PURPOSELimited information is available on multiple myeloma (MM), chronic lymphocytic leukemia (CLL), and non-Hodgkin lymphoma (NHL) management in Latin America. The primary objective of the Hemato-Oncology Latin America (HOLA) study was to describe patient characteristics and treatment patterns of Latin American patients with MM, CLL, and NHL.METHODSThis study was a multicenter, retrospective, medical chart review of patients with MM, CLL, and NHL in Latin America identified between January 1, 2006, and December 31, 2015. Included were adults with at least 1 year of follow-up (except in cases of death within 1 year of diagnosis) treated at 30 oncology hospitals (Argentina, 5; Brazil, 9; Chile, 1; Colombia, 5; Mexico, 6; Panama/Guatemala, 4).RESULTSOf 5,140 patients, 2,967 (57.7%) had NHL, 1,518 (29.5%) MM, and 655 (12.7%) CLL. Median follow-up was 2.2 years for MM, 3.0 years for CLL, and 2.2 years for NHL, and approximately 26% died during the study observation period. Most patients had at least one comorbidity at diagnosis. The most frequent induction regimen was thalidomide-based chemotherapy for MM and chlorambucil with or without prednisone for CLL. Most patients with NHL had diffuse large B-cell lymphoma (DLBCL; 49.1%) or follicular lymphoma (FL; 19.5%). The majority of patients with DLBCL or FL received rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone.CONCLUSIONThe HOLA study generated an unprecedented level of high-quality, real-world evidence on characteristics and treatment patterns of patients with hematologic malignancies. Regional disparities in patient characteristics may reflect differences in ethnoracial identity and level of access to care. These data provide needed real-world evidence to understand the disease landscape in Latin America and may be used to inform clinical and health policy decision making.
5067 Introduction Myelofibrosis (MF) is a myeloproliferative neoplasm (MPN) that is characterized by ineffective hematopoiesis and symptomatic burden such as cytopenias, and splenomegaly. The prevalence of MF symptoms is relatively uniform across the 3 main subtypes: primary MF (PMF), post – polycythemia vera MF (PPV MF), and post – essential thrombocythemia MF (PET MF). Available therapies (AT) in Mexico, includes hydroxyurea (HU), interferon (IFN), for ET, besides phlebotomy for PV, as well as androgens, steroids, chemotherapy, IFN, thalidomide, EPO and radiotherapy for PMF. The only potentially curative therapy is allogeneic hematopoietic stem cell transplantation (HSCT) but treatment-related mortality remains high. Recently ruxolitinib an oral Janus kinase–2 inhibitor (JAK-2) has been approved to treat patients with MF. The safety and efficacy of Ruxolitinib has been evaluated 528 patients from COMFORT I and COMFORT II trials. Objective To report the first clinical experience in a CUP with an oral JAK–2 Inhibitor (ruxolitinib) in 40 MF patients refractory to AT in Mexico. Patients and Methods PMF patients and PPV/PET MF eligible for the ruxolitinib CUP, were diagnosed according to the 2008 WHO criteria, irrespective of JAK2 mutation status; classified as high risk; intermediate risk level 2; or, intermediate risk level 1 with an enlarged spleen; with a peripheral blood blast count of < 10%; adequate renal and liver function, platelet count >100×109/L, all of them were treated with best available therapies in Mexico. Therapy with ruxolitinib was administered to all patients. Doses were adjusted according to the platelet counts. Clinical and demographic characteristics were assessed at baseline and during the follow-up. The analyzed characteristics were: Demographic: age, gender; Clinical: Risk group, Bone marrow fibrosis grade, spleen size, ECOG, MPN subtype, JAK mutation, CBC counts;Spleen size at baseline and at week 20 of treatment. Results The median age was 64. 2 (Interval 41 – 75). Gender distribution was 46% female and 54% male. Patients according to the International Prognostic Scoring System (IPSS) were distributed in the following risk category: 10% low risk; 53. 3% intermediate – 1 risk; 26. 7 % intermediate – 2 risk; and 20% high risk. Bone marrow fibrosis grade distribution was: Grade I 46. 15%; Grade II 23. 07%; Grade III 30. 76%. Spleen length below costal margin: <10 cm, 80. 7%; 10 to <20 cm, 11. 5% and > 20 cm, 7. 7% of patients. Spleen Average size was 9. 58 cm below costal margin at the beginning of treatment. ECOG 0 was present in 15% of patients; ECOG 1, 73%; and ECOG 2, 12% of patients. The disease subtype distribution was: PMF 45%; PPV-MF 36% and PET-MF 46%. JAK mutation was positive for 19% of patients, 46% were negative, and 35% did not have mutation analysis. The findings from the baseline to week 20 were: Splenomegaly decreased from 9. 58 cm (avg) to 4. 5 cm (avg) (53. 02% of reduction); Median Hemoglobin level was 13. 2 gr/dL at baseline versus 10. 24 gr/dL (22. 42% of decrease). Median Platelet count was 437, 000/mm3 at baseline versus 341, 503/mm3 at week 20 of treatment (21. 85% of decrease). Median time of treatment is 20. 1 weeks. Hematologic adverse events presented: Hemoglobin level decrease events (CTCAE grade 2 and 3) resolved with transfusion support. Platelet count decreases (CTCAE grade 2) were transitory and resolved after two weeks of treatment interruption. Conclusion Data showed demonstrate principal characteristics of this MF cohort. Until recently, most treatments provided only palliative care with no single treatment addressing all of the complications and symptoms of the MF. Ruxolitinib showed a primary therapeutic benefit as reduction in splenomegaly and significant improvement in MF-related symptoms in this cohort of Mexican patients with myelofibrosis. Disclosures: No relevant conflicts of interest to declare.
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