Tumour Burden Reporting in Phase III Clinical Trials of Metastatic Lung, Breast, and Colorectal Cancers: A Systematic Review.

ABSTRACT:

Background

Randomised phase III clinical trials represent a methodological milestone to select effective drugs against metastatic cancers. In this context, and particularly in the efficacy assessment of biologic drugs, the initial metastatic tumour burden is a strong prognostic factor.

Methods

A systematic literature review of randomised, phase III, first-line, clinical trials in metastatic breast, colorectal, and lung cancers, published from 2016 to 2021, was performed. Three groups of variables were collected: identity-, method- (including tumour burden assessment) and outcome-related.

Results

Seventy trials were selected. A large portion of studies (41.4%) focused on the effects of biologic agents (signal inhibitors and immuno-therapies). A definition of low-burden

SUBMITTER: Santorsola M 

PROVIDER: S-EPMC9264965 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature