scholarly journals Epidemiology of Hematologic Malignancies in Real-World Settings: Findings From the Hemato-Oncology Latin America Observational Registry Study

2019 ◽  
pp. 1-19
Author(s):  
Vania Tietsche de Moraes Hungria ◽  
Carlos Chiattone ◽  
Miguel Pavlovsky ◽  
Lina M. Abenoza ◽  
Gladys P. Agreda ◽  
...  
Keyword(s):  
Latin America ◽  
Latin American ◽  
Real World ◽  
B Cell Lymphoma ◽  
Patient Characteristics ◽  
Hematologic Malignancies ◽  
Treatment Patterns ◽  
Lymphocytic Leukemia ◽  
Real World Evidence

PURPOSE Limited 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. METHODS This 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). RESULTS Of 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. CONCLUSION The 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.

Real-world evidence of cancer immunotherapy (CIT) combination treatment in first-line (1L) extensive-stage small cell lung cancer (ES-SCLC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8561-8561
Author(s):  
Eric S. Nadler ◽  
Anupama Vasudevan ◽  
Kalatu Davies ◽  
Yunfei Wang ◽  
Ann Johnson ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Real World ◽  
Performance Status ◽  
Descriptive Analysis ◽  
Patient Characteristics ◽  
Treatment Patterns ◽  
Combination Regimen ◽  
Duration Of Treatment ◽  
The Real

8561 Background: Atezolizumab plus chemotherapy was the first CIT combination regimen approved for 1L treatment of ES-SCLC in 2019. This study investigated patient characteristics and treatment patterns for patients with ES-SCLC receiving this regimen in the real-world community oncology setting. Methods: This was a retrospective study including adult patients diagnosed with ES-SCLC between 01-Oct-2018 (after IMpower 133 publication in NEJM Sep-2018) and 31-Dec-2019, with follow-up through 31-March-2020 using The US Oncology Network electronic health records data. Descriptive analyses of patient characteristics and treatment patterns were conducted, with Kaplan-Meier (K-M) methods used to assess time to treatment discontinuation (TTD) and time to next treatment/death (TTNT). Results: Of the 408 patients included in this study, 267 (71.4%) received atezo+carboplatin+etoposide (Atezo+Chemo), 80 (21.4%) received carboplatin+etoposide (Chemo only) and the rest received other regimens. The Atezo+Chemo patients in the real-world cohort compared with the IMpower 133 trial (n = 201) were older (median age 68 vs. 64 years) and included fewer males (45% vs. 64%), fewer white race (73% vs. 81%), more patients with brain metastases at baseline (23% vs. 9%), and more patients with worse ECOG (2/3) performance-status score (24% vs. 0%). The median follow-up, TTD, and TTNT in months (mo) for the real-world cohort are presented in the table alongside the best comparable measures reported for the trial. Conclusions: Most patients in this real-world ES-SCLC cohort received the Atezo+Chemo regimen in the 1L setting. While the follow-up was much shorter and patients had worse baseline characteristics (age, brain metastases, ECOG) in the real-world setting compared to the IMpower 133 trial, the real-world median TTD in this descriptive analysis was found to be in line with the median duration of treatment in the trial. Further research with longer follow-up comparing the real-world effectiveness of the CIT and chemo regimens is needed.[Table: see text]

scholarly journals Patient Characteristics and Treatment Patterns in the First-Line and Second-Line Treatment of Diffuse Large B-Cell Lymphoma and Follicular Lymphoma in the United Kingdom, France, and Germany

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4234-4234 ◽  
Author(s):  
Aaron Galaznik ◽  
Nate Way
Keyword(s):  
Systemic Therapy ◽  
B Cell Lymphoma ◽  
Patient Characteristics ◽  
Current Treatment ◽  
Treatment Patterns ◽  
Initial Diagnosis ◽  
The United Kingdom ◽  
Real World Evidence ◽  
The Uk ◽  
Combination Regimens

