Health-Related Quality-of-Life of Patients Treated with Repotrectinib for Neurotrophic Tyrosine Receptor Kinase (NTRK)-Positive Advanced Solid Tumors: Results from TRIDENT-1
Author(s)
Sherif B1, Besse B2, Solomon B3, Bazhenova L4, Kim DW5, Lin JJ6, Wolf J7, Popat S8, Goto K9, de Langen AJ10, Springfeld C11, Reynolds M1, Odom D1, Yuan Y12, Lee A13, Blum SI14, Thamake S14, Ades F14, Drilon A15
1RTI Health Solutions, Research Triangle Park, NC, USA, 2Paris-Saclay University, Gustave Roussy Cancer Center, Villejuif, France, 3Peter MacCallum Cancer Centre, Melbourne, VIC, Australia, 4UC San Diego Moores Cancer Center, La Jolla, CA, USA, 5Seoul National University Hospital, Seoul, Korea, Republic of (South), 6Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA, 7Centrum für Integrierte Onkologie – Uniklinik Köln, Köln, Germany, 8The Royal Marsden NHS Foundation Trust, London, UK, 9National Cancer Center Hospital East, Kashiwa, Japan, 10Netherlands Cancer Institute, Amsterdam, Netherlands, 11Heidelberg University Hospital, National Center for Tumor Diseases, Heidelberg, Germany, 12Bristol Myers Squibb, Plainsboro, NJ, USA, 13Bristol Myers Squibb, Uxbridge, LON, UK, 14Bristol Myers Squibb, Princeton, NJ, USA, 15Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY, USA
Presentation Documents
OBJECTIVES: In a multi-cohort phase 1/2 study (TRIDENT-1), repotrectinib, a next-generation tyrosine kinase inhibitor (TKI), has shown clinical activity and manageable safety in ROS1+ advanced non-small cell lung cancer (NSCLC) and NTRK+ locally advanced/metastatic solid tumors. We analyzed treatment-related symptoms and general health status in patients with NTRK+ solid tumors using the EORTC QLQ-C30
METHODS: Patients with NTRK+ advanced solid tumors who received either no prior TKI (TKI-naive) or ≤2 prior lines of TKI (TKI-pretreated) received repotrectinib 160 mg once daily for 14 days, followed by twice daily if tolerated. The QLQ-C30 was administered at screening, prior to each cycle, and end-of-treatment visit. Change from baseline in GHS/QOL and each of the functional and symptom scales/items were summarized. Time to first improvement (TFI) and time to definitive deterioration (TDD) were assessed using Kaplan-Meier methods. ≥10-point changes from baseline were prespecified as thresholds for meaningful change. Analysis was conducted on NTRK cohorts using data collected through December 2022.
RESULTS: Among the 79 patients with NTRK+ solid tumors (35 TKI-naïve [median follow-up: 17.8 months [range, 8.7–64.6]) and 44 TKI-pretreated (median follow-up: 20.1 months [8.7–69.4]) analyzed, the most frequent tumor type was NSCLC (43%). Mean baseline GHS/QOL scores were 70.2 in TKI-naïve and 64.9 in TKI-pretreated patients. Mean changes in GHS/QOL and functional scales were stable through the first year on treatment in both groups. Overall, symptom scales were stable, except worsening in Constipation for TKI-naïve. Median TDD in GHS/QOL was 17.5 (95% CI, 9.2–19.3) months for TKI-naïve and 13.1 (8.4–NE) months for TKI-pretreated. Median TFI in GHS/QOL was not reached for either group.
CONCLUSIONS: Patients with NTRK+ solid tumors who were treated with repotrectinib generally experienced stable HRQoL as measured by the QLQ-C30. These results compliment the efficacy and safety profile of repotrectinib as a treatment option for patients with NTRK+ solid tumors.
Conference/Value in Health Info
Value in Health, Volume 26, Issue 11, S2 (December 2023)
Code
PCR181
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Oncology