The evolution and understanding of skeletal complication endpoints in clinical trials of tumors with metastasis to the bone
JournalCritical Reviews in Oncology/Hematology
PublisherElsevier Ireland Ltd
MetadataShow full item record
AbstractBone metastases are a frequent complication of solid tumors, leading to significant skeletal sequelae that negatively impact quality of life and survival. Prevention and management of skeletal-related complications are critical treatment goals in oncology. Endpoints used in clinical trials to evaluate skeletal-related complications have evolved. In contrast to single measures of bone health, contemporary clinical trial endpoints reflect composite measures of skeletal-related complications, and increasingly also survival. In addition, key symptomatic components, which are more reflective of quality of life and the patient experience, are being incorporated. Given the evolution and resulting diversity of the endpoints being used in pivotal trials, it is becoming increasingly relevant to clarify the utility and the potential clinical impact of these measures not only within the context of trials but also in the real-world setting. Here, we describe the development and evolution of skeletal endpoints used in trials, and discuss their clinical relevance. Copyright 2019 The Authors
SponsorsPart of AH's time was supported by a Merit Review Award (I01 BX000545), Medical Research Service, Department of Veterans Affairs .
Identifier to cite or link to this itemhttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85066431295&doi=10.1016%2fj.critrevonc.2019.04.020&partnerID=40&md5=2bc6747d3a7777c35fa9ca5f552b0b52; http://hdl.handle.net/10713/10236