The Choice of the Endpoint to Assess the Efficacy or Effectiveness in Advanced or Metastatic Cancer Tumors
Division of Modern Medical Technology, Institute for Clinical Research, National Hospital Organization Kure Medical Center, Kure, 737-0023
- *Corresponding Author:
- Dr. Takayoshi Kiba, MD, PhD
Division of Modern Medical Technology
Institute for Clinical Research
National Hospital Organization Kure Medical Center
Kure, 737-0023, Hiroshima, JAPAN
E-mail: [email protected]
Received Date: March 09, 2011; Accepted Date: September 08, 2011; Published Date: September 11, 2011
Citation: Kiba T (2011) The Choice of the Endpoint to Assess the Efficacy or Effectiveness in Advanced or Metastatic Cancer Tumors. J Cancer Sci Ther 3:154-157. doi: 10.4172/1948-5956.1000079
Copyright: © 2011 Kiba T. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
It is important to investigate whether other clinical endpoints, such as response rate, disease stabilization rate, or progression free survival could replace overall survival as the primary endpoint for the patients with advanced or metastatic cancer. Before a surrogate end point can replace a so-called 'true' end point of interest, it must be formally validated, a process that has caused considerable controversy in the past two decades. The aim of this review manuscript is to discuss some of the limitations encountered when survival is used as the primary study end point for evaluating the efficacy or effectiveness in phase II or III trials for advanced or metastatic cancer tumors.