (for mCRC) TNM stage of colorectal cancer. Stage I: Cancer is still in the inner lining, but has grown through the mucosa of the colon and invaded the muscle layer. Stage II: The cancer has grown beyond the mucosa of the colon but has not spread to the lymph nodes Stage III: The cancer has spread to the lymph nodes near the colon, it has not spread further. Stage IV: The cancer has spread outside of the colon and has been carried through the lymph and blood systems to distant parts of the body, this is known as metastasis.
Time frame: from the date of the start of first-line treatment for mCRC up to 31 December 2020
Progression-free Survival (PFS)
the length of time between initiation of first-line treatment for mCRC and the first documented disease progression or death. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: from the date of the start of first-line treatment for mCRC up to 31 December 2020
Overall Survival (OS)
length of time between first-line treatment initiation (for mCRC) and death (due to any cause)
Time frame: from the date of the start of first-line treatment for mCRC up to 31 December 2020
Overall Response Rate (ORR)
complete response (CR) or partial response (PR), during the first line treatment Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time frame: from the date of the start of first-line treatment for mCRC until the end of first-line treatment up to 31 December 2020
Time to Treatment Cessation
the length of time between initiation of first-line treatment for mCRC and documented disease progression (or start of subsequent Line Of Treatment (LOT), if disease progression is not well documented in patient medical record), treatment discontinuation or switch to another treatment (defined as change from one treatment regimen to another treatment regimen, e.g., change from FOLFOX-based regimen to FOLFIRI or irinotecan-based regimen)
Time frame: from the date of the start of first-line treatment for mCRC until the documented disease progression up to 31 December 2020
Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
Description of testing procedures of BRAF mutation testing since mCRC diagnosis and since first-line treatment for mCRC
Time frame: from the date of the start of first-line treatment for mCRC until the end of first-line treatment up to 31 December 2020
Description of BRAF Mutation Testing Timing in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
Time to BRAF mutation testing since mCRC diagnosis and since first-line treatment for mCRC
Time frame: from the date of the start of first-line treatment for mCRC until the end of first-line treatment up to 31 December 2020
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CHRU de Besançon
Besançon, France
GHPSO (Groupe Hospitalier Sud de l'Oise)
Creil, France
CHU Grenoble Alpes
La Tronche, France
Hôpital Franco-Britannique
Levallois-Perret, France
...and 24 more locations