scholarly journals Covid-19 Infection in Hematological Malignancies: Registry Data from India

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1938-1938
Author(s):  
Arihant Jain ◽  
Lingaraj Nayak ◽  
Uday Prakash Kulkarni ◽  
Nikita Mehra ◽  
Uday Yanamandra ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Hematological Malignancies ◽  
Healthcare Access ◽  
Anticancer Therapy ◽  
Cell Transplant ◽  
Access And Quality ◽  
The Impact ◽  
Acute Myeloid

Abstract Background: The impact of COVID-19 pandemic has been highly heterogeneous across the globe and different regions within the country. The differences in the outcome of these patients is related to their demographic profile, genetics, socio-economic conditions, and government health policies. Prior to the COVID-19 pandemic, the Healthcare Access and Quality (HAQ) Index for hematological malignancies (HAQ index <30) in a low-middle socio-demographic index(SDI) country like India was less than the mean HAQ index for all other diseases (HAQ index 41) with a significant regional disparity.(1)Several national and international registries from high socio-demographic Index (SDI) countries have reported worse short-term outcomes of coronavirus disease (COVID-19) in patients with hematologic as compared to other solid cancers. The outcomes of COVID-19 in patients with hematologic malignancies from a low-middle SDI country are yet unknown. The COVID-19 Hematologic Cancer registry of India reports these outcomes from India. Methods: Ten tertiary referral hospitals across India reported the demographic, clinical, laboratory, treatment, and outcomes of COVID-19 infection in patients with hematological malignancies. The registry was retrospective from March 21, 2020, and prospective from November 1, 2020, till March 20, 2021. Risk factors associated with severity and mortality were evaluated using the penalised logistic regression and Cox proportional hazards model. Findings: Data from 565 patients was included in this study. Among these, 429 (76%) patients were hospitalized, 186 (33%) patients had moderate/severe COVID-19.There were 116 (20.5%) non-survivors at a mean follow up of 147 (95% CI : 142-153) days. Age >60 years (HR 2·55, 1·23 - 5·27), diagnosis of acute myeloid leukemia (HR 2·85, 1·58 - 5·13), interruption or alteration of anticancer therapy (HR 2·78, 1·65 - 4·68), and post hematopoietic cell transplant status (HR 3·68, 1·82 - 7·45) predicted mortality. In contrast, increasing age [20-40 years (OR 2·54, 1·32 - 4·90), 41-60 years (OR 3·51, 1·84 - 6·71), >60 years (OR 6·04, 3·01 - 12·10), comorbidities such as diabetes mellitus (OR 1·89, 1·18 - 3·04), hypertension (OR 1·94, 1·17 - 3·19), diagnosis of AML (OR 3·70, 2·06 - 6·67), indolent non-hodgkin lymphoma (OR 3·20, 1·68 - 6·09), multiple myeloma (OR 2·88, 1·64 - 5·05), malignancy not being in remission (OR 1·71, 1·12 - 2·60)were significantly associated with severe COVID-19 on univariate analysis. Of these, only increasing age [20-40 years (OR 2·60 (1·31 - 5·15), 40-60 years (OR 3·44, 1.60 - 7·41), more than 60 years (OR 5·70, 2·43 - 13·35)] , AML (OR 2·73, 1·45 - 5·12), and malignancy not being in remission (OR 1·85, 1·18 - 2·89) were significantly associated with severe COVID-19 on multivariable analysis Conclusion: The overall mortality from COVID-19 infection of the entire cohort was 20.5%; the mortality was 46.2% in patients who had moderate to severe disease COVID-19 illness. Similar to previous studies, age, diagnosis of acute myeloid leukemia and a post stem cell transplant status was associated with mortality. In addition, interruption or de-escalation of anticancer therapy during Covid-19 infection was identified as an important factor associated with higher mortality on follow up in the current study. References 1. Measuring performance on the Healthcare Access and Quality Index for 195 countries and territories and selected subnational locations: a systematic analysis from the Global Burden of Disease Study 2016. Lancet (London, England)2018; 391(10136): 2236-71.Lee AJX, Purshouse K. COVID-19 and cancer registries: learning from the first peak of the SARS-CoV-2 pandemic. Br J Cancer 2021; 124(11): 1777-84. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

