ALBERT

Description: Background The presence of comorbidities, including infections and neurological conditions, among older patients with acute lymphoblastic leukemia (ALL) may impact treatment decisions and influence patient prognosis. Thus, understanding the epidemiology of comorbidities among patients with ALL is useful for identifying subpopulations most likely to benefit from treatment. However, literature describing the epidemiology of comorbidities among older patients with ALL is sparse. Objective To characterize the incidence of comorbidities among older adults with ALL in routine clinical practice. Methods Using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, we identified a cohort of Medicare beneficiaries with a primary cancer diagnosis of ALL between 2000 and 2007. Individuals from a random 5% sample of cancer-free Medicare beneficiaries residing in SEER regions were matched (1:1) to ALL patients on year of diagnosis (i.e., the cancer-free individual was enrolled in Medicare Parts A and B during the same year), and county of residence. Individuals were required to be enrolled in Medicare Parts A and B for ≥ 4 months prior to diagnosis or index date (i.e., June 1st of the matched year for cancer-free individuals). Time-at-risk for each comorbidity began on the diagnosis or index date and continued until the first of the following events: a claim for the comorbidity, change in Medicare coverage, death, or end of follow-up. Patients were identified with a comorbidity if they had ≥ 2 outpatient claims at least 30 days apart, or 1 inpatient claim with an appropriate diagnosis code. Three- and 12-month crude incidence rates were estimated for a broad range of comorbidities. Results There were 646 Medicare beneficiaries with a primary diagnosis of ALL and 646 cancer-free individuals. Incidence rates of comorbidities selected based on clinical relevance and/or large observed differences between patients with ALL and cancer-free individuals are presented (Table). In general, 3- and 12-month incidence rates were considerably higher among ALL patients than in cancer-free individuals. Conclusions In older adults with ALL, there is a high incidence of comorbidities, including infections and neurological conditions. The incidence rates of comorbidities are particularly high within the first 3 months of diagnosis, but remain elevated even when observation time is extended up to 12 months following diagnosis. High incidence rates of comorbidities may be attributable to ALL and/or toxicities associated with therapy, or may represent recognition of prevalent conditions at the time of ALL diagnosis. Disclosures: Cetin: Amgen, Inc.: Employment. Danese:Amgen, Inc.: Consultancy, Research Funding; Genentech: Consultancy, Research Funding; MedImmune: Consultancy, Research Funding. Katz:Amgen, Inc.: Employment. Kelsh:Amgen, Inc.: Employment. Gleeson:Amgen, Inc.: Consultancy, Research Funding; Genentech: Consultancy, Research Funding; MedImmune: Consultancy, Research Funding. Alekar:Amgen, Inc.: Employment. Griffiths:Amgen, Inc.: Consultancy, Research Funding; Genentech: Consultancy, Research Funding; MedImmune: Consultancy, Research Funding.

