Racial and ethnic enrollment disparities in acute myeloid leukemia clinical trials.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6523-6523
Author(s):  
Andrew Hantel ◽  
Daniel J. DeAngelo ◽  
Marlise Rachael Luskin ◽  
Jacqueline Suen Garcia ◽  
Gregory A. Abel
Keyword(s):  
Clinical Trials ◽  
Acute Myeloid Leukemia ◽  
Race And Ethnicity ◽  
Myeloid Leukemia ◽  
Ethnic Disparities ◽  
Hispanic Patients ◽  
Incident Cases ◽  
Over Time ◽  
Acute Myeloid ◽  
White Patients

6523 Background: Racial and ethnic disparities in clinical trial enrollment compound inequities in drug development and the delivery of patient-centered care. Despite significant survival disparities in acute myeloid leukemia (AML), enrollment disparities data are limited. Methods: We performed a structured search and abstraction of demographic data for all United States (US) AML clinical trials from 2002-2017 listed on clinicaltrials.gov and compared the results to the incidence and demographic distribution of AML using the Surveillance, Epidemiology, and End Results program and 2010 US Census. We calculated enrollment fractions (the number of enrollees divided by the number of incident cases) for the five mutually exclusive race/ethnicity groups of non-Hispanic White (NH-White), Black (NH-Black), Asian/Pacific Islander (NH-Asian/PI), American Indian/Native Alaskan (NH-AI/AN), and Hispanic patients. We compared these using X2 testing, with NH-White as the comparator, and reported odds ratios with 95% confidence intervals (CI). To assess trends over time, we adjusted enrollment from 2005-2008 for changes in AML incidence and NH-White enrollment for a later period (2011-2014), comparing this expected enrollment fraction to the actual enrollment fraction during that later period. Results: Of 223 eligible studies (patient N=17372) on clinicaltrials.gov, 99 (44.4%) reported racial demographics (N=8417; 48.5%) and 68 (30.5%) reported race and ethnicity (N=6554; 37.7%). Enrollment and incidence proportions by race are shown in the table. Among trials reporting race and ethnicity, all groups had lower odds of enrollment compared to NH-White patients (Table). For the 99 trials reporting race data, Black and AI/AN patient enrollment odds were lower (OR 0.60 [95% CI: 0.55, 0.65]; 0.50 [95% CI: 0.33, 0.76]), but Asian/PI enrollment was not (OR 0.91 [95% CI: 0.82, 1.01]). The relative enrollment of NH-Black, NH-Asian/PI, and Hispanic patients declined later in the study period (Table). Conclusions: In AML clinical trials performed in the US from 2002-2017, NH-White patients were enrolled at higher rates compared to other racial and ethnic groups; enrollment diversity declined over time. An important first step to reducing enrollment disparities will be to improve the reporting of demographic enrollment data.[Table: see text]

scholarly journals Association of race and ethnicity with clinical phenotype, genetics, and survival in pediatric acute myeloid leukemia

2021 ◽  
Author(s):  
Shannon E. Conneely ◽  
Casey L McAtee ◽  
Rohit Gupta ◽  
Joseph Lubega ◽  
Michael E. Scheurer ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Race And Ethnicity ◽  
Myeloid Leukemia ◽  
Ethnic Disparities ◽  
Gemtuzumab Ozogamicin ◽  
Survival Outcomes ◽  
Black Patients ◽  
Hispanic Patients ◽  
Pediatric Aml ◽  
Acute Myeloid

Black and Hispanic children with acute myeloid leukemia (AML) have worse outcomes compared to White children. AML is a heterogeneous disease with numerous genetic subtypes in which these disparities have not been specifically investigated. In this study, we used the Therapeutically Applicable Research to Generate Effective Treatments (TARGET) database to examine the association of race-ethnicity with leukemia cytogenetics, clinical features, and survival outcomes within major cytogenetic subgroups of pediatric AML. Compared to White non-Hispanic patients, t(8;21) AML was more prevalent among Black (OR, 2.22; 95% CI, 1.28-3.74) and Hispanic patients (OR, 1.74; 95% CI, 1.05-2.83). The poor prognosis KMT2A rearrangement t(6;11)(q27;q23) was more prevalent among Black patients (OR, 6.12; 95% CI, 1.81-21.59). Among those with KMT2Ar AML, Black race was associated with inferior event-free survival (EFS) (HR, 2.31; 95% CI, 1.41-3.79) and overall survival (OS) (HR, 2.54; 1.43-4.51). Hispanic patients with KMT2Ar AML also had inferior EFS (HR, 2.20; 95% CI, 1.27-3.80) and OS (HR, 2.07; 95% CI, 1.09-3.93). Similarly, among patients with t(8;21) or inv(16) AML (i.e., core binding factor AML), Black patients had inferior outcomes (EFS HR, 1.93; 95% CI, 1.14-3.28 and OS HR, 3.24; 95% CI, 1.60-6.57). This disparity was not detected among patients receiving gemtuzumab ozogamicin. In conclusion, racial-ethnic disparities in survival outcomes among young people with AML are prominent and vary across cytogenetic subclasses. Future studies should explore the socioeconomic and biologic determinants of these disparities.