Acute myeloid leukemia: Comparison of epidemiology and treatment outcomes between insured and uninsured patients.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e17012-e17012
Author(s):  
Samer Ali Srour ◽  
Michael Machiorlatti ◽  
Usman Bhutta ◽  
Namali Pierson ◽  
Mohamad Ali Cherry ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Treatment Outcomes ◽  
Myeloid Leukemia ◽  
Private Insurance ◽  
Cell Transplant ◽  
Public Insurance ◽  
Insurance Type ◽  
The Impact ◽  
Acute Myeloid

e17012 Background: The overall prognosis for most acute myeloid leukemia (AML) patients remains poor. The majority of adult patients (pts) with AML will ultimately need allogeneic stem cell transplant (allo-SCT). Limited data is available comparing epidemiology and treatment outcomes between uninsured and insured pts with AML. We describe a retrospective analysis of adult pts with AML treated at our institution. Methods: From January 2000 to June 2011 we identified 239 pts with AML, of which 185 met inclusion criteria. Patients were classified as having private insurance, public insurance (Medicaid and Medicare), or no insurance. Primary outcomes were overall survival at follow up (OS), complete remission (CR), and percent of pts receiving allo-SCT. Kaplan-Meier analysis was used to estimate survival rates. Results: Of the 185 pts studied, 146 (81%) were white, 16 (9%) African-American and 11 (6%) were Native American. The median age at diagnosis was 49 years. 75 pts had private insurance at the time of diagnosis, 70 had public insurance, and 33 were uninsured. Of those receiving allo-SCT (n=60; 38 male) 48% had private insurance, 30% public, and 22% were uninsured. Whether a patient underwent allo-SCT did not differ according to insurance source (p=0.2189) nor to status at follow-up (p= 0.6480). The proportion of patients achieving CR was higher among those undergoing allo-SCT (p=0.0002). Median OS was 920 days for those who underwent allo-SCT and 192 days for those who did not (p< 0.0001). Median OS did not differ by insurance type (p = 0.1454). The proportion of patients achieving CR did not differ by insurance type (p=0.2665) (66.7% of those with private, 62.7% of those with public, and 78.8% of those with no insurance). Conclusions: For the population referred to our institution, a tertiary referral center for the state, there were no differences in treatment outcomes or in the percent of pts receiving allo-SCT when pts were stratified according to insurance source. Further analysis of this dataset will identify the impact of pretreatment variables stratified by type of insurance.

scholarly journals Gemtuzumab Ozogamicin Reduces Relapse Risk in FLT3-ITD+ Acute Myeloid Leukemia: A Report from the Children's Oncology Group

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 486-486
Author(s):  
Katherine Tarlock ◽  
Todd A. Alonzo ◽  
Robert B. Gerbing ◽  
Susana C. Raimondi ◽  
Betsy A. Hirsch ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Gemtuzumab Ozogamicin ◽  
Cell Transplant ◽  
Intensive Chemotherapy ◽  
Conventional Chemotherapy ◽  
Hematopoietic Stem ◽  
Poor Outcomes ◽  
The Impact ◽  
Acute Myeloid

