Additional Concern Research Articles

Quality of Life Was Not Negatively Impacted By the Addition of Lenalidomide to R-CHOP Chemotherapy (R2-CHOP) Compared with Placebo Plus R-CHOP Chemotherapy in Patients with Previously Untreated Activated B-Cell (ABC)-Type Diffuse Large B-Cell Lymphoma (DLBCL): Health-Related Quality of Life (HRQoL) Analysis of the International Robust Study

Quality of Life Was Not Negatively Impacted By the Addition of Lenalidomide to R-CHOP Chemotherapy (R2-CHOP) Compared with Placebo Plus R-CHOP Chemotherapy in Patients with Previously Untreated Activated B-Cell (ABC)-Type Diffuse Large B-Cell Lymphoma (DLBCL): Health-Related Quality of Life (HRQoL) Analysis of the International Robust Study

Psychometric validation study of the Korean version of the Functional Assessment of Cancer Therapy-Vanderbilt Cystectomy Index.

PurposesTo evaluate the reliability and validity of a Korean version of the Functional Assessment of Cancer Therapy (FACT)-Vanderbilt Cystectomy Index (VCI) in Korean patients who underwent radical cystectomy (RC) and urinary diversion (UD).Materials and methodsWe prospectively recruited 108 RC and UD patients who did not have evidence of recurrence from 1994 December to 2015 March. All participants were instructed to complete the Korean FACT-VCI and Short-Form 36-Item Health Survey (SF-36; 1st measurement) and to repeat the Korean FACT-VCI survey one month later (2nd measurement). Statistical analysis included intraclass correlation, Cronbach’s α, time and UD type fixed mixed linear model, principal components analysis, and criterion-related validity with SF-36.ResultsKorean FACT-VCI was internally consistent (α = 0.802) and had adequate test-retest reliability (interclass correlation = 0.803 and 0.822). The three components model of principal component analysis (cumulative explanatory power, 49.2%) confirmed the internal structural validity of the additional concerns (AC) component of the Korean FACT-VCI, and each component represented the “voiding problem”, “bowel problem”, and “social/functional problem with equivalent explanatory power (19.5%, 15.4%, and 14.4%). Korean FACT-VCI domain scores were generally well correlated with SF-36 domain scores (Pearson correlation coefficients range: 0.286–0.688; all p <0.01). Mixed linear models revealed that the major effect of measurement times was not significant on FACT-VCI (p = 0.589)ConclusionsThis prospective study confirms the reliability and validation of the Korean FACT-VCI. We expect that this validated tool can be widely utilized in the health-related quality of life studies of Korean patients.

Soliciting additional concerns in the primary care consultation and the utility of a brief communication intervention to aid solicitation: A qualitative study

ObjectiveTo investigate the perspectives of general practitioners (GPs) on the practice of soliciting additional concerns (ACs) and the acceptability and utility of two brief interventions (prompts) designed to aid the solicitation. MethodsEighteen GPs participating in a feasibility randomised controlled trial were interviewed. Interviews were semi-structured and audio-recorded. Data were analysed using a Framework Approach. ResultsParticipants perceived eliciting ACs as important for: reducing the need for multiple visits, identifying serious illness early, and increasing patient and GP satisfaction. GPs found the prompts easy to use and some continued their use after the study had ended to aid time management. Others noted similarities between the intervention and their usual practice. Nevertheless, soliciting ACs in every consultation was not unanimously supported. ConclusionThe prompts were acceptable to GPs within a trial context, but there was disagreement as to whether ACs should be solicited routinely. Some GPs considered the intervention to aid their prioritisation efficiency within consultations. Practice implicationsSome GPs will find prompts which encourage ACs to be solicited early in the consultation enable them to better organise priorities and manage time-limited consultations more effectively.