scholarly journals FDA Analysis of Screen Failures By Race in Clinical Trials of Acute Myeloid Leukemia

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 23-24
Author(s):  
Dianne Pulte ◽  
Guo Wei ◽  
Kelly J. Norsworthy ◽  
Yutao Gong ◽  
Nicole J. Gormley ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Clinical Trials ◽  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Precision Oncology ◽  
Failure Rates ◽  
Asian Patients ◽  
Screen Failure ◽  
Acute Myeloid ◽  
White Patients

Background: Ethnic and racial minorities are underrepresented in oncologic clinical trials. One potential barrier to participation may be narrow eligibility criteria which contribute to an increased rate of screen failure among minorities. Prior work in multiple myeloma demonstrated a higher rate of screen failure among black or African-American (AA) patients and lower rate of screen failure among Asian patients compared with white patients (1). Here, we examine screen failure rates by race in patients screened for participation in clinical trials of acute myeloid leukemia (AML). Methods: Trials submitted to the U.S. Food and Drug Administration (FDA) to support approval of new treatments for AML between 2016-2019 were examined. Trials which included information on screen failures and race were included. Trial, screen failure status, basic demographic information (age, gender, race, and ethnicity), country of participant, and reason for screen failure (if relevant) were abstracted from the trials. Screen failure rates were calculated based on this information. Results: Twenty-one trials of AML therapies were identified, of which screen failure and race information were available in fourteen. Of these, information on reason for screen failure was available in nine. A total of 6,471 patients were identified across fourteen trials (Table 1). Race was recorded as unknown for 2,934 (46%) of patients. A total of 3,372 (52%) screen failures occurred. Minorities were more likely to be screen failures at 201/603 (33%) compared to whites at 27%. Of minorities, screen failures occurred in 29% of black/AA patients, 36% of Asians, and 36% of patients of any other race. A total of 579 patients were included in the nine trials that included data on reasons for screen failures (Table 2). Lack of appropriate mutation (i.e. IDH1/2, FLT3) was the most common reason for screen failure overall and was more common in black/AA (41%) and Asian patients (66%) compared to white patients (29%). Other issues related to the disease course (e.g. not at the appropriate point in treatment, not treated within the time limit set in the protocol) led to screen failure in 28% black/AA patients versus 9-22% for other races (19% overall). White patients were more likely than patients of other races to be screen failures due to cardiac issues (4%) and laboratory abnormalities (6%). Conclusions: Minority patients were numerically more likely to be screen failures compared to whites in trials of AML therapeutics, which exemplifies the known issue of lower minority recruitment in clinical trials. Minority patients were more likely to be screen failures due to lack of appropriate mutation and less likely due to lab abnormalities or cardiac issues. The significance of this finding is uncertain given the limited information on reasons for screen failure and the small number of minority patients in the database. Further investigation into screen failures in minority patients with AML is indicated. These results underscore the importance of including racial and ethnic minorities in all phases of translational and clinical research to further precision oncology for all patients since oncogenic driver mutation frequencies may vary among different populations. (1) Kanapuru B, Fernandes L FDA analysis of multiple myeloma trials supporting approval; Presented at FDA-AACR workshop to examine under-representation of African Americans in multiple myeloma clinical trials 2/13/20 Disclosures No relevant conflicts of interest to declare.

scholarly journals Real World Management of Patients with Acute Myeloid Leukemia: Results from French Cancer Population-Based Registries