Abstract CD33 is variably expressed on most acute myeloid leukemia (AML) blasts and is the target of gemtuzumab ozogamicin (GO), a calicheamicin-conjugated anti-CD33 monoclonal antibody. COG studies AAML03P1 and AAML0531 evaluated the safety and efficacy of GO combined with conventional chemotherapy to determine the impact of GO on treatment outcomes. We have previously demonstrated that those with high CD33 expression are more susceptible to GO. As FLT3-ITD is associated with high levels of CD33 expression, this group of patients represents a subgroup of particular interest for this therapeutic approach. Patients with high-allelic ratio (HAR) FLT3-ITD have poor outcomes with conventional chemotherapy alone and experience improvement with allogeneic hematopoietic stem cell transplant (HCT). Thus, COG AAML0531 allocated HAR FLT3-ITD+ patients enrolled after April 14, 2008 to consolidation allogeneic HCT with the best available donor. In combined evaluation of COG AAML0531 and its preceding pilot study AAML03P1, 479 patients received conventional MRC based induction chemotherapy (0531 Arm A) and 735 patients received conventional chemotherapy + GO (03P1 and 0531 Arm B). A total of 183 FLT3-ITD+ patients were treated on 0531 Arm A (n=71) and on 03P1/0531 Arm B (n=112). Overall, patients with FLT3-ITD had significantly lower rates of complete remission (CR) compared to FLT3-ITD negative patients, 64% v. 77% respectively (p<0.001). Among FLT3-ITD+ patients, CR rates were identical in those with or without induction GO exposure of 64% vs. 64% respectively (p=0.98). Analysis of 5-year outcomes for FLT3-ITD+ patients treated with GO compared to no GO demonstrated no difference in overall survival (OS) (50% v 49% respectively, p=0.74). Importantly, cumulative incidence of relapse (CIR) at 5 years from CR for patients treated with GO was 37% vs. 59% in those who did not receive GO (p=0.018). This GO-associated improvement in relapse was offset by higher treatment related mortality (TRM) among GO compared to no GO recipients (16% v 0% respectively, p=0.008), leading to similar DFS of 47% vs. 41% respectively (p=0.45). The benefit of decreased relpase risk (RR) was most significant for patients receiving GO in addition to HCT. Among FLT3-ITD+ patients who underwent HCT, those who received GO (n=33) had a 5-yr RR of 22% compared to 56% for the no GO cohort (n=25, p=0.003). There was a trend towards increased TRM among patients receiving GO compared to no GO (22% v. 4% respectively, p=0.078), with a corresponding DFS in GO recipients of 56% vs. 40% for the no GO cohort (p=0.09). Evaluation of the 8 GO recipients who died at HCT revealed that 3 (38%) were the result of complications from transplant-associated sinusoidal obstructive syndrome. Patients with HAR FLT3-ITD, who experience poor outcomes with conventional chemotherapy alone, were analyzed separately to evaluate the impact of induction GO on outcomes. Among HAR FLT3-ITD+ patients who underwent HCT, those treated with GO (n=26) had a significantly lower RR of 15% compared to 53% among no GO recipients (n=15, p=0.007). Additionally, patients receiving GO had a trend towards higher DFS of 65% compared to 40% for no GO group, (p=0.079). In this cohort, TRM in GO vs. no GO recipients was 19% vs. 7% respectively (p=0.297). Among HAR FLT3-ITD+ patients who did not receive HCT, there were no significant differences in DFS, RR, and TRM among the GO versus no GO recipients. Data from the two consecutive COG studies AAML03P1 and AAML0531 suggest that FLT3-ITD+ patients may benefit from the addition of GO to intensive chemotherapy. There is further evidence that HCT may augment the therapeutic impact of induction GO by further reducing the risk of relapse. However, clinical impact of GO was tempered by higher incidence of TRM in GO recipients. CD33 targeting represents an attractive approach in FLT3-ITD+ patients as they often have elevated blast CD33 expression. Further understanding of the toxicity profile of GO, especially when used in conjunction with intensive chemotherapy and HCT, is needed to enhance its therapeutic benefit. Additionally, its impact may be most significant in certain biologic subsets of AML. Our findings demonstrate that CD33 targeting is an important treatment strategy in AML that warrants further investigation in FLT3-ITD+ patients. Disclosures No relevant conflicts of interest to declare.

scholarly journals Updated Results of a Randomized Phase II Trial of Idarubicin and Cytarabine with Clofarabine or Fludarabine in Patients with Newly Diagnosed Acute Myeloid Leukemia

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1067-1067
Author(s):  
Nicholas J. Short ◽  
Farhad Ravandi ◽  
Xuelin Huang ◽  
Jorge E. Cortes ◽  
Naveen Pemmaraju ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Research Funding ◽  
Advisory Board ◽  
Cell Transplant ◽  
Newly Diagnosed ◽  
Historical Cohort ◽  
To Receive ◽  
Acute Myeloid

