scholarly journals Feasibility of Peri-Transfusion Quality of Life Assessment for Patients with Myelodysplastic Syndromes

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 25-26
Author(s):  
Gregory A. Abel ◽  
Heidi D. Klepin ◽  
Emily S. Magnavita ◽  
Tim Jaung ◽  
Rory M. Shallis ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Myelodysplastic Syndromes ◽  
Conflicts Of Interest ◽  
Performance Status ◽  
Life Assessment ◽  
Ecog Performance Status ◽  
Before And After ◽  
Ecog Ps ◽  
Rbc Transfusion

BACKGROUND: Decreased quality of life (QOL) due to fatigue in the setting of anemia is common with myelodysplastic syndromes (MDS), often leading to dependence on red blood cell (RBC) transfusions. Moreover, the COVID-19 pandemic has resulted in considerably reduced blood supply such that the importance of conserving donor RBCs for patients particularly in need is even more crucial (Shander, Anesth Analg 2020). While some patients with MDS experience improved QOL after transfusions, many do not, even at the same ECOG performance status (PS) and hemoglobin (Hb). In a pilot study, we sought to assess the feasibility of a peri-transfusion QOL assessment (PTQA; QOL assessed before and after transfusion) to determine if it could help inform future transfusion decisions for patients with MDS. METHODS: Starting in 2019, patients with MDS at Dana-Farber Cancer Institute, Yale School of Medicine, and Wake Forest University were screened for eligibility using clinic schedule reports in Epic; those 18 or older with biopsy-proven MDS presenting to clinic for RBC transfusions with no evidence of known CHF or unstable angina were eligible to participate. A Hb threshold of 7.5 g/dL or greater was required for participation (Tanasijevic, Leuk Lymph 2020). The QUALMS, a validated PRO for patients with MDS (Abel, Haematologica, 2016), was used to assess patients' QOL before and after RBC transfusion. At consent, patients were given a study packet including a copy of the QUALMS and were instructed to fill out the survey the day before their upcoming transfusion. One week after RBC transfusion, the patient completed the QUALMS again. Surveys were scored, compared, and compiled into a report that was sent to patients and providers (Figure). Based on the QUALMS validation study, we considered a change by 5 or more points to be potentially clinically significant. After descriptive statistics, two-sided Fisher's Exact tests assessed for associations between patient characteristics (ECOG PS and Hb) and post-transfusion increase in QOL. RESULTS: As of July 2020, a total of 57 patients had been enrolled. Of these, 28 (49%) have completed PTQA with both a pre-transfusion and post-transfusion QUALMS. Mean age was 72 years (standard deviation (SD)=11.6), 19% were female, and 89% had had one or more RBC transfusions within 8 weeks prior to enrollment. For the 29 patients who did not undergo PTQA, 11 are still awaiting their index transfusion; 4 passed away before the index transfusion; 4 were transplanted before the index transfusion; 2 developed AML; 7 later became ineligible or were lost to follow up; and 1 withdrew consent. Of the 28 who underwent PTQA, about half had an ECOG performance status of 1, and median Hb at transfusion was 8.05 g/dL (Table). The mean pre-transfusion QUALMS score was 56.1 (SD=15.3) and post-transfusion score was 59.3 (SD=18.0); overall, 35.7% experienced an increase in QOL. Patients with ECOG PS of 1 or 2 were no more likely to have an increase in QOL after RBC transfusion compared to those with PS of 0 (p=1.00). In contrast, 50% of patients with pre-transfusion Hb < 8.0 g/dL had an increase in QOL compared to 25% of patients with Hb >= 8.0 g/dL, although this difference also did not reach significance (p=0.24). CONCLUSIONS: Although PTQA was feasible for about half of patients enrolled, there were many barriers when working with this high-risk MDS population. Moreover, only about one-third of patients experienced an increase in QOL one week after RBC transfusion, arguing that, for some patients, a more limited transfusion schedule may be possible. Disclosures No relevant conflicts of interest to declare.

