ALBERT

Description: Background: Individuals with acute myeloid leukemia (AML) are at risk for significant physical and psychological burden related to their illness. While overall survival rates are improving, treatments may be associated with lengthy hospitalizations, and the risk of relapse remains substantial. This study explores cancer-related distress and concerns among AML survivors, as well as supportive care received from their healthcare team. Methods: 58 AML patients and survivors enrolled in the Cancer Support Community's online Cancer Experience Registry; 38 completed CancerSupportSource® (CSS) questions, a 25-item distress screening tool in which they rated their level of concern (0=Not at all; 4=Very seriously) about emotional well-being, symptom burden and impact, body image and healthy lifestyle, healthcare team communication, and relationships and intimacy. CSS includes validated subscales that identify individuals at risk for clinically significant depression and anxiety. Participants also completed questions about their unmet needs and desired help. Pearson's correlation coefficients were used to explore bivariate associations between socio-demographic variables and clinical history with overall distress (sum of CSS ratings) in AML respondents. Results: Mean (SD) age was 50 (14) years (range: 18-77); mean time since diagnosis was 5.6 years. Participants were 87% White and 64% female. 33% were receiving treatment at the time of taking the survey; 23% had ever experienced a recurrence of their cancer. Participants' greatest concerns (% rated Moderately to Very seriously) included: eating and nutrition (61%); exercising (57%); fatigue (53%); worry about the future and what lies ahead (51%); feeling irritable (51%); health insurance or money worries (49%); sleep problems (47%); changes or disruptions in work, school, or home life (46%); and feeling sad or depressed (45%). Based on responses to CSS risk screening subscales, more than half of participants (54%) were at risk for clinically significant level of anxiety; 42% were at risk for clinically significant levels of depression. Over half of respondents indicated their healthcare team asked about emotional concerns (58%); half said they were asked about lifestyle concerns such as diet and exercise (50%) and about financial concerns (e.g., out-of-pocket costs) (50%); roughly two-out-of-five had a health professional talk to them about employment concerns (40%) or family (42%). A majority of participants wished they had received more help with managing emotions related to cancer (67%), managing short-term (50%) and long-term (61%) side effects and symptoms, changing lifestyle behaviors (53%), and financial advice/assistance (47%). In bivariate analysis, greater overall distress was associated with younger age (r=-.49; p

Description: 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.

Description: BACKGROUND. Patterns, prevalence, and associated pt variables of CML pts’ nonadherence (PNA) with ImRx are being better understood. Reducing ImRx PNA may impact on treatment outcomes. Various AESs have been proposed but their perceived value and clinical applicability to treating MDs are unknown. OBJECTIVES. 1. Describe the perceptions of ImRx prescribing MDs of the utility (in terms of FX, FB, CO) of 13 AESs. 2. Describe MD rankings of the applicability in daily practice of each AES. DESIGN AND SUBJECTS. MD data subset from prospective, 90d observational, open-label, multicenter study [1]. 51 evaluable MDs: age 45.6±11.2 years (ys); ys of practice 17.7±8.1; 74% hematologists, 26% oncologists; 65.3% practicing in university(-affiliated) hospital, 34.7% in other hospitals. MEASUREMENTS. Utility rated 0=none to 3=high. For applicability to daily practice, MDs were asked to give top 5 AESs (5=most applicable); nonranked AESs were given zero value. RESULTS. See Table 1. CONCLUSIONS. MDs tended to rate the utility and applicability of AESs higher if an AES involved active MD participation or decision-making. AESs requiring significant patient involvement, behaviorally or through assistive devices, were perceived as less helpful and applicable in clinical practice. Importantly, the critical role of patient education was recognized, thus challenging clinicians to accept greater responsibility for this AES. Nurses in particular may prove pivotal in patient education. These findings provide significant direction for interdisciplinary healthcare education, especially in terms of chronic illness management. Further research is needed to elucidate the physician-centric approach to adherence enhancement in CML pts on ImRx. Table 1 - Physician Utility Ratings and Applicability Rankings of Adherence-Enhancing Strategies Utility (0–3) Applicability FX FB CO in Practice (0–5) M±SD M±SD M±SD M±SD Rx selection per pt characteristics 1.9±1.1 1.6±1.1 1.3±1.0 1.0±1.5 Pt education 2.6±0.6 2.1±0.8 1.4±0.8 3.1±1.9 Improved pt-MD communication 2.7±0.5 2.3±0.8 1.3±0.8 2.8±1.7 Simplifying Rx regimen 2.5±0.7 2.3±0.7 1.6±0.9 2.3±1.9 Pt self-monitoring 1.7±0.8 1.5±0.8 1.1±0.9 0.4±1.1 Pt health status diary 1.7±0.8 1.5±0.8 1.0±0.8 0.5±1.3 Memory aids 1.7±0.8 1.9±0.8 1.0±0.8 0.6±1.3 Spouse/family involved 2.2±0.9 2.0±0.9 0.6±0.8 1.3±1.4 Regular MD contact 2.4±0.5 2.2±0.7 1.7±0.8 2.2±1.8 MD monitoring of PA 2.2±0.7 1.8±0.9 1.4±0.8 0.7±1.1 Electronic reminders 1.5±0.9 1.2±0.8 2.3±0.9 0.3±1.1 Electronic Rx monitoring 1.6±0.9 1.3±0.7 2.3±0.9 0.3±1.1 Rewards for good PA 1.4±1.0 1.3±0.8 1.8±0.9 0.5±1.4