Abstract Background: Fludarabine and clofarabine are purine nucleoside analogues with established clinical activity in acute myeloid leukemia (AML). We sought to evaluate the relative safety and efficacy of idarubicin and cytarabine with either clofarabine (CIA) or fludarabine (FAI) in adult patients (pts) with newly diagnosed AML. Methods: Adult pts ≤60 years of age with newly diagnosed non-APL AML were randomized using a Bayesian adaptive design to receive either CIA or FAI. All pts received induction with idarubicin 10 mg/m2 IV daily on days 1-3 and cytarabine 1000 mg/m2 IV daily for on days 1-5. Pts in the CIA arm also received clofarabine 15 mg/m2 IV daily on days 1-5; pts in the FAI arm received fludarabine 30 mg/m2 IV daily on days 1-5. Responding pts could receive up to 6 cycles of consolidation with attenuated doses of the same drug combination. The primary endpoint was to compare the event-free survival (EFS) of CIA and FAI. Secondary endpoints included the CR/CRp rates, overall survival (OS) and the safety of the regimens. Results: Between 8/2011 and 6/2016, 182 pts have been randomized to receive either CIA (n=106) or FAI (n=76). Baseline characteristics of the 2 arms were well-balanced and are summarized in Table 1. Response rates are summarized in Table 2. Of the 180 pts evaluable for response, the CR/CRp rate was similar in the CIA and FAI arms (80% and 81%, respectively). However, the rate of MRD negativity by multiparameter flow cytometry at the time of CR/CRp was significantly higher in pts who received CIA than in those who received FAI (80% vs. 64%, respectively, P<0.05). Rates of stem cell transplant (SCT) in first remission were similar in the two arms (35% vs. 38%, respectively). The median duration of follow-up was 27 months. The median EFS and OS for the entire cohort were 12 months and 39 months, respectively. The median EFS was similar in the CIA and FAI arms (13 months and 12 months, respectively, P=0.91). The imbalance in sample size between these two arms was caused by better performance of the CIA arm during the initial period of the trial, although the difference largely disappeared after further follow-up. There was also no difference in OS between the two regimens; the 2-year OS rates were 51% and 57%, respectively (P=0.24). No difference in survival was observed if pts were censored at the time of SCT. Overall, treatment was safe with 8-week mortality rates of 4% in the CIA arm and 1% in the FAI arm. When compared to a historical cohort of pts treated with idarubicin and cytarabine (IA) alone, the triplet regimen (pooled population of CIA + FAI) resulted in improved EFS and OS among a subgroup of patients <40 years of age. In this group of younger patients, the median EFS for CIA/FAI (n=38) and IA (n=16) were 25 months and 9 months, with a 2-year EFS rate of 52% and 33% respectively (P=0.27). There was also a strong trend towards superior OS in the CIA/FAI compared to the IA groups (median OS: not reached vs. 20 months; 2-year OS rate 68% vs. 47%; P=0.08). Conclusions: In adult pts with newly diagnosed AML, CIA and FAI resulted in similar rates of CR/CRp and had similar EFS and OS. Compared to a historical cohort of pts treated with IA alone, the addition of a nucleoside analogue appears to result in superior EFS and OS in younger pts. Disclosures Cortes: ARIAD: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Teva: Research Funding. Daver:Ariad: Research Funding; BMS: Research Funding; Pfizer: Consultancy, Research Funding; Otsuka: Consultancy, Honoraria; Kiromic: Research Funding; Karyopharm: Honoraria, Research Funding; Sunesis: Consultancy, Research Funding. Jain:Novimmune: Consultancy, Honoraria; Infinity: Research Funding; Abbvie: Research Funding; Genentech: Research Funding; Seattle Genetics: Research Funding; Celgene: Research Funding; Servier: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria, Research Funding; BMS: Research Funding; Incyte: Research Funding; Novartis: Consultancy, Honoraria; ADC Therapeutics: Consultancy, Honoraria, Research Funding; Pharmacyclics: Consultancy, Honoraria, Research Funding. Konopleva:Calithera: Research Funding; Cellectis: Research Funding. Wierda:Acerta: Research Funding; Novartis: Research Funding; Gilead: Research Funding; Genentech: Research Funding; Abbvie: Research Funding. DiNardo:Novartis: Other: advisory board, Research Funding; Daiichi Sankyo: Other: advisory board, Research Funding; Agios: Other: advisory board, Research Funding; Abbvie: Research Funding; Celgene: Research Funding. O'Brien:Janssen: Consultancy, Honoraria; Pharmacyclics, LLC, an AbbVie Company: Consultancy, Honoraria, Research Funding. Jabbour:ARIAD: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Novartis: Research Funding; BMS: Consultancy.

