Table 1.

Potential benefits of a response biomarker for antineoplastic agents.

Beneficiary	Benefits
Benefits to the Patient	Minimize exposure to ineffective and potentially harmful chemotherapy drugs. Avoidance of unnecessary toxicities, improving quality of life and possibly survival. A response biomarker that reflects chemosensitivity may expand therapeutic options available by identifying subpopulations that will directly benefit from such drugs, expanding antineoplastic formulary for individuals. Preservation of performance status will facilitate administration of later lines of therapy.
Effects on Clinical Practice	Therapy will be individualized using a biomarker that reflects response, resistance and sensitivity to therapeutic administration. Will enable dose titration. The lowest effective dose for an individual could be administered, thus reducing treatment-related toxicities. Early detection of chemoresistance will have the following benefits: (a) inappropriate dose escalations can be avoided, and so could the attendant toxicities; (b) inappropriately prolonged treatments can be avoided, avoiding cumulative toxicities; (c) it will be possible to rotate to a new (potentially effective) drug regimen before gross disease progression and the associated clinical deterioration occur. Will enable improved monitoring of treatment effect in patients with malignant conditions that are difficult to gauge radiologically (e.g., peritoneal disease, malignant effusions).
Socioeconomic Benefits	Payers (including insurance companies, governments and patients) will pay much less for ineffective drugs. 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 activities, including work. Novel drug development will be less expensive and more efficient, which may translate to development of more, less-costly drugs.
Benefits to Industry	Clinical trial designs would be revolutionized: the availability of a biomarker of chemosensitivity will provide a new trial endpoint, enabling identification of appropriate doses and patient populations with less harm to trial patients in phase I trials. Opportunity for industry to reintroduce some drugs to clinical practice that have efficacy in CRC but insufficient benefit to the aggregate. Phase II trials can be performed more quickly, using the biomarker as a surrogate marker for benefit. Such trials would also be less onerous on trial participants. This would result in new drugs being screened and introduced more quickly and efficiently to the market, translating to more, less-costly drugs. There will be less need for predictive biomarkers, which take years to develop and validate.