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Optimal chemotherapy management is substandard in low and middle-income countries. We aimed to identify major gaps to design interventional strategies for improved chemotherapy management at Tikur Anbessa Specialized Hospital (TASH), Ethiopia. This study was conducted using an observational checklist, open-ended questions, record review, and key informant interviews of department heads and focal persons at TASH. Findings were categorized into specific themes that developed. Chemotherapy represented 60.2% of the hospital medication budget. Drug utilization was quantified via monthly consumption documentation and forecasting. However, unreliable data resulted in frequent stockouts (unavailability of the item when it is needed) of chemotherapy with only 67.8% availability. Thirteen healthcare personnel (9 nurses, 2 pharmacists and 2 hospital cleaners) were interviewed: all clinical staff but neither of hospital cleaners believed that they were at risk of hazardous agents. Challenges identified included inadequate and frequent stockouts (unavailability of the item when it is needed) of personal protective equipment, lack of standardized guidelines for chemotherapy handling, admixture, and disposal, lack of designated preparation rooms, and lack of training. All nine nurses handled chemotherapy admixtures despite only two nurses previously receiving in-service training. Most of the participants had never witnessed the disposal of anticancer drugs. Prompted by the results of this study, a dialogue was initiated among members of TASH, the American Cancer Society and the University of North Carolina to implement action-oriented projects to address the gaps identified at TASH. These gaps directly and indirectly affect care and treatment outcomes of patients at a large cancer center. Collaborations with well-resourced centers are potential models for improving chemotherapy management.

Equity in vaccine outreach and delivery has been prioritized given the disproportionate harms of the COVID-19 pandemic on communities of color and those with lower socioeconomic status. Health systems have largely communicated availability or signup for vaccines to patients through electronic patient portal messages, emails, or online materials; however, rates of portal use and internet access are limited among rural populations, individualswith lower socioeconomic status, and racial and ethnic minority patients. For purposes of this analysis, these groups are referred collectively as marginalized populations. Reliance on these media as the primary means for communication may inadvertently widen vaccination disparities.

Acute myeloid leukemia (AML) is a disease of older adults, with a median age at diagnosis of 68 years. The availability of oral anticancer medications has increased, although the standard treatment for AML remains in intravenous form. We aim to identify barriers to adherence to oral medications in patients with AML and proposed solutions for improvements. Following institutional review board approval, patients with AML and their caregivers were recruited to participate in focus groups. Sessions were digitally recorded, transcribed verbatim, and analyzed for thematic content using Dedoose qualitative software. 11 patients (five < 65 years; six ≥ 65 years) and 4 caregivers participated in these sessions. Three central themes emerged: 1) medication adherence challenges, 2) managing an oral adherence plan, and 3) strategies to improve oral adherence. Participants recommended written schedules, taking medications around meals, and using pillboxes and alarms. We believe that patients are an important source of insight into barriers and solutions to oral medication adherence.

