Objective response to treatment as a potential surrogate marker of survival in breast cancer.
Until recently, objective tumor response to chemotherapy was used as the primary endpoint in phase II trials aimed at assessing the anti-tumor activity of new drugs. However, it was not accepted as a surrogate endpoint of survival for efficacy trials in solid tumors, and it was not believed to be associated with survival benefit. The recent demonstration that objective response is indeed a valid surrogate endpoint of survival in colorectal cancer, together with strong indirect evidence supporting a similar role of response in breast cancer, opens new possibilities for both the design of trials in metastatic breast cancer and the clinical decision in individual patients with the disease.
Bruzzi
Paolo
P
Unit of Clinical Epidemiology and Trials, National Cancer Research Institute, 16132 Genoa, Italy. paolo.bruzzi@istge.it
D015415:Biomarkers / Q000032:analysis; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000378:metabolism / Q000401:mortality; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D017063:Outcome Assessment, Health Care; D015996:Survival Rate
D015415:Biomarkers