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

A. Hussain, R. J. Lee, Julie Graff, S. Halabi

Research output: Contribution to journalReview article

Abstract

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.

Original languageEnglish (US)
Pages (from-to)108-116
Number of pages9
JournalCritical Reviews in Oncology/Hematology
Volume139
DOIs
StatePublished - Jul 1 2019

Fingerprint

Quality of Life
Clinical Trials
Neoplasm Metastasis
Bone and Bones
Survival
Life Change Events
Neoplasms
Health
Therapeutics

Keywords

  • Bone
  • Bone metastases
  • Endpoint
  • Skeletal-related event
  • Symptomatic skeletal event

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Geriatrics and Gerontology

Cite this

The evolution and understanding of skeletal complication endpoints in clinical trials of tumors with metastasis to the bone. / Hussain, A.; Lee, R. J.; Graff, Julie; Halabi, S.

In: Critical Reviews in Oncology/Hematology, Vol. 139, 01.07.2019, p. 108-116.

Research output: Contribution to journalReview article

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