BACKGROUND: The incidence of AML is increasing, in part due to the overall aging population; median age at presentation is 67 years. Overall 5-year survival rates are as low as 5%-10% in adults >60 years (Wang, 2014). While standard treatment for AML is intravenous chemotherapy, the availability of oral medication (OM) has increased in recent years, providing significant benefits to patients, along with new tradeoffs and risks. This means the burden of daily adherence has shifted from the provider to the patient. A 2016 systematic review of 63 adherence studies found that as few as 46% of patients take the prescribed dose on the correct schedule (Greer et al, 2016). A clear understanding of barriers to adherence with OM in the AML population is critically important. We sought to identify and summarize adherence for OM as described by patients with AML. METHODS: This was a mixed methods study design using focus groups and patient surveys. Focus groups were conducted with four individual groups. 11 patients (5 65 years) and 4 caregivers participated. All sessions were digitally recorded, and files were transcribed verbatim by a professional service. Focus groups results were used to develop a 37-item OM adherence needs assessment. The survey allowed patients to list barriers to oral adherence and side effects from OM. AML patients were recruited and consented at three cancer centers. Surveys were completed online at either the clinic or from home. RESULTS: 100 patients completed the OM survey and were mostly male (62%), white (67%), less than 65 years of age (59%), and college educated (52%). Overall, there were no significant differences found between the older (>65 years) and younger age groups. The most frequent and troublesome challenge in taking OM is the number of pills (54%). Loss of appetite (55%) and nausea (40%) were the most commonly reported side effects of OM and loss of appetite is the most problematic (35%). Although half of the patients said no side effect would cause them to stop taking OM, another 25% indicated nausea would cause them to stop taking them. When asked what has been used to support taking OM, the most commonly cited strategy was to make it part of the daily routine. Patients felt information from the health care team was the best source of directions for taking medication. Nearly a third of patients indicated that they skip the medication altogether when they forget to take it. When asked what would help them to adhere to taking their OM as prescribed, smaller pills, easier packaging, and assistance with scheduling were most frequently selected. 12 questions on attitudes (pros and cons) towards taking OM were answered on a 1 to 4 response scale with and 1 = "Strongly Disagree" and 4 = "Strongly Agree". The means for each question ranged from 1.11 to 3.25 and the mean for all 12 items was 2.45, SD=.40. Age group differences showed older individuals had a slightly higher score indicating a more positive attitude towards OM t(94) =.67, p =.51. Attitudes towards IV vs OM were assessed using 9 Likert style questions with responses ranging from 1 - 5 with 1= "Disagree Strongly" and 5 = "Agree Strongly". Mean scores for each question ranged from 1.67 to 5.00 and the mean for all 9 items was 3.32, SD=.58. Younger patients were more accepting of taking Oral vs IV meds. Adherence challenges were number and size of pills, different directions, cost, availability, and side effects. An adherence plan was recommended to include written schedules, taking medications around meals, and use of pillboxes and alarms. Main sources of information were the health care team and medication bottle directions. Recommendations for providing adherence assistance included better instructions, assistance with scheduling, making pills smaller, and consistency in packaging. CONCLUSION: This project represents the first assessment of OM adherence in patients with AML. Three themes emerged in focus group transcript analysis that informed the development of a 37-item survey. Several implications for clinicians and OM manufacturers were identified. Findings provide the basis for further exploration of interventions to enhance and increase adherence to OM regimens, which could include symptom monitoring and/or a medication management tool to address incorporating OM into the patient's daily routine. Disclosures LeBlanc: Duke University: Research Funding; American Cancer Society: Research Funding; Helsinn: Consultancy; Pfizer Inc: Consultancy; Flatiron: Consultancy; Seattle Genetics: Consultancy, Research Funding; Celgene: Honoraria; Medtronic: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees; Heron: Membership on an entity's Board of Directors or advisory committees; Otsuka: Consultancy, Membership on an entity's Board of Directors or advisory committees; Daiichi-Sankyo: Membership on an entity's Board of Directors or advisory committees; CareVive: Consultancy; NINR/NIH: Research Funding; Jazz Pharmaceuticals: Research Funding; Agios: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AbbVie: Membership on an entity's Board of Directors or advisory committees; Astra Zeneca: Consultancy, Research Funding. Albrecht:Oncology Nursing Society: Honoraria; Cancer Support Community: Membership on an entity's Board of Directors or advisory committees; Carevive: Research Funding. Foster:Bellicum Pharmaceuticals, Inc: Research Funding; Daiichi Sankyo: Consultancy; MacroGenics: Research Funding; Celgene: Research Funding.