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3540-3540
Author(s):  
Morgane Mounier ◽  
Mohamad Sobh ◽  
Alain Monnereau ◽  
Xavier Troussard ◽  
Marc Maynadie ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Population Based ◽  
Survival Outcome ◽  
University Hospitals ◽  
Cancer Centers ◽  
Anti Cancer ◽  
Over Time ◽  
Acute Myeloid

Abstract Introduction: Cancer registries are required for the analysis of incidence and mortality rates and trends but are also useful as complement to clinical studies to support decision on individual patient management. Acute myeloid leukemia (AML) is more common in older people, with a continuous slow rise in young adulthood turning into rapidly increasing incidence by age from approximately 50 years. Clinical studies have criteria for inclusion and exclusion, which impose selection. This has less implication in younger patients because most of them receive intensive treatment, fewer have secondary AML, and few have severely impaired performance status. Many clinically relevant questions cannot be answered in randomized studies, because of limited patient numbers, problems with randomization, or resource availability. Population-based registries provide a way to achieve new information through the study of geographic differences. Healthcare authorities are interested in geographic variation to ensure equal level of health care for the citizens and the general population to know where to go for the best of care. The aim of this study was to describe the management and outcomes of adult AML patients diagnosed and reported to 3 different regional cancer population-based registries considered representative of the whole French population between years 2006 and 2012. Patients and methods: A total of 1106 patients were available in the 3 registries (446 in Gironde department, 472 in Basse-Normandie, and 188 in Côte d'Or department); 584 (53%) were males, age at diagnosis was comparable between the 3 departments with median of 66 years (range: 18-99), 431 (39%) were less than 65 years old and 437 (39%) were older than 75 years. Therapy-related AML was diagnosed in 126 (11%) patients, cytogenetic analysis was not homogeneously performed among the three departments, and also among those who had it done (N=815, 74%), 29% were normal, and from the remaining with abnormal cytogenetics, 69 (8%) were favorable prognosis, 121 (15%) intermediate, and 359 (44%) were unfavorable. Results: Two-third of patients (N=725, 66%) were followed in university hospitals, 7% in anti-cancer centers and the rest were followed in other hospitals. Among the total population, 915 (83%) were treated for their AML, most of them were <75 years old, and the rest of patients were not treated or received palliative care, only 67% of patients > 75 years were treated. There was no statistical difference in terms of overall survival (OS) between males and females (p=0.99). When stratifying according to age < 60, 60-65, 66-75 and > 75 years, OS probability at 5 years was 50% (95%CI: 44-56), 20% (95%CI: 12-27), 16% (95%CI: 11-21), 2% (95%CI: 1-4) respectively. OS was not different between the 3 departments. Information about inclusion in clinical trials was available for 50% of patients, among them 174 (19%) were included in clinical trials and 284 (31%) not. There was a clear significant survival advantage for patients included in clinical trial independently from age, p<0.001. OS was significantly better for patients treated in university hospitals and anti-cancer centers than those followed in other centers p<0.001. When evaluating the impact of period of treatment, survival outcome significantly improved during years 2010-2012 compared to years 2006-2009, p=0.04 only for patients aged less than 65 years, while patients older than 65 years did not have survival improvement over time, p=0.41. In addition patients who received allogeneic hematopoietic cells transplantation (allo-SCT) had a better OS, p=0.01. In multivariate analysis, age <65 years (HR=0.45, 95% CI: 0.38-0.54, p<0.001), favorable cytogenetics (HR=0.26, 95% CI: 0.15-0.45, p<0.001), unfavorable cytogenetics (HR=1.61, 95% CI: 1.32-1.97, p<0.001) and allo-SCT (HR=0.49, 95% CI: 0.38-0.64, p<0.001) significantly impacted OS. Conclusion: This analysis allowed to point out some disparities in the real world management of AML patients. Interestingly, the fact that survival outcome for patients treated in clinical trials is different from the rest of the population reflects an important point to consider by health authorities. In addition, we observed a lack of improvement over time for older patients that needs more attention. A prognostic evaluation is ongoing to verify patients deemed eligible for allo-SCT to find out among them the proportion of those really transplanted. Disclosures Troussard: Gilead: Other: scientific advisory board. Michallet:Octapharma: Membership on an entity's Board of Directors or advisory committees; Chugai: Consultancy; Novartis: Research Funding.