Description: BACKGROUND. ImRx for CML is a long-term treatment. Patterns and prevalence of NA to ImRx remain largely unknown. Short-term NA trends may be indicative of long-term NA. Methods for clinical NA assessment vary in reliability. A multimethod approach is indicated. OBJECTIVE. Multimethod estimation of patterns and prevalence of ImRx NA in CML pts at baseline (BL) and follow-up (FU) at 90 days (90d), incl. BL to 90d changes. DESIGN AND PATIENTS. Data subset from prospective, 90d observational, open-label, multicenter study. 169 evaluable pts on ImRx for minimum 30d at enrollment [1]. METHODS OF NA ASSESSMENT. At BL (NA with prior ImRx) and 90d (NA during study): visual analog scale (VAS) for physicians (phs; mVAS), pts (pVAS), cos (cVAS); Basel Assessment of Adherence Scale for pts (pBAAS; structured interview re NA in past 4 weeks [4wks]); pts reported persistence (pPST); % clinic appointments (%CAPPTS) kept (if any scheduled). At 90d also: % of ImRx taken per pill count (%pts@ImRx). RESULTS. See Table 1. CONCLUSIONS. Intuitive adherence ratings (VAS) by phs, pts, and cos are very high and differ from those from structured interview, where about one-third of patients exhibited NA behavior in 4wks prior to BL and FU - despite high persistence. Pill count suggests patterns of under- and overtaking, with only 1 out 7 patients being perfectly adherent. Rate of clinic appointments may be affected by physician scheduling practices and collateral input is a function of availability of collateral person. Consenting to participate in the ADAGIO study did not reduce NA. Though patient self-reports in structured interview (pBAAS) and pill counts have inherent biases, both indices suggest that NA with ImRx may be similar to NA rates in other disease categories. Especially pBAAS and pill count may be useful rapid clinical assessment tools, with pBAAS having the benefit of validated categorical assessment (vs. continuous in other methods). Determinants of NA and the impact of NA on treatment outcomes must be examined. Table 1 - Multimethod Assessment of Non-Adherence with Imatinib Method BL 90d n M±SD/Min-Max M±SD/Min-Max P mVAS 164 95.0±7.6/60–100 94.9±9.9/0–100 ns pVAS 169 95.3±8.5/25–100 95.7±6.1/75–100 ns cVAS 56 97.1±5.1/80–100 97.4±5.1/75–100 ns %pts@ImRx 162 - 91.0±21.1/29.5–2002.2 71.0% @ 〈 100% ImRx 14.2% @ 100% ImRx n % NA % NA P pBAAS 163 36.2% 32.5% ns %CAPPTS 51 94.1% 88.2% 0.001 pPST 163 98.8% 100.0% ns