Prognostic Significance of Quality of Life in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation

Patient-reported outcomes and quality of life (QOL) are becoming increasingly recognized as important factors in cancer clinical trials and patient care. Many studies have described the predictive value of QOL in cancer survival beyond the standard clinical measures. Allogeneic hematopoietic cell transplant (HCT) is the only curative option for many hematologic malignancies, however is often complicated by a high incidence of treatment related morbidity and mortality. While the HCT comorbidity index (HCT-CI) has been developed to assess the impact of co-morbidities and risk of death in patients undergoing allogeneic HCT, we hypothesized that QOL prior to transplant may also add to the assessment of patient risk for post-transplant survival. We thus undertook an analysis to determine the prognostic impact of pre-transplant QOL scores, as captured by the FACT-BMT, on post-HCT non-relapse (NRM) and overall mortality.From 2003-2012, 512 adult patients underwent a first allogeneic transplant at our institution. Prospective psychometric instruments (FACT-BMT) were administered to 409 patients. No significant differences were found between the study cohort and the 103 patients who did not participate in a baseline assessment during the same time period in regards to transplant outcomes or baseline characteristics, except for year of transplant, higher proportion of females, and a shorter time from diagnosis to transplant in the study cohort. Patients with QOL assessments underwent HCT for malignant (n=395) and non-malignant (n=14) diseases. Most patients (n=314, 77%) underwent a myeloablative HCT, while the remaining received a reduced-intensity (RIC) preparative regimen (n=95, 23%). At the time of analysis, median time to follow up was 49 months, range (1.2-128). 41% of patients remained alive, 23% of patients died from relapse and 36% from NRM. We examined the association of overall mortality and NRM with: (1) individual QOL domains captured by the FACT-BMT instrument (physical wellbeing (PWB) functional wellbeing (FWB), social wellbeing (SWB), emotional wellbeing (EWB) and additional concerns (AC), (2) trial outcome index (TOI; PWB+FWB+AC), and (3) total score. In univariable analysis, poor performance status, high risk disease, and high (≥3) HCT-CI score were found to be significant factors for overall mortality but not NRM; umbilical cord, unrelated and mismatched donor transplants were risk factors for both overall mortality and NRM. Additionally, worse FACT-BMT PWB scores (HR 0.97, 95% CI 0.94-0.99, p=0.004), TOI score (HR 0.94, 95% CI 0.88-0.99, p=0.043), and total score (HR 0.95, 95% CI 0.90-0.99, p=0.043) were significant variables associated with overall mortality, but not NRM. In multivariable analyses evaluating individual FACT-BMT QOL domains and adjusted for patient and disease factors, including HCT-CI score, only PWB score was associated with overall mortality, but not NRM (Table). TOI scores which is representative of changes in physical and functional outcomes were associated with overall mortality but not NRM (Table). Total score was not associated with overall or NRM (Table). High (≥3) HCT-CI score remained prognostic for adverse overall mortality but not NRM in all multivariable models.In summary, QOL assessments, particularly PWB and the TOI, may provide independent prognostic information beyond standard clinical measures. While the magnitude of difference of these measures is small, further study on how QOL may be reflected by disease burden or co-morbidities and how patient-reported outcomes and behaviors may further impact survival is warranted.Table:Results of multivariable analysis (separate models were built for each QOL domain)VariableOverall MortalityNon-relapse mortalityHR95% CIP-valueHR95% CIP-valuePWB*0.970.94-0.990.030.970.94-1.010.20SWB*1.000.97-1.040.760.990.95-1.030.57EWB*1.000.96-1.040.950.990.94-1.040.57FWB*0.950.95-1.010.161.000.96-1.050.80AC†1.040.95-1.140.381.030.91-1.170.60TOI‡0.930.87-0.990.040.970.89-1.070.56Total score‡0.950.90-1.000.060.970.90-1.050.46Abbreviations: PWB- physical well-being; SWB- social well-being; EWB- emotional wellbeing; FWB- functional well-being; AC- additional concerns; TOI- total outcome index*per 1 point increase†per 5 point increase‡per 10 point increase DisclosuresNo relevant conflicts of interest to declare.

Superior Quality of Life Scores in Patients Over 60 Years of Age in Allogeneic Hematopoietic Cell Transplant.

