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Everolimus increased PFS in rare neuroendocrine tumors
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Everolimus increased PFS by 5.1 months in patients with advanced neuroendocrine tumors — specifically by 2.4-fold in patients with advanced pancreatic neuroendocrine tumors, according to study findings.
Although uncommon, neuroendocrine tumors are often non-responsive to chemotherapy, and until recently, few treatment options existed. Findings from a recent placebo-controlled trial showed that octreotide acetate injection has anti-tumor effects in neuroendocrine tumors of the small intestine.
For this reason, researchers for the RADIANT-2 trial assigned 216 patients with progressing, well- or moderately differentiated advanced neuroendocrine tumors to treatment with 10 mg daily everolimus (Afinitor, Novartis) plus 30 mg octreotide acetate injection for 28 days; 213 patients received placebo plus octreotide acetate injection.
All patients had a history of symptoms, such as flushing and diarrhea. Primary origin of tumor sites were the small intestine, lung, colon, pancreas and liver.
Patients assigned everolimus plus octreotide acetate injection had a median PFS of 16.4 months, compared with 11.3 months PFS in patients assigned placebo plus octreotide acetate injection.
Moreover, everolimus plus octreotide acetate injection was associated with a 23% reduction in the risk for disease progression (HR=0.77; 95% CI, 0.59-1.00).
In a separate presentation, James C. Yao, MD, of The University of Texas M.D. Anderson Cancer Center, in Houston, highlighted data from the RADIANT-3 trial.
For the randomized, double blind, placebo-controlled, multicenter phase 3 trial, Yao and colleagues randomly assigned 410 patients with advanced pancreatic neuroendocrine tumors to everolimus (n=207) or placebo (n=203).
Results indicated everolimus significantly prolonged PFS 2.4-fold when compared with placebo in patients with advanced pancreatic neuroendocrine tumors. Further, 18-month data indicated a prolonged benefit of treatment on PFS.
“Since chemotherapeutic drugs are not effective in this type of neuroendocrine tumor patient, we now have for the first time a drug that has been studied in a phase 3 trial that offers antitumor efficacy in addition to the currently available agents, somatostatin analogs and interferon,” Marianne Pavel, MD, assistant director, leader of the section of Neuroendocrine Tumors and Clinical Trial Unit, at Charité University in Berlin, said in a press release. “It seems important to identify patients that may benefit most from the combination of everolimus and octreotide LAR compared to octreotide LAR alone.”
For more information:
- Pavel M. #LBA8. Presented at: the ESMO 35th Congress; Oct. 8-12, 2010; Milan, Italy.