scholarly journals Occurrence of Treatment-Related Cardiotoxicity and Its Impact on Outcomes Among Children Treated in the AAML0531 Clinical Trial: A Report From the Children’s Oncology Group

2019 ◽  
Vol 37 (1) ◽  
pp. 12-21 ◽  
Author(s):  
Kelly D. Getz ◽  
Lillian Sung ◽  
Bonnie Ky ◽  
Robert B. Gerbing ◽  
Kasey J. Leger ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Left Ventricular Systolic Dysfunction ◽  
Systolic Dysfunction ◽  
Left Ventricular ◽  
Oncology Group ◽  
Late Cardiotoxicity ◽  
The Impact ◽  
Acute Myeloid

Purpose Late cardiotoxicity after pediatric acute myeloid leukemia therapy causes substantial morbidity and mortality. The impact of early-onset cardiotoxicity on treatment outcomes is less well understood. Thus, we evaluated the risk factors for incident early cardiotoxicity and the impacts of cardiotoxicity on event-free survival (EFS) and overall survival (OS). Methods Cardiotoxicity was ascertained through adverse event monitoring over the course of follow-up among 1,022 pediatric patients with acute myeloid leukemia treated in the Children’s Oncology Group trial AAML0531. It was defined as grade 2 or higher left ventricular systolic dysfunction on the basis of Common Terminology Criteria for Adverse Events (version 3) definitions. Results Approximately 12% of patients experienced cardiotoxicity over a 5-year follow-up, with more than 70% of incident events occurring during on-protocol therapy. Documented cardiotoxicity during on-protocol therapy was significantly associated with subsequent off-protocol toxicity. Overall, the incidence was higher among noninfants and black patients, and in the setting of a bloodstream infection. Both EFS (hazard ratio [HR], 1.6; 95% CI, 1.2 to 2.1; P = .004) and OS (HR, 1.6; 95% CI, 1.2 to 2.2, P = .005) were significantly worse in patients with documented cardiotoxicity. Impacts on EFS were equivalent whether the incident cardiotoxicity event occurred in the absence (HR, 1.6; 95% CI, 1.1 to 2.2; P = .017) or presence of infection (HR, 1.6; 95% CI, 1.0 to 2.7; P = .069) compared with patients without documented cardiotoxicity. However, the reduction in OS was more pronounced for cardiotoxicity not associated with infection (HR, 1.7; 95% CI, 1.2 to 2.5; P = .004) than for infection-associated cardiotoxicity (HR, 1.3; 95% CI, 0.7 to 2.4; P = .387). Conclusion Early treatment-related cardiotoxicity may be associated with decreased EFS and OS. Cardioprotective strategies are urgently needed to improve relapse risk and both short- and long-term mortality outcomes.

Outcome after Relapse of Childhood Acute Myeloid Leukemia: The St. Jude Experience.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 273-273
Author(s):  
Jeffrey Rubnitz ◽  
Bassem Razzouk ◽  
Shelly Lensing ◽  
Stanley Pounds ◽  
Ching-Hon Pui ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Cell Transplant ◽  
Hematopoietic Stem ◽  
Significant Difference ◽  
First Remission ◽  
Acute Myeloid

