Roy Elias

Developing a Predictive Model for Clinical Outcomes of Advanced Non-Small Cell Lung Cancer Patients Treated With Nivolumab

Micro‐Abstract A single biomarker cannot account for the heterogeneous tumor biology and immune interplay in patients with advanced non–small cell lung cancer who receive programmed death inhibitor. This article reports our initial model development that incorporates differential weightings of clinical and hematologic variables for a future algorithm. The immunotherapy, Sex, Eastern Cooperative Oncology Group performance status, Neutrophil‐to‐lymphocyte ratio (NLR), and Delta NLR are incorporated into the model that categorizes patients into different risk groups and significantly discriminates each groups clinical outcome. Introduction Despite significant improvement of clinical outcomes of advanced non–small‐cell lung cancer (NSCLC) patients treated with immunotherapy, our knowledge of optimal biomarkers is still limited. Patients and Methods We retrospectively evaluated 159 advanced NSCLC patients in our institution treated with nivolumab after disease progression during platinum‐based chemotherapy. We correlated several variables with progression‐free survival (PFS) to develop the immunotherapy, Sex, Eastern Cooperative Oncology Group performance status, Neutrophil‐to‐lymphocyte ratio (NLR), and Delta NLR (iSEND) model. We categorized patients into iSEND good, intermediate, and poor risk groups and evaluated their clinical outcomes. Performance of iSEND at 3, 6, 9, and 12 months was evaluated according to receiver operating characteristic (ROC) curves and internally validated using bootstrapping. The association of iSEND risk groups with clinical benefit was evaluated using logistic regression. Results Median follow‐up was 11.5 months (95% confidence interval [CI], 9.4‐13.1). There were 50 deaths and 43 with disease progression without death. PFS rates at 3, 6, 9, and 12 months were 78.4%, 63.7%, 55.3%, and 52.2% in iSEND good; 79.4%, 44.3%, 25.9%, and 19.2% in iSEND intermediate; and 65%, 25.9%, 22.8%, and 17.8% in iSEND poor. Time‐dependent area under ROC curves of iSEND for PFS at 3, 6, 9, and 12 months were 0.718, 0.74, 0.746, and 0.774. The iSEND poor group was significantly associated with progressive disease at 12 ± 2 weeks (odds ratio, 9.59; 95% CI, 3.8‐26.9; P < .0001). Conclusion The iSEND model is an algorithmic model that can characterize clinical outcomes of advanced NSCLC patients receiving nivolumab into good, intermediate, or poor risk groups and might be useful as a predictive model if validated independently.

Acute leukemia in adult Hispanic Americans: a large-population study

Acute leukemia (AL) is a diverse group of clonal hematopoietic disorders that are broadly categorized into two types: acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).1, 2, 3 AML is further grouped into acute promyelocytic leukemia (APL, a highly curable disease with a unique and pathognomonic genetic lesion) and non-APL AML. ALL is also further lineage classified into B-cell ALL or T-cell ALL. Unlike older classification systems that defined AL according to how leukemia cells looked and stained under the light microscope,1 the current iteration of the World Health Organization (WHO) classification of hematopoietic neoplasms incorporates cytogenetic and molecular data to provide prognostic and therapeutic information of value to the treating clinician.2, 3 When applied to large-population databases, the WHO framework also provides useful insights into the distribution of AL among ethnic groups, informing on the causative factors of AL, which are at this time poorly understood. For example, in the United States, whites have higher rates of AML compared with other groups.4 B-ALL is uncommon in blacks and Asians, whereas Hispanics have the highest incidence rates (IR) of this leukemia.5 AML appears less common in Hispanics when compared with whites, however, APL appears comparatively more common in Hispanics.6 The varied distribution of AL among these ethnic groups suggests that host susceptibility factors are critical determinants of disease in one group, but not in another. The extent to which the environment interacts with these factors is unknown. In Florida, Hispanics comprise 23.6% of the population, with up to 65% of this group residing in South Florida. About 51% of Hispanics in Florida are native born, 49% are foreign born. In 2015, it is estimated that 3930 new cases of AL will be diagnosed.7 Given the known interaction between ethnicity and AL incidence, we sought for the first time, to better understand the epidemiological patterns of AL distribution throughout Florida. Utilizing the Florida Cancer Data System (FCDS), we analyzed the patterns of B-cell ALL, T-cell ALL, non-APL AML and APL AML among Hispanics and non Hispanic Whites.