Abstract Introduction: Diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) are hematologic malignancies with poor prognosis for patients who do not respond well to therapy. As current treatment options may be suboptimal for many patients, it is important to better understand the current treatment landscape for DLBCL and FL. Here we provide recent real-world evidence on patient characteristics and treatment patterns in relapsed/refractory (R/R) DLBCL and R/R FL across the United Kingdom (UK), France (FRA), and Germany (DE). Methods: Hematologists and oncologists (N=140) from the UK, FRA, or DE retrospectively identified patients diagnosed with R/R DLBCL or R/R FL who received at least two lines of therapy and had radiographically or clinically measurable disease with at least one target lesion per International Working Group criteria for malignant lymphoma. Descriptive statistics examined patient characteristics and treatment patterns in first-line (1L) and second-line (2L) therapy. Results: Mean (SD) age at initial diagnosis was 59.9 (10.9) years for the aggregate DLBCL patient sample (N=272). DLBCL patients were primarily male (69.1%), distributed across the UK (29.0%), FRA (36.8%), and DE (34.2%), and had various Eastern Cooperative Oncology Group (ECOG) performance statuses at initial diagnosis (0 ECOG 28.7%, 1 ECOG 48.9%, 2 ECOG 14.3%, ≥3 ECOG 5.9%, unknown ECOG 2.2%). Mean (SD) age at initial diagnosis was 61.0 (10.2) years for the aggregate FL patient sample (N=282). FL patients were primarily male (53.9%), distributed across the UK (29.4%), FRA (36.9%), and DE (33.7%), and had various ECOG performance statuses at initial diagnosis (0 ECOG 30.5%, 1 ECOG 50.7%, 2 ECOG 13.5%, ≥3 ECOG 4.2%, unknown ECOG 1.1%). DLCBL and FL patient characteristics by country are presented in Table 1. DLCBL patients in 1L and 2L received combination regimens (93.8% and 82.7%, respectively) or monotherapy regimens (6.2% and 17.3%, respectively). DLCBL patients in 1L received treatment largely consistent with current guidelines, consisting mainly of systemic therapy only (86.8%) and treatment with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisolone (R-CHOP, 68.0%). DLCBL patients in 2L completed multiple therapy cycles (median 3 cycles) and were treated with systemic therapy only (79.4%), systemic therapy and radiation (4.0%), systemic therapy and stem cell transplantation (SCT, 16.2%), or systemic therapy, radiation, and SCT (0.4%). The most common 2L DLCBL regimens were: rituximab, dexamethasone, high-dose cytosine arabinoside, and cisplatin (R-DHAP, 19.5%); bendamustine plus rituximab (12.9%); rituximab, dexamethasone, cytarabine, and oxaliplatin (R-DHAX, 12.5%). FL patients in 1L and 2L received combination regimens (86.5% and 78.4%, respectively) or monotherapy regimens (13.5% and 21.6%, respectively). FL patients in 1L received treatment largely consistent with current guidelines, consisting mainly of systemic therapy only (90.8%) and treatment with R-CHOP (35.1%). FL patients in 2L completed multiple therapy cycles (median 4 cycles) and were treated with systemic therapy only (90.1%), systemic therapy and radiation (2.1%), systemic therapy and SCT (6.0%), or systemic therapy, radiation, and SCT (1.8%). The most common 2L FL regimens were: bendamustine plus rituximab (33.3%); R-CHOP (9.6%); R-DHAP (8.5%). DLCBL and FL 2L treatment patterns by country are presented in Table 2. Conclusion/Summary: Given the rapid evolution of therapies used to treat FL and DLBCL, these findings fill a crucial data gap in real-world evidence on patient characteristics and treatment patterns in R/R DLCBL and R/R FL in the UK, FRA, and DE. There is an unmet need in DLBCL and FL. As novel treatments for patients with DLBCL and FL are currently in development, it is important to better understand the patients being treated for these conditions and the current treatment landscape. Disclosures Galaznik: Takeda Pharmaceuticals International Co.: Employment. Way:Seattle Genetics: Research Funding; Kantar Health: Employment.

Real-world treatment patterns and overall survival in previously treated advanced renal cell carcinoma patients receiving nivolumab in the UK.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16561-e16561
Author(s):  
Tom Waddell ◽  
Kate Fife ◽  
Richard Griffiths ◽  
Anand Sharma ◽  
Poonam Dhokia ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Cell Carcinoma ◽  
Real World ◽  
Renal Cell ◽  
Treatment Patterns ◽  
Case Report Form ◽  
Real World Evidence ◽  
Previously Treated

