International Workshop on CLL Revises Consensus Guideline Criteria for Prognostic Indicators, Response Assessments

03/27/18

Major advances in the biology and treatment of patients with chronic lymphocytic leukemia (CLL) have prompted the International Workshop on CLL to evaluate and revise the criteria for their consensus guideline in this disease setting.

It is the first time since 2008 that the International Workshop on CLL have evaluated and published revisions to their original criteria, which were inspired by previously published consensus guideline by the National Cancer Institute-sponsored Working Group.

The guideline provides definitions intended to standardize the assessment of patients that were adopted by the Unite States Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the examination of new drugs.

The guideline update is published in Blood (online March 14, 2018; doi:10.1182/blood-2017-09-806398).

One of the most notable changes introduced to the guideline is the clinical relevance of the recent discoveries on the genomic alterations found in CLL. “The assessment of both del(17p) and TP53 mutation has prognostic and predictive value and should guide therapeutic decisions in routine practice,” the guideline reads. “For clinical trials, it is recommended that molecular genetics be performed prior to treating a patient on protocol. As additional genetic abnormalities may be acquired during the course of the disease, genetic analysis (in particular for del(17p)/TP53 mutations) should be repeated prior to any subsequent, second- or third-line of treatment.”

Additionally, the guideline details the increasingly important prognostic role of the IGHV mutational status, as well as the current use of clinical staging, novel genetic or biological prognostic markers, and prognostic scores.

The guideline offers an improved assessment of splenomegaly, hepatomegaly, and lymphadenopathy. Details of these conditions can be found in relevant sections of the updated lymphoma response guidelines.

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Furthermore, the guideline provides details of an updated response assessment for novel targeted drugs (ie, kinase inhibitors, Bcl2 inhibitors) that need to be evaluated during continuous therapy. “The timing of response assessment for therapies with a defined treatment duration (such as chemoimmunotherapeutic approaches) should be at least 2 months after completion of therapy,” the guideline reads.

The guideline provides a table of recommendations regarding the response assessment for novel targeted drugs in patients with CLL. The table lists diagnostic tests and when they should be used in general practice and in clinical trials. Among the listed tests are “Assessment for minimal residual disease” (not generally indicated in general practice, desirable in clinical trials) and “CT scans of chest, abdomen, and pelvis (not general indicated in general practice, recommended in clinical trials if previously abnormal and otherwise with a complete or partial response to therapy).

Among further changes or additions to the guideline are the increasing role of assessing minimal residual disease, as well as updates regarding the baseline assessment and prophylaxis of viral diseases before and while receiving therapy for CLL.—Zachary Bessette