ASH Clinical News October 2017 | Page 39

CLINICAL NEWS classification) to weighted scores. See TABLE 1 for a description of the components in each risk model. “The strong impact of cytogenetic/molecular risks on mortality is not a surprise,” the authors commented, but “why increasing age continues to have a significantly independent impact on mortality after accounting for comorbidities is unclear.” They suggested that the acquisition of additional adverse molecular AML markers with aging could explain this association. In the validation set, the authors compared the TABLE 1. Components of the AML-CM prognostic ability of the novel AML-CM with the and Their Corresponding Scores AML-CI, the original hematopoietic cell transplanta- tion comorbidity index (HCT-CI), and an augmented Comorbidity Score HCT-CI (constructed from the 17 comorbidities in the The HCT-CI original HCT-CI plus hypoalbuminemia, thrombocy- Arrhythmia 1 topenia, and high LDH values – predictive factors that Cardiac dysfunction (coronary artery 1 were identified in multivariate analyses). disease, congestive heart failure, myocardial The prognostic models’ performances were com- infarction, or EF ≤50%) pared using C statistics for continuous outcomes and Inflammatory bowel disease 1 area under the curve (AUC) for binary outcomes. Diabetes 1 As seen in TABLE 2 , the augmented HCT-CI Cerebrovascular disease (transient ischemic 1 performed better than either AML-CI or the original attack or cerebrovascular accident) HCT-CI in predicting early and late mortality, Psychiatric disturbance 1 “[validating] that comorbidities have a significant Mild hepatic dysfunction 1 impact on early and one-year mortality [in this Obesity 1 patient population],” the authors noted. And, when comorbidities, age, and cytogenetic/molecular risks Infection 1 were incorporated into the AML-CM, it performed Rheumatologic comorbidity 2 better than any of the individual risk components Peptic ulcer 2 alone (C statistic = 0.72 and AUC = 0.76 for 1-year Moderate/severe renal dysfunction 2 mortality; AUC=0.78 for 8-week mortality). Moderate pulmonary comorbidity 2 “Just as using the HCT-CI before allogeneic HCT Prior malignancy 3 has had a major impact on the decision to proceed to HCT, we believe use of the AML-CM could inform Heart valve disease 3 decisions as to whether patients with newly diagnosed Severe pulmonary comorbidity 3 AML should receive more intensive or less intensive Moderate/severe hepatic dysfunction 3 therapies for their disease,” the researchers concluded. The Augmented HCT-CI (all of the above, plus the “This model could prove useful to the U.S. Food following) and Drug Administration when monitoring clinical Hypoalbuminemia <3.5 g/dL 1 trials to ensure adequate representation of high-risk Thrombocytopenia 1 patients in these trials and, hence, generalizability of LDH >200-1,000 U/L 1 trial results to the whole AML population.” The model did not incorporate treatment LDH >1,000 U/L 2 intensity (though it was shown to predict mortal- The AML-CM (all of the above, plus the following) ity), because patients received therapies of differing Age 50-59 years 1 intensities and because “this is the decision that we Age ≥60 years 2 plan to improve based on the AML-CM scores,” ELN intermediate cytogenetic/molecular 1 they added. The study also is limited by the retro- risk spective nature of data collection. ELN adverse cytogenetic/molecular risk 2 The authors report no conflicts. REFERENCE Sorror ML, Storer BE, Fathi AT, et al. Development and validation of a novel acute myeloid leukemia–composite model to estimate risks of mortality. JAMA Oncol. 2017 September 7. [Epub ahead of print] HCT = hematopoietic cell transplantation; CI = comorbidity index; EF = ejection fraction; AML = acute myeloid leukemia; LDH = lactate dehydrogenase; ELN = European Leukemia Net Comparisons of the Performance of Risk Factors and Indices in the Validation Set TABLE 2. Risk factor AML-CI C-statistic for 1-year mortality True AUC for 1-year mortality True AUC for 8-week mortality n (SD) n (SD) n (SD) 314 0.596 (0.019) 297 0.606 (0.039) 305 0.659 (0.043) Original HCT-CI 352 0.649 (0.025) 326 0.674 (0.028) 339 0.684 (0.042) Augmented HCT-CI 305 0.664 (0.023) 289 0.687 (0.035) 296 0.721 (0.046) Age (groups) 367 0.640 (0.020) 340 0.682 (0.029) 354 0.640 (0.040) Cytogenetic/molecular risks (groups) 350 0.614 (0.020) 324 0.654 (0.023) 337 0.597 (0.042) AML-CM 292 0.719 (0.022) 277 0.758 (0.030) 283 0.776 (0.035) KPS (groups) 291 0.619 (0.027) 266 0.646 (0.035) 279 0.676 (0.048) AUC = area under the curve; SD = standard deviation; AML = acute myeloid leukemia; CI = comorbidity index; CM = composite model; HCT-CI = hematopoietic cell transplantation comorbidity index; KPS = Karnofsky performance status ASHClinicalNews.org Luspatercept Shows Activity in Patients With Lower-Risk MDS and Anemia Erythropoiesis-stimulating agents (ESAs) are a standard treatment for patients with myelodysplastic syndromes (MDS) and anemia; however, only around one-third of patients have an erythroid response to ESAs, suggesting that improving erythropoiesis in MDS might be best achieved by targeting downstream processes indepen- dent of erythropoietin regulation. In the phase II, dose-finding PACE-MDS study with long-term extension, Uwe Platzbecker, MD, from the Department of Internal Medicine I at the University Hospital Carl Gustav Carus in Dresden, Germany, and co-authors evaluated whether the recombinant fusion protein luspatercept could provide a new therapeutic approach in anemic patients with lower-r