scholarly journals Lenalidomide for the Treatment of Low- and Int-1-Risk MDS with Del(5q): Efficacy and Quality of Life Study.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2763-2763 ◽  
Author(s):  
Esther Natalie Oliva ◽  
Roberto Latagliata ◽  
Fortunato Morabito ◽  
Antonella Poloni ◽  
Riccardo Ghio ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Performance Status ◽  
Cytogenetic Response ◽  
Study Entry ◽  
International Prognostic Scoring System ◽  
Ecog Performance Status ◽  
Cytogenetic Abnormalities ◽  
Preliminary Results ◽  
Transfusion Independence

Abstract Abstract 2763 Poster Board II-739 Introduction: Chronic anemia of myelodysplastic syndromes (MDS) is associated with poor quality of life (QoL) and an inferior clinical course. Transfusion dependence in lower-risk patients is associated with reduced survival as a result of iron overload, heart failure, and progression to acute myeloid leukaemia. Lenalidomide is approved for the treatment of transfusion-dependent anemia in patients with International Prognostic Scoring System (IPSS) Low- or Intermediate (Int)-1-risk MDS with deletion 5q [del(5q)]. Rapid and durable responses include transfusion independence with a rise in Hb, suppression of the del(5q) clone, and improvement in bone marrow morphological features. We present preliminary results of a prospective single-arm trial investigating the effect on QoL, efficacy, and safety of lenalidomide in the treatment of 49 adult patients with IPSS Low- and Int-1-risk MDS with del(5q) with/without additional cytogenetic abnormalities and Hb < 10 g/dL. Methods: Exclusion criteria include: ANC < 500/mm3; PLT count < 50,000/mm3; prior chemotherapy; and ongoing treatment with rHuEpo. Lenalidomide was administered orally at a starting dose of 10 mg/day. If necessary, dosing was reduced to 5 mg/day or 5 mg on alternate days. Treatment will be continued for a maximum of 12 months or until evidence of unacceptable non-hematological adverse events, lack of response, disease progression, or relapse following erythroid improvement. QoL was assessed at study entry and weeks 8, 12, and 24 using the QOL-E v.2 questionnaire. QoL scores are standardized in a 0–100 scale with lower scores representing a worse QoL. Response was evaluated according to the modified International Working Group (IWG) response criteria. Results: Twenty patients (5 M, 15 F, mean age 72 ± 10 years) are evaluable for erythroid responses and cytogenetic changes at 12 weeks and 13 patients have reached a 24-week follow-up. At baseline, mean disease duration was 3.4 ± 2.3 years. Seventeen patients were transfusion dependent (TD), 3 were transfusion free (TF). ECOG performance status was 0 in 14 patients and 1 in 6 patients. After 12 weeks from study entry, 17 (85%) patients obtained an erythroid response with a mean Hb level increase from baseline 8.6 ± 0.9 g/dL to 11.1 ± 2.4 (p=0.001). By 24 weeks, 11 of the 13 patients re-evaluated were erythroid responders obtaining transfusion independence and significant improvements in Hb (mean change from baseline 3.7 ± 2.7 g/dL, and increase to mean 11.1 ± 2.4 g/dL (p<0.001). Eight out of 20 cases (35%) reached normal Hb levels after 12 weeks and 8 out of 13 patients (62%) by 24 weeks. A cytogenetic response (at least 50% reduction in del[5q]) was observed in 5 responders out of 13 patients evaluated at 24 weeks. Additional cytogenetic abnormalities were observed in 4 responders. A progressive improvement in QoL was experienced in responders in the first 24 weeks of treatment. Physical QoL scores increased from 35 ± 9 at baseline to 69 ± 25 at week 24 (p = 0.086). Social-QoL scores significantly changed from 29 ± 20 at baseline to 83 ± 20 at week 12 (p = 0.021). Changes in physical QoL correlated with improvements in Hb (r = 0.768, p=0.001). Drug interruption followed by reduction to 5 mg/day was required in 16 patients within the first 8 weeks due to significant neutropenia, which was associated with thrombocytopenia in 3 patients and hospitalization because of infection in 2 patients. One patient withdrew from treatment because of progressive anemia. Conclusions: Preliminary results confirm that in Low- and Int-1-risk MDS patients with del(5q) lenalidomide induces clinically significant erythroid responses and transfusion independence. Most patients require a dose reduction mainly due to neutropenia. Responders experience improvements in physical and social QoL. Disclosures: Oliva: Celgene: Consultancy. Finelli:Celgene: Consultancy.