e16561 Background: CheckMate 025 demonstrated favorable efficacy and safety results for nivolumab monotherapy in previously treated advanced or metastatic renal cell carcinoma (aRCC). However, real-world evidence on treatment patterns and clinical outcomes is limited. Methods: This multi-centre, retrospective cohort study examined treatment patterns and overall survival (OS) in aRCC patients treated with nivolumab monotherapy. Eligible patients who initiated nivolumab at second-line (2L) or beyond (index) between 01 March 2016 and 30 June 2018 were sampled from four UK centers. Data were extracted using an electronic case report form from index to earliest of: most recent visit; death; end of follow up (31 May 2019). Results: Overall , 151 patients were included in analyses (mean age at index 66.9 years, 72.2% male, median follow-up from index 15.2 months), with 109 (72.2%) and 42 (27.8%) receiving nivolumab at 2L and ≥ third-line (3L+), respectively. Key clinical characteristics are outlined in Table 1. All 2L nivolumab patients had received first-line (1L) tyrosine kinase inhibitors (TKI), pazopanib (57.8%), sunitinib (30.3%), or both in sequence (10.1%). After 2L nivolumab, 3L cabozantinib (36/52, 69.2%) was most common. Most 3L nivolumab patients received 2L TKI (31/36, 86.1%) - commonly axitinib (70.9%). After 3L nivolumab, most patients received fourth-line cabozantinib (8/12, 66.7%). Median time on line of therapy (LOT) decreased with LOT progression: from 7.8 months at 1L to 4.6 months at fifth-line (5L). The proportion of patients who discontinued treatment due to adverse events decreased by LOT, (28.6%, 22.7%, 16.0% and 0%, and 34.7%, 28.1%, 0% and 0% from 2L to 5L, overall and for nivolumab treatment, respectively). Overall, median OS from nivolumab initiation was 19.2 months [95% CI, 16.9-27.0]. Patients who received 2L nivolumab had longest median OS (23.0 months [95% CI, 17.2, not reached]), comparable to CheckMate 025 (25.8 months [95% CI, 22.2-29.8]). Median OS for 3L+ nivolumab patients was 12.4 months [95% CI, 8.8, 23.2]. Among 2L nivolumab patients, 73.9%, 46.2%, and 33.6% survived 12, 24, and 36 months, respectively. For the same respective timeframes, 52.4%, 24.7%, and 18.6% of 3L+ nivolumab patients survived. Conclusions: This study provides real-world evidence on the characteristics, treatment patterns and effectiveness of 2L or ≥ 3L nivolumab monotherapy in previously treated aRCC patients. OS results from UK routine clinical care were comparable to those found in CheckMate 025.[Table: see text]

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

Hematology ◽  
2020 ◽  
Vol 25 (1) ◽  
pp. 366-371
Author(s):  
Carlos Chiattone ◽  
David Gomez-Almaguer ◽  
Carolina Pavlovsky ◽  
Elena J. Tuna-Aguilar ◽  
Ana L. Basquiera ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Clinical Outcomes ◽  
Latin American ◽  
Real World ◽  
Treatment Patterns ◽  
Lymphocytic Leukemia ◽  
Newly Diagnosed ◽  
Latin American Countries

P3674Patient characteristics and treatment patterns in the multicentre, retrospective chart review of first-time Opsumit (macitentan) users in the United States (OrPHeUS)

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
V McLaughlin ◽  
R Channick ◽  
K Chin ◽  
P Leary ◽  
C Miller ◽  
...  
Keyword(s):  
Chart Review ◽  
Retrospective Chart Review ◽  
Patient Characteristics ◽  
Exposure Period ◽  
The United States ◽  
Treatment Patterns ◽  
Functional Class ◽  
Kaplan Meier ◽  
Real World Evidence

