ASH Clinical News ACN_5.6_SUPP_DIGITAL_correction_p20 | Page 26

FEATURES CMML: A Unique Overlap Syndrome Receiving Increased Attention For many years, chronic myelomonocytic leukemia (CMML) has been treated as a form of myelodysplastic syndrome (MDS), de- spite its unique clinical and biological characteristics. “Everyone recognized that, clearly, there were some patients who had highly proliferative features that weren’t at all typical of MDS, but CMML was still considered to be part of MDS for decades,” Mrinal Patnaik, MBBS, a hematologist at the Mayo Clinic in Rochester, Minnesota, told ASH Clinical News. Inclusion of CMML under the umbrella of MDS for so long – beginning with the 1976 and 1982 French-American-British MDS classifications – has hindered a deeper understanding of the disease that might have resulted from studying it as a separate entity. There also are no CMML-specific approved drugs. In recent years, clinicians and researchers have ramped up efforts to clarify the pathogenesis, natural disease progression, and presentation of CMML. ASH Clinical News spoke with Dr. Patnaik and other specialists about these efforts, as well as the challenges of defining uniform response criteria to guide clinical trials of CMML-specific treatments. What Is CMML? CMML is a clonal hematopoietic stem cell disorder that frequent- ly progresses to acute myeloid leukemia (AML). It is classified as a rare disease and is estimated to occur in four of every million people in the U.S. each year. It occurs more commonly in men and rarely in young people – 90 percent of the people diagnosed with CMML are age 60 or older. 1 Its incidence may be slightly higher than previously estimated, according to Eric Padron, MD, fromthe Moffitt Cancer Center in Tampa, Florida, because it often is recognized only when a patient with MDS seeks a second opinion. The disease is an “overlap” syndrome that displays characteristics of both MDS (such as peripheral blood cytopenias) and myeloproliferative neoplasms (MPNs; such as leukocytosis and splenomegaly). The 2001 World Health Organization (WHO) classification of leukemias and other hematopoietic neoplasms first separat- ed CMML from MDS and created a distinct category of MDS/ MPN overlap syndromes. In 2008, the WHO separated CMML via blast proportion into CMML-0 (<5% blasts), CMML-1 (5-9% blasts), and CMML-2 (10-19% blasts). Finally, in 2016, the WHO again revised its classification, including recommend- ing that CMML be classified into two subtypes: proliferative (MPN-CMML) and dysplastic (MDS-CMML) depending on the patient’s white blood cell count. 2 Dr. Patnaik said that the WHO’s decision to confirm that CMML should not be put into either MDS or MPN but should stand alone was a positive step forward. In addition, investigators have identified certain genetic mutations such as SRSF2, ASXL1, CBL, SETBP1, and JAK2 that are not exclusive to CMML but are more commonly found in patients with CMML than MDS without proliferative features, which can aid diagnosis. Expected survival for patients diagnosed with CMML ranges 24 Focus on Myeloid Malignancies from just a few months to a few years, depending on a variety of risk factors that are not yet well defined. Fifteen to thirty percent of patients will progress to AML, at which point survival rates drop to 4.7 months without a hemato- poietic cell transplantation (HCT) and 14.3 months with an HCT. “The whole story with CMML is that it is a spectrum in the pro- cess of evolution to AML,” said Dr. Patnaik. “So, about 30 percent of all patients with CMML will eventually transform to AML within three to five years. When that happens, survival is very poor.” One known prognostic factor for survival is CMML subtype. The dysplastic and proliferative subtypes affect patients very differently: Patients with the dysplastic subtype have low blood counts and their natural history and clinical problems related to marrow failure are more similar to patients with MDS; those with the proliferative subtype have high blood counts and often have constitutional symptoms or symptoms related to organomegaly. Patients with proliferative forms of the disease also have shorter survival and a higher risk of transformation to AML. How Is CMML Treated? There is only one curative treatment for CMML: allogenic HCT. Unfortunately, only a minority of CMML patients will qualify for the procedure. 3 Complicating matters further, there are no studies that define when a transplant is the most appropriate option for CMML. Dr. Padron recommends that all patients with high-risk disease who are young and fit enough to be considered transplant candidates should be referred for consideration of an HCT. Two other treatments are approved for CMML, both hypo- methylating agents approved for MDS for which the FDA indica- tion included CMML: azacitidine and decitabine. However, the pivotal trials included few patients with CMML, and response rates are low, especially in proliferative forms of the disease.