Description: Background ALL is the most common childhood cancer, with remission rates exceeding 90% and 5-year survival exceeding 80% in pediatric patients. However, in older adult patients, ALL is associated with high morbidity and mortality. Nonetheless, because ALL is rare in older adults, information about patterns of care and outcomes in these patients is limited. Objective To characterize the treatment and mortality patterns in a cohort of older adults with ALL. Methods Using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, we identified a cohort of Medicare beneficiaries (including patients under age 65 enrolled due to disability) with a first primary cancer of ALL diagnosed between 2000 and 2007. Patients were followed using Medicare claims from the first day of the month of diagnosis through December 31, 2009. Patients were required to be enrolled in Medicare Parts A and B for at least 4 months prior to diagnosis, and those diagnosed on autopsy were excluded. Patients were followed until the first of the following events: death, change in Part A and B Medicare coverage, or end of follow-up. Chemotherapy was identified using available diagnosis and procedure codes in the outpatient and inpatient settings. Results There were 646 ALL patients who accrued 653 patient-years of observation. During the observation period, 570 (88%) died. The median survival time was 160 days, with 25% of patients surviving ≤ 41 days, and 25% surviving ≥ 472 days. In the overall cohort, within 90 days of diagnosis, 345 (53%) had at least one inpatient or outpatient claim indicating chemotherapy was provided. Older age, higher comorbidity burden, and claims-based evidence of mobility limitations were each associated with a lower probability of receiving chemotherapy (Table). Of the 345 patients with at least one claim for chemotherapy, 271 (79%) had both inpatient and outpatient chemotherapy claims, 60 (17%) had only outpatient claims, and the remaining 14 (4%) had only inpatient claims. There were 557 individuals accounting for 1,164 inpatient admissions in the first 90 days after diagnosis. Among these patients, 84 (15%) died during their first admission. The average length of stay (LOS) for the initial admission was 12.6 days, and 25% had a LOS ≥ 20 days. Among the 472 (84.7%) patients alive after their first hospitalization, 329 (69.7%) were readmitted within the first 90 days following diagnosis. Conclusions About half of Medicare beneficiaries diagnosed with ALL between 2000 and 2007 received chemotherapy, the vast majority of whom received at least one treatment in an inpatient setting. Median survival time in the cohort was short, while the hospitalization rate, duration of hospitalization, in-hospital mortality rate, re-hospitalization rate, and overall mortality rate were high. Older adults with ALL would be expected to benefit from any improvements in treatment options. Disclosures: Danese: Amgen, Inc.: Consultancy, Research Funding; Genentech: Consultancy, Research Funding; MedImmune: Consultancy, Research Funding. Cetin:Amgen, Inc.: Employment. Katz:Amgen, Inc.: Employment. Kelsh:Amgen, Inc.: Employment. Gleeson:Amgen, Inc.: Consultancy, Research Funding; Genentech: Consultancy, Research Funding; MedImmune: Consultancy, Research Funding. Griffiths:Amgen, Inc.: Consultancy, Research Funding; Genentech: Consultancy, Research Funding; MedImmune: Consultancy, Research Funding.

Description: Background Prognosis of patients with relapsed or refractory AML has been poor as no standard salvage therapy exists. Most trials of investigational agents begin in r/r AML and accrue a wide range of patients with different characteristics. Historical context for outcomes can be used as a reference for the development of future protocols and novel agents. The objective of this study was to evaluate outcomes of patients presenting with r/r AML in a single institution. Methods We analyzed the outcomes of patients who were treated for r/r AML for at least one treatment course at our institution between the years 2002 and 2016. At the time of inclusion in this study, patients had at least one prior treatment failure, were ≥18 years old at time of AML diagnosis, and had no central nervous system (CNS) involvement. Patients with acute promyelocytic leukemia were excluded. Descriptive characteristics of patients were summarized by proportions. Complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) rates were described as proportion with Wald 95% confidence intervals. Time to event analyses was estimated using the Kaplan-Meier method. Univariate and multivariate Cox models estimated p-values from Wald chi-square. Results A total of 1021 patients were included. Median age was 60 years (range, 18 - 87). At least one cytogenetic abnormality was present in 53.3% (n=546) of the population, 34.5% (n=352) had a history of an antecedent hematologic disease, and 10.5% (n=107) were therapy-related AML. For patients with available induction records, approximately 46% (295/635) were refractory. Among patients who achieved a CR after induction, 45% (118/264) had a CR duration 60 years of age (1st salvage p=0.05, 2nd salvage p=0.003, 3rd salvage p=0.09). Among various types of salvage regimens, the range of CR was from 0 to 36%. Regimens based on high dose cytarabine (HDAC) were the most common (n=297). Although sample size was modest, HDAC regimens that additionally contained a FLT3 inhibitor induced the highest CR and CR/CRi rates (33% CR2, 44% CR3) (Table 2). Age (p=0.0006), cytogenetics (p