Description: Imatinib mesylate (imatinib) has been shown to be highly efficacious in the treatment of chronic myeloid leukemia (CML). Continuous and adequate dosing is essential for optimal outcomes and with imatinib treatment possibly being lifelong, patient adherence is critical. The ADAGIO (Adherence Assessment with Glivec: Indicators and Outcomes) study aimed to assess prospectively over a 90-day period the prevalence of imatinib nonadherence in patients with CML; to develop a multivariate canonical correlation model of how various determinants may be associated with various measures of nonadherence; and to examine whether treatment response is associated with adherence levels. A total of 202 patients were recruited from 34 centers in Belgium, of whom 169 were evaluable. One-third of patients were considered to be nonadherent. Only 14.2% of patients were perfectly adherent with 100% of prescribed imatinib taken. On average, patients with suboptimal response had significantly higher mean percentages of imatinib not taken (23.2%, standard deviation [SD] = 23.8) than did those with optimal response (7.3%, SD = 19.3, P = .005; percentages calculated as proportions × 100). Nonadherence is more prevalent than patients, physicians, and family members believe it is, and therefore should be assessed routinely. It is associated with poorer response to imatinib. Several determinants may serve as alert signals, many of which are clinically modifiable.

Description: BACKGROUND. The A.C.T. study has shown that in Europe more cancer patients (pts) with anemia are being treated with ESAs than 7 years ago. ESAs are indicated for lymphoma. Variability in treatment patterns, outcomes, and response rates in daily clinical practice need to be further investigated. OBJECTIVE. To examine anemia treatment patterns, outcomes, and response rates in the subsample of A.C.T. patients with lymphoma. DESIGN & PATIENTS. Multicenter, longitudinal retrospective study with at least 3 time points at approximately 1 month intervals, with visit 1 coinciding with start of ESA treatment. 128 centers in 13 European countries contributed 324 multiple myeloma pts who were anemic (hemoglobin [Hb] 11g/dL) and treated with an ESA (14.8% of total European sample). MEASUREMENTS. All data collected through retrospective chart review. Key variables reported here: age, chemotherapy regimen, Hb, WHO/ECOG performance status, ESA type, ESA dose incl. escalation, and iron supplementation. Response to ESA Rx: Hb rise ≥1g/dL, Hb rise ≥1g/dL within 8 weeks, hematopoietic response (Hb rise ≥2g/dL or Hb≥12g/dL achieved), Hb rise ≥2g/dL, and Hb target range of 12.0–12.9g/dL achieved by visit 3. RESULTS. Pts ranged in age from 18 to 92 years (58.4±17.6). 96.1% of pts were on chemotherapy, of which 83.4% on standard vs. 16.6% on high dose; and 17.8% on platinum vs. 82.2% on nonplatinum. Types of ESA prescribed included epoetin alfa (13.0%), epoetin beta (43.5%), darbepoetin alfa (43.5%). Results are summarized in Table 1. No severe adverse events were reported. Table 1 Treatment patterns and outcomes Visit 1 Visit 2 Visit 3 P Mean (SD) ESA dose (IU/week) 31851 (6912) 33844 (10296) 33610 (10199) 0.002 Median ESA dose (IU/week) 30000 30000 30000 n.s. Mean (SD) Hb (g/dL) 9.3 (1.0) 10.2 (1.4) 10.9 (1.7)

