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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Stable disease is a valid end point in clinical trials
1START-South Texas Accelerated Research Therapeutics, San Antonio, TX 78229, USA. atolcher@start.stoh.com
Cancer Journal (Sudbury, Mass.)
|October 15, 2009
Summary
Stable disease is a valid outcome in early cancer clinical trials, even with lower objective response rates. New methods improve the interpretation of stable disease, enhancing its value as a clinical endpoint.
Area of Science:
- Oncology
- Clinical Trials
- Drug Development
Background:
- Traditional phase II studies defined drug activity by a ≥20% response rate.
- Targeted therapies show survival benefits with lower objective response rates but significant stable disease proportions.
- Skepticism exists regarding stable disease as a valid outcome in early-phase oncology trials.
Purpose of the Study:
- To review evidence supporting stable disease as a valid endpoint in clinical trials.
- To discuss contemporary methods for accurately interpreting stable disease.
- To address the evolving criteria for assessing new oncologic agents.
Main Methods:
- Review of recent clinical trial data and literature.
- Analysis of response evaluation criteria in solid tumors (RECIST).
- Discussion of methods to improve the precision of stable disease interpretation.
Main Results:
- Stable disease is increasingly recognized as a meaningful outcome, particularly with targeted therapies.
- Objective response rates alone are insufficient to evaluate new oncologic agents.
- Contemporary methods offer improved accuracy in defining and interpreting stable disease.
Conclusions:
- Stable disease represents a valid and important endpoint in oncology clinical trials.
- Accurate interpretation of stable disease is crucial for predicting treatment success.
- Further research and standardized methods are needed to fully leverage stable disease data.
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