AbstractAbstract 3068Advanced age is becoming less of a barrier to allogeneic hematopoietic cell transplantation (HCT) and transplantation has become an established standard of care for many older patients (pts) with hematologic malignancies. We previously reported superior quality of life (QOL) scores in pts age 60 and over undergoing high dose chemotherapy and autologous stem cell transplant compared with pts less than 60 (Dabney J et al, Blood 2008 112: Abstract 2381). These data prompted us to evaluate QOL assessments in pts≥60 undergoing allogeneic HCT compared to pts<60 years.435 adult pts underwent allogeneic HCT from June 2003 to December 2010. Prospective psychometric instruments were administered to 304 pts <60 years of age (median 47, range 18–59) and 47 pts≥60 years of age (median 62, range 60–70) with acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, non-Hodgkins lymphoma, Hodgkins disease, myeloproliferative neoplasms, aplastic anemia, and plasma cell neoplasms. Psychometric data was assessed longitudinally (at baseline, first post-discharge visit, day 100, 180, and 365) by validated questionnaires: Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT), coping inventory (Brief COPE), and the Profile of Mood State- Short Form (POMS). The FACT-BMT measures five components of QOL: physical well being (PWB), social well being (SWB), emotional well being (EWB), functional well being (FWB), and additional concerns (AC). The POMS measures depression, vigor, anger, tension, confusion and fatigue. Brief COPE has 14 coping skills, such as use of emotional and instrumental support, venting, and positive reframing. Secondary endpoints included overall survival (OS), relapse-free survival (RFS), incidence of acute and chronic graft versus host disease (GVHD), and relapse. Imbalances between the two groups (p<0.01 for all) included comorbidity index (HCT-CI), (62% of pts<60 with a comorbid score of >1 compared to 74% in pts≥60), preparative regimen, (84% myeloablative in pts <60, 21% in pts ≥60%), and source of hematopoietic cells, (29% peripheral stem cells in pts<60 versus 72% in pts≥60), with a higher median CD34+ cell dose (4.51×106/kg in pts≥60) compared with pts<60 (2.51×106/kg).Psychosocial functioning and QOL differences were compared between age groups over time by repeated measures analysis of variance, using intensity of transplant as a variable given the imbalance. On FACT, pts≥60 reported better social (p=0.006) and functional well being (p=0.05), and had better total FACT scores, (p=0.043) across all time points. On POMS, pts≥60 reported less fatigue than patients<60 (p=0.01), while COPE assessment indicated that older pts reported worse use of planning (p=0.012) and humor (p=0.041) compared with younger pts. Pts≥60 years also reported worse scores for active coping, but only at day 365 (p=0.019), and scored worse on behavioral disengagement at the first post-transplant time point (p=0.016), but this difference became non-significant by day 100 (p=0.81). With a median follow up of 49 months, there were no significant differences in OS, RFS, relapse, or chronic GVHD. There was a lower incidence of grade 3–4 acute GVHD in pts≥60 compared to pts<60, (6.4% versus 15.8% at 6 months, p=0.016).This study provides further evidence that advanced age should not be a barrier in the decision to pursue allogeneic HCT. Older pts achieved better total scores in QOL assessments when compared to younger pts. One can hypothesize that older pts are more likely to have experienced adversity or family and personal health related problems, making them better able to endure symptoms than younger pts. In addition, younger pts may be more affected due to non-health related concerns including the adverse effect of transplantation on their careers, family, and finances. While our older population has proven to have similar medical outcomes and improved QOL, younger pts may benefit from social work interventions that focus on adapting to changes in functioning and social well-being. [Display omitted] [Display omitted] [Display omitted] Disclosures:No relevant conflicts of interest to declare.

Comparison of Quality of Life Outcomes and Psychosocial Functioning Between Patients Undergoing Myeloablative or Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Myeloid Malignancies