106 Background: AML is a disease of older adults (median age 67 years). Although standard AML treatment is intravenous (IV) chemotherapy, availability of oral anti-cancer medications has increased , providing benefits and risks to patients. Patients prefer their convenience, absence of IV infusions, potential for fewer clinic visits, and increased subjective feeling of control over their disease. Poor adherence can increase toxicity risk and compromise treatment effectiveness. We aim to identify barriers to adherence to oral medications in patients with AML and proposed solutions for improvements. Methods: Following IRB approval, patients with AML and their caregivers were recruited to participate in focus groups. An experienced moderator conducted the groups using an interview guide developed by AML experts. Participants received gift cards for their participation. Sessions were digitally recorded, transcribed verbatim, and analyzed for thematic content using Dedoose qualitative software. Results: 11 patients (5 65 years) and 4 caregivers participated in sessions lasting 60-75 minutes. Three central themes emerged: medication adherence challenges, managing an oral adherence plan, and strategies to improve oral adherence. Adherence challenges: number and size of pills, different directions, cost, availability, and side effects. An adherence plan was recommended: written schedules, take medications around meals, and use of pillboxes and alarms. Main sources of information: health care team and bottle directions. Recommendations for providing adherence assistance included better instructions, assistance with scheduling, making pills smaller, and consistency in packaging. Conclusions: Patients are an important source of insight into barriers and solutions to oral medication adherence. These responses were used to develop a survey to be administered to 100 patients with AML. Results will inform development of an intervention to improve oral medication adherence in the AML population.

105 Background: The incidence of AML is increasing, in part due to an aging population. Amid established intravenous (IV) or subcutaneous chemotherapies , recent drug approvals have ushered in an era of oral medication (OM) approaches to treating AML, shifting the burden of daily adherence from clinicians to patients. We aimed to identify and summarize adherence to oral therapy in this population. Methods: Our mixed methods study design used focus groups (FG) and patient surveys. After IRB approval, 11 patients and 4 caregivers participated in 4 focus groups. Results were used to develop a 37-item OM adherence needs assessment. Subsequently, AML patients were recruited and consented at three cancer centers to complete surveys (online, at the clinic, hospital, or from home). Results: 100 patients completed the OM survey. Most were male (62%), racial/ethnic diversity (33%), < 65 years (59%), and college-educated (52%). The to be taken was the most frequent and troublesome challenge. Loss of appetite was the most commonly reported and problematic side effect. Although half of the patients stated, “no side effect would cause them to stop taking OM”, another 25% indicated nausea would cause non-adherence. The best strategy to support taking OM was to make it part of the daily routine. Directions for taking OM were most commonly found on medication bottles or received from the health care team (HCT); patients felt HCTs were the best source of directions. Nearly 1/3 of patients indicated they skip the OM dose altogether when they forget to take it. When asked what would help improve adherence: smaller pills, easier packaging, and scheduling assistance were most frequently reported. Older individuals (>65 years) had a slightly more positive attitude towards oral medication (p =.51). Younger patients (

Background This study evaluated the safety and immune responses to an autologous dendritic cell vaccine pulsed with class I peptides from tumor-associated antigens (TAA) expressed on gliomas and overexpressed in their cancer stem cell population (ICT-107). Methods TAA epitopes included HER2, TRP-2, gp100, MAGE-1, IL13Rα2, and AIM-2. HLA-A1- and/or HLA-A2-positive patients with glioblastoma (GBM) were eligible. Mononuclear cells from leukapheresis were differentiated into dendritic cells, pulsed with TAA peptides, and administered intradermally three times at two-week intervals. Results Twenty-one patients were enrolled with 17 newly diagnosed (ND-GBM) and three recurrent GBM patients and one brainstem glioma. Immune response data on 15 newly diagnosed patients showed 33 % responders. TAA expression by qRT-PCR from fresh-frozen tumor samples showed all patient tumors expressed at least three TAA, with 75 % expressing all six. Correlations of increased PFS and OS with quantitative expression of MAGE1 and AIM-2 were observed, and a trend for longer survival was observed with gp100 and HER2 antigens. Target antigens gp100, HER1, and IL13Rα2 were downregulated in recurrent tumors from 4 HLA-A2+ patients. A decrease in or absence of CD133 expression was seen in five patients who underwent a second resection. At a median follow-up of 40.1 months, six of 16 ND-GBM patients showed no evidence of tumor recurrence. Median PFS in newly diagnosed patients was 16.9 months, and median OS was 38.4 months. Conclusions Expression of four ICT-107 targeted antigens in the pre-vaccine tumors correlated with prolonged overall survival and PFS in ND-GBM patients. The goal of targeting tumor antigens highly expressed on glioblastoma cancer stem cells is supported by the observation of decreased or absent CD133 expression in the recurrent areas of gadolinium-enhanced tumors.

