Guidelines for Testing New Endocrine Agents in Cancer Therapy
Author Information
Author(s): R.C. Coombes, R. Paridaens, M. Schneider, J.G.M. Klign, B. Fox, M. Dowsett, P.J. Nicholls, T. Connors, M. Jarman, J.-P. de Slypere, S. Todd, C. Praga, E. Disalle
Primary Institution: Cancer Research Campaign Headquarters
Hypothesis
To prepare guidelines for testing new endocrine agents for therapy of cancer.
Conclusion
The document establishes guidelines for the selection, preclinical toxicology, quality control, and clinical study of new endocrine agents.
Supporting Evidence
- Endocrine agents have been developed from drugs initially aimed at other conditions.
- Different selection procedures are needed for endocrine therapies compared to cytotoxic drugs.
- Guidelines for phase I and II trials of cytotoxic drugs have been adapted for endocrine agents.
Takeaway
This document is like a recipe for doctors on how to test new cancer treatments that use hormones, making sure they are safe and effective.
Methodology
The guidelines include recommendations for preclinical toxicology, clinical trial design, and patient eligibility criteria.
Limitations
The guidelines may not cover all unique challenges associated with endocrine therapies compared to cytotoxic drugs.
Participant Demographics
Patients with hormone-sensitive cancers, including breast and prostate cancer.
Want to read the original?
Access the complete publication on the publisher's website