BACKGROUND:: NTRK gene fusions have been identified as oncogenic drivers in patients (pts) with TRK fusion cancer across multiple solid tumors. Larotrectinib, a highly selective, CNS-active TRK inhibitor has shown high response rates, durable disease control, and a favorable safety profile in pts with TRK fusion cancer and is approved in over 40 countries. Larotrectinib has demonstrated rapid health-related quality of life (HRQOL) improvement in a group of 57 adult and pediatric pts (Kummar et al, Curr Prob Canc 2021). Here, we report updated HRQOL results for larger group of pts treated with larotrectinib.
METHODS: HRQOL data were collected in two ongoing trials (NCT02576431, NCT02637687) of larotrectinib in pts with TRK-fusion cancer using the EORTC QLQ-C30, EQ-5D-5L questionnaires and were analyzed descriptively and longitudinally. Scores from the EORTC QLQ-C30 Global Health Status (GHS), EQ-5D-5L VAS range from 0 to 100, with higher scores indicating better QOL. We also calculated the proportion of pts with either below normal or normal and above normal HRQOL scores against values in the literature for the US general population.
RESULTS: By July 2021, 113 adults with TRK-fusion cancer had received larotrectinib and completed the baseline (BL) and ≥ 1 post-BL questionnaire. The majority of pts had clinically meaningful HRQOL improvements during treatment (Table). For EORTC QLQ-C30 GHS, most adults maintained or improved scores from BL at or above the normal population level category. HRQOL improvements (change from BL > 0) occurred after ̃2 months of treatment in 75% of adults. Median duration of pts with sustained improvement in EORTC QLQ-C30 GHS, and EQ-5D-5L VASs was 12.5 months (range, 1.8-34.1), and 12.9 months (range, 1.8-34.0), respectively. HRQOL results were consistent across multiple data cuts.
COONCLUSIONS: Patients with TRK-fusion cancer treated with larotrectinib continued to have rapid, clinically meaningful, and sustained improvements in HRQOL
