David Brill
Everolimus could provide a viable new treatment option for advanced gastric cancer, Japanese investigators said recently, following the conclusion of a phase II trial of the drug.
After 8 weeks of therapy everolimus halted tumor growth in 55 percent of patients, with 45 percent showing signs of tumor shrinkage.
A phase III trial involving some 500 patients will open for enrollment later this year, the drug’s manufacturer, Novartis, announced following the presentation of the new data at an American Society of Clinical Oncology symposium in January.
The multicenter, open-label study involved 54 Japanese patients of Asian descent who had previously undergone heavy treatment with chemotherapy.
"There are very limited treatment options for patients who progressed despite the standard treatment for this aggressive cancer," said lead researcher Dr. Atsushi Ohtsu, director of the Research Center for Innovative Oncology at the National Cancer Center Hospital East, Chiba, Japan. "The results from this study demonstrate that [everolimus] has the potential to provide an effective new option for these patients."
Patients in the study took 10 mg oral everolimus daily for an average of 57 days. The overall rate of adverse events – including anorexia, vomiting and stomatitis – was around 10 percent, with serious adverse events occurring in some 3 percent.
The median progression-free survival with everolimus was 83 days. At 4 months, around 30 percent of patients were still progression-free.
Everolimus inhibits the mammalian target of rapamycin (mTOR) – a cell signaling protein which is implicated in the development of several cancers. The drug has already shown promise for advanced renal cancer carcinoma and is currently under regulatory review in Europe and the US for this indication. A phase III randomized controlled trial, published last year, found that the drug prolonged progression-free survival by a median of 2.1 months over placebo in patients with metastatic renal cell carcinoma. [Lancet 2008 Aug 9;372(9637):449-56]
Gastric cancer is the most common type of cancer in East Asia, accounting for 18.9 percent of new cases in 2007, according to data from the American Cancer Society. Globally, it is the second leading cancer and is responsible for some 866,000 deaths worldwide each year, according to the WHO.
The risk of gastric cancer is thought to be increased by eating a diet high in salted, pickled and smoked foods, and by long-term infection with Helicobacter pylori. Male gender, smoking and age above 50 are also important risk factors.
No comments:
Post a Comment