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13-02-2011 | Oncology | Article

Everolimus shows promising results in pancreatic cancer patients

Abstract

Free abstract

MedWire News: Results from the RADIANT-3 trial show that patients with low-grade or intermediate-advanced pancreatic neuroendocrine tumors have a significantly reduced risk for disease progression or death after treatment with everolimus versus placebo.

Everolimus - which inhibits the mammalian target of rapamycin, a serine-threonine kinase that stimulates cell proliferation and angiogenesis - has shown promising antitumor activity in previous phase II trials involving patients with the disease, explains the research team.

However, there have been no randomized studies to guide treatment decisions for these patients, add James Yao (University of Texas MD Anderson Cancer Center, Houston, USA) and colleagues.

"In fact currently, there's only one approved therapy for the treatment of this rare disease," said Yao, who with his co-investigators evaluated results from the phase III RAD001 in Advanced Neuroendocrine Tumors, third trial study (RADIANT-3).

After a median follow-up period of 17 months, the team observed a median progression-free survival period of 11.0 months in 207 pancreatic neuroendocrine patients randomly assigned to receive a daily oral dose of everolimus 10 mg, compared with 4.6 months in 203 patients with the condition who received placebo.

This equated to a hazard ratio of 0.35, or a 65% reduction in the risk, for disease progression or death from any cause with everolimus, report Yao et al in the New England Journal of Medicine.

Indeed, an estimated 34% of patients treated with everolimus were progression-free at 18 months, compared with 9% of those treated with placebo, "indicating that a sizeable proportion of patients derived a prolonged benefit with everolimus," remarks the group.

In addition to these measures of efficacy, the researchers investigated the safety profile of the drug compared with placebo. Consistent with its "known safety" profile, most adverse events were grade 1 or 2 as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.

The most common adverse events were stomatitis, rash, and diarrhea, which presented in 64%, 49%, and 34% of patients taking everolimus, and 17%, 10%, and 10% of patients taking placebo.

"Because treatment options available to patients with pancreatic neuroendocrine tumors are so limited, and the data in terms of the size of the treatment effect is so clear, I do believe this research will have immediate clinical applications," concluded Yao.

However, in a related commentary on the research, Robert Jensen (National Institutes of Health, Bethesda, Maryland, USA) and Gianfranco Delle Fave (University La Sapienza, Rome, Italy) warn that although the study "provides optimism," it raises some important questions that render the optimism guarded.

They ask: "Will the improvement in disease-free survival with everolimus result in improved overall survival?" and raise concerns regarding the length of time patients will have to take the treatment, since it primarily stabilizes, rather than cures the disease.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2011

By Sarah Guy