Symptom Burden, Quality of Life, and Distress in Acute Myeloid Leukemia Patients Receiving Induction Chemotherapy: Results of a Prospective Electronic Patient-Reported Outcomes Study

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 4496-4496 ◽  
Author(s):  
Thomas W. LeBlanc ◽  
Steven P Wolf ◽  
Areej El-Jawahri ◽  
Debra M Davis ◽  
Susan C Locke ◽  
...  

Abstract Background: Induction chemotherapy for acute myeloid leukemia (AML) is more intensive than many other cancer treatments, and may be associated with a different symptom burden. Little is known about the most prevalent symptoms during AML induction, nor how they change over time, and with remission status. Similarly, little is known about the trajectory of quality of life (QoL) and distress scores in this population. We aimed to learn more about the natural history of these issues via a prospective, longitudinal, observational patient-reported outcomes study. Methods: We enrolled 43 inpatients with AML at initiation of induction chemotherapy, and assessed their symptoms, quality of life (QoL), and distress weekly during their month-long hospitalization for induction, and monthly thereafter, using 3 validated instruments: Patient Care Monitor v2.0 (PCM); Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu); and NCCN distress thermometer (DT). We used descriptive statistics and ANOVA to analyze results. Results: Mean age of study participants was 59.4 (SD 13.4); 21 (49%) were female. Patients were mostly high-risk for recurrence, with 25 (58%) being ≥60 years old, 19 (44%) having high-risk cytogenetics, and 10 (23%) having relapsed disease. Among relapsed patients, the mean number of prior treatments was 2.7 (SD 1.3). At the time of this analysis, 5 patients (18%) had gone on to receive a stem cell transplant. As expected, symptoms were most prominent during the second and third weeks of treatment. However, across all 4 weeks of induction patients consistently reported 5 symptoms at a moderate or severe level (scores of 4 to 6, or 7 to 10 out of 10, respectively), including: poor appetite (35%), dry mouth (37%), difficulty sleeping (38%), dysgeusia (44%), and fatigue (56%). Other prominent moderate-to-severe symptoms included diarrhea (35%), daytime sleepiness (30%), and nausea (27.5%), despite standard supportive care. Mean QoL by FACT-Leu worsened substantially from week 1 (121.8, SD 27.6) to week 2 (108.2, SD 26.3), and then slowly recovered thereafter, improving to better than baseline by month 3 and continuing to improve throughout 1-year of follow-up (p<0.01; see Figure 1). The mean distress score across all 4 weeks of induction was 4 (SD 3.2), which is the threshold for recommended referral to additional support services, but was higher in week 1 (4.4; SD 3.5) compared to week 4 (3.0; SD 3.1). Grouping patients by remission status based on bone marrow assessments done between 30 and 45 days post-induction, QoL and DT scores appear markedly different, and diverge at this point (Figures 2 and 3), such that patients with persistent disease after induction have progressively worse QoL and more distress compared to patients in remission. Conclusion: AML patients receiving induction chemotherapy face a significant symptom burden, impaired QoL, and moderate psychological distress. Several of the most prevalent and severe symptoms during induction may be amenable to further targeted intervention. Longitudinal QoL and distress scores diverge markedly on the basis of post-induction remission status, suggesting that further targeted interventions may be needed to address the greater burden of issues among patients with relapsed disease. The overall prevalence and severity of symptom, QoL, and distress issues suggests sizeable unmet palliative care and psychosocial needs among patients with AML. Figure 1. Figure 1. Figure 2. Figure 2. Figure 3. Figure 3. Disclosures LeBlanc: Flatiron: Consultancy; Epi-Q: Consultancy; Boehringer Ingelheim: Membership on an entity's Board of Directors or advisory committees; Helsinn Therapeutics: Honoraria, Research Funding. Abernethy:Flatiron: Employment.

2020 ◽  
Author(s):  
Joao Beato ◽  
Sonia Torres-Costa ◽  
Joao Esteves-Leandro ◽  
Manuel Falcão ◽  
Vitor Rosas ◽  
...  