Abstract 843Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) following reduced intensity conditioning (RIC) compared to myeloablative conditioning (MAC) results in less treatment related morbidity and mortality. RIC permits older and less healthy patients (pts) to undergo Allo-HSCT. Whether RIC is also associated with better quality of life (QOL) and psychosocial functioning (PF) among pts with myeloid malignancies has not been systematically analyzed. We prospectively collected QOL and PF outcomes in 192 consecutive pts with AML (n=130), MDS (n=52), or myeloproliferative neoplasms (n=10) who received MAC (n=154) or RIC (n=38) Allo-HSCT from 2004 to 2010. Psychometric data were assessed longitudinally (at baseline, post-transplant, day100, 180, and 365) by validated questionnaires (Functional Assessment of Cancer Therapy- Bone Marrow Transplant Scale [FACT-BMT], coping inventory [Brief COPE], and Profile of Mood States Short Form [POMS]). FACT-BMT consisted of individual and summary scores for physical (PWB), social (SWB), emotional (EWB), functional (FWB) well-being along with additional concerns (AC). Brief COPE has 14 components such as use of emotional and instrumental support, venting, positive reframing etc. POMS consisted of 6 components such as depression, vigor, anger etc. Secondary endpoints included overall survival (OS), relapse-free survival (RFS), incidence of acute (aGVHD) and chronic (cGVHD) graft vs. host disease. QOL and PF differences were compared between transplant types over time by repeated measures analysis of variance. Adjustment for baseline differences in QOL and PF was made in mixed linear model analysis. Kaplan-Meier and cumulative incidence methods were used for analyses of secondary endpoints. RIC and MAC patients were comparable (all p>0.1) for gender, race, hematopoietic cell transplantation comorbidity index, number of prior chemotherapies, donor relation, length of follow up. Differences between RIC and MAC groups (all p<0.001) were detected for median age at transplant (61 for RIC vs. 48 yrs for MAC), stem cell (SC) source (95% peripheral SC in RIC vs. 19% in MAC), TBI-containing preparative regimen (95% for RIC vs. 24% for MAC), CD34+ dose (5.2 for RIC vs. 2.2 ×106/kg for MAC), GVHD prophylaxis. RIC pts had shorter median time-to-neutrophil (11 vs. 15 days, p<0.001) and -platelet (12 vs. 21 days, p<0.001) recovery. There was no baseline QOL difference between RIC and MAC according to FACT-BMT. RIC pts had better baseline scores for anger, emotional support use, venting, and positive reframing (all p<0.05). As compared to MAC, pts with RIC had superior QOL scores post-transplant, i.e FWB (up to day 180, p<0.01), AC (up to day 100, p<0.05), and summary (up to day 100, p<0.05) despite the absence of baseline differences. FWB advantage of RIC remained significant up to half a year (p<0.05) in mixed linear model analysis adjusted for baseline differences. RIC pts had better depression (p<0.01) and anger (p<0.01) scores post-discharge after controlling for baseline differences. In adjusted analysis of COPE, RIC pts had better positive reframing (p=0.02) and use of instrumental support (p=0.02) during early post-transplant follow up. All QOL and PF metrics equalized between RIC and MAC by post-transplant day365 (all p>0.1). With a median follow up of 34 months, there were no differences between RIC and MAC in incidence of aGVHD or cGVHD, RFS, or OS (all p>0.3). In conclusion, our prospective study provides further evidence on overall comparable clinical, QOL and PF outcomes between RIC and MAC and it is the first to demonstrate significant early advantage of RIC in certain QOL and PF metrics up to 180 days post-transplant across all three psychometric instruments. [Display omitted] Disclosures:No relevant conflicts of interest to declare.

Quality of Life Scores Pre and Post Autologous Stem Cell Transplant: A Comparison of Patients Greater Than 60-Years-Old Vs Younger Than 60-Years-Old

Prospective quality of life instruments were administered to 304 patients with non-Hodgkin's lymphoma (NHL), Hodgkin disease (HD), and Multiple Myeloma (MM) undergoing autologous stem cell transplantation (ASCT) from June 2003 through December 2007. The two groups were fairly balanced with respect to baseline characteristics with the younger group having slightly more HD and the older group having slightly more NHL. Of the 304 total patients, 65% had NHL, 21% MM, and 14% HD; median age was 53; 60% were male; 25% received prior radiation therapy; preparative regimens were busulfan based or melphalan; all patients received peripheral stem cells alone, median inpatient length of stay was 21 days. The Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) and the Profile of Mood State (POMS) were administered to patients prior to their priming for stem cell collection and again 40–44 days (Day 42) post ASCT. The FACT-BMT measures five components: physical well being (PWB), social well being (SWB), emotional well being (EWB), functional well being (FWB), and additional concerns (AC). The POMS measures depression, vigor, anger, tension, confusion, and fatigue. In looking at the FACT-BMT the 60 + group reported better emotional well-being at baseline than the <60 group (p= 0.008) and on day 42 post transplant the 60+ group reported significantly better EWB from the under 60 group (p<0.001). Both groups report a decrease in FWB from baseline to day 42 (p=0.022) but the 60+ group reports higher FWB than the other group. Results of the POMS indicates that the <60 group reported higher depression and anger at baseline than did the 60+ group (p<0.001). The <60 group also reported greater tension (p=0.002) at baseline. Confusion was rated slightly higher at baseline also by the <60 group (p=0.020). There were no significant differences between the two groups in these areas at day 42. In conclusion, one can speculate that the 60+ group is more likely to have experienced family or personal crisis prior to their diagnosis and may have more established coping mechanisms on which to rely. Additionally, those in the <60 group may tend to have more family and employment considerations that may distract them from being able to focus on their treatment and preparation for transplant. It is possible that the <60 group would benefit from earlier involvement from the social worker to assess their needs and more specialized family oriented education and/or materials.