scholarly journals Patient-reported outcomes at discontinuation of anti-angiogenesis therapy in the randomized trial of chemotherapy with bevacizumab for advanced cervical cancer: an NRG Oncology Group study

2020 ◽  
Vol 30 (5) ◽  
pp. 596-601
Author(s):  
Dana Chase ◽  
Helen Q Huang ◽  
Bradley J Monk ◽  
Lois Michelle Ramondetta ◽  
Richard T Penson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cervical Cancer ◽  
Patient Reported Outcomes ◽  
Performance Status ◽  
Well Being ◽  
Treatment Discontinuation ◽  
Life Assessment ◽  
Recurrent Cervical Cancer ◽  
Patient Reported

IntroductionTo describe patient-reported outcomes and toxicities at time of treatment discontinuation secondary to progression or toxicities in advanced/recurrent cervical cancer patients receiving chemotherapy with bevacizumab.MethodsSummarize toxicity, grade, and health-related quality of life within 1 month of treatment discontinuation for women receiving chemotherapy with bevacizumab in GOG240.ResultsOf the 227 patients who received chemotherapy with bevacizumab, 148 discontinued study protocol treatment (90 for disease progression and 58 for toxicity). The median survival time from treatment discontinuation to death was 7.9 months (95% CI 5.0 to 9.0) for those who progressed versus 12.1 months (95% CI 8.9 to 23.2) for those who discontinued therapy due to toxicities. The most common grade 3 or higher toxicities included hematologic, gastrointestinal, and pain. Some 57% (84/148) of patients completed quality of life assessment within 1 month of treatment discontinuation. Those patients who discontinued treatment due to progression had a mean decline in the FACT-Cx TOI of 3.2 points versus 2.2 in patients who discontinued therapy due to toxicity. This was a 9.9 point greater decline in the FACT-Cx TOI scores than those who discontinued treatment due to progression (95% CI 2.8 to 17.0, p=0.007). The decline in quality of life was due to worsening physical and functional well-being. Those who discontinued treatment due to toxicities had worse neurotoxicity and pain.DiscussionPatients who discontinued chemotherapy with bevacizumab for toxicity experienced longer post-protocol survival but significantly greater declination in quality of life than those with progression. Future trial design should include supportive care interventions that optimize physiologic function and performance status for salvage therapies.

Quality of life assessment in children before and after a successful ablation for supraventricular tachycardia

2020 ◽  
Vol 30 (3) ◽  
pp. 413-417 ◽  
Author(s):  
M Cecilia Gonzalez Corcia ◽  
Laura Peters ◽  
Thierry Sluysmans ◽  
Stephane Moniotte ◽  
Karlien Carbonez ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Negative Impact ◽  
Accessory Pathway ◽  
Young Patients ◽  
Life Assessment ◽  
Percutaneous Ablation ◽  
Supraventricular Arrhythmias ◽  
Ectopic Atrial Tachycardia ◽  
Before And After

ABSTRACTBackground and Objectives:Young patients suffering from rhythm disorders have a negative impact in their quality of life. In recent years, ablation has become the first-line therapy for supraventricular arrhythmias in children. In the light of the current expertise and advancement in the field, we decided to evaluate the quality of life in young patients with supraventricular arrhythmias before and after a percutaneous ablation procedure.Methods:The prospective cohort consisted of patients <18 years with structurally normal hearts and non-pre-excited supraventricular arrhythmias, who had an ablation in our centre from 2013 to 2018. The cohort was evaluated with the PedsQL™ 4.0 Generic Core Scales self-questionnaire prior to and post-ablation.Results:The final cohort included 88 patients consisted of 52 males (59%), with a mean age at ablation of 12.5 ± 3.3 years. Forty-two patients (48%) had a retrograde-only accessory pathway mediating the tachycardia, 38 (43%) had atrio-ventricular nodal re-entrant tachycardia, 7 (8%) had ectopic atrial tachycardia, and 1 (1%) had atrial flutter. The main reason for an ablation was the patient’s choice in 53%. There were no severe complications. Comparison between the baseline and post-ablation assessments showed that patients reported significant improvement in the scores for physical health, emotional and social functioning, as well as in the total scores.Conclusions:The present study demonstrates that the successful treatment of supraventricular arrhythmias by means of an ablation results in a significant improvement in the quality of self-reported life scores in young patients.

