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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.

In a randomized study with 234 previously untreated patients with multiple myeloma, 129 were treated with melphalan (8 mg/m2 perorally for four days) and prednisone (40 mg/m2 perorally for seven days, both every four weeks) and 105 with melphalan and prednisone at the same doses plus cyclophosphamide (600 mg/m2 intravenously every four weeks), MeCCNU (100 mg/m2 PO every eight weeks), and vincristine (MPCCV, 0.6 mg/m2 IV every four weeks). A total of 49 (38%) of the 129 patients treated with melphalan and prednisone (MP) and 48 (46%) of the 105 patients treated with MPCCV showed good response (GR) (P not significant); the overall response rates were 58% and 70%, respectively. Thirty-seven percent of the MP group and 39% of the MPCCV group remain alive at 48 months from first treatment (P not significant). The estimated 48-month survival from first treatment, according to different prognostic factors at diagnosis, in both groups was as follows: stage 1,56%; stage II, 46%, and stage III, 23% (I and II v III P less than .001). Survival at 48 months according to response was GR, 68%; partial response (PR), 33%; and null, 16% (GR v null, P less than .0005; GR v PR, P less than .0005). Survival according to renal function was 43% for a creatinine level less than 2 mg/100 mL and 27% for a creatine level greater than or equal to 2 mg/100 mL (P less than .0005). No significant difference has been found between the two treatment schedules in terms of response rate and survival time, in any stage of disease.

Introduction: There are few reports of standard of care and outcomes in Latin America. The HOLA study is a retrospective chart review of patients with B-cell malignancies in Latin America (LATAM). Methods: The objective of this registry is to describe patient characteristics, diagnostic and treatment patterns, and clinical outcomes in patients with Chronic Lymphocytic Leukemia (CLL) from a mix of public and private sites in Brazil, Mexico, Chile, Argentina, Colombia, Guatemala, and Panama. We report 472 patients with CLL diagnosed in the period from January 2006 to March 2016. Results: Median age at diagnosis was 66 years (range 23 - 95). Male gender predominance (53.6 vs 46.4%). Twenty-three percent of the patients (n=103) were dead, median time from diagnosis to death of 2.4 years (range 0-6.6 years). Seventeen percent (n=19) died before frontline treatment, 35%(39) after first-line treatment, 19%(21) in second-line, 27%(30) at or after third-line treatment. Anemia reported on 34%. Of the 34% (n=162) patients with COOMBS test, it was positive on 13%. Frequent comorbidities were high blood pressure (46%), heart disease (17%) and diabetes (15%). Binet status reported on 63% of patients, Rai status on 55%. (Table 1) Flow cytometry missing on 27% of patients (not performed/missing report). Diagnostic markers were positive as follows: CD23, 94% and CD5, 92%. Prognostic markers: 52% tested for CD38 and 10% ZAP 70, positivity on 24% and 26% of tested patients, respectively. Cytogenetic/FISH test performed on 21% (102), del(17p) was present on 7.4% of tested patients at diagnosis. Seventy two per cent of patients were considered for watch- and-wait approach. Median time from diagnosis to treatment initiation was 113 days (range 1 -2808). Sixty one per cent (288/472) receive front line treatment at any time. Frequent reasons to start treatment were B symptoms (25%), anemia (21%) and lymphocyte doubling time <6 months (17%). (Table 2) Response was assessed by clinical exam and blood count in 95% of patients, CT scan 24 %, abdominal ultrasonography 12%. Twenty-eight per cent of patients (135) relapsed and received second-line treatment. The most frequent second-line treatments were Chlorambucil (Chl) 37%; Fludarabine + Cyclophosphamide (FC) 16%, Cyclophosphamide + Vincristine + Prednisone (CVP) 9%. Clinical complete responses were as follows: FC = 4.5%, FCR= 25%. Sixty-five out of 472 patients (14%) received third-line treatment. Most frequently used treatments at this line were: Chlorambucil 23%, FC 20%, CVP 13%, FCR 9.2%, BR 4.6 %, and other chemotherapies 4.6%. Only 7% of patients in the registry relapsed and received fourth-line treatment. Conclusions: HOLA registry describes patterns of demographics, diagnosis and treatments in the real world in Latin America. CLL diagnosis in Latin America is made based on flow cytometry for the majority of the patients. Cytogenetic and FISH test are scarcely performed. For the deceased patients, median time from diagnosis to death was 2.4 years. This could be related to the high risk, but since prognostic tests were not always present this merits further investigation. Watch-and-wait was the most frequent approach. Time elapsed from diagnosis to treatment initiation was less than a year. Lymphocyte doubling time as reason to start treatment was frequent. Chlorambucil remains the most frequently used treatment for elderly in newly diagnosed and relapsed /refractory patients, use is also frequent in the young/fit patient population. Access barriers to innovative drugs and monoclonal antibodies could explain this situation. Disclosures Chiattone: Janssen: Membership on an entity's Board of Directors or advisory committees; roche: Membership on an entity's Board of Directors or advisory committees; abbvie: Membership on an entity's Board of Directors or advisory committees. Gomez-Almaguer:Bristol: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Pavlovsky:Janssen: Speakers Bureau; Novartis: Speakers Bureau; Bristol Myers Squib: Speakers Bureau. Tuna-Aguilar:Janssen: Speakers Bureau. Farias:Janssen: Consultancy. Galvez:Novartis: Consultancy. Santos:Janssen: Employment. De La Mora Estrada:Janssen: Employment, Membership on an entity's Board of Directors or advisory committees.

Objective: To describe chronic lymphocytic leukemia (CLL) treatment patterns and patient outcomes in Latin America. Methods: This chart review study (NCT02559583; 2008-2015)evaluated time to progression (TTP) and overall survival (OS) outcomes among patients with CLL who initiate done (n = 261) to two (n = 96) lines of therapy (LOT) since diagnosis. Differences in TTP and OS were assessed by Kaplan-Meier analysis, with a log-rank test for statistical significance. Association between therapeutic regimen and risk for disease progression or death was estimated using Cox proportional hazard regression. Results: The most commonly prescribed therapies in both LOTs were chlorambucil-, followed by fludarabineand cyclophosphamide (C)/CHOP-based therapies. Chlorambucil-and C/CHOPbased therapies were largely prescribed to elderly patients (≥65 years) while fludarabine-based therapy was predominantly used by younger patients (≤65 years). In LOT1, relative to chlorambucil-administered patients, those prescribed fludarabine-based therapies had lower risk of disease progression (hazard ratio [HR] and 95% confidence interval [CI] 0.32 [0.19-0.54]), whereas C/CHOP-prescribed patients had higher risk (HR 95%CI 1.88 [1.17-3.04]). Similar results were observed in LOT2. There was no difference in OS between treatments in both LOTs. Discussion: Novel therapies such as kinase inhibitors were rarely prescribed in LOT1 or LOT2in Latin America. The greater TTP observed forfludarabine-based therapies could be attributed to the fact that fludarabine-based therapies are predominantly administered to young and healthy patients. Conclusion: Chlorambucil-based therapy, which has limited benefits, is frequently prescribed in Latin America. Prescribing novel agents for fludarabine-based therapy-ineligible patients with CLL is the need of the hour.