Guidelines For Response Criteria For Use In Oncology Trials

Standardized Guidelines

The guidelines provide Baseline instructions for data collection/reporting. At Baseline, tumors and lesions will be categorized into measurable (target) and non-measurable (non-target). The target lesions must be accurately measured in at least one dimension (longest diameter in the plane of measurement to be recorded). Assessing tumor growth and cancer cell proliferation in patients is important for judging the effectiveness of individual treatment and for the evaluation of therapies in clinical trials. RECIST 1.1 provides a simple and pragmatic methodology to evaluate the activity and efficacy of new cancer therapeutics in solid tumors.

New Guidelines for Novel Cancer Treatments

The approval of intratumoral (IT) immunotherapy, the direct inoculation of immune-stimulating agents into the tumor itself, for metastatic melanoma and the active development of numerous novel IT drugs has created a need for standardized evaluation of response to this unique treatment strategy.