Larotrectinib, a selective TRK inhibitor has showed marked and durable antitumor activity in patients with NTRK gene-fusion-positive tumors regardless of the tumor type, gene partner and patient's age. Because of this and the lack of alternative therapy in this rare but severe disease, the French National Agency for Medicines and Health Products Safety (ANSM) granted in April 2019, a "cohort" Temporary Authorization for Use (ATU) in the indication:"Larotrectinib is indicated as monotherapy for the treatment of adult and paediatric patients from one month, with locally advanced or metastatic solid tumours with a Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion, refractory to standard treatments or in the absence of appropriate therapeutic alternative." Despite the potential benefit of identifying these fusions, the clinicopathologic features of NTRK fusion-positive tumors which are treated with Larotrectinib, are not well characterized. This study will provide information about the diagnosis and management of patients with locally advanced or metastatic NTRK fusion cancer treated with Larotrectinib under real-world treatment conditions in France, and describes the dosing patterns, safety and effectiveness of this agent.
Age range
25 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Clinical activity of larotrectinib
Timeframe: From the date of the first larotrectinib dose until the date of objectively documented progression or date of subsequent anti-cancer therapy, whichever came first, assessed up to 60 months.
Clinical activity of larotrectinib
Timeframe: From the start of Complete Response or Partial Response (whichever response came first) until the date of observed disease progression or death due to any cause, whichever came first, assessed up to 60 months.
Clinical activity of larotrectinib
Timeframe: From the start of larotrectinib treatment until the first evidence of Objective Response according to RECIST V1.1 classification i.e assessed by investigators), assessed up to 60 months. Time to response will be calculated for responders only.
Clinical activity of larotrectinib
Timeframe: From the start of Larotrectinib treatment until the date of first observed disease progression (radiological or clinical, whichever came first) or death due to any cause, whichever came first, assessed up to 60 months
Clinical activity of larotrectinib
Timeframe: From the start of larotrectinib treatment until the date of death, due to any reason, assessed up to 60 months. Patients alive or lost to follow-up at the time of analysis will be censored at their last date of follow-up.