scholarly journals Core outcome set measurement for future clinical trials in acute myeloid leukemia: the HARMONY study protocol using a multi-stakeholder consensus-based Delphi process and a final consensus meeting

2020 ◽  
Author(s):  
Katharina M Lang ◽  
Kathryn L. Harrison ◽  
Paula R. Williamson ◽  
Brian J.P. Huntly ◽  
Gert Ossenkoppele ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Face To Face ◽  
Outcome Set ◽  
Multi Stakeholder ◽  
Stakeholder Consensus ◽  
Acute Myeloid

Abstract Background Acute myeloid leukemia is the most common acute leukemia in adults with an unacceptably low cure rate. In recent years a number of new treatment strategies and compounds were developed for the treatment of acute myeloid leukemia. There were several randomized, controlled clinical trials with the objective to improve patients’ management and patients’ outcome in acute myeloid leukemia. Unfortunately, these trials are not always directly comparable, as they do not measure the same outcomes and currently there are no core outcome sets that can be utilized to guide outcome selection and harmonization in this disease area. The HARMONY Alliance is a public-private European Network established in 2017, which currently includes 53 partners and 32 associated members from 22 countries. Amongst many other goals of the HARMONY Alliance, Work Package 2 focuses on defining outcomes that are relevant to each hematological malignancy. In accordance, a pilot study will be performed to define core outcome set in acute myeloid leukemia. Methods The pilot study will use a three-round Delphi survey and a final consensus meeting to define a core outcome set. Participants will be recruited from different stakeholder groups, including patients, clinicians, regulators and members of the European Federation of Pharmaceutical Industries and Associations (EFPIA). At the pre-Delphi stage a literature research was conducted followed by several semi-structured interviews of clinical public and private key opinion leaders. Subsequently the preliminary outcome list was discussed in several multi-stakeholder face-to-face meetings. The Delphi survey will reduce the preliminary outcome list to essential core outcomes. After completing the last Delphi round a final face-to-face meeting is planned to achieve consensus about core outcome set in acute myeloid leukemia. Discussion The pilot Delphi as part of HARMONY Alliance aims to define a core outcome set in acute myeloid leukemia based on a multi-stakeholder consensus. Such a core outcome set will help to allow consistent comparison of future clinical trials and real world evidence research and ensures that appropriate outcomes valued by a range of stakeholders are measured within future trials.

scholarly journals Target Therapy in Acute Myeloid Leukemia

2020 ◽  
Author(s):  
Vasko Graklanov
Keyword(s):  
Clinical Trials ◽  
Acute Myeloid Leukemia ◽  
Elderly Patients ◽  
Acute Leukemia ◽  
Mechanism Of Action ◽  
Myeloid Leukemia ◽  
Target Therapy ◽  
New Drugs ◽  
Cytotoxic Treatment ◽  
Acute Myeloid

Acute myeloid leukemia (AML) is the most common form of acute leukemia in elderly patients. Over the past four decades the basic therapeutic armamentarium was the standard cytotoxic treatment. The new insights in understanding the pathogenesis of AML was the momentum that revolutionized the treatment landscape in AML. The last five years unprecedented growth has been seen in the number of target therapy drugs for the treatment of AML. These new drugs did not just have a clinical benefit as single agents but also have improved AML patient outcomes if combined with conventional cytotoxic therapy. Here, we review recent advances in target-based therapy for patients with AML focusing on their mechanism of action and the results from already published clinical trials.

scholarly journals Survival Improvement Of Secondary Acute Myeloid Leukemia Over Time: Experience From 962 Patients Included In 13 EORTC-Gimema-HOVON Leukemia Group Trials

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 829-829 ◽  
Author(s):  
Safaa M. Ramadan ◽  
Stefan Suciu ◽  
Marian J.P.L. Stevens-Kroef ◽  
Roelof Willemze ◽  
Sergio Amadori ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Research Funding ◽  
Malignant Disease ◽  
Risk Group ◽  
Toxic Exposure ◽  
Secondary Acute Myeloid Leukemia ◽  
History Of ◽  
Over Time ◽  
Acute Myeloid

