Minimal exposure to potentially toxic drugs that are unbeneficial. |
Can tailor therapy for patients by development of a biomarker that reflects chemosensitivity and resistance. |
Payors (including insurance companies and patients) will pay much less for ineffective drugs. |
Clinical trial design would be revolutionized: a) Will provide a new trial endpoint for phase I trials, enabling identification of appropriate doses and patient populations with less harm to trial participants. b) Phase II trials can be performed more quickly, using the biomarker as a surrogate marker for benefit. c) Would greatly facilitate a “go-no go” phase II-III adaptive designs106. |
Reduced cumulative toxicities will improve quality of life. |
The current practice is to administer a drug until toxicities or disease progression occur. A response biomarker may inform on early chemoresistance. This has the following benefits: a) Inappropriate dose escalations can be avoided. b) Inappropriately prolonged treatments can be avoided. c) Possibility of rotating to a new potentially effective drug regime before progression and clinical deterioration occur. |
Patients whose quality of life is preserved and whose disease is controlled with less toxicity will be more likely to be able to resume normal work activities. |
Subpopulations that will benefit from drugs will be more easily identified. |
Preservation of performance status will facilitate administration of later lines of therapy. |
May enable dose titration: lowest effective dose for an individual could be administered. |
Novel drug development will be less expensive and more efficient. This may translate to development of more, less costly drugs. |
It may become cost effective to screen agents for use in rare cancers. |
A response biomarker may expand the therapeutic armamentarium available for patients: low cost trials of drugs on individuals. |
A serum biomarker of response would enhance treatment of patients with malignant conditions that are difficult to gauge radiologically e.g. peritoneal disease, bile duct cancer and esophagogastric cancer. |
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There may be less need for predictive biomarkers, which are specific to each drug, and which take years to develop and validate. |