Early mortality rate (EMR) in Acute Myeloid Leukemia (AML)

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1 Early mortality rate (EMR) in Acute Myeloid Leukemia (AML) George Yaghmour, MD Hematology Oncology Fellow PGY5 UTHSC/West cancer Center, Memphis, TN May,1st,2015

2 Off-Label Use Disclosure(s) I do not intend to discuss an off-label use of a product during this activity

3 Financial Disclosure(s) I have not had any relevant financial relations during the past 12 months to disclose

4 Our Question: SWOG described the expected EMR for patients with Non-M3 AML by age enrolled in clinical trials. However, the real world data from experience outside of clinical trials is unknown? Aim of study To fill this knowledge gap, we aimed to use a large national cancer registry database to estimate the frequency of early mortality in patients with newly diagnosed AML in the United States And compare these findings with the SWOG cohort.

5 INTRODUCTION AML is the most common type of leukemia in adults with an estimated incidence of 3.7 per 100,000 persons Estimated 14,000 new cases of AML were diagnosed and 10,000 deaths were reported in the year The overall prognosis of AML is poor with 5-year relative survival rate of 17 19%. AML is an oncologic emergency due to the potential for early mortality from infection, hemorrhage, or sequelae of hyperleukocytosis.

6 INTRODUCTION There is limited data regarding the incidence of early death in these patients. A significant proportion of deaths related to AML occur within the first month of diagnosis. A previously published study based on SWOG cohort showed an estimated EMR of 12%. We sought to compare SWOG s reported EMR in AML to those of the general population.

7 Methods AND MATERIALS Our study utilized case listings from 18 population-based regional cancer registries in the National Cancer Institute s Surveillance, Epidemiology, and End Results (SEER) program from 1973 to 2010 SEER 18 covers approximately 28% of the US population. SEER registries maintain data including patient demographics, incidence, mortality, primary site, tumor structure, and follow-up information. The SEER database classifies cancer histology and topography information on the basis of the third edition of the International Classifications of Diseases for Oncology (ICD-O-3).

8 Methods AND MATERIALS we identified patients > 18 years of age diagnosed with non- M3 AML between 1990 and 2005 from SEER 18. We examined EMR of these patients overall and by age group then compared them with those reported by SWOG. EMR in SWOG studies was defined as death within 30 days of initiation of induction chemotherapy.

9 Methods AND MATERIALS We used two definitions of EMR to include deaths within 1 month (EMR1) and deaths within 2 months of diagnosis (EMR2). We calculated survival rates at 1 month and 2 months overall and for levels of each covariate using the actuarial method. The difference between the EMR in the two groups was analyzed using Fisher s Exact test. We also performed stepwise logistic regression analysis to identify the predictors of early mortality in the SEER study cohort.

10 Analysis SEER*Stat Microsoft Excel 2007, Statistical Package for Social Sciences (SPSS) 21.0 (IBM Corporation, Armonk, NY) and GraphPad Prism 6 Comparisons made using Fishers Exact test Log Rank test(mantel-cox) 2 sided p-values

11 Results In the SEER studies: Total of 26,272 patients with AML were identified 54% males and 85% were whites. The SEER EMR rate was 27% (n = 7022) within one month and was 38% (n = 10,068) within two months of diagnosis The SWOG cohort : Total 968 patients from 5 different clinical trials. 55% Male, 89% white. The SWOG cohort had an EMR of 12.2% (n=116) with the difference being statistically significant (p value <0.001).

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16 Conclusions Our population-based study shows that EMR in AML is much higher than suspected across all age groups Both the SEER and SWOG cohorts demonstrated a strong correlation between age and higher EMR. It also identifies patients with monocytic differentiation and black patients as being at higher risk for early mortality. This study reinforces the thought that AML should be treated in highly specialized referral centers.

17 Conclusions Limitations The SEER registry does not include information about chemotherapy use. A significant proportion of EMR in AML patient is related to chemotherapy related toxicity. We could not analyze performance status, cytogenetic profile and cause of death among the patients studied. Strengths large sample size in a population-based setting, which provides clinicians with real world data of EMR in an unselected AML population highly representative to what most US clinicians will encounter. Future studies could further investigate the causes of EMR as well as response to induction chemotherapy in SEER.

18 Questions? THANK YOU