Abstract Background Secondary acute myeloid leukemia (sAML) describes patients (pts) with a history of malignant or non-malignant disease or AML secondary to environmental, occupational or therapeutic exposures. They are generally associated with poor outcome despite the use of intensive treatments. The impact of clinical features and type of treatment on pts' outcome is still not well established. In the current analysis we evaluated sAML pts who were treated in 13 EORTC collaborative trials conducted between May 1986 and January 2008. sAML pts in the database were pooled to characterize clinical features of the disease and evaluate changes in survival over these years (yrs). Method Main selection criteria were AML with bone marrows blasts ≥20% and documented history of prior malignancy, non-malignant disease and/or toxic exposure. AML-M3 and MDS without confirmed diagnosis ≥2 months before AML were excluded. All pts were eligible for standard treatment. Induction regimens were anthracycline and AraC based: 7+3, including etoposide, intensified with high dose (HD)-AraC randomized to standard doses (SD) in younger (AML12) or gemtuzumab ozogamicin in elderly pts. Consolidation regimens were age adapted. In mid-1980s, autologous transplant was tested vs a 2nd consolidation cycle (AML8A) in pts ≤45 yrs and thereafter used systematically in pts ≤60 yrs without available donor. Allogeneic transplant (Allo-SCT) was offered to pts ≤46 yrs with HLA-compatible sibling since mid-1980s and expanded in the last decade to pts up to 59 yrs. Selected pts were divided into 3 sAML cohorts, cohort A after MDS, cohort B after other malignant diseases and cohort C after non-malignant conditions and/or toxic exposure. Results Of 8858 pts enrolled in the 13 evaluated studies, 962 were sAML. Median age was 63 yrs (range 16-85), 413 were young (≤60 yrs) and 549 were elderly (≥61 yrs); 54% were males. Cohort A consisted of 509 pts (median age 64 yrs), cohort B of 362 pts (median age 59 yrs) and cohort C of 91 pts (median age 61 yrs). In cohort B, breast cancer (24%) and lymphoma (14%) were the most frequent primary tumors. Autoimmune diseases represented 22% of non-malignant conditions. In young pts, complete remissions (CR/CRi) rate was 59%; 55% in SD-AraC vs 89% in HD-AraC treated pts. Allo-SCT in CR1 was performed in 21% of all pts. The Allo-SCT rate increased from 5% before 1990, 20% in 1990-1999 to 25% from 2000 (20% in SD-AraC vs 31% of HD-AraC treated pts). CR/CRi was achieved in 45% of elderly pts. Median follow-up was 6 yrs. Median overall-survival (OS) was 14.5 months in young and 9 months in elderly pts. The 5-yr OS was 28% and 7% respectively. Five-yr OS was 11% in cohort A and 22% in both cohort B and C. Treatment outcome of younger pts according to disease features and treatment type over time in cohort A and B are detailed in table 1 & 2. Using Cox model stratified by cohort age, gender, WBC, risk group, year of treatment and HD-AraC were independent prognostic factors for OS. In the AML12 study, compared to denovo pts, sAML pts ≤45 yrs had worse outcome if treated with SD-AraC whereas a better OS was seen if treated with HD-AraC. In elderly pts only the good/intermediate risk group of cohort B had a relatively better 5-yr OS (15%). Conclusions The outcome of sAML in younger pts has improved over the yrs in parallel with HD-AraC introduction in induction of remission. HD-AraC should be considered for younger pts with sAML. Disclosures: Ramadan: Alwaleed Bin Talal Foundation : A research funding is under advanced negotiation with the foundation Other. Suciu:Alwaleed Bin Talal Foundation : A research funding is under advanced negotiation with the foundation Other. Meert:Alwaleed Bin Talal Foundation : A research funding is under advanced negotiation with the foundation Other. de Schaetzen:Alwaleed Bin Talal Foundation : A research funding is under advanced negotiation with the foundation Other Other.

scholarly journals Venetoclax for the treatment of newly diagnosed acute myeloid leukemia in patients who are ineligible for intensive chemotherapy

2019 ◽  
Vol 10 ◽  
pp. 204062071988282 ◽  
Author(s):  
Guillaume Richard-Carpentier ◽  
Courtney D. DiNardo
Keyword(s):  
Clinical Trials ◽  
Acute Myeloid Leukemia ◽  
Adverse Events ◽  
B Cell ◽  
Drug Administration ◽  
Myeloid Leukemia ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Intensive Chemotherapy ◽  
Acute Myeloid