Home Azacitidine Administration in High Risk Myelodysplastic Syndromes: Favorable Results of a Pilot Study in 48 Patients

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 1719-1719
Author(s):  
Sylvestre Guillevic ◽  
Thibault Comont ◽  
Jonathan Khalifa ◽  
Christian Recher ◽  
Daniel Adoue ◽  
...  
Keyword(s):  
Quality Of Life ◽  
High Risk ◽  
Myelodysplastic Syndromes ◽  
Conflicts Of Interest ◽  
Age Distribution ◽  
Hospital Administration ◽  
Number Of Cycles ◽  
Home Administration ◽  
At Home

Abstract Abstract 1719 Background: Myelodysplastic syndromes (MDS) affect elderly patients. Azacitidine represents the gold standard treatment of high risk MDS. French health organization allows home chemotherapy administration after the first cycle of treatment. We decided to develop a home administration program of this drug. Moreover we hypothesized that this modality of treatment will improve patient's quality of life. Patients and methods: after one cycle in hospitalization, high risk MDS patients who were agree to receive home chemotherapy were included in the study. As recommended each first day of Azacitidine cycle was still administrated at hospital. Due to drug instability a quality statement was created to control all steps of administration (including storage temperature before administration). Feasibility and safety were evaluated. Comparison between home or hospital administration was performed: number of cycles, dose, tolerance, problems of administration. Results: 68 patients were included in the home chemotherapy program, 75% were MDS patients and 48 received Azacitidine. Age distribution was 7 patients 60/69 yrs (14%), 22 patients 70/79 yrs (46%) and 19 patients 80–89 yrs (40%). More than 2000 days of hospitalization were performed at home during a 18-month period. Similar median number of cycles and delays were observed in the two groups as well as same level of adverse events and hospitalizations between 2 cycles. In few cases administration was not possible at home due to unresolved infection, cytopenia or drug availability (excessive time between preparation and distribution). No patient was excluded of this program. Discussion and conclusion: home administration of Azacitidine was safe and feasible. All patients agree to continue this modality of administration and high level of satisfaction was observed. Next step will consist in a randomized study to compare quality of life between home and hospital administration of the drug. For this population of patient home treatment will represent an alternative which could improve quality of life as observed for children in ALL (1) or in colorectal cancer (2). Disclosures: No relevant conflicts of interest to declare.

Phase II clinical trial of nab-paclitaxel plus gemcitabine in elderly patients with previously untreated locally advanced or metastatic pancreatic adenocarcinoma: BIBABRAX study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4615-4615 ◽  
Author(s):  
Jaime Feliu Batlle ◽  
Monica Jorge Fernandez ◽  
Teresa Macarulla ◽  
Bartomeu Massuti ◽  
Ana Albero ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Elderly Patients ◽  
Phase Ii ◽  
Clinical Benefit ◽  
Performance Status ◽  
Locally Advanced ◽  
Standards Of Care ◽  
Ecog Ps