Abstract BackgroundDiabetic retinopathy (DR) and cataract are major complications that lead to significant visual impairment of diabetic patients. This study aims to compare the changes in visual acuity, quality of life and satisfaction after phacoemulsification between type 2 diabetic and nondiabetic patients.MethodsFifty-seven diabetic patients (37 with no diabetic retinopathy [DR], 11 with mild/moderate nonproliferative DR and 9 with severe nonproliferative/proliferative DR) and 45 controls were submitted to first-eye cataract surgery by phacoemulsification alone or with co-adjuvant intravitreal injection of bevacizumab or triamcinolone. National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was recorded preoperatively and 6 months after surgery; and satisfaction evaluated at 1-month. ResultsCorrected distance visual acuity (CDVA) of the operated eye at 1 and 6-months (p<0.001) was significantly higher than preoperative value in the controls and all diabetic subgroups. The final CDVA in the severe nonproliferative/proliferative DR subgroup was significantly lower compared to the controls and the remaining diabetic subgroups (p<0.05). The mean NEI VFQ-25 composite score significantly improved in both control (15.413.2 points) and diabetic (15.413.0 points) groups, without differences among the diabetic subgroups (p>0.05). Overall patient satisfaction was 93% in both control and diabetic groups. ConclusionThis study provides vision-related patient-reported outcomes that support the benefit from phacoemulsification in all stages of DR, as long as there is adequate monitoring and treatment of retinopathy.


2012 ◽  
Vol 18 ◽  
pp. S41-S42
Author(s):  
Sunanda Kane ◽  
Arpita Nag ◽  
Lori Taylor ◽  
Gary Hogge ◽  
Jean-Frédéric Colombel ◽  
...  

2014 ◽  
Vol 32 (31_suppl) ◽  
pp. 167-167
Author(s):  
Thomas William LeBlanc ◽  
Steven Wolf ◽  
Debra M. Davis ◽  
Greg Samsa ◽  
Susan C. Locke ◽  
...  

167 Background: Induction chemotherapy for acute myeloid leukemia (AML) is more intensive than many solid tumor treatments, and may be associated with a different symptom burden. Little is known about the most prevalent symptoms during AML induction, nor how they change over time. Methods: We enrolled AML inpatients at initiation of induction chemotherapy, and assessed their symptoms, quality of life (QoL), and distress weekly during their month-long hospitalization for treatment, using 3 validated instruments: Patient Care Monitor v2.0 (PCM); Functional Assessment of Cancer Therapy–Leukemia (FACT-Leu); and NCCN distress thermometer (DT). Here we report results from the first 16 enrolled patients, using standard descriptive statistics. Results: Mean age of study participants was 59.6 (SD 12.2), and most were newly diagnosed with AML (SD 87.5%, n=14). Patients were mostly high-risk for recurrence, with 50% (8) being >60 years old and 71% (10) having high-risk cytogenetics. Fatigue was the most prevalent symptom, with an average of 59% of patients reporting moderate to severe fatigue at each assessment. The other most prevalent moderate/severe non-functional symptoms were dysgeusia (50%), dry mouth (42%), diarrhea (41%), decreased appetite (37.5%), insomnia (37.5%), daytime sleepiness (36%), nausea (36%), hair loss (36%), and mouth sores (34%). Median QoL by FACT-Leu total score decreased substantially between weeks 1 and 2 (118.5 to 104.5); the most substantial decrements were in subscales for personal well-being and functional well-being (20.5 to 14.5, and 13.5 to 8.5, respectively). QoL did not return to baseline by week 4. Median DT score at baseline was 6.5, with a trend towards weekly improvements in distress (DT = 3 at week 4). Depressive symptoms like hopelessness and sadness were reported by an average of 25% and 31.3% of patients, respectively. Conclusions: AML patients receiving induction chemotherapy have significant symptom burden, impaired QoL, and psychological distress. The prevalence of these issues suggests sizeable unmet palliative care and psychosocial needs in AML patients receiving induction chemotherapy.


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 21-22
Author(s):  
Mazie Tsang ◽  
Joseph Cleveland ◽  
Miguel Carlos Cerejo ◽  
Huimin Geng ◽  
James L. Rubenstein

