An LY2606368 dose of 105 mg/m(2) once every 14 days is being evaluated as the recommended phase II dose in dose-expansion cohorts for patients with SCC.
Prexasertib, a checkpoint kinase 1 inhibitor, demonstrated single-agent activity in patients with advanced squamous cell carcinoma (SCC) in the dose-escalation portion of a phase I study (NCT01115790). Monotherapy prexasertib was further evaluated in patients with advanced SCC. Patients were given prexasertib 105 mg/m as a 1-hour infusion on day 1 of a 14-day cycle. Expansion cohorts were defined by tumor and treatment line. Safety, tolerability, efficacy, and exploratory biomarkers were analyzed. Prexasertib was given to 101 patients, including 26 with SCC of the anus, 57 with SCC of the head and neck (SCCHN), and 16 with squamous cell non-small cell lung cancer (sqNSCLC). Patients were heavily pretreated (49% ≥3 prior regimens). The most common treatment-related adverse event was grade 4 neutropenia (71%); 12% of patients had febrile neutropenia. Median progression-free survival was 2.8 months [90% confidence interval (CI), 1.9-4.2] for SCC of the anus, 1.6 months (90% CI, 1.4-2.8) for SCCHN, and 3.0 months (90% CI, 1.4-3.9) for sqNSCLC. The clinical benefit rate at 3 months (complete response + partial response + stable disease) across tumors was 29% (23% SCC of the anus, 28% SCCHN, 44% sqNSCLC). Four patients with SCC of the anus had partial or complete response [overall response rate (ORR) = 15%], and three patients with SCCHN had partial response (ORR = 5%). Biomarker analyses focused on genes that altered DNA damage response or increased replication stress. Prexasertib demonstrated an acceptable safety profile and single-agent activity in patients with advanced SCC. The prexasertib maximum-tolerated dose of 105 mg/m was confirmed as the recommended phase II dose. .
Editorial acknowledgement: Writing and editorial assistance was provided by Laura Yee, of Caudex, funded by Bristol-Myers Squibb Company.Legal entity responsible for the study: Bristol-Myers Squibb Company.
Despite advances in diabetes therapies and technologies, the majority of people with diabetes (PWD) are not achieving treatment targets.Therapeutic inertia has been identified as a key contributor, and although multifactorial, a major obstacle to timely therapy optimization is the lack of access to data. 1 The increasing use of connected diabetes digital technologies that automatically record, share, and increasingly interpret diabetes-related data can facilitate more timely and better informed care plan adjustments made in collaboration with the person living with diabetes. 2 The American Diabetes Association Standards of Medical Care in Diabetes opens the Diabetes Technology chapter stating, "there is no one-size-
CRCS prevalence can be markedly improved in the public sector with a data-driven panel management approach supported by departmental and clinic-specific QI committees and group outreach events. Continued prioritization of and focus on CRCS is required to ensure long-term success. Even small increases will result in avoidable morbidity and mortality associated with this highly preventable disease.
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