Description: BACKGROUND. Imatinib therapy for chronic myeloid leukemia (CML) is a long-term treatment potentially compromised by patient nonadherence. OBJECTIVE. To examine whether patients (pts) at different levels of treatment response differ in adherence to imatinib treatment. DESIGN & PATIENTS. The ADAGIO study1 is a prospective, 90-day (90d) observational, open-label, multicenter study of pts with chronic myeloid leukemia (CML) and treated with imatinib. 169 evaluable pts who had been on imatinib for a minimum 30 days at enrollment were studied. A sub-analysis included pts with optimal vs. suboptimal response (all patients) and complete vs. incomplete cytogenetic response (CgR; all patients and those treated with imatinib ≥12 months). MEASUREMENTS. Adherence: imatinib pill count over 90d expressed as % of prescribed imatinib taken. Suboptimal response (SR): incomplete hematologic response at 3 months, and/or less than partial CgR at 6 months, and/or less than major molecular response and, in case of loss of major molecular response, other limitations or chromosomal abnormalities at 18 months (all else: optimal response [OR]). CgR: complete (0% Ph+ metaphases) or incomplete (≥1 Ph+ metaphases). RESULTS. Pill count percentages ranged from 29%–202% of prescribed dose (M=90.9±20.1). Pts with SR (n=14) had significantly higher %s of imatinib not taken (23.2±23.8) than did those with OR (n=124; 7.3±19.3, P=0.005). Among pts treated with imatinib ≥12 months, those with complete CgR (n=98) had significantly lower mean percentages of imatinib not taken (9.0±18.6) than those with incomplete CgR (n=9; 26.0±24.4, P=0.012). Among all patients regardless of length of treatment, those with complete CgR (n=109) also had significantly lower mean percentages of drug not taken (9.1±18.1) than those with incomplete CgR (n=19; 23.9±19.2, P=0.004). CONCLUSIONS. Proportions of CML patients with poor treatment response are low (10.1%, 8.4%, and 14.8% resp. for parameters above), underscoring the high efficacy of imatinib in CML. Pts with poor response tended to have higher % of imatinib not taken over 90d, an index of overall adherence behavior. Clinicians should be aware of the association between adherence and imatinib response and should query patients about their adherence behavior. Nonadherence should be ruled out prior to classifying a patient as imatinib-resistant. Enhanced adherence is likely to optimize the effectiveness of imatinib treatment in CML.

Description: BACKGROUND. The A.C.T. study has shown that in Europe more cancer patients (pts) with anemia are being treated with ESAs than 7 years ago. ESAs are indicated for hematological malignancies. Variability in treatment patterns, outcomes, and response rates in daily clinical practice need to be further investigated. OBJECTIVE. To examine anemia treatment patterns, outcomes, and response rates in the subsample of A.C.T. patients with hematological malignancies. DESIGN & PATIENTS. Multicenter, longitudinal retrospective study with at least 3 time points at approximately 1 month intervals, with visit 1 coinciding with start of ESA treatment. 152 centers in 13 European countries contributed 630 pts with hematological malignancies who were anemic (hemoglobin [Hb] ≤11g/dL) and treated with an ESA (14.8% of total European sample). MEASUREMENTS. All data collected through retrospective chart review. Key variables reported here: age, chemotherapy regimen, Hb, WHO/ECOG performance status, ESA type, ESA dose incl. escalation, and iron supplementation. Response to ESA Rx: Hb rise ≥1g/dL, Hb rise ≥1g/dL within 8 weeks, hematopoietic response (Hb rise ≥2g/dL or Hb ≥12g/dL achieved), Hb rise ≥2g/dL, and Hb target range of 12.0–12.9g/dL achieved by visit 3. RESULTS. Pts ranged in age from 18 to 92 years (62.4±15.3). 94.4% of pts were on chemotherapy, of which 89.1% on standard vs. 10.9% on high dose; and 12.8% on platinum vs. 87.2% on nonplatinum. Types of ESA prescribed included epoetin alfa (14.4%), epoetin beta (44.8%), darbepoetin alfa (40.8%). Results are summarized in Table 1.No severe adverse events were reported. Table 1 Treatment Patterns & Outcomes Visit 1 Visit 2 Visit 3 P Mean (SD) ESA dose (IU/wk) 31067 (7247) 32354 (9418) 32309 (9638) 0.001 Median ESA dose (IU/wk) 30000 30000 30000 n.s. Mean (SD) Hb (g/dL) 9.3 (1.0) 10.2 (1.5) 10.9 (1.7)

