We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Larotrectinib Treatment for Patients With TRK Fusion-Positive Salivary Gland Cancers.
- Authors
Le, Xiuning; Baik, Christina; Bauman, Jessica; Gilbert, Jill; Brose, Marcia S; Grilley-Olson, Juneko E; Patil, Tejas; McDermott, Ray; Raez, Luis E; Johnson, Jennifer M; Shen, Lin; Tahara, Makoto; Ho, Alan L; Norenberg, Ricarda; Dima, Laura; Brega, Nicoletta; Drilon, Alexander; Hong, David S
- Abstract
Background Larotrectinib is a first-in-class, highly selective, and central nervous system-active tropomyosin receptor kinase (TRK) inhibitor approved for the treatment of adult and pediatric patients with TRK fusion cancer. We report the efficacy and safety of larotrectinib in patients with TRK fusion-positive salivary gland cancers. Patients and Methods Patients with TRK fusion-positive salivary gland cancer treated with larotrectinib were identified from two clinical trials (NCT02122913 and NCT02576431). Patients received larotrectinib 100 mg twice daily (BID) except for one patient who received 150 mg BID in the phase I trial. The primary endpoint was objective response rate (ORR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1. Results At the data cut-off (July 20, 2020), 24 patients with TRK fusion-positive salivary gland cancer had been treated. The most common histologies were secretory carcinoma (54%), adenocarcinoma (25%), and mucoepidermoid carcinoma (13%). All 24 patients had an ETV6-NTRK3 gene fusion. The ORR was 92% (95% confidence interval, 73-99). Best overall response was complete response in three (13%) patients, partial response in 19 (79%), and progressive disease in two (8%). The rate of progression-free survival at 24 months was 78% (median follow-up 30.9 months). Most treatment-related adverse events (AEs) were grade 1-2, and no patients discontinued treatment due to AEs. Conclusion Larotrectinib demonstrated robust and durable efficacy in patients with TRK fusion-positive salivary gland tumors of various histologies, and a favorable safety profile. These findings support NTRK gene fusion testing in patients with advanced salivary gland cancers. ClinicalTrials.gov numbers NCT02122913 and NCT02576431.
- Subjects
THERAPEUTIC use of antineoplastic agents; PROTEIN kinase inhibitors; HETEROCYCLIC compounds; ADENOCARCINOMA; PATIENT safety; RESEARCH funding; SALIVARY gland tumors; DESCRIPTIVE statistics; DRUG efficacy; TUMORS; CONFIDENCE intervals; PROGRESSION-free survival; DISEASE progression; TIME
- Publication
Oncologist, 2024, Vol 29, Issue 6, pe779
- ISSN
1083-7159
- Publication type
Article
- DOI
10.1093/oncolo/oyac080