ALBERT

Description: Abstract 4471 Background: Patient-Reported Outcome (PRO) measures help clinicians and researchers monitor symptoms, HRQOL, satisfaction, and adherence related to cancer treatment. Symptoms affect HRQOL, and when both are reported frequently and longitudinally, a patient-reported data stream emerges that reflects physiological functioning and complements traditional laboratory and clinician-based assessments. Such data could significantly enhance risk prediction and safety monitoring in patients undergoing HCT. This study evaluates the feasibility of collecting daily and weekly PRO measurements to inform our ability to capture variation in patient experiences over time. Patients and methods: We enrolled 32 patients undergoing planned HCT (10 autologous, 11 myeloablative allogeneic, 11 reduced intensity allogeneic) in a feasibility study of frequent HRQOL and symptom surveillance following HCT. All surveys were administered electronically though patients could opt for pen and paper. PRO measures were derived from the NIH PROMIS and PRO-CTCAE measures, which have not been previously used extensively or at all in HCT patients. All patients completed a 10-question HRQOL measure (PROMIS-Global Health) and a 34-question symptom measure (a pre-selected subset of the 83-question PRO-CTCAE, with 7-day recall period) prior to HCT and weekly until D+100. Auto patients completed a daily 21-question symptom measure (a pre-selected subset of the weekly symptom surveys, with 24-hour recall period) until hospital discharge, and allo patients completed daily symptom surveys until 100 days after stem cell infusion (D+100). Kruskal-Wallis tests were used to compare groups. Median age of the sample was 55 years (range 18–70). 16 patients (50%) were female. Most auto patients had myeloma (N=8, 80%) and most allo patients had acute leukemia (16, 72%); other diagnoses included NHL (4), CML, MDS and AA. Twenty-six (81%) patients were Caucasian, 4 (12.5%) were African American, 2 were other (6.2%). Thirteen (41%) had a high school education or lower. Results: Median daily survey completion percentages prior to hospital discharge for surviving patients were 94% among auto patients, 90% among reduced intensity allo patients and 70% among myeloablative allo patients (p=0.07). Prior to D+100, median daily survey completion percentages were 87% among reduced intensity allo patients and 58% among myeloablative allo patients (p=0.004). Median weekly survey completion percentages prior to hospital discharge were 100% in all cohorts. Prior to D+100, these were 100% in auto and reduced intensity allo cohorts, and 80% among myeloablative allo patients (p=0.002). Daily surveys were completed in a median of 3 minutes, and longer weekly surveys in a median of 4.3 minutes. 93% of respondents were satisfied with survey length and 85% of respondents were satisfied with the electronic self-report system. Median weekly total symptom scores (higher scores indicated greater symptom severity) prior to conditioning were 16 in autos, 12 in myeloablative allos, and 5 in reduced intensity allos (p=0.3) and at D+7 were 23 in autos, 40 in myeloablative allos and 18 in reduced intensity allos (p=0.01). For the physical health subscale of the PROMIS measure (lower scores indicated greater impairment), baseline mean weekly HRQOL scores were 47.7 in autos, 50.8 in myeloablative allos and 50.8 in reduced intensity allos (p=0.9). By D+7, mean HRQOL scores were 37.4 in autos, 37.4 in myeloablative allos and 52.5 in reduced intensity allos (p=0.005). Conclusion: Frequent symptom and HRQOL surveillance is feasible and acceptable to HCT patients, and survey data correlates with toxicity and physiological function after transplant. Compliance rates were lower in myeloablative allo patients, especially for daily surveys, perhaps reflecting the higher burden of critical illness in this population. Future studies may be enhanced by caregiver-reported proxy data. Analyses of weekly symptom and HRQOL surveys beyond D+7, daily surveys, symptom clusters, biologic correlates and individualized profiles are ongoing. Larger studies are warranted to explore and develop risk prediction models based on this technique. Disclosures: No relevant conflicts of interest to declare.

Description: Abstract 4152 Background: Peak oxygen consumption (VO2peak, in mL/kg*min) is assessed by cardiopulmonary exercise testing (CPET) and reflects overall physical fitness. VO2peak has prognostic value in healthy and chronically ill patients, including patients with solid tumor malignancies. To our knowledge, direct measurement of peak oxygen uptake has not previously been examined in patients undergoing HCT, an area in which prognostic models are needed to understand and limit treatment-related toxicity. Current HCT prognostic models measure disease-related risk or indirectly measure patient fitness by assessing comorbidity burden. The purpose of this study was to evaluate the feasibility of assessing functional status in HCT patients by exercise testing and physiological measurements, and to investigate the potential prognostic usefulness of these variables in this population. Patients and methods: We evaluated the feasibility of assessing cardiopulmonary fitness (CPET with gas exchange on cycle ergometer), body composition (Dual Energy X-ray Absorptiometry-DEXA), and physical function (6 minute walk test-6MW) in 32 patients undergoing planned HCT (10 autologous HCT patients, 11 myeloablative allogeneic HCT patients, 11 reduced intensity allogeneic HCT patients). Tests were conducted prior to receipt of conditioning chemotherapy and again at 100 days following stem cell infusion (D+100). Feasibility was determined by the ability of patients to successfully and safely complete a full set of tests. Exploratory analyses to investigate the relationships of variables with one another and with survival utilized Kruskal-Wallis and Wilcoxon Signed Rank tests, Pearson Correlation coefficients, and Cox regression analyses. Median age of the sample was 55 years (range 18–70). Sixteen patients (50%) were female. Most autologous HCT patients had myeloma (N=8, 80%) and most allogeneic HCT patients had acute leukemia (16, 72%); other diagnoses included NHL (4), CML, MDS and AA. Twenty-six patients (84%) had intermediate or late stage disease, and 16 patients (50%) had a Hematopoietic Cell Transplantation-specific Comorbidity Index (HCT-CI) score of 〉 3. Results: VO2peak testing was successfully completed prior to HCT in 29 (91%) patients with no adverse events during testing. Two patients had lower limb limitations preventing participation in cycle ergometry, and one patient had baseline EKG abnormalities with exclusion per clinician discretion. No significant differences in median VO2peak were observed at baseline among patients undergoing autologous, myeloablative allogeneic, and reduced intensity allogeneic HCT (20.1 (15.20–28.0), 20.8 (9.2–35.4), and 23.8 (10.8–28.7) mL/kg*min respectively, p=0.9). Across cohorts, eight (28%) patients had a VO2peak

