Olivia Le Saux1, Claire Falandry2. 1. Oncology Department, Centre Hospitalier Lyon Sud, 165 chemin du grand Revoyet, 69495, Pierre-Bénite, France. Olivia.lesaux@gmail.com. 2. Geriatric Oncology Department, Centre Hospitalier Lyon Sud, 165 chemin du grand Revoyet, 69495, Pierre-Bénite, France.
Abstract
PURPOSE OF REVIEW: We will review the reasons that explain the poor accrual of elderly patients to clinical trials, then we will discuss the relevance of an age threshold for holding off on testing novel therapies. RECENT FINDINGS: Little progress has been made in enrolling elderly patients in clinical trials. Reasons to hold off on testing novel therapies in elderly patients are mainly explained by exclusion criteria and industrials' reluctance to include elderly patients for fear of negative results. No age threshold should exist for testing novel therapies as long as well-designed clinical trials are developed and requested by regulatory authorities. Furthermore, clinical trials assessing novel anticancer therapies such as targeted therapies or immune checkpoint inhibitors should be developed in elderly patients regardless of age as these therapies may present a favorable benefit-risk profile compared to chemotherapy which is often more toxic and at risk of geriatric deconditioning.
PURPOSE OF REVIEW: We will review the reasons that explain the poor accrual of elderly patients to clinical trials, then we will discuss the relevance of an age threshold for holding off on testing novel therapies. RECENT FINDINGS: Little progress has been made in enrolling elderly patients in clinical trials. Reasons to hold off on testing novel therapies in elderly patients are mainly explained by exclusion criteria and industrials' reluctance to include elderly patients for fear of negative results. No age threshold should exist for testing novel therapies as long as well-designed clinical trials are developed and requested by regulatory authorities. Furthermore, clinical trials assessing novel anticancer therapies such as targeted therapies or immune checkpoint inhibitors should be developed in elderly patients regardless of age as these therapies may present a favorable benefit-risk profile compared to chemotherapy which is often more toxic and at risk of geriatric deconditioning.
Authors: Martine J Piccart-Gebhart; Marion Procter; Brian Leyland-Jones; Aron Goldhirsch; Michael Untch; Ian Smith; Luca Gianni; Jose Baselga; Richard Bell; Christian Jackisch; David Cameron; Mitch Dowsett; Carlos H Barrios; Günther Steger; Chiun-Shen Huang; Michael Andersson; Moshe Inbar; Mikhail Lichinitser; István Láng; Ulrike Nitz; Hiroji Iwata; Christoph Thomssen; Caroline Lohrisch; Thomas M Suter; Josef Rüschoff; Tamás Suto; Victoria Greatorex; Carol Ward; Carolyn Straehle; Eleanor McFadden; M Stella Dolci; Richard D Gelber Journal: N Engl J Med Date: 2005-10-20 Impact factor: 91.245
Authors: Matthew T Seymour; Lindsay C Thompson; Harpreet S Wasan; Gary Middleton; Alison E Brewster; Stephen F Shepherd; M Sinead O'Mahony; Timothy S Maughan; Mahesh Parmar; Ruth E Langley Journal: Lancet Date: 2011-05-11 Impact factor: 79.321