Quality of Life Scores Pre and Post Autologous Stem Cell Transplant for Patients with Lymphoid Malignancies

We performed prospective quality of life assessments on 304 patients with non-Hodgkin's lymphoma (NHL), Hodgkin's disease (HD), or Multiple Myeloma (MM), undergoing an autologous stem cell transplant (ASCT) from June 2003 through December 2007. Patients underwent QOL assessment one to two weeks prior to stem cell mobilization for ASCT, and 40–44 days (Day 42) post ASCT. We used the Functional Assessment of Cancer Therapy–Bone Marrow Transplant (FACT-BMT) assessment tool which includes five component scores: physical well being (PWB), social well being (SWB), emotional well being (EWB), functional well being (FWB), and additional concerns (AC). The total scores the sum of the score of the five components. We also administered a Profile of Mood State (POMS) scale which measures depression, vigor, anger, tension, confusion, and fatigue. Of 304 total patients, 65% had NHL, 21% MM, and 14% HD; median age was 53; 60% were male; 25% received prior radiation therapy; preparative regimens were busulfan based or melphalan; all patients received peripheral stem cells alone, median inpatient length of stay was 21 days. Using the FACT scale, there was a significant change from baseline data to day 42 scores. 218/304 patients completed baseline and Day 42 evaluations. Compared to baseline, patients had a significantly increased day 42 EWB score (p < 0.001), which occurred despite the fact that the functional well being scores decreased in a statistically significant fashion (p = 0.002). Using the POMS tool, statistically significant changes from baseline to day 42 were a reduction in depression (p < 0.001), a reduction in anger (p < 0.001), a reduction in tension (p < 0.001), and a reduction in confusion (p < 0.001), which occurred despite the fact that patients also had a reduction in vigor (p < 0.001). We conclude that using these two QOL tools despite a reduction in functional well being and vigor one month after ASCT, other parameters of coping, including emotional well being, depression, anger, and tension, improve as patients are recovering from the transplant experience. We hypothesize that this reflects resolution of pre transplant fears and anxiety. Whether these scores can be further improved with additional intervention requires further study.

Exercise Program Preferences among Head and Neck Cancer Survivors: Associations with Quality of Life

PURPOSE: Determine exercise program preferences for head and neck cancer (HNCa) survivors and associations with quality of life (QoL). METHODS: Cross-sectional, self-administered survey assessing demographics, program preferences, and QoL (i.e., FACT H&N) was obtained from 90 HNCa out-patients (convenience sample; response rate = 83%). Chart audit provided medical variables. RESULTS: Most respondents were male (78%), Caucasian (96%), off treatment (86%) with mean age of 60 ± 12 years and ≤ 12 years of education (70%). Cancer site was primarily pharyngeal (47%) or oral (23%) with disease stage III or IV (81%). Mean physical well-being (PWB) was 20 ± 7, social well-being (SWB) 21 ± 7, emotional well-being (EWB) 19 ± 4, functional well-being (FWB) 17 ± 8, additional concerns (AC) 30 ± 8, and total QoL 106 ± 26. Most (74%) were interested in an exercise program and 50% felt able to participate. For counseling source, 17% preferred a health professional, 17% an exercise specialist, and 65% had no preference. For counseling delivery, 38% preferred face to face, 13% media type, and 47% had no preference. For location, 49% preferred outdoors and 35% preferred at home. Half (50%) preferred to exercise alone, 30% with family/friend, and 20% had no preference. Based on distribution, QoL associations were tested with independent t-tests, analysis of variance (ANOVA), or Kruskal Wallis test. Participants interested in an exercise program reported lower PWB (p=.004), EWB (p=.025), FWB (p=.006), AC (p=.022), and total QoL (p=.004). Participants preferring counseling from a health professional reported higher AC when compared with those without a preference (p=.039). When compared with participants who preferred to exercise alone, those preferring to exercise with family/friend had lower PWB (p=.036) and those without a preference reported lower FWB (p=.006), AC (p=.018), and total Qol (p=.034). QoL was not associated with perceived ability, counseling delivery, or location. No significant associations were noted between program preferences and SWB. CONCLUSION: Individuals who may benefit the most from exercise intervention (i.e., lower QoL) have a greater interest in program participation. Studies assessing whether tailoring interventions based on QoL preference differences will enhance effectiveness are warranted.

