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. 2023 Dec 29;16(1):55. doi: 10.3390/pharmaceutics16010055

Table 3.

The amendments from iwCLL, ERIC, and ESMO about the diagnosis regime.

Morphology and Immunophenotype Test Genetic Radiographic Imaging Prognosis Refs.
ESMO Obligatory

Diagnosis is usually possible through immunophenotyping peripheral blood only (III, A).

LN biopsy and/or bone marrow biopsy may be helpful if immunophenotyping is not conclusive for the diagnosis of CLL (IV, A).
Del(17p), TP53mut, and IGHV status should be assessed before treatment (III, A).

In the early and asymptomatic stage is not recommended (V, D).
It is not recommended in asymptomatic patients.
Recommended for pulmonary symptomatic patients.
Recommended before treatment with the BCL2 inhibitor to assess the tumor load and risk of tumor lysis syndrome.
Binet and Rai staging systems are relevant for treatment indication (III, A) [58]
iwCLL Obligatory Molecular cytogenetics (FISH) for del(13q), del(11q), del(17p), and add (12) in PB lymphocytes.
(Desirable).
Conventional karyotyping in PB lymphocytes (Desirable).
TP53 mutation (needed to establish a prognostic profile in addition to the clinical staging).
IGHV mutational status (needed to establish a prognostic profile in addition to the clinical staging).
Serum β2-microglobulin
(Desirable).
CT scan of chest, abdomen, and pelvis
(Desirable)
MRI and PET scans (NGI)
Abdominal ultrasound (NGI)
Binet and Rai staging systems.
CLL-IPI (Desirable).
[9]
ERIC Obligatory Strongly needed TP53 gene before starting the first and each subsequent line of treatment. Analyzing exons 4–10 is a minimal requirement with Sanger sequencing or NGS.
Strongly needed to interpret IGHV mutational analysis before starting the first line of treatment. Alignment and determination of homology with PAGE or GeneScan.
[59,60]

CLL-IPI: CLL international prognostic index, NGI: not generally indicated, PAGE: Polyacrylamide gel electrophoresis, and PB: peripherical blood.