2 Drugs Look Promising for Rare Pancreatic Cancer
Targeted Treatment Slowed Disease Progression in Studies
The Sutent/Afinitor Studies
The Sutent phase III study was originally designed to include about 340 patients with advanced pancreatic neuroendocrine tumors taking either the drug or placebo. But it was stopped after only about half that number had been enrolled to allow the patients in the placebo arm of the study to switch to Sutent because the drug’s benefits were so obvious.
At the data cutoff point, nine deaths had been reported in the Sutent group (10%), compared to 21 deaths in the placebo group (25%).
The Afinitor trial included 410 patients treated with the drug or placebo until evidence of disease progression was seen, researcher James C. Yao, MD, of the University of Texas M.D. Anderson Cancer Center, tells WebMD.
After 18 months, 34% of the Afinitor-treated patients showed no evidence of disease progression, compared to just 9% of the placebo-treated patients.
Although both drugs were clearly effective, a significant number of patients reported troubling side effects, including a drop in infection-fighting white blood cells in 12% of those who took Sutent.
Yao says canker sores were the most commonly reported side effect in the Afinitor trial, with 64% of patients developing the sores at some point in treatment and 7% developing sores severe enough to cause problems eating and drinking.
In an editorial published with the studies, Robert T. Jensen, MD, of the NIH’s Digestive Disease Branch and Gianfranco Delle Fave, MD, of Italy’s University La Sapienza, write that it remains to be seen how the side effect profiles of the drugs will affect patient adherence.
“Drug-related side effects...are particularly important to consider, given that treatment will be long term and that many patients have an excellent quality of life with no treatment until late in the disease course, even with advanced disease that is progressive,” they write.
Data from both the studies, which were funded by the drugs’ manufacturers, were presented last summer at the 12th World Congress on Gastrointestinal Cancer in Barcelona, Spain.