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Everolimus breast cancer trial halted early with primary end point met
Novartis announced that it has stopped early its phase 3 trial of everolimus (Afinitor) plus exemestane in women with estrogen receptor-positive locally-advanced or metastatic breast cancer after an interim analysis showed that the primary end point of progression-free survival was met, the company said.
Novartis announced that it has stopped early its phase 3 trial of everolimus(Afinitor) plus exemestane in women with estrogen receptor-positive locally-advanced or metastatic breast cancer after an interim analysis showed that the primary end point of progression-free survival was met.
The Breast cancer trials of OraL EveROlimus-2 (BOLERO-2) study was investigating everolimus in combination with exemestane versus placebo plus exemestane in postmenopausal women with estrogen receptor-positive locally-advanced or metastatic breast cancer, whose disease had progressed, despite treatment with the nonsteroidal aromatase inhibitors letrozole or anastrozole.
The study enrolled more than 700 patients at more than 195 sites worldwide who had received no more than 1 prior chemotherapy treatment for advanced breast cancer. Patients were randomly assigned (2:1) to receive continuous therapy with everolimus 10 mg/day orally or placebo plus oral exemestane 25 mg/day. The primary end point was progression-free survival. Secondary end points included overall survival, overall response rate, incidence of adverse events, patient-reported outcomes, and clinical benefit rate. The company did not mention the results of the secondary end points, but said that results would be presented at an upcoming medical conference and that the company is planning to file marketing applications worldwide by the end of the year.
Everolimus targets mTOR in cancer cells, a protein that acts as an important regulator of tumor cell division, blood vessel growth, and cell metabolism. The drug can cause serious side effects including lung or breathing problems, infections, and renal failure, which can lead to death. Mouth ulcers and mouth sores are common side effects, the company stated.
"Despite clinical progress in advanced breast cancer, most women are either initially resistant or develop resistance to endocrine therapy over time. As a result, there is a significant need for new treatment options," said Hervé Hoppenot, president, Novartis Oncology, in a company statement. "Based on these study results, this combination has the potential to extend the time until chemotherapy is needed for these patients."
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
