From: Response biomarkers: re-envisioning the approach to tailoring drug therapy for cancer
Benefits to the Patient | Effects on Clinical Practice | Socioeconomic Benefits | Benefits to Industry |
---|---|---|---|
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. | There may be less need for predictive biomarkers, which are specific to each drug, and which take years to develop and validate. |