4615 Background: FOLFIRINOX and nab-paclitaxel plus gemcitabine (nab-P+G) are the standard of care in the first-line treatment of mPC patients (pt) with good performance status. However, no standards of care exist for elderly ( > 70 years) pt as they are usually excluded in clinical trials. This study aimed to evaluate whether the clinical benefit of nab-P+G could be extended to elderly pt with mPC. Methods: This was an open-label, single-arm, multicenter, phase II trial, to assess the efficacy and safety of Nab-P+G in elderly pt (≥ 70 years) with ECOG PS 0–1 and untreated unresectable locally advanced or metastatic PC. Pt received four-week cycles of intravenous (i.v.) nab-paclitaxel 125 mg/m2, followed by i.v. gemcitabine 1,000 mg/m2, on days 1, 8 and 15, until disease progression. Efficacy was evaluated according RECIST v 1.1 criteria and safety according NCI-CTCAE v 4.0 criteria. Results: Eighty pt were enrolled in the study. Median age was 74.6 years (range 70-87.9), 57.5% were men, 71% had ECOG PS 1 and 86% metastatic disease. 16.3% of patients had a history of prior tumor surgical resection, 12.5% received chemotherapy and 3.8% radiotherapy. Primary tumor was located in head (32.5%), tail (25.0%) and body (22.5%). Nab-P and G was reduced in 49% and 41% of pt respectively. 15 pt definitely interrupt study treatment due to toxicity: neurotoxicity (7), asthenia (5), neutropenia (1), leukocytosis (1) and hepatotoxicity (1). Time until definite deterioration (reduction ≥10 points as compared to baseline in EORTC-QLQ C30) was 1.6 months and deterioration-free rate at 3 months was 54.3%. Overall response rate was 13.8%, clinical benefit rate 67.5%, median PFS 7.2 months and median OS 9.2 months. The most common treatment-related adverse events were asthenia (60.0%), diarrhea (40.0%), neutropenia (33.8%), hair loss (28.8%), thrombocytopenia (26.3%), and nausea (23.8%). Only asthenia and neutropenia presented a relatively high incidence of grade 3 and 4 toxicities (21.3%). At least 1 SAE was reported in 55% of pt. Conclusions: BIBABRAX study confirms the clinical benefit of nab-P+G in an elderly population with mPC, in terms of survival, clinical response and tolerance, therefore it could be considered a treatment option for elderly patients. However, it was unable to demonstrate the preplanned benefit on the quality of life. Further research is needed on treatment strategies that could reduce deterioration of the quality of life in these pt. Clinical trial information: NCT02391662 .

Quality Of Life Assessment In Wheezy Infants Before And After Using Montelukast(singulair)

2011 ◽  
Vol 127 (2) ◽  
pp. AB226-AB226
Author(s):  
M. Kwofie-Mensah ◽  
R.J. Green ◽  
R. Masekela ◽  
O. Kitchin ◽  
T. Moodley
Keyword(s):  
Quality Of Life ◽  
Life Assessment ◽  
Quality Of Life Assessment ◽  
Before And After

scholarly journals Quality of Life in Patients with Multiple Sclerosis after Autologous Hematopoietic Stem Cell Transplantation

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5708-5708
Author(s):  
Juan Carlos Olivares-Gazca ◽  
Iván Murrieta-Álvarez ◽  
Jesús Mauricio Olivares-Gazca ◽  
Yarely Itzayana García-Navarrete ◽  
Yahveth Cantero-Fortiz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Cell Transplantation ◽  
Hematopoietic Cell Transplantation ◽  
Conflicts Of Interest ◽  
Hematopoietic Stem ◽  
Before And After ◽  
Quasi Experimental ◽  
The Impact

Introduction Multiple sclerosis (MS) is an inflammatory, demyelinating and neurodegenerative disease of the central nervous system (CNS) that causes a whole spectrum of neurological disorders associated with a profound decrease in the quality of life of affected patients. Currently, autologous hematopoietic cell transplantation (ASCT) is a validated therapeutic approach and has been shown to be superior to new immunomodulatory agents. However, the impact of these therapies on the quality of life of patients with MS is unknown. Objective Identify the impact on the quality of life in patients with multiple sclerosis after ASCT at our center. Methods A quasi-experimental, longitudinal, prospective and single-center study was conducted in which the quality of life was determined in patients with MS before and after ASCT. Patients who could not answer the questionnaire themselves were excluded and incomplete questionnaires were eliminated. The quality of life was determined by applying the MS-QoL 29 instrument which is validated instrument for this pathology (Cronbach 0.88-0.90 and Pearson with high correlation with MS-QoL56). The variables related to the physical and mental components of the instrument as well as demographic characteristics were studied. The statistical analysis of the data included measures of central tendency as well as inferential for the comparison of means and proportions (NC 95%, p <0.05). Results We included 52 patients prospectively from October 2018 to June 2019, 71% of the patients were women and the remaining 29% men. The median of age of the subset is 50 years (Interval 27-65). Of the selected patients, 45% has PPMS, 39% has SPMS and 16% has PPMS. Twenty six patients were followed at 3 months and seventeen were followed 6 months after ASCT. The statistical differences between the quality of life in the patients prior to the ASCT and the follow-up at 3 and 6 months in both the physical and mental components was analyzed. In the physical component the differences at 3 months (A) were significant (p = 0.019, 95% NC) as well as the differences at 6 months (b) after ASCT (p = 0.0024, