46. What constitutes a remission in CLL?
According to the National Cancer Institute-sponsored Working Group (NCI-WG) on Chronic Lymphocytic Leukemia, complete remission (CR) requires all of the following for a period of at least 2 months:
- absence of enlarged lymph nodes
- absence of enlarged spleen and liver
- absence of constitutional symptoms
- normal complete blood count (CBC) as exhibited by:
- neutrophils greater than or equal to 1,500 per microliter of blood
- platelets greater than 100,000 per microliter of blood
- hemoglobin greater than 11 grams per 100 milliliters of blood (untransfused)
- A bone marrow aspirate and biopsy should be performed 2 months after all of the above requirements have been met. The marrow sample must have less than 30% of nucleated cells that are lymphocytes, and lymphoid nodules should be absent. If the bone marrow is hypocellular, a repeat determination should be made in four weeks. Samples should be re-reviewed in conjunction with prior pathology.
A decrease in the absolute lymphocyte count is not considered in the response criteria for complete remission. Although this parameter may identify a therapy that has lymphocytotoxic activity, there is no evidence that it has long term clinical implications.
A partial remission (PR) requires that the patient exhibit the following features for a period of at least two months:
- a fifty percent or greater decrease in the peripheral lymphocyte count from the pretreatment baseline value
- a fifty percent or greater reduction in lymphadenopathy and/or
- a fifty percent or greater reduction in the size of the liver and/or spleen (if abnormal prior to therapy)
In addition to the factors outlined above, the patient must also exhibit one or more of the following:
- Neutrophils greater than or equal to 1,500 per microliter of blood or a fifty percent improvement over the pretreatment baseline
- Platelets greater than 100,000 per microliter of blood or a fifty percent improvement over baseline
- Hemoglobin greater than 11 grams per 100 milliliters of blood or a fifty percent improvement over baseline without transfusions.