Abstract We reviewed the records of 408 patients who were less than 21 years old at the time of diagnosis of acute myeloid leukemia (excluding patients with Down syndrome or acute promyelocytic leukemia) treated on five consecutive institution protocols from 1980–2002 to investigate prognostic factors for attainment of second complete remission (CR2) and overall survival (OS) after first relapse. Of the 320 (78%) patients who achieved CR, 158 patients suffered hematologic relapses at a median of 11.9 months (range, 2.9–119.9 months) from the time of diagnosis. Forty-one patients relapsed on therapy and 117 relapsed after the completion of all planned therapy. For patients who relapsed off therapy, 38 were diagnosed with relapse because of symptoms suggestive of recurrent leukemia and 78 were diagnosed at the time of a routine follow up (information not available for one patient). After relapse, 20 patients received palliative care, 82 received chemotherapy alone, 36 received chemotherapy followed by hematopoietic stem cell transplant (SCT), and 20 proceeded directly to SCT. Eighty-five (54%) patients attained CR2. In univariate analyses, factors associated with the achievement of CR2 include initial therapy (chemotherapy alone, 56%; autologous SCT, 71%; allogeneic SCT, 20%; p=0.008) and time from the diagnosis of AML to relapse (≤ 1 year, 44%; &gt; 1 year, 65%; p=0.010). Logistic regression analysis demonstrated that patients with male gender (odds ratio [OR], 2.46; 95% confidence interval [CI], 1.14–5.28; p=0.021) and greater time from diagnosis to relapse (OR, 1.05; CI, 1.01–1.09; p=0.016) were more likely to achieve CR2, whereas patients with M7 morphology (OR, 0.11; CI, 0.01–1.04; p=0.054) and allogeneic SCT in first remission (OR, 0.17; CI, 0.03–0.85; p=0.031) were less likely to achieve CR2. At the time of last follow up, 19 patients were alive, 115 died of progressive disease, and 24 died of regimen-related toxicity. The 2-year OS estimate ± SE for the entire cohort of 158 patients was 15.8% ± 2.8%. For patients who relapsed off therapy, there was no significant difference in outcome between those whose relapse was diagnosed at the time of a routine follow up and those diagnosed because of symptoms. Cox proportional-hazards regression modeling indicated that M7 morphology (hazard ratio [HR], 3.06; CI, 1.44–6.51; p=0.004) and allogeneic SCT in first remission (HR, 2.17; CI, 1.22–3.87; p=0.008) were associated with significantly worse OS after relapse. In fact, there were no survivors in these two groups of patients. In contrast, age 1–10 years (HR, 0.53; CI, 0.36–0.77; p=0.001), M2 morphology (HR, 0.57; CI, 0.39–0.85; p=0.006), allogeneic SCT after relapse (HR, 0.34; CI, 0.22–0.53; p&lt;0.001), and greater time from diagnosis to relapse (HR, 0.97; CI, 0.95–0.99; p=0.003) had significantly favorable effects on OS. However, outcome was poor even among patients who underwent allogeneic SCT after relapse (2-year OS, 34.5% ± 6.1%) and among patients who relapsed greater than one year from diagnosis (2-year OS, 19.2% ± 4.3%), suggesting that novel therapies are warranted for all patients with relapsed AML.

Analysis Of Impact Of Distance From Residence To Treatment Center On The Outcome Of Patients With Acute Myeloid Leukemia

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1712-1712 ◽  
Author(s):  
David W. Lam ◽  
Hossein Maymani ◽  
Michael G Machiorlatti ◽  
Samer A Srour ◽  
Minh Phan ◽  
...  
Keyword(s):  
Overall Survival ◽  
Acute Myeloid Leukemia ◽  
Complete Remission ◽  
Myeloid Leukemia ◽  
Treatment Center ◽  
Cell Transplant ◽  
Tertiary Center ◽  
Remission Rates ◽  
The Impact ◽  
Acute Myeloid

Abstract Background The overall prognosis for most acute myeloid leukemia (AML) patients remains poor with only 50-55% of patients achieving durable remission. The majority of adult patients (pts) who do achieve remission, will ultimately need allogeneic stem cell transplant (allo-SCT) to achieve long term survival. Treatment of AML requires intensive therapy, transfusion support, antimicrobials, and repeated admissions to the hospital. Limited data is available comparing epidemiology and treatment according to the distance from patient residence to treatment center. Oklahoma University Health Sciences Center (OUHSC) is the major tertiary center for Oklahoma residents to receive treatment for AML. Few patients receive AML treatment from distant states or oversea areas. We describe a retrospective analysis of adult pts with AML treated at our institution evaluating impact on distance from center. Methods From January 2000 to June 2011,we identified a total of 269 patients with 217 meeting inclusion criteria for the study. We then performed an analysis of variance (ANOVA) on the relationship between distance to treatment center (in miles) and relapse rate or remission rates. Kaplan-Meier method was used to estimate survival rates. Age and cytogenetics were identified as the major confounders. A Cox Proportional Hazards model on overall survival (OS) was implemented using the independent variables age category ( ≤60 and > 60), cytogenetic risk status (groups were divided into favorable, intermediate and unfavorable risks), and distance to treatment center. Statistical analysis was performed using SAS 9.2 software (SAS Institute Inc.). Fisher’s exact test was used to compare patients in the different groups. Results Of the 217 pts (52.2% Males, 47.8% Females) included in the study, 81.5% were white, 9.0% African American, and 6.2% Native American. Median age at diagnosis was 51.0 years. Median distance to treatment center was 62 miles (range: 0-420). Distance of residence to treatment center was significantly related to complete remission rates, with patients living at longer distances having lower chances of achieving complete remission( p = 0.03). Distance from residence to treatment center however was not related to the risk of having relapsed disease (p = 0.22). A Cox proportional hazard model was performed including distance to travel, age and cytogenetic risks (unfavorable versus intermediate or favorable) and revealed that all three variables are associated with a trend towards shorter overall survival (p <0.1). Conclusions In this present study, we have identified that distance from residence to treatment center as a risk factor for achieving lower complete remission rate with no significant effect on the risk of relapse. There was a trend toward lower overall survival for those who live at longer distance from center. Further analysis of this dataset will identify the impact of other pretreatment variables on the distance to treatment center by performing a multivariate analysis. Larger studies are needed to further explore the impact of distance to treatment center on outcome in patients with AML. Disclosures: No relevant conflicts of interest to declare.

