Results from Hemato-Oncology Latin America Observational Registry (HOLA) Providing Real World Outcomes for the Treatment of Patients with CLL

Abstract

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.

Availability of secondary healthcare data for conducting pharmacoepidemiology studies in Colombia: A systematic review

“…Most publications were full‐text articles (71%), and 29% posters, mainly from scientific conferences. Only 34 articles (10%) included information of additional countries besides Colombia 23,50,54,59,61,62,80‐83,85,86,159,160,169,178,181,198,206,241,260,265,267,278,279,292,304,305,307,326,331,333,334,337 …”

Real-world analysis of treatment patterns and clinical outcomes in patients with newly diagnosed chronic lymphocytic leukemia from seven Latin American countries

“…All information on each patient was collected during a one-time abstraction. The study protocol has been described in greater detail in an earlier report [5]. In the present analysis, only CLL patients who initiated treatment were included and assessed for up to two lines of therapy (LOTs).…”

“…Important advances have recently been made in treating chronic lymphocytic leukemia (CLL) with the development of new treatments including immunotherapies [1][2][3] (alone or with chemotherapy), Burton tyrosine kinase inhibitors [4] and other novel therapies, which have improved clinical outcomes. However, the adoption of novel therapies in Latin America often lags behind that of other Western countries [5]. Furthermore, improving care for patients with CLL in this region is challenging as there are only limited data regarding CLL treatment patterns.…”

Multiple myeloma treatment patterns and clinical outcomes in the Latin America Haemato‐Oncology (HOLA) Observational Study, 2008–2016

“…The Haemato‐Oncology Latin America (HOLA) Observational Study (http://ClinicalTrials.gov identifier: NCT02559583) was a multi‐centre, retrospective cohort study of patients with selected haematological malignancies seen between 2008 and 2015 at one of 30 clinics in seven Latin American countries: Argentina (5 sites), Brazil (9 sites), Chile (1 site), Colombia (5 sites), Mexico (6 sites), Panama (3 sites) and Guatemala (1 site) (Pavlovsky et al , ; Chiattone et al, ). A list of participating institutions by country and public/private clinic status is provided in Table SI.…”