A set of common criteria and calculations for Chronic Lymphocytic Leukemia
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Binet JL, Auguier A et al. A new prognostic classification of chronic lymphocytic leukemia derived from a multivariate survival analysis. Cancer 1981; 48:198-216 .
Rai KR, Montserrat E. Prognostic factors in chronic lymphocytic leukemia. Semin Hematol. 1987; 24:252-256.
NCI WG criteria to identify patients with chronic lymphocytic leukemia showing disease activity needing treatment.
Presence of at least one of the following:
(1) one or more of the following disease-related symptoms
(1a) weight loss >= 10% within the previous 6 months, without trying to lose weight
(1b) extreme fatigue
(1c) fevers > 100.5 F for >= 2 weeks without evidence of infection
(1d) night sweats without evidence of infection
(2) evidence of progressive marrow failure
(3) autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy
(4) massive or progressive splenomegaly
(5) massive or progressive lymphadenopathy
(6) progressive lymphocytosis with an increase > 50% over a 2 month period, or an anticipated doubling time of < 6 months.
Progressive marrow failure is indicated by the development of, or worsening of, anemia and thrombocytopenia.
Extreme fatigue is ECOG performance status 2 or worse; the patient cannot work or is unable to perform usual activities.
Massive splenomegaly is > 6 cm below the left costal margin.
Massive lymphadenopathy is > 10 cm in maximum diameter.
Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient evidence of active disease.
The criteria of Rai et al differ from those of the NCI-WG in that the following were included as criteria for starting treatment:
(6) A doubling time of < 12 months, rather than < 6 months
(6) A blood lymphocyte count > 150,000 per L
(7) An increased susceptibility to bacterial infection
Cheson BD, Bennett JM, et al. Guidelines for clinical protocols for chronic lymphocytic leukemia: Recommendations of the National Cancer Institute-Sponsored Work Group. Am J Hematology. 1988; 29: 152-163 (page 154).
2008 NCI guidelines on the diagnosis and treatment of CLL
Absolute B lymphocyte count in the peripheral blood ≥5000/µL [5 x 10^9/L], with a preponderant population of morphologically mature-appearing small lymphocytes.
Demonstration of clonality of the circulating B lymphocytes by flow cytometry of the peripheral blood. A majority of the population should express the following pattern of monoclonal B-cell markers: extremely low levels of SmIg and either kappa or lambda (but not both) light chains; expression of B-cell associated antigens (CD19, CD20, and CD23); and expression of the T-cell associated antigen CD5.
Hallek M, Cheson BD, Catovsky D, Caligaris-Cappio F, Dighiero G, Döhner H, Hillmen P, Keating MJ, Montserrat E, Rai KR, Kipps TJ, International Workshop on Chronic Lymphocytic Leukemia. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood. 2008;111(12):5446.