NCI Best Case Series Criteria for Optimal Case Studies

There are four NCI Best Case Series Program criteria for optimal cases:

1. Definitive Diagnosis of Cancer
   There must be a documented cancer diagnosis through a tissue biopsy or fine needle aspiration, or in the case of some leukemias and a few other cancer types, appropriate blood testing.
2. Documentation of Disease Response
   There must be documented disease to follow radiographically, or through other validated indicators of tumor response (e.g. M protein level in patients with multiple myeloma) during treatment with the alternative therapy. Measurement of the tumor(s) before treatment and during or after treatment is required.
3. Absence of Confounders
   The patient should not have received concurrent treatments with known therapeutic potential (e.g. chemotherapy or radiation therapy). There should be sufficient time between the end of any conventional anticancer therapy and the beginning of an alternative therapy to minimize the probability that a response was due to the conventional therapy.
4. Documented Treatment History
   There must be documentation that the patient received the conventional and alternative therapies described, dates of interventions, and responses of the tumor to all interventions received by a patient during the period in question.