Description: BACKGROUND. ImRx for CML is a long-term treatment potentially compromised by NA. Identifying APVs may assist in reducing NA and optimizing treatment outcomes. OBJECTIVE. To model the relationships between two NA measures and selected APVs using CCA, a multivariate analog of multiple regression to accommodate multiple criterion variables. DESIGN AND PATIENTS. Data subset from prospective, 90d observational, open-label, multicenter study. 169 evaluable pts on ImRx for minimum 30d at enrollment [1]. MEASUREMENTS. NA at 90d vector: Basel Assessment of Adherence Scale for pts (pBAAS; 0/1 with 1=NA); and % of ImRx taken per pill count (%ImRx, subtracted from 100 to reflect NA). APVs at BL vector: age; months since CML diagnosis (mCML); months since ImRx initiation (mImRx); knowledge of CML disease, treatment, and ImRx (KCMLRx); and general health (SF-8). RESULTS. The criterion (dependent) vector of NA indicators included pBAAS and %ImRX. The predictor (independent) vector of APVs included: age, mCML, mImRx, KCMLRx, and SF-8. Two canonical correlations were generated: 0.389 (Bartlett Chi-squared=23.564, P=0.009) and 0.170 (Bartlett Chi-squared= 3.590, P=0.464); the second correlation was deleted due to nonsignificance from zero. The canonical loadings (or structure coefficients) for the retained model were: age 0.951, mCML 0.205, mImRx 0.145, SF-8 0.016, and KCMLRx -0.367. Redundancy analysis showed that 22.1% of variance in the predictor set was explained by variables within that set. CONCLUSIONS. The patient NA vector (composed of a binary assessment of NA per pBAAS 0/1 with 1=NA) and continuous quantification of % of ImRx not taken was related to the APV vector as follows: NA increased as patients were older, had been diagnosed with CML for a longer period of time, had been on imatinib treatment for a longer period time, and were in slightly better health at enrollment. These may be considered warning signs for NA for clinicians to consider in practice, given the long-term nature of ImRx. Importantly, better patient knowledge of disease and treatment, a clinically modifiable APV, was associated with a decrease in NA. The initial insights in patient NA with ImRX provided by these findings, though some are counterintuitive to the NA literature at large, must be studied further to better understand the dynamics of NA in the CML population.

Description: BACKGROUND. The A.C.T. study has shown that in Europe more cancer patients (pts) with anemia are being treated with ESAs than 7 years ago. ESAs are indicated in solid and hematological malignancies. Variability in treatment patterns, outcomes, and response rates in these tumor categories needs to be further explored. OBJECTIVE. To examine differences in anemia treatment patterns, outcomes, and response rates between patients with solid vs. hematological malignancies. DESIGN & PATIENTS. Multicenter, longitudinal retrospective study with 3 time points at approximately 1 month intervals; start of ESA treatment at visit 1. 307 centers in 13 European countries contributed 2192 pts (n=630 with hematological tumors; n=1562 with solid tumors) who were anemic (hemoglobin [Hb] 11g/dL) and treated with an ESA. MEASUREMENTS. Retrospective chart review. Variables reported here: age, chemotherapy regimen, Hb, WHO/ECOG performance status, ESA type, ESA dose incl. escalation, and iron supplementation. Response to ESA Rx: Hb rise≥1g/dl within 8 weeks, hematopoietic response (Hb rise≥2g/dl or Hb≥12g/dl achieved), Hb rise≥2g/dl, and Hb target range of 12.0–12.9g/dl achieved by visit 3. RESULTS. Pts ranged in age from 18 to 94 years (61.5 12.7) with no difference between groups (p=ns). 95.2% of pts were on chemotherapy, of which 92.9% on standard vs. 7.1% on high dose (solid 94.3% and 5.7% vs. hemato 89.1% and 10.9%, p=0.001); and 40.5% on platinum vs. 59.5% on nonplatinum (solid 49.1% and 50.9% vs. hemato 12.8% and 87.2%, p=