Articles related to CLINICAL TRIALS

Early triple-negative breast cancer patients who received pembrolizumab along with neoadjuvant chemotherapy had a significantly higher rate of pathological complete responses than those who received placebo along with neoadjuvant chemotherapy.

Working from the hypothesis that stomach ulcer bleeds in people on long-term low-dose aspirin therapy was secondary to H. pylori infection, this team gave antibiotic treatment to aspirin takers who test positive for the bacteria, and followed them for up to 7 years. Protection started rapidly and persisted, while diminishing somewhat, over the period of observation.

The 8-week treatment with mindfulness-based stress reduction was a well-tolerated treatment option with comparable effectiveness to a first-line medication for patients with anxiety disorders in this randomized clinical trial of 276 adults with anxiety disorders.

Eighty-eight children ages 6 through 12 were randomized to daily pine bark extract, methylphenidate, or placebo for 10 weeks. Total ADHD-Rating Scales scores decreased 29% with pine bark extract, 45% with methylphenidate, and 5% with placebo. Hyperactivity/impulsivity decreased 34% with pine bark extract and 36% with methylphenidate and increased 1% with placebo. Inattention decreased 25% with pine bark extract, 52% with methylphenidate, 9% with placebo. Adverse events were reported 5 times more frequently with methylphenidate than with pine bark.

Mikkael A. Sekeres, MD, currently Chief of the Division of Hematology at the Sylvester Comprehensive Cancer Center at the University of Miami, worked on the decision to remove Avastin’s indication for the treatment of HER2-negative metastatic breast cancer in 2008. As a result of the hearing, Dr. Sekeres poses the following question in his most recent book, Drugs and the FDA: Safety, Efficacy, and the Public’s Trust: “Had the FDA made a mistake in initially approving the drug?” Dr. Sekeres discussed with OBR the rise of accelerated approvals, progression-free survival as an endpoint, and the consequences of the Avastin hearing.

Judith Trotman, MBChB, FRACP, FRCPA, clinical professor at the University of Sydney in Concord, New South Wales, Australia, and head of the Hematology Department at Concord Repatriation General Hospital, provides background on mantle cell lymphoma, its unique treatment challenges, and the significance of the SHINE trial, which assessed ibrutinib plus bendamustine and rituximab in untreated mantle cell lymphoma.