BACKGROUND: Cediranib is an orally available pan-VEGFR tyrosine kinase inhibitor. Previously phase III study in patients with recurrent glioblastoma did not meet primary end of progressive-free survival (PFS) (J Clin Oncol. 2013 Sep 10; 31(26): 3212-3218) METHODS: We identified 1 patient, 53-year old Caucasian female, who developed tumor progression of left posterior frontal 1.2 x 1.5 cm in February, 2009 following surgery on 10/15/08 and concurrent temozolomide (TMZ) and radiation therapy from 11/8/08 -1/6/09 with one cycle of maintenance TMZ. She was enrolled in a randomized, phase III, placebo-controlled, partially blinded clinical trial of cediranib either as monotherapy or in combination with lomustine (CCNU) versus CCNU. RESULTS: She was randomized to receive a combination therapy with 1st cycle CCNU 190 mg and cederanib 20 mg/day on 4/13/09. Four weeks later, she developed grade 4 thrombocytopenia (17, 000) associated with gum bleeding and dizziness. She received a platelet transfusion. She continued with cediranib alone and 2nd reduced CCNU 100 mg was delayed till 6/16/09, 3rd CCNU on 2/2/2010. She developed hypertension, proteinuria and diarrhea from cediranib in April of 2010 and she continued with reduced dose to 15 mg/day alone without CCNU. However, she developed nephrotic syndrome and poorly controlled hypertension and was taken off this study in May 2010. At 6-week MRI showed 50% tumor regression (PR) and complete response at 24-weeks. With no enhancement seen on MRI on 6/4/15, she has been off therapy and in clinical remission over 5 years with high functional level and good quality of life (KPS 90%). CONCLUSION: This is a case report of successful therapy for recurrent glioblastoma with long term remission despite termination of therapy > 5 years from cediranib and limited CCNU dosage.

2087 Background: This study evaluated the safety and immune responses to an autologous dendritic cell vaccine pulsed with class I peptides from tumor associated antigens (TAA) expressed on gliomas and overexpressed in their cancer stem cell population (ICT-107). These TAA epitodes AIM-2. TRP-2, HER2 and AIM-2, are also overexpressed on glioblastoma multiforme (GBM) cancer stem cells. Methods: TAA epitopes included HER2, TRP-2, gp100, MAGE-1, IL13Rα2, and AIM-2. HLA-A1 and/or HLA-A2 positive glioblastoma (GBM) patients with gross total resection were eligible. Mononuclear cells from leukapheresis were differentiated into dendritic cells, pulsed with TAA peptides, and administered intradermally three times at two-week intervals in the axilla region after a standard treatment with concurrent temozolomide (TMZ) and radiation therapy for newly diagnosed (ND-GBM). Results: Twenty-one patients were enrolled with 17 ND-GBM and three recurrent GBM patients and one brainstem glioma. Immune response data on 15 newly diagnosed patients showed 33% responders. TAA expression by qRT-PCR showed all patient tumors expressed at least three TAA with 75% expressing all six. Correlations of increased PFS and quantitative expression of MAGE1, AIM-2, gp100 and HER2 were observed. A decrease or absence of CD133 expression was seen in five patients who underwent a second resection. As of February 1, 2012, six of 16 ND-GBM patients showed no evidence of tumor recurrence (44-63 months). Median progressive free survival (PFS) in newly diagnosed patients was 16.9 months with a two-year PFS rate was 43.8% (95%CI,19.8-66.0 ). The median overall survival rate (OS) was 38.4 months and a two-year OS was 80.3% (95%CI,58.6-96.7). Conclusions: Expression of four ICT-107 targeted antigens in the pre-vaccine tumors correlated with prolonged overall survival and PFS in ND-GBM patients. The goal of targeting tumor antigens highly expressed on glioblastoma cancer stem cells is supported by the observation of decreased or absent CD133 expression in the recurrent areas of gadolinium-enhanced tumor.

2097 Background: Active immunotherapy offers the potential for high tumor-specific toxicity and sustained tumoricidal activity. We therefore have developed this protocol to exploit the most current...