Description: INTRODUCTION: Febrile neutropenia (FN) is a serious complication of myelosuppressive chemotherapy associated with significant morbidity and mortality. Prophylaxis with G-CSFs reduces the risk of FN. While G-CSFs have been used for many years, there is little information on the factors US oncologists consider when making G-CSF use decisions or the impact of participation in emerging payment and delivery models. STUDY OBJECTIVE: To describe oncologist's perceptions and opinions on national or institutional guidelines for G-CSF use, eligibility of patients for, and barriers to, G-CSF use stratified by physicians' institutional affiliation (i.e., Oncology Care Model [OCM] vs. non-OCM practice). METHODS: In May 2018, we recruited 200 randomly selected US oncologists from a national database to participate in a 30-minute, independent review board approved, online survey. Physicians from Vermont, Maine, and Massachusetts were not included because of the state regulations regarding survey participation. We specifically targeted recruiting at least 125 community-based oncologists and at least 50 oncologists primarily affiliated with an OCM practice. Survey questions were developed to include topics such as risk factors and criteria considered to determine a patient's FN risk level; drivers and barriers to G-CSF use; and perceptions and experience with G-CSFs. The survey was pilot tested by nine oncologists in pen and paper (n=5) and online (n=4) version to improve its content and clarity. Oncologists participating in the pilot were considered ineligible to participate in the main study. We calculated proportions (%) and 95% confidence intervals (CI) for categorical variables collected via the survey. RESULTS: Of the 200 oncologists, 114 (57%) were hematologist-oncologists (vs. 86 oncologists), 125 (63%) were community-based (vs. 75 academic), and 70 (35%) were affiliated with an OCM practice (vs. 130 non-OCM). Most of survey participants (71%) followed National Comprehensive Cancer Network (NCCN) guidelines for G-CSF use. More OCM affiliated oncologists reported that their practices offer, and strongly encourage them to follow, a specific treatment protocol for G-CSF use (49% [95% CI: 37%, 61%]) compared to non-OCM practices (31% [95% CI: 24%, 40%]). Furthermore, 65% of oncologists overall agreed or strongly agreed that all patients with high risk for FN should receive prophylaxis with G-CSF; 60% [95% CI: 48%, 71%] in OCM affiliated versus 68% [95% CI: 59%, 75%] in non-OCM affiliated oncologists. Half of the oncologists agreed or strongly agreed that benefits of G-CSF therapy outweighed the potential adverse effects (Figure 1). Overall, the most common reported barriers to G-CSF use among patients at high risk for FN included patient refusal (27%), limitations to prescribing based on set protocols and guidelines (27%), and concerns about insurance coverage (26%) with the ranking of barriers differing by OCM affiliation (Figure 2). Oncologists reported that among all patients receiving chemotherapy that they treated in the past 6 months, 46% (95% CI: 42%, 49%) of patients in curative setting and 37% (95% CI: 33%, 41%) of patients in metastatic setting received G-CSF for primary prophylaxis. Oncologists affiliated with practices that offer or strongly encourage to follow specific treatment protocol were more likely to use G-CSF for primary prophylaxis in curative setting (54% [95% CI: 47%, 61%] vs. 42% [95% CI: 37%, 48%]). A majority (67%) of the oncologists reported an increase in use of pegfilgrastim on-body injector in the last 2 years and attributed it to convenient dosing (67%) and patients' need for active lifestyle (45%). CONCLUSIONS: Despite national guidelines and evidence from clinical trials, only two-thirds of oncologists agree or strongly agree that all patients at high risk for FN should receive primary prophylaxis, and only half agree or strongly agree that benefits of G-CSF therapy outweigh the potential adverse effects. Oncologists affiliated with OCM practices had different opinions on barriers to G-CSF use than oncologists not affiliated with OCM. Decisions for G-CSF use may be affected by factors other than risk of FN, such as patient convenience, lack of reimbursement to the practice, concerns regarding insurance coverage, and practice-specific treatment protocols. Disclosures McNamara: Adelphi Research: Consultancy. Gawade:Amgen: Employment, Equity Ownership. Belani:Amgen: Employment, Equity Ownership. Kelsh:Amgen: Employment, Equity Ownership.