Introduction: Management of primary CNS lymphoma (PCNSL) in patients age &gt;70 represents a significant challenge. In most clinical series, median OS for PCNSL patients age &gt;70 is &lt;1 year (Mendez et al., Neuro-Oncology 2018). Since late 2011, our group has used low-dose lenalidomide as maintenance therapy in older patients with newly-diagnosed PCNSL who had &gt;partial response (PR) to induction chemotherapy or salvage chemotherapy for relapsed disease. A preliminary report by our group supported the feasibility and efficacy of low-dose lenalidomide maintenance for 13 older patients with PCNSL, in lieu of consolidation with radiation or high-intensity chemotherapy (Vu et. al., BJH 2019).Here, we present the outcomes of 22 consecutive older patients with PCNSL (inclusive of updated outcomes on the original 13 patients) treated with low-dose lenalidomide after achieving &gt;PR following induction chemotherapy. In addition, we provide a first report on the impact of maintenance low-dose lenalidomide on quality of life (QOL), overall functioning, and symptom burden. Methods: We performed a retrospective analysis of consecutive patients age &gt;65 years with PCNSL, who achieved &gt;PR to induction methotrexate/rituximab+temozolomide (MTR) chemotherapy and were subsequently treated with low-dose lenalidomide maintenance (5-10 mg/dose) in PR1/CR1. We determined their clinical characteristics, progression-free survival (PFS) and overall survival (OS) by Kaplan-Meier. In addition, we obtained correlative data on QOL and symptom burden on a representative sample of older PCNSL patients who were treated with low-dose IMiDs over the course of &gt; 2 months, via the European Organization of Research and Treatment of Cancer (EORTC) QOL questionnaire (QLQ)-C30. Our study was approved by the University of California San Francisco Institutional Review Board with patient informed consent. Results: The median age at diagnosis of the 22 consecutive older newly-diagnosed PCNSL patients was 77 (range 64 - 86). Median Karnofsky Performance Status was 70. Twenty patients received induction MTR (2 received M-R) without consolidative dose-intensive chemotherapy, autologous stem cell transplant, or whole brain irradiation. The median methotrexate dose was 2.5 gm/m2 (range 0.5 - 8). With median follow-up of 47 months, median time on low-dose lenalidomide maintenance was 14 months. Median PFS was 84 months, and median OS has not been reached. (Figure 1). At progression, patients received methotrexate followed by lenalidomide or pomalidomide. Thus far, there have been 3 deaths: one due to PCNSL, one by myocardial infarction, 4 years after discontinuation of lenalidomide, and one without definitive cause. To assess the tolerability of low-dose lenalidomide (and/or pomalidomide) in this population, we determined patient-reported outcomes with respect to quality of life, as measured by the EORTC QLQ-C30. We summarize our findings in Figure 2 on 8 consecutive PCNSL patients age &gt;70 that received maintenance IMiD therapy for at least 2 months. Seven of the 8 patients were treated with maintenance low-dose lenalidomide for a median of 11 months, and one patient was on maintenance pomalidomide (1-2 mg/day) for a total of 76 months. Overall low-dose IMiDs were well-tolerated: mild-to-moderate fatigue and insomnia were the two most commonly reported symptoms. Conclusions: Our experience suggests that low-dose lenalidomide as maintenance therapy after induction chemotherapy in older patients with PCNSL may result in improved PFS and OS. Importantly, our data suggest that QOL and overall functioning as measured by the EORTC QLQ-C30 was comparable, if not better, than QOL as assessed for patients receiving high dose methotrexate-based therapy, autologous stem cell transplant, whole brain radiation therapy, and/or blood brain barrier disruption (Doolittle et. al., Neurology 2013). In conclusion, based on this preliminary assessment, maintenance low-dose lenalidomide (and pomalidomide) appear to be well-tolerated in older PCNSL, with patients reporting good quality of life, low symptom burden, and overall good level of functioning. Survival outcomes remain encouraging. A phase I trial in newly-diagnosed, non-transplant eligible PCNSL that evaluates combination nivolumab with lenalidomide, both as a component of induction therapy and as low-dose lenalidomide maintenance, is in development via Alliance (A051901). Disclosures Rubenstein: Kymera: Research Funding. OffLabel Disclosure: Low-Dose Lenalidomide as Maintenance in Older Patients with Primary CNS Lymphoma


Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 4456-4456
Author(s):  
Carmelita P. Escalante ◽  
Stephanie Chisolm ◽  
Juhee Song ◽  
Marsha Richardson ◽  
Salkeld Ellen ◽  
...  