Exercise and Quality of Life in Head and Neck Cancer Patients

Exercise is known to improve quality of life (QoL) in certain cancer survivor groups but there is limited research with head and neck cancer survivors. PURPOSE: To examine the prevalence of exercise in head and neck cancer survivors and determine any preliminary associations with QoL. METHODS: 59 of 64 (92%) eligible head and neck cancer survivors were recruited from an academic oncology clinic in the midwest United States. Participants completed a self-administered survey that included a modified Godin Leisure-Time Exercise Questionnaire and the Functional Assessment of Cancer Therapy-Head & Neck (FACT-H&N) scale which consists of five subscales: physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and additional concerns (AC). PWB, FWB, EWB, and SWB can also be summed to form the FACT-General (FACT-G). Medical variables were obtained by medical record review. RESULTS: The majority of participants were men (83%) and Caucasian (92%) with mean age = 58 ± 12.8. Current smoking and drinking was reported by 25% and 34% of participants, respectively. Cancer site was primarily oral cavity (24%), oropharynx (37%), or larynx (25%) with 20% being stage I, 7% stage II, 19% stage III, and 54% stage IV disease. Chemotherapy and/or radiation were ongoing in 14%. Half (51%) were <6 months after diagnosis. Only 3 (5.1%) participants reported any vigorous exercise minutes (M = 7.3 ± 35.4) and only 7 (11.9%) reported any moderate exercise minutes (M = 19.5 ± 70.6). Light exercise was reported by 26 (44.1%) participants (M = 83.4 ± 147). Only 5 (8.5%) participants were meeting current public health exercise guidelines. Means and standard deviations for each QoL scale were: FACT-H&N (103.2 ± 26.5), FACT-G (74.9 ± 18.9), PWB (19.1 ± 7.6), SWB (21.4 ± 5.9), EWB (18.3 ± 4.5), FWB (16.0 ± 7.5), and AC (28.3 ± 9.4). Pearson correlations showed that total exercise minutes (i.e., light + moderate + vigorous) was significantly associated with PWB (r = 0.23; p = 0.089), FWB (r = 0.32, p = 0.015), FACT-G (r = 0.27, p = 0.043), and FACT-H&N (r = 0.26, p = 0.053) but not SWB (r = 0.03; p = 0.850), EWB (r = 0.17, p = 0.208), or AC (r = 0.19, 0.166). CONCLUSIONS: Few head and neck cancer survivors are participating in any moderate or vigorous exercise and over half are completely sedentary. Despite this limited variability in exercise behavior and a modest sample size, there were meaningful associations between total exercise minutes and physical and functional aspects of QoL. These data provide preliminary evidence that an exercise intervention may have utility in this understudied cancer survivor group but further research is warranted.

A Quality of Life Assessment of Ablative Allogeneic Bone Marrow Transplant (BMT) Recipients One and Twelve Months after Transplant.

Quality of life (QOL) data concerning allogeneic BMT recipients is relatively sparse. We surveyed allogeneic BMT recipients at baseline, one month post-transplant, and one year from transplant attempting to determine fluctuations in QOL over time. We used the FACT-BMT tool, which consists of five component scores, including physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and additional concerns (AC). PWB, SWB, and FWB uses a 0–28 point scale while EWB ranges from 0–24. Fifty-three patients were initially entered into this analysis, all of whom received ablative allogeneic transplants from 6/2003 to 6/2005. Median age was 46 years; the majority (57%) were female; underlying diagnoses included AML (42%), ALL (23%), MDS (13%), and other (22%). Median time from diagnosis to transplant was rapid, at 5.2 months. Fifty-one percent had a matched related donor, and 49% had a matched unrelated donor. As of August 2005, 70% of these 53 patients are alive. This analysis compares scores obtained one month from transplant and one year from transplant to baseline values. The average hospital length of stay for this ablative transplant was 29 days. One month after transplant, 21% of patients had grade 2–4 acute GVHD. The median WBC was 4.4 K/μL and the median platelet count was 51 K/μL. When surveyed one month post-transplant, not surprisingly, patients had a significant deterioration of physical well-being and functional well-being scores as shown in the table below. However, this was coupled by a significant increase in emotional well-being:FACT-BMT SCORES: median (range)ComponentBaseline (n = 53)1-month post-transplant BMT (n = 53)1-month p-value compared to baseline12-months post-BMT (n = 23)12-month p-value compared to baselinePWB21 (6–28)18 (2–26)p < 0.00121 (3–28)0.82FWB17 (0–27)13 (4–23)p = 0.00617 (6–27)0.46EWB17 (3–24)19 (1–24)p < 0.00119 (5–24)0.015The decrease in PWB and FWB was expected given the rigors of an ablative allogeneic transplant, but the significant rise in EWB was surprising. This may reflect a sense of accomplishment, relief, and optimism among patients concerning their underlying diagnosis and treatment. Twenty-three patients were available to complete the survey tool 12 months after transplant. This was a favorable cohort of patients with continued remissions. Fifty-two percent of these 23 patients, however, did have some degree of chronic graft-versus-host disease. The PWB and SWB scores returned to baseline, and the enhanced EWB scores persisted. Thus, the negative impact of the BMT on PWB and SWB was self-limited. The underlying mechanisms of the sustained EWB improvement one year post-transplant may reflect the fact that these patients were doing well clinically. Further analysis of the early rise in emotional well-being after ablative allogeneic BMT would be of interest.

