A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)
- Conditions
- Metastatic Colorectal CancerBRAF V600E Mutation Positive
- Interventions
- Other: Non Interventional study
- Registration Number
- NCT04317599
- Lead Sponsor
- Pierre Fabre Medicament
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 274
- 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
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non interventional Non Interventional study 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
- Primary Outcome Measures
Name Time Method Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients time from treatment initiation (for mCRC) up to 31 December 2020 First-line SACT treatment patterns in BRAFV600E mutant mCRC patients described by agent or combination of agents received
Duration of Treatment for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients time from treatment initiation (for mCRC) up to 31 December 2020 First-line SACT treatment patterns in BRAFV600E mutant mCRC patients described by Duration of Treatment
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients time from treatment initiation (for mCRC) up to 31 December 2020 Switch in mCRC first-line SACT treatment in BRAFV600E mutant mCRC patients.
- Secondary Outcome Measures
Name Time Method Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients 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 testing procedures of BRAF mutation testing since mCRC diagnosis and since first-line treatment for mCRC
Description of BRAF Mutation Testing Timing in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients 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 BRAF mutation testing since mCRC diagnosis and since first-line treatment for mCRC
Overall Survival (OS) from the date of the start of first-line treatment for mCRC up to 31 December 2020 length of time between first-line treatment initiation (for mCRC) and death (due to any cause)
Demographic and Clinical Characteristics from the date of the start of first-line treatment for mCRC up to 31 December 2020 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.Progression-free Survival (PFS) from the date of the start of first-line treatment for mCRC up to 31 December 2020 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.Overall Response Rate (ORR) from the date of the start of first-line treatment for mCRC until the end of first-line treatment up to 31 December 2020 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 to Treatment Cessation from the date of the start of first-line treatment for mCRC until the documented disease progression up to 31 December 2020 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)
Trial Locations
- Locations (34)
UZ Leuven
🇧🇪Leuven, Belgium
Barmherzige Brüder Krankenhaus St. Veit/Glan.
🇦🇹St. Veit/Glan, Austria
Medizinische Universität Wien
🇦🇹Vienna, Austria
Imelda VZW
🇧🇪Bonheiden, Belgium
Santa Maria Goretti Hospital
🇮🇹Latina, Italy
Instituto Nazionale Tumori, IRCCS, Fondazione G. Pascale
🇮🇹Napoli, Italy
Asst Valle Olona
🇮🇹Saronno, Italy
CHU de Poitiers
🇫🇷Poitiers, France
University College London Hospitals NHS Foundation Trust
🇬🇧London, United Kingdom
Hospital del Mar
🇪🇸Barcelona, Spain
AZ Klina
🇧🇪Brasschaat, Belgium
CHC MontLégia
🇧🇪Liège, Belgium
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
Studienzentrale Gokos
🇩🇪Dresden, Germany
Centre Oscar Lambert
🇫🇷Lille, France
ICM Val d'Aurelle
🇫🇷Montpellier, France
Gustave Roussy
🇫🇷Villejuif, France
Klinikum Aschaffenburg Medical Klinik IV
🇩🇪Aschaffenburg, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
MVZ Mitte Leipzig
🇩🇪Leipzig, Germany
Facharztzentrum Eppendorf
🇩🇪Hamburg, Germany
Oncoresearch Lerchenfeld
🇩🇪Hamburg, Germany
MZ Onkologie Velbert/Ratingen/Mettmann
🇩🇪Velbert, Germany
Clinica Oncologica Ospedali Riuniti di Ancona
🇮🇹Ancona, Italy
Azienda Ospedaliero-Universitaria Pisana
🇮🇹Pisa, Italy
AUSL-IRCCS of Reggio Emilia-Clinical Cancer Center
🇮🇹Reggio Emilia, Italy
Hospital General Universitario de Valencia
🇪🇸Valence, Spain
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Harrogate & District NHS Foundation Trust
🇬🇧Harrogate, United Kingdom
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
La Paz University Hospital
🇪🇸Madrid, Spain