Abstract Introduction The OPsumit® Historical USers cohort (OrPHeUS) is a multicentre, US, retrospective medical chart review conducted to supplement the OPsumit® USers (OPUS) Registry to fulfil the FDA request to characterise the safety of macitentan in clinical practice. Purpose To describe patient characteristics, treatment patterns, hepatic safety and survival in patients with pulmonary hypertension (PH) newly treated with macitentan. Methods OrPHeUS (NCT03197688) aimed to include 2200 new users of macitentan, between October 2013 and March 2017, who were not enrolled in OPUS. Here we present patients with follow-up data, including characteristics and treatment patterns at macitentan initiation, hepatic adverse events (HAEs) identified using preferred terms in chart entries and pharmacovigilance reporting, hospitalisations and survival. Results OrPHeUS included 2982 patients newly treated with macitentan and with follow-up data; the reason for macitentan prescription was pulmonary arterial hypertension (PAH) in 2362 (79.3%) patients, other PH aetiologies in 612 (20.6%) patients and 8 patients with other/unknown reasons. At macitentan initiation, the median (Q1, Q3) age of the patients was 62 (51, 72) years and 73.9% were female. WHO functional class (FC) was documented in 654 (21.9%) patients, 35.6% of patients were in FC I/II and 64.4% in FC III/IV; median (Q1, Q3) 6-minute walk distance, documented in 411 (13.8%) patients, was 293 (200, 383) metres. At macitentan initiation, 41.5% (n=1239) of patients were not receiving PAH therapy, 46.3% (n=1382) were already receiving one PAH therapy and 11.9% (n=356) were already receiving two PAH therapies. The median (Q1, Q3) exposure to macitentan was 14.9 (5.6, 27.1) months; 57% and 43% of patients had exposures of >12 and >18 months. During the exposure period, 933 (31.3%) patients discontinued treatment, including 474 (15.9%) patients who discontinued due to an adverse event (AE), 6 (0.2%) due to a HAE, 449 (15.1%) for reasons other than an AE/HAE, and 4 (0.1%) for unknown reasons. There were 275 (9.2%) patients who experienced ≥1 HAE (incidence rate [IR]: 0.07 [95% CI, 0.06, 0.08] per 1 person-year); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3x upper limit of normal (ULN) were experienced by 113 (3.8%) patients (IR: 0.028 [95% CI, 0.023, 0.033] per 1 person-year); ALT/AST ≥x3 ULN and bilirubin ≥2x ULN was experienced by 33 (1.1%) patients (IR: 0.008 [95% CI, 0.006, 0.011] per 1 person-year). There were 1148 (38.5%) patients who experienced at least one hospitalisation (IR: 0.36 [95% CI, 0.34, 0.39] per 1 person-year). The 12-month Kaplan-Meier survival estimate was 92% (95% CI, 91, 93). Conclusion OrPHeUS provides additional real-world evidence in patients newly treated with macitentan, confirming the hepatic safety profile of macitentan. Acknowledgement/Funding Actelion Pharmaceuticals Ltd

scholarly journals Real World Evidence in Relapsed/Refractory Classical Hodgkin Lymphoma Patients Who Are Ineligible for Stem Cell Transplant in the United States (US)

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2268-2268
Author(s):  
Joseph Feliciano ◽  
Nate Way ◽  
Gerald Engley ◽  
Nilanjan Ghosh
Keyword(s):  
Real World ◽  
Systemic Therapy ◽  
Research Funding ◽  
Patient Characteristics ◽  
The United States ◽  
Treatment Patterns ◽  
Cell Transplant ◽  
Real World Evidence ◽  
The Us ◽  
Line Of Therapy

Abstract Introduction: Treatment of relapsed or refractory classical Hodgkin lymphoma (R/R cHL) in patients considered ineligible for stem cell transplant (SCT) in the United States (US) has evolved since 2011. It is important to understand the current treatment landscape and the outcomes associated with current standards of care as new treatment options have been introduced. This analysis provides recent real-world evidence on patient characteristics, treatment patterns, and outcomes in R/R cHL patients in the US who are initially considered ineligible for SCT and are treated with or without brentuximab vedotin (BV). Methods: Hematologists and oncologists (N=205) from the US retrospectively identified patients diagnosed with R/R cHL who received at least two lines of therapy and received their most recent line of therapy between January 2014 and May 2018. The physicians were responsible for abstracting data and completing response forms for variables of interest. The current analysis focused on patients who were considered ineligible for SCT by their physician: descriptive statistics on patient demographics/clinical characteristics, treatment patterns, and outcomes by line of therapy; bivariate analyses (chi-square) comparing treatment modalities by line of therapy. Results: Physicians retrospectively identified 297 patients that they considered ineligible for SCT. Mean (SD) age at initial cHL diagnosis was 53.0 (18.5), most patients were male (69.4%) and Caucasian (61.3%). The most common cHL subtype at diagnosis was nodular sclerosis HL (40.4%), and patients had either Stage I/II (45.8%) or Stage III/IV (54.2%) cHL at initial diagnosis. Median follow-up time for the cohort included here was 15.96 months from initiation of 1L treatment. The majority of the cohort (N = 297) received systemic therapy alone (84.5%) compared to those who received systemic therapy in combination with radiation therapy (RT) (15.5%) in 1L. 1L systemic regimens included regimens that contained ABVD alone or ABVD in combination with other regimens (69.4%). Of those who used ABVD alone or in combination with another regimen (N = 206), 24.8% used a PET adapted approach and deescalated to AVD (N = 51) and 11% escalated to be BEACOPP (N = 18). Other systemic regimens included AVD (10.1%), BEACOPP (7.4%) and ICE (5.7 %). The majority of patients achieved a complete response (CR) or partial remission (PR) after 1L therapy (41.4%, 38% respectively) while 34.1% (N = 61) failed to achieve remission or progressed while on therapy. The most common systemic regimens in 2L (N = 293) were BV monotherapy or in combination with bendamustine (34.6%), salvage regimens [including ICE, DHAP, ESHAP or gemcitabine based combinations] (33%), re-challenge with a previous 1L regimen (19.5%), and PD-1 inhibitors (10.8%). Very few patients received systemic therapy in combination with RT (6.7%) in 2L.The most common systemic regimens used in 3L (N = 21) for the selected cohort of patients not eligible for SCT were BV monotherapy (28.6%) and PD-1 inhibitors (33.3%). Median (range) number of cycles in 2L and 3L was four (1-18) and two (1-14), respectively. Treatment outcomes were variable for patients in 2L and 3L. In 2L, 27.6% achieved a CR, 25.6% achieved a PR, while 24.2% and 15.8% were refractory or progressed on treatment. There were no CRs reported in 3L (N = 21). 26 patients died in 2L and 3L combined. Conclusion/Summary: Given the rapid evolution of therapies used to treat R/R cHL, these findings fill a crucial data gap in real-world evidence on patient characteristics, treatment patterns, and outcomes of patients deemed SCT ineligible in the US. Disclosures Feliciano: Seattle Genetics: Employment. Way:Kantar Health: Employment; Seattle Genetics: Research Funding. Engley:Seattle Genetics: Employment. Ghosh:Juno: Consultancy, Research Funding; SGN: Consultancy, Research Funding, Speakers Bureau; PCYC: Consultancy, Research Funding, Speakers Bureau; Celgene: Consultancy; Spectrum: Consultancy; Gilead: Consultancy, Speakers Bureau; Pharmacyclics, an Abbvie Company: Consultancy, Research Funding, Speakers Bureau; Genentech: Research Funding; F. Hoffman-La Roche Ltd: Research Funding; Abbvie: Consultancy, Speakers Bureau; Forty seven Inc: Research Funding; TG Therapeutics: Honoraria, Research Funding.