Acute myeloid leukemia (AML) is an aggressive hematological malignancy with a globally poor outcome, especially in patients ineligible for intensive chemotherapy. Until recently, therapeutic options for these patients included low-dose cytarabine (LDAC) or the hypomethylating agents (HMA) azacitidine and decitabine, which have historically provided only short-lived and modest benefits. The oral B-cell lymphoma 2 inhibitor, venetoclax, Venetoclax, an oral B-cell lymphoma 2 (BCL2) inhibitor, is now approved by the USA Food and Drug Administration (FDA) in combination with LDAC or HMA in older AML patients ineligible for intensive chemotherapy. Is now approved by the US Food and Drug Administration for this indication. In the pivotal clinical trials evaluating venetoclax either in combination with LDAC or with HMA, the rates of complete remission (CR) plus CR with incomplete hematological recovery were 54% and 67%, respectively and the median overall survival (OS) was 10.4 months and 17.5 months, respectively, comparing favorably with outcomes in clinical trials evaluating single-agent LDAC or HMA. The most common adverse events with venetoclax combinations are gastrointestinal symptoms, which are primarily low grade and easily manageable, and myelosuppression, which may require delays between cycles, granulocyte colony-stimulating factor (G-CSF) administration, or decreased duration of venetoclax administration per cycle. A bone marrow assessment after the first cycle of treatment is critical to determine dosing and timing of subsequent cycles, as most patients will achieve their best response after one cycle. Appropriate prophylactic measures can reduce the risk of venetoclax-induced tumor lysis syndrome. In this review, we present clinical data from the pivotal trials evaluating venetoclax-based combinations in older patients ineligible for intensive chemotherapy, and provide practical recommendations for the prevention and management of adverse events associated with venetoclax.

Practically All Patients with Acute Myeloid Leukemia (AML) in Continuous Complete Remission for 3 Years or More Are Cured of Their Disease: The ECOG Experience

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 132-132
Author(s):  
Justin M Watts ◽  
Lynette Zickl ◽  
Mark R Litzow ◽  
Selina M Luger ◽  
Hillard M Lazarus ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Acute Myeloid Leukemia ◽  
Complete Remission ◽  
Myeloid Leukemia ◽  
Late Relapse ◽  
Published Data ◽  
High Dose ◽  
Acute Myeloid

Abstract Abstract 132 Late relapse in acute myeloid leukemia (AML) has been infrequently studied and variably defined in the literature. Two series have shown that late relapse of AML ≥5 years after first complete remission (CR1) is uncommon, with rates of 1.19–3% (Medeiros et al, Leuk Lymphoma 2007; Verma et al, Leuk Lymphoma 2010). We searched the long-term data available on 784 adults (<60 years-old) who were treated on 1 of 4 ECOG clinical trials (E3483, PC486, E3489, or E1900) and achieved CR1 for reports of late relapse (defined as recurrence of AML ≥3 years after CR1). Median follow-up for the 553 patients last known alive was 11.1 years. The longest median follow-up was 17.2 years on trial PC486. Outcomes We found that 11 patients (1.4%) relapsed late; of these, 2 were treated on E3483, 1 on PC486, 5 on E3489, and 3 on E1900. Seven patients with late relapse died from their disease and 4 were living at last known follow-up. Only 1 patient (0.13%) had recurrence of AML ≥5 years after achieving CR1. It is possible that more late relapses will occur on E1900 (a more recent study with ongoing follow-up). All of these trials except E3483 treated some patients with autologous hematopoietic cell transplantation (autoHCT) as part of post remission therapy. On PC486, no post remission consolidation chemotherapy was administered before autoHCT. Ninety-eight total patients on E3489 and PC486 received autoHCT, and there were no late relapses; on E1900, 2 of the 141 patients treated with autoHCT developed late relapse. No patients who underwent allogeneic (allo) HCT in CR1 experienced late relapse on any of the 4 clinical trials. Nine of the 11 patients with late relapse did not undergo HCT; of these, 5 were consolidated with high-dose cytarabine, 2 received maintenance with low-dose cytarabine and 6-thioguanine, and 2 received unknown post remission therapy. Of the 3 patients with late relapse on E1900, 2 received standard-dose and 1 high-dose daunorubicin with induction. Conclusions Across all 4 trials, only 2 of the 239 patients (0.8%) treated with post remission autoHCT experienced late relapse of AML (≥3 years after CR1), which reinforces previously published data that late relapse after autoHCT is uncommon (Cassileth et al, J Clin Oncol 1993). Furthermore, of the 35 patients treated with autoHCT on PC486, 11 relapsed early and no patients relapsed late, suggesting that post remission chemotherapy may not be necessary before autoHCT. Based on this large AML cohort of nearly 800 patients with long-term follow-up, patients who remain in CCR for at least 3 years have a very low risk of relapse and can be considered cured of their disease. Moreover, given that recurrent AML was extremely rare after 5 years or more of CCR (<0.2%), the risk of therapy-related AML from contemporary induction and post remission strategies including HCT appears to be minimal. Disclosures: No relevant conflicts of interest to declare.

