Abstract
Ideally, new treatments should either improve overall survival or the health-related quality of life (HRQOL) of patients, or both, and should have a favourable cost-to-benefit ratio. For instance, FOLFIRINOX (leucovorin, fluorouracil, irinotecan, and oxaliplatin) significantly improves progression-free survival, overall survival, and HRQOL compared with gemcitabine in patients with metastatic pancreatic adenocarcinoma, even though it causes substantially more side-effects. 1 Gourgou-Bourgade S Bascoul-Mollevi C Desseigne F et al. Impact of FOLFIRINOX compared with gemcitabine on quality of life in patients with metastatic pancreatic cancer: results from the PRODIGE 4/ACCORD 11 randomized trial. J Clin Oncol. 2013; 31: 23-29 Crossref PubMed Scopus (344) Google Scholar , 2 Conroy T Desseigne F Ychou M et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011; 364: 1817-1825 Crossref PubMed Scopus (5177) Google Scholar After publication of the RADIANT-3 and RADIANT-4 randomised, placebo-controlled, phase 3 studies, everolimus was approved for all non-functional, advanced, neuroendocrine tumours (NETs), including those of the pancreas, 3 Yao JC Shah MH Ito T et al. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med. 2011; 364: 514-523 Crossref PubMed Scopus (2257) Google Scholar lung, and gastrointestinal tract, 4 Yao JC Fazio N Singh S et al. for the RAD001 in Advanced Neuroendocrine TumoursFourth Trial (RADIANT-4) Study GroupEverolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract (RADIANT-4): a randomised, placebo-controlled, phase 3 study. Lancet. 2016; 387: 968-977 Summary Full Text Full Text PDF PubMed Scopus (784) Google Scholar and sunitinib has been approved for pancreatic NETs (pNETs). 5 Raymond E Dahan L Raoul JL et al. Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med. 2011; 364: 501-513 Crossref PubMed Scopus (1959) Google Scholar Everolimus did not improve overall survival compared with placebo but was approved on the basis of a significant improvement versus placebo in progression-free survival. 3 Yao JC Shah MH Ito T et al. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med. 2011; 364: 514-523 Crossref PubMed Scopus (2257) Google Scholar , 4 Yao JC Fazio N Singh S et al. for the RAD001 in Advanced Neuroendocrine TumoursFourth Trial (RADIANT-4) Study GroupEverolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract (RADIANT-4): a randomised, placebo-controlled, phase 3 study. Lancet. 2016; 387: 968-977 Summary Full Text Full Text PDF PubMed Scopus (784) Google Scholar Health-related quality of life for everolimus versus placebo in patients with advanced, non-functional, well-differentiated gastrointestinal or lung neuroendocrine tumours (RADIANT-4): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trialHRQOL was maintained for patients with advanced, non-functional, gastrointestinal or lung NETs, with no relevant differences noted between the everolimus and placebo groups. In view of the previous RADIANT-4 findings of longer progression-free survival with everolimus, our findings suggest that everolimus delays disease progression while preserving overall HRQOL, even with the usual toxic effects related to active targeted drug treatment for cancer. Full-Text PDF
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