Description: INTRODUCTION: Peak oxygen consumption (VO2peak) and 6-minute walk distance (6MWD) measure overall fitness and functionality. Higher values have been shown to be directly related to lower mortality following allogeneic hematopoietic cell transplant (alloHCT) [Wood WA, et. al. Bone Marrow Transplant 2013;48:1342-1349. Kelsey CR, et. al. Cardiopulmonary exercise testing prior to myeloablative allo-SCT: a feasibility study. Bone Marrow Transplant (e-pub ahead of print 28 July 2014; doi:10.1038/bmt.2014.159.]. These parameters may represent targets for pre-HCT exercise interventions to ultimately improve post-HCT outcomes. Interval exercise training (IET), a type of exercise intervention that utilizes intermittent bouts of individualized high intensity exercise, has demonstrated the ability to induce rapid mitochondrial and enzymatic changes and to improve cardiorespiratory fitness in short periods of time. Thus, IET represents an attractive potential intervention for the time-limited pre-HCT setting. The purpose of this study was to evaluate the feasibility, safety and efficacy of 6 weeks of IET upon cardiorespiratory fitness (VO2peak) and 6MWD prior to HCT. We hypothesized that IET prior to HCT would be feasible and safe in the HCT population. Further, we hypothesized that IET prior to HCT would improve pre-HCT VO2peak and 6MWD. Because of the association of pre-HCT fitness with post-HCT mortality in the alloHCT patient population, this finding could support the use of IET in preparing this high-risk patient population to withstand the physiologic stress of transplantation. METHODS: We planned to recruit 40 adult participants with planned auto (N=20) or allo (N=20) HCT for a study of a 6-week personalized, home-based IET intervention prior to HCT. IET consisted of a 2-week lead-in period followed by 4 weeks of thrice weekly sessions of five 3-minute intervals at 65-85% maximal heart rate (MHR). Each interval was followed by 2 minutes of rest. The mode of home-based exercise was decided in consultation with the participant and the exercise physiologist. A total of 18 sessions were prescribed for each participant. Intensity and compliance were assessed with heart rate monitors and accelerometers that were recorded weekly. Before and after the 6-week intervention 6MWD and exercise testing for the assessment of VO2peak conducted. Accelerometer data was used to assess total daily activity (steps per day) throughout the duration of the study. RESULTS: Twenty-three participants (10 auto, 13 allo) are available for analysis at this time with recruitment ongoing (65% male; median age 53 years [range 27-75]; median BMI 27.6 kg/m2 [range 19.5-35.2]). For these participants, a median of 5 of the 6 prescribed weeks of exercise were completed, with a median of 10 interval exercise sessions performed during this time. Participants achieved target MHR for a median of 9 exercise sessions. Participants achieved a mean of 85% (SD±9) of MHR during exercise sessions. Subjects took an average of 5445 steps per day (SD±1738) throughout the intervention period. One patient reported dizziness, nausea, and shortness of breath during exercise, which resolved without complication; there were no other adverse events noted. For patients planning to undergo alloHCT, median VO2peak before the intervention was 18.8 ml/kg/min (IQR 17.1-26.4), and the median VO2peak improvement following the intervention was 3.7 ml/kg/min (IQR 2.6-5.0, p=0.002). For the entire population including planned autoHCT, these values were pre-intervention VO2peak 18.5 ml/kg/min (IQR 16.0-25.4) and VO2peak change 2.2 ml/kg/min (IQR 0.8-4.1, p=0.01). 6MWD also improved for those with planned alloHCT (median 37m, IQR 18-68, p=0.007) and for the overall group (median 40m, IQR 4-69, p=0.002). CONCLUSIONS: Our findings demonstrate that patients planning to undergo auto or alloHCT are motivated and able to participate in a 6-week intensive, home-based interval exercise training intervention in the immediate pre-transplantation period. Participants were able to safely achieve high-intensity heart rates in the target range. Some participants could not complete the planned 6 weeks because of the timing of transplantation, while others completed the entire duration of the intervention. Preliminarily, the intervention appears to show efficacy in improving pre-HCT cardiorespiratory fitness as measured by VO2peak and 6MWD. Disclosures No relevant conflicts of interest to declare.