Ethnic Disparities In Acute Myeloid Leukemia Survival In The United States

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1691-1691
Author(s):  
Binay K. Shah ◽  
Amir Bista ◽  
Bahman Shafii
Keyword(s):  
Acute Myeloid Leukemia ◽  
Native American ◽  
Myeloid Leukemia ◽  
Ethnic Disparities ◽  
Patient Characteristics ◽  
The United States ◽  
Recent Time ◽  
Gradual Improvement ◽  
Time Period ◽  
Acute Myeloid

Abstract Background There is scarcity of data on differences in survival in acute myeloid leukemia (AML) patients by ethnicity. We utilized data from the Surveillance Epidemiology and End Result (SEER) database to investigate the ethnic disparities of survival in general U.S. population. Methods The SEER-18 Registry was used to identify adult (>=18) patients with AML as the only or the first primary cancer diagnosed from 1992 to 2010. We only included cases which were microscopically confirmed and actively followed. Cases that were alive without survival time, those resulted in death certificate/autopsy, and those with ethnicity recorded as unknown were excluded from this study. A total of 29,477 patients (54.5% males) were identified. For the subsequent analyses, various cohorts were formed. Age group cohorts included: 18-44 (5394; 18.3%), 45-54 (3751; 12.7%), 55-64 (4913; 16.7%), 65-74 (6513; 22.1%) and 75+ (8906; 30.2%). The total study period was divided into four groups, 1992-1995 (3409; 11.6%), 1996-2000 (5816; 19.7%), 2001-2005 (9984; 33.9%) and 2006-2010 (10268; 34.8%) for the survival analyses over time. Ethnic stratification used included White (21338; 72.4%), African American (AA: 2322; 7.9%), Asians/Pacific Islanders (A/PI: 2389; 8.1%), Native American/Alaskan Natives (NA/AN: 137; 0.5%) and Hispanics (3291; 11.2%). NA/AN categories were excluded from the final analysis due to their small numbers. Kaplan Meier (KM) curve and log rank test were used to evaluate association between patient characteristics and survival in overall population, OS, and AML-specific survival(AMLSS). Cox proportional hazards model was used for the analysis of association between patient characteristics and survival. Statistical analyses were carried out using SPSS version 16.0.0 Results Median age at diagnosis for the patient population was 66 years. Median follow-up period was 6.17 years for the whole population. Median OS for whole population was 6 months with highest survival among Hispanics and lowest among Whites (10 months versus 5 months, p <0.001). The AMLSS was highest for Hispanics and lowest for Whites (24 months versus 12 months, p <0.001). Median OS and AMLSS deteriorated significantly with advancing age (p<0.001). The median OS and AMLSS were the same for males and females (p>0.05), in overall population. OS for females were better than males among AA and Hispanic patients (p value <0.001). AMLS survival was better for A/PI females compared to males (median AMLSS 22 months vs. 17 months, p =0.015). When comparing survival among year of diagnosis cohorts, OS as well as AMLSS were comparable among 1992-1995 and 1996-2000 cohorts, (p>0.05); however, there was a gradual improvement in the more recent time period cohorts. Results of the proportional hazard models indicated that when compared to Whites, the OS was best for A/PI and worst for AA patients (HR= 0.933, p= 0.006, and HR = 1.139, p <0.001 ,respectively). The OS was higher for females, younger patients, and for patients diagnosed during recent time period cohorts. Similarly, AMLS survival among Hispanics and AA was comparable to whites and, best for Asians/PI (HR 0.911, p =0.003). Conclusions This study demonstrated significant differences in survival rates among AML patients belonging to various ethnic groups with highest OS and AMLSS among A/PI AML patients. Disclosures: No relevant conflicts of interest to declare.

Sign in / Sign up

Export Citation Format

Share Document