Safety and efficacy of CPX-351 in younger patients < 60 years old with secondary acute myeloid leukemia: An updated analysis.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18530-e18530 ◽  
Author(s):  
Amanda Cecile Przespolewski ◽  
Chetasi Talati ◽  
Salman Fazal ◽  
Pankit Vachhani ◽  
Srinivasa Sanikommu ◽  
...  
Keyword(s):  
Overall Survival ◽  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Small Sample ◽  
Cell Transplant ◽  
Complex Karyotype ◽  
Phase 3 ◽  
Secondary Acute Myeloid Leukemia ◽  
Acute Myeloid

e18530 Background: Patients (pts) with secondary acute myeloid leukemia (s-AML) have poor long-term outcomes following standard induction chemotherapy with 7+3. In 2017 CPX-351 was FDA approved for upfront treatment of s-AML. The phase 3 trial demonstrated improved overall survival in pts aged 60-75 years old. Although CPX-351 treatment is indicated in all adults with s-AML, it is unclear whether CPX-351 is safe and effective in younger pts < 60 years. We sought to address this unanswered question by retrospective review of clinical experience since FDA approval. Methods: Medical records were retrospectively reviewed at five large academic centers to identify pts aged 18-59 years old with untreated s-AML, prior cytotoxic therapy, or AML-MRC treated with CPX-351 as induction therapy. Results: 30 pts with confirmed s-AML received CPX-351 therapy. Mean age was 53 years (range 23 – 59), 18 were male (60%). The majority (60%, N = 18) had AML-MRC, 7 (23%) had treatment-related AML (t-AML) and 6 (20%) had antecedent MDS. 6 pts had received prior HMA therapy. 19 pts had a complex karyotype (70%), and 4 patients were found to have a normal karyotype (15%). The most common molecular event was TP53 mutation observed in 10 pts (36%), followed by FLT3-ITD identified in 4 pts (14%). Overall response rate (CR/CRi/PR) was 46.7% with 5 CR (17.2%), 3 CRi (10.3%), and 6 PR (20.7%). The remaining pts (15/29, 51.7%) were non-responders. 8 pts have received an allogenic stem cell transplant. The most common AE was infection (80%, 24/30) with 4 clinically significant bleeding events. Thirty-day mortality was 13.3%, with 60-day mortality of 16.7%. Overall survival was 7 months (range 0.5 – 12.4 months), with mean follow up of 4.4 months. Conclusions: This multi-institutional retrospective analysis suggests that CPX-351 results in lower response rates (CR/CRi 27.6%) and shorter overall survival (7 mos) than reported in the recently published phase 3 trial in pts aged 60-75 years old. Potential explanations for this discrepancy include short follow up, small sample size, retrospective design, and the significant proportions of pts with complex karyotype and TP53 mutations. Historically, patients < 65 years old with s-AML have had a reported overall survival of approximately 7 months. Further investigation of this regimen in younger pts with s-AML as compared with 7+3 and other approaches is warranted.

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