Abstract Background: Fatigue is common and very distressing among patients with myelodysplastic syndrome (MDS), aplastic anemia (AA), and paroxysmal nocturnal hemoglobinuria (PNH), frequently affecting their quality of life. Often, this is combined with other symptoms such as pain, depression, anxiety, and stress. Limited data exists on the perceived level and impact of fatigue, quality of life and related symptoms in these patients. The objectives are to describe fatigue, quality of life (QOL) and related symptoms in patients with MDS, AA, and PNH by prospectively assessing these using the Functional Assessment of Cancer Therapy-Anemia (FACT-An) for fatigue and QOL (subscales within FACT- An), pain using the Brief Pain Inventory (BPI), and depression, anxiety and stress using the DASS-21, and to define management strategies routinely used. Methods: Surveys were administered via the AA and MDS International Foundation's patient database from 10/2014 through 1/2015 via a secure internet portal associated with the Foundation's website. Descriptive statistics were utilized. Results: Of 313 pts, 145 (46%) had MDS, 84 (27%) had AA, 74 (24%) PNH, and 10 (3%) unreported [31 (10%), >1 diagnosis]. The mean age was 57 years with 210 (67%) female, 197 (92%) white among 214 with known race and 70 (25%) received a blood transfusion in the past 90 days. The mean fatigue score overall was 25 (range 1-52) and 28, 25, and 24 for AA, MDS, and PNH, respectively, p=0.12. (severe level). The overall quality of life score was 68 (range 10-104) and 67, 69, 67 for AA, MDS, PNH, respectively, p=0.82. Please note with the FACT-An, FACT-G and FACT-F -The higher the score, the better the QOL. The overall ranges for stress were normal; pain and depression, mild; and anxiety, moderate. Among the subgroups, stress was normal (all); pain and depression were mild (all); anxiety was mild in MDS, moderate in AA, PNH. None of the subgroups had statistical significance for these symptoms including anxiety. Most common management strategies used for fatigue in the past month were preserving energy 252 (81%); physical activity 234 (75%); naps 228 (73%). The strategies that were helpful to extremely helpful were preserving energy 216/252 (86%), physical activity 162/234 (69%), and naps 154/228 (68%). Among subgroups, physical activity (p=0.03) and meditation (p=0.03) showed significant differences. Frequency of use 3 or more times/week were preserving energy 166/237 (70%), physical activity 128/226 (57%), and naps 131/213 (62%) among those who indicated the frequency of use. Among subgroups, the frequency of physical activity p= 0.03, eating healthy p=0.005, and counseling p=.005 showed significant differences. Conclusions: There are few patient reported outcomes of fatigue, QOL and related symptoms in this population of rare disorders. Fatigue and QOL are significant challenges with similar findings of fatigue, QOL and related symptoms among the subgroups. However, there were differences among the types of management strategies and the frequency of use among the subgroups. Further focus on development of interventions tailored for AA, MDS, and PNH may assist in better management of fatigue with potential improvement in QOL. Disclosures No relevant conflicts of interest to declare.


Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5198-5198
Author(s):  
Tatyana Ionova ◽  
Tatyana Nikitina ◽  
Elza Lomaia ◽  
Alexandr Myasnikov ◽  
Tatyana Pospelova ◽  
...  

Abstract Myelofibrosis (MF) is the most symptomatic of the myeloproliferative neoplasms and is associated with the greatest symptom burden and poorest prognosis. Patient-reported outcomes is an effective way to identify patients' needs and risks/benefits of MF treatment. We aimed to study quality of life (QoL) and symptom burden in MF patients in a real-world setting. 44 MF patients - 27 primary MF, 8 post-essential thrombocytopenia, 9 post-polycythemia vera - were enrolled in the multicenter real-world QoL study. Mean age - 60.8±13.3; male/female - 14/30. All the patients received the best available treatment (BAT, n=28) or novel treatment modality ruxolitinib (n=16) for at least 6 months (range 6-160 mths). A high proportion of patients (80%) had intermediate to high prognostic risk scores according to International Prognostic Scoring System. All the patients completed the QoL questionnaire SF-36, symptom assessment questionnaire CSP-MF and Patient Global Impression of Change (PGIC) tool. Integral QoL Index (IQoLI) in MF patients was calculated on the basis of SF-36 and QoL impairment grade was assessed in comparing with QoL population norms (PN). Comparison t-test for independent samples or Mann-Whitney test was applied. The heterogeneity of MF patients population in terms of QoL impairment was shown: 55% of patients had mild QoL impairment (IQoLI≤25% from PN), 7% - moderate (IQoLI≤25-50% from PN), 38% - severe or critical QoL impairment (IQoLI≤50% from PN). Patients receiving BAT exhibited more pronounced QoL impairment as compared to patients receiving ruxolitinib (p<0.05); they had worse physical functioning, general health, vitality, social functioning, and mental health (p<0.05). All the patients experienced multiple symptoms; the most severe symptoms were fatigue, inactivity and pain in bones/muscles. The symptoms were more expressed in patients on BAT as compared to patients on ruxolitinib (p<0.005). Patient's impression of health changes was better in patients treated with ruxolitinib: the mean PGIC score was higher in patients on BAT on ruxolitinib - 4.4 vs 2.3 (p=0.001). Quality of life and perceived change in health condition are better and symptom severity is less in MF patients on ruxolitinib therapy than those on BAT. Results of this real-world study demonstrate benefits of ruxolitinib therapy from patient perspective. Patient-reported outcomes are of help to better identify the needs of MF patients. Disclosures No relevant conflicts of interest to declare.


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