OCTOPUS: Ambispective Observational Study Describing Diagnosis and Treatment Patterns in Adults with Metastatic NSCLC with BRAF V600E Mutation in Clinical Practice, to Assess Treatment Effectiveness and Quality of Life (TIP)
Author(s)
Planchard D1, Adhikaree J2, Chella A3, Christoph D4, Couraud S5, Oramas J6, Beghdad F7, Messaoudi F8, Khan S9, Popat S10
1Gustave Roussy, Villejuif, Ile de France, France, 2Nottingham University Hospitals NHS Trust, Nottingham, Nottingham, UK, 3Azienda Ospedaliero Universitaria Pisana, Pisa, Pisa, Italy, 4Evang. Kliniken Essen-Mitte, Essen, Essen, Germany, 5Lyon Sud Hospital, Lyon, Lyon, France, 6Hospital Universitario de Canarias-San Cristóbal de la Laguna, La Laguna, La Laguna, Spain, 7Pierre Fabre Medicament, Boulogne, France, 8Pierre Fabre Medicament, Boulogne Billancourt, France, 9Pierre Fabre Médicament, Boulogne Billancourt, France, 10The Royal Marsden NHS Foundation Trust, London, UK
OBJECTIVES: BRAF mutations are reported in about 3%-5% of patients with NSCLC. Most BRAF mutations occur on codon 600 (BRAFV600), BRAFV600E (BRAFMT) present in more than 50% of BRAF mutated cases.
The small number of BRAFMT patients in large studies and variability in findings make it difficult to identify specific clinical phenotype. BRAF mutations appear to occur frequently in patients with adenocarcinoma, history of smoking, and women. Evidence suggests that BRAFMT tumors are associated with aggressive phenotype, poor prognosis and lack of sensitivity to platinum-based chemotherapy.METHODS: OCTOPUS is a multi-country, multicenter, observational, descriptive, ambispective study. The study aims to enroll up to 200 patients from Germany, France, Italy, Spain, and United Kingdom.
The study population consists of adults with BRAFMT mNSCLC who initiated a first systemic treatment in the metastatic setting from December 01, 2017 and prior to study entry (180 retrospective), as well as BRAFMT patients who initiated a first metastatic treatment upon inclusion (30 prospective). The study observation period is from Dec2017 to 1y after last patient enrollment . Primary objective is to describe real-world treatment patterns, including treatment persistence and median treatment duration, for first- and second- systemic treatment lines given in metastatic setting. Secondary objectives are to describe patient and disease characteristics, real-world treatment patterns for subsequent systemic treatments, treatment effectiveness, QoL, adverse events (AEs) related to first and second lines of treatment and BRAF mutation testing practices.RESULTS: To date, 40 sites are participating in the study. Six analyzable patients are enrolled in the prospective part and 109 patients in the retrospective part. The first interim analysis on the retrospective data is planned for Q3 2023.
CONCLUSIONS: This study will describe the treatment patterns in clinical practice in adult patients with mNSCLC with a BRAF V600E mutation and assess Real-World effectiveness, safety and QoL.
Conference/Value in Health Info
Value in Health, Volume 26, Issue 11, S2 (December 2023)
Code
CO175
Topic
Study Approaches
Topic Subcategory
Prospective Observational Studies
Disease
Oncology, Rare & Orphan Diseases