Table 3.
Derivation of treatment initiation criteria and components of GELF, BNLI, and GITMO criteria available in MER database.
Any treatment initiation criteria (applied for the analysis) | GELF criteria | GITMO criteria | BNLI criteria |
---|---|---|---|
High tumor burden defined by —A tumor >10 cm (1.5%, n = 6, missing = 5), or >2 nodes in 3 distinct areas each >3 cm (2.7%, n = 11, missing = 19) | High tumor burden defined by —A tumor >7 cm,b or >2 nodes in 3 distinct areas each > 3 cma | Extra nodal diseasea | Rapid generalized disease progression in the last 3 months |
Symptomatic splenic enlargement (4.5%, n = 18, missing = 3) | Symptomatic splenic enlargementa | Spleen enlargementa | Life-threatening organ involvement |
Presence of systemic symptoms (ECOG PS > 1) (2.8%, n = 11, missing = 4) | Organ compression | Leukemia phasea | Renal or macroscopic liver infiltrationa (4.9%, n = 20, missing = 0) |
Serum LDH > ULN (10%, n = 40, missing = 44) | Ascites or pleural effusion | Serous effusions | Bone lesionsa (2.0%, n = 8, missing = 0) |
Β2-microglobulin > ULN (21%, n = 85, missing = 261) | Presence of systemic symptoms (ECOG PS > 1)a | Nodal or extranodal mass >7 cmb | Presence of systemic symptomsa |
Extra nodal disease (27%, n = 110, missing = 0) | Serum LDH > ULNa | >2 nodal masses, each >3 cma | Hemoglobin <10 g/dLa |
Leukemia phase (4.7%, n = 19, missing = 0) | Β2-microglobulin > ULNa | B symptomsa | WBC < 3.0 × 109 related to marrow infiltrationa |
B symptoms (3.0%, n = 12, missing = 1) | Presence of systemic symptoms (ECOG PS > 1)a | ||
Cytopenia due to marrow infiltration; Hemoglobin < 10 g/dL; WBC < 3.0 × 109 related to marrow infiltration (1.0%, n = 4, missing = 0) | Serum LDH or Β2-microglobulin > ULNa | ||
ESR > ULN | |||
Cytopenia due to marrow infiltrationa | |||
Bone lesions (2.0%, n = 8, missing = 0) |
PS performance status, LDH lactate dehydrogenase, ULN upper limit of normal, ESR erythrocyte sedimentation rate, WBC white blood cell count.
aCaptured in MER as described in the criteria
bCaptured in MER with different cut off value, nodal mass >10 cm instead of 7 cm.