Complete remission (CR) |
Requires all of the following criteria:
|
CR with incomplete bone marrow recovery (CRi) |
Fulfills all requirements for CR except has persistent neutropenia, anemia, or thrombocytopenia thought to be unrelated to the disease and likely related to drug toxicity. These patients must have a normal bone marrow aspirate and biopsy with no evidence of clonal infiltrates. |
Partial remission (PR) |
At least two of these criteria must be documented:
One of the following hematologic parameters must be met in addition to two of the above criteria in order to qualify for a PR:
If only one parameter was abnormal before therapy, only one needs to improve to achieve PR. |
Nodular PR |
Persistent bone marrow nodules on bone marrow biopsy in patients achieving a CR or PR. Lymphoid aggregates should be evaluated with immunohistochemistry to determine whether they are comprised of CLL cells, lymphocytes other than CLL cells, or T cells. If nodules are not composed of CLL cells, a CR can be documented provided all other criteria are met. |
Progressive disease (PD)Δ |
At least one of these criteria must be documented:
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Stable disease |
Patients who do not meet the criteria for a complete remission, partial remission, or progressive disease, have stable disease. Stable disease is therapeutically equivalent to a nonresponse (ie, refractory disease). |
CLL: chronic lymphocytic leukemia; SLL: small lymphocytic lymphoma; ANC: absolute neutrophil count.
* These include ≥10% unintentional weight loss within the previous six months, fatigue that interferes with work or usual activities, fevers greater than 100.5°F (>38°C) for ≥2 weeks, or night sweats for >1 month.
¶ Assessment of residual CLL cells in the bone marrow for this purpose is not based on flow cytometry. Assessment for measurable residual disease (MRD, also called 'minimal residual disease') is reserved for clinical trials. Although bone marrow biopsy is required to confirm a CR, it is not always recommended in general practice as it may not impact management. If the above clinical and hematologic parameters are compatible with a CR and the clinician chooses not to perform a bone marrow biopsy, the documented response can be "partial remission."
Δ Transient increases in lymph node size may occur during treatment with novel inhibitors and should not be considered PD.
◊ For patients treated with therapies that may cause lymphocytosis (eg, kinase inhibitors), an increase in blood lymphocyte count, by itself, does not uniformly indicate an increased tumor burden, but may reflect redistribution of leukemia cells from lymphoid tissues. In such cases, increased lymphocytosis alone is not a sign of treatment failure or progressive disease.
§ Cytopenias cannot be used to determine disease progression during active therapy since they may be due to administered cytotoxic agents. Cytopenias that occur at least three months after the completion of therapy and are accompanied by an infiltrate of clonal CLL cells on bone marrow biopsy can be used to define disease progression. Specific values that define progression include a decrease in hemoglobin level by more than 2 g/dL (20 g/L) or to less than 10 g/dL (100 g/L) or a decrease in platelet count by more than 50% or to less than 100,000/microL (100 × 109/L).Do you want to add Medilib to your home screen?