The evolution and understanding of skeletal complication endpoints in clinical trials of tumors with metastasis to the bone.

Journal Article (Journal Article;Review)

Bone 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.

Full Text

Duke Authors

Cited Authors

  • Hussain, A; Lee, RJ; Graff, JN; Halabi, S

Published Date

  • July 2019

Published In

Volume / Issue

  • 139 /

Start / End Page

  • 108 - 116

PubMed ID

  • 31170574

Pubmed Central ID

  • PMC6609290

Electronic International Standard Serial Number (EISSN)

  • 1879-0461

Digital Object Identifier (DOI)

  • 10.1016/j.critrevonc.2019.04.020


  • eng

Conference Location

  • Netherlands