Age Does Not Influence Long-Term Quality of Life (QOL) after Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for AML/MDS.

Allogeneic HSCT has the potential to cure patients with AML or MDS, but is associated with significant morbidity and complications that can affect the QOL of survivors. We examined QOL of AML/MDS patients surviving 2 years or more in remission after allo HSCT, including physical, psychosocial and functional well being.OBJECTIVES: We seek to describe QOL of long-term survivors (LTS) with AML/MDS and to compare QOL as a function of age at transplant.METHODS: Long-term survivorship was defined as survival in remission beyond 2 years from HSCT; 2 years was chosen given the stabilization of the failure rate on the 3rd year after HSCT. There were 544 adult AML/MDS patients treated with allogeneic HSCT between January 1976 and September 2001. Of these, 129 (24%) were in remission for at least 2 years and were eligible for the study. QOL was assessed using the standardized Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire that measures multidimensional QOL concepts and consists of 5 subscales measuring physical (PWB), functional (FWB), social/family (SFWB), and emotional well being (EWB), including satisfaction with the doctor-patient relationship (RWD) (McQuellon et al., Bone Marrow Transplant, 1997). There was an additional concern (AC) subscale that asked questions related to job, appetite, body appearance, tiredness, interest in sexual activity etc. FACT-BMT allowed for responses to have values ranging from 0 (not at all) to 4 (very much). Specified QOL questions were recorded so that higher score reflected a higher QOL in the reported dimension. The questionnaire was mailed, and delivery could be confirmed for 121 patients out of whom 82 (68%) responded. Demographic and clinical characteristics were collected from patient charts and clinical database.RESULTS: Median age at transplant was 38.44 years (range 18.54–68.08). Median time from HSCT to receipt of questionnaire was 4.53 years. Gender: 47 males and 35 females. Diagnosis: AML (n=70) and MDS (n=12). Conditioning regimens were of reduced intensity in 29 cases and myeloablative in 53 cases. Stem cell source: bone marrow (n=52), and peripheral blood (n=30). GVHD prophylaxis: tacrolimus based in 61 cases and cyclosporine based in 18 cases; none in 2 cases. Disease status at HSCT: complete remission (n=40), relapsed (n= 37) and untreated disease (n=5). Median follow-up time was 4.53 years (range 2.0–21.1 yrs). There were no significant differences in QOL scores between the older and younger patients (above and below the median age at transplant) in the PWB, SFWB, EWB, FWB and RWD subscales. In the AC subscale, however, older patients had higher QOL scores than younger patients (mean score 37.97 vs. 33.25, p=0.005). When we compared non-myeloablative (NMA) vs. myeloablative (MA) regimens, there were no significant differences in mean QOL scores in all but the AC subscale where NMA group did better (39.00 vs. 33.34, p=0.001). Acute graft versus host disease (aGVHD) did not impact long-term QOL but lack of chronic GVHD was associated with better QOL score in the PWB, EWB, FWB and AC subscales (PWB: 25.04 vs. 20.62, p=0.005; EWB: 21.77 vs. 18.98, p=0.003; FWB: 22.91 vs. 18.00, p=0.008; and AC: 40.00 vs. 34.28, p=0.002).CONCLUSIONS: Among LTS with AML/MDS, older age did not affect QOL at a median of 4.5 yrs post HSCT.