Assessing tolerability with the Functional Assessment of Cancer Therapy item GP5: psychometric evidence from LIBRETTO-531, a phase 3 trial of selpercatinib in medullary thyroid cancer.

Background: This psychometric analysis generated evidence to support the use of the Functional Assessment of Cancer Therapy item GP5 (GP5) as a measure of tolerability and confirms the appropriateness of categorizing "high side-effect burden" using a rating of 3 or 4 (score ranges 0-4) in patients with advanced/metastatic RET-mutant medullary thyroid cancer (MTC).

Methodology: Blinded, pooled interim data from the safety population (n=290) enrolled in the phase 3 LIBRETTO-531 trial (NCT04211337) were used. Intraclass correlation coefficients (ICC) were calculated for test-retest reliability using data from cycles 1-2 post-baseline.

Long term T cell response and safety of a tetravalent dengue vaccine in healthy children.

As robust cellular responses are important for protection against dengue, this phase 2 study evaluated the kinetics and phenotype of T cell responses induced by TAK-003, a live-attenuated tetravalent dengue vaccine, in 4-16-year-old living in dengue-endemic countries (NCT02948829). Two hundred participants received TAK-003 on Days 1 and 90. Interferon-gamma (IFN-γ) enzyme-linked immunospot assay [ELISPOT] and intracellular cytokine staining were used to analyze T cell response and functionality, using peptide pools representing non-structural (NS) proteins NS3 and NS5 matching DENV-1, -2, -3, and -4 and DENV-2 NS1.

Stifle arthrodesis in dogs using semi-circular saw: Cadaveric study.

The aim of this study was to develop a novel surgical technique for stifle arthrodesis in dogs using a semicircular saw for tibial and femoral ostectomies through a medial approach. Ten pelvic limbs from five canine cadavers underwent stifle arthrodesis. Prior to the surgical procedure, the limbs were radiographed to rule out musculoskeletal abnormalities.

Durability of Response With Selpercatinib in Patients With -Activated Thyroid Cancer: Long-Term Safety and Efficacy From LIBRETTO-001.

JCO LIBRETTO-001 is a registrational phase I/II, single-arm, open-label study of selpercatinib in patients with (REarranged during Transfection)-activated cancers (ClinicalTrials.gov identifier: NCT03157128). We present long-term safety and efficacy from LIBRETTO-001 in patients with -mutant medullary thyroid cancer (MTC; n = 324) and fusion-positive thyroid cancer encompassing different histological subtypes (TC; n = 66).