scholarly journals Profiling Clinical Characteristics and Treatment Patterns Among Non-Valvular Atrial Fibrillation Patients: A Real-World Analysis in Dubai, United Arab Emirates

2019 ◽  
Vol 6 (1) ◽  
pp. 33-41 ◽  
Author(s):  
Moutaz El Kadri ◽  
Nooshin Bazargani ◽  
Mohamed Farghaly ◽  
Rauf Mohamed ◽  
Nancy Awad ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
United Arab Emirates ◽  
Real World ◽  
Patient Characteristics ◽  
International Normalized Ratio ◽  
Baseline Period ◽  
Treatment Patterns ◽  
Peripheral Vascular ◽  
Real World Evidence ◽  
Artery Disease

Background: There is a dearth of real-world evidence regarding patient characteristics, Oral Anti-Coagulant (OAC) treatment, and International Normalized Ratio (INR) patterns in Dubai, United Arab Emirates (UAE). Methods: This was a retrospective observational study among newly diagnosed adult Non-valvular Atrial Fibrillation (NVAF) patients in the Dubai Real World Claims Database. Selected patients had at least one activity claim during the 12 months pre-index date (baseline period), and a pharmacy claim for apixaban, dabigatran, rivaroxaban, or warfarin from 01 JAN 2015-31 JUL 2017. Patients with valvular heart disease, cardiac surgery, venous thromboembolism, transient atrial fibrillation, pregnancy, or OAC claims during baseline were excluded. Comorbidities and treatment patterns related to OAC use, index dosing, baseline medications, and INR patterns were described. Results: Among 5,072 NVAF patients, 468 met the study criteria. A minority of them (14.3%) were prescribed warfarin, and the most frequently prescribed non-vitamin K antagonist OACs (NOACs) were rivaroxaban (33.3%) and apixaban (31.4%), followed by dabigatran (20.9%). Patients’ mean age was 59 years and mean CHA2DS2-VASc score was 2.3, with most frequent comorbidities of diabetes mellitus, hypertension, coronary artery disease, and peripheral vascular disease. Additionally, 51% and 33% were on statins and aspirin, respectively, while 39% were on other anticoagulant agents. A large proportion of dabigatran patients were on a lower dose (57%). INR patterns revealed 13% of rivaroxaban, 12% of apixaban, and 7% of dabigatran patients had INR claims. Conclusion: This study provides relevant insights into the use of OACs in real-world clinical practice settings in Dubai, UAE.

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