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Everolimus may be viable option for advanced pancreatic neuroendocrine tumors
Yao JC. N Engl J Med. 2011;364:514-523.
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Everolimus was linked to PFS more than twice as long as placebo in a cohort of patients with pancreatic neuroendocrine tumors, according to study results.
The current phase 3 study involved 410 patients with advanced, low-grade or intermediate-grade disease who had experienced radiologic progression within the previous 12 months. The treatment regimens were 10 mg everolimus (Afinitor, Novartis) daily, or placebo.
The median PFS among 207 patients in the treatment group was 11 months vs. 4.6 months among 203 patients in the placebo group (HR for disease progression or death from any cause with everolimus=0.35; 95% CI, 0.27-0.45). The researchers said this amounts to a 65% reduction in the estimated risk for progression or death.
Estimated survival and PFS at 18 months was 34% (95% CI, 26-43) among patients receiving everolimus and 9% (95% CI, 4-16) among patients receiving placebo.
Results of an analysis by an independent panel indicated that the median PFS was 11.4 months (95% CI, 10.8-14.8) with everolimus and 5.4 months (95% CI, 4.3-5.6) with placebo (HR=0.34; 95% CI, 0.26-0.4).
The most commonly reported grade 1 or 2 adverse events in the everolimus group vs. the placebo group were as follows: stomatitis, 64% vs. 17%; rash, 49% vs. 10%; diarrhea, 34% vs. 10%; fatigue, 31% vs. 14%; and infections 23% vs. 6%. Most of the infections were upper respiratory.
Everolimus was linked to a greater incidence of grade 3 or 4 adverse events than placebo, including anemia (6% vs. 0%) and hyperglycemia (5% vs. 2%).
Patients in the everolimus arm were exposed to the drug for a longer median duration than patients in the placebo arm by a factor of 2.3 (38 weeks vs. 16 weeks).
Supportive care was comparable in both arms.
The primary intention-to-treat outcome was PFS. If progression occurred among patients in the placebo group, treatment assignments were revealed, and those patients were offered the opportunity to receive the study drug in an open-label format.