Articles related to CLINICAL TRIALS

With two cycles of neoadjuvant immunotherapy, nearly every patient with mismatch repair-deficient (dMMR) colon cancer in the NICHE-2 trial achieved a pathologic response. At a median follow-up of 13.1 months, the disease-free survival (DFS) rate was 100% vs. an expected rate for this patient population of 15%.

In this double-blind randomized clinical trial with 93 participants, the percentage of heavy drinking days during 32 weeks of follow-up was significantly lower in the psilocybin group than in the diphenhydramine group and was accompanied by a decrease in daily alcohol consumption.

Sixty-one unmedicated adults — 75% female, mean age of 45 years — with major depressive disorder, body mass index > 25 kg/m2, and plasma high-sensitivity C-reactive protein (hs-CRP) ≥ 3.0 mg/L were randomly assigned to receive EPA 1 g/d, 2 g/d, or 4 g/d or placebo for 12 weeks. The EPA 4 g/d demonstrated a medium effect versus placebo. This dose may alleviate MDD in overweight individuals with elevated inflammatory markers. Further, decline in hs-CRP may be correlated with clinical response.

Dextromethorphan HBr-buproprion HCl has been FDA approved in extended-release tablet form for MDD. The study supporting the approval showed improved MADRS total score at 6 weeks (15.9 points for Auvelity vs 12.1 points for placebo) and a statistically significant difference in the change from baseline in MADRS total score at weeks 1 and 2 between Auvelity (AXSOME) and placebo. “The approval of Auvelity represents a milestone in depression treatment based on its novel oral NMDA antagonist mechanism, its rapid antidepressant efficacy demonstrated in controlled trials, and a relatively favorable safety profile.” Maurizio Fava, MD, Psychiatrist-In-Chief, Massachusetts General Hospital

This trial included 33 patients with clinical node-positive locally advanced breast cancer who underwent NET and breast surgery. MRI exams were performed before the first treatment regimen, at least two months after the first treatment cycle but prior to crossing-over, and immediately before surgery. MRI did not demonstrate sufficient diagnostic performance to avoid surgical axillary staging in the authors’ analysis.

The prospective, open-label, single-arm, phase 2 TUXEDO-1 trial enrolled patients with HER2-positive breast cancer and newly diagnosed untreated brain metastases or brain metastases progressing after previous local therapy. Patients received trastuzumab deruxtecan intravenously at the standard dose of 5.4 mg per kg bodyweight once every 3 weeks. Fifteen patients received at least one dose of study drug. Two patients (13.3%) had a complete intracranial response, nine (60%) had a partial intracranial response and three (20%) had stable disease as the best intracranial response. There were no new safety signals.