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. 2017 Jun 4;24(6):433–452. doi: 10.1177/1078155217710553

Table 2.

Monitoring and testing schedule for patients with CML on BCR-ABL1 TKI therapy.10,33,34

Test Sample source Performed to confirm diagnosis Related response NCCN timing of testing NCCN additional testing ESMO testing guidelines
Complete blood count (CBC) Peripheral blood Yes Normal platelet and blood counts; no blasts or immature cells in blood Per physician recommendation Per physician recommendation Every 15 days until CHR, then every 3 months
Bone marrow cytogenetics Bone marrow Yes CCyR; 0 Ph+ metaphases At 3 and 6 months if qPCR (IS) is unavailable; or there is no CCyR or MMR at 12 monthsa If BCR-ABL1 transcript levels increase ≥1-log without MMR At 3 and 6 months, every 6 months until CCyR, then every 12 months if MMR unavailable
qPCR (IS) Peripheral blood or bone marrow Yes CMR; no detectable BCR-ABL1 transcripts by qPCR (IS) using an assay with a sensitivity of ≥4.5 logs below standardized baseline If CCyR achieved, every 3 months for 2 years; every 3–6 months thereafter If BCR-ABL1 transcript levels increase ≥1-log with MMR Every 3 months until MMR, then every 6 months; qualitative PCR at diagnosis
BCR-ABL1 mutation analysis Peripheral blood or bone marrow No N/A If BCR-ABL1/ABL1 >10% by qPCR (IS) after 3–6 months of treatment; if CCyR is not present at any time after 12 months Any loss of response; 1-log increase in BCR-ABL1 transcript levels and loss of MMR; or disease progression to blast phase Defined failureb at 3, 6, or 12 months or loss of CHR or CCyR at any time

CCyR: confirmed cytogenetic response; CHR: complete hematologic response; CML: chronic myeloid leukemia; CMR: complete molecular response; ESMO: European Society for Medical Oncology; IS: International Scale; MMR: major molecular response; N/A: not applicable; qPCR: quantitative polymerase chain reaction; TKI: tyrosine kinase inhibitor.

a

Absence of MMR in the presence of a CCyR is not considered a treatment failure. bFailure by ESMO guidelines is defined as Ph+ metaphases >95% or BCR-ABL1 >10% at 3 months, Ph+ metaphases >65% or BCR-ABL1 >10% at 6 months, or Ph+ metaphases ≥1% or BCR-ABL1 >1% at 12 months. Table adapted from NCCN Tests and Treatment Responses in Chronic Phase CML, accessed November 2016; NCCN CML Guidelines v1.2016, accessed October 2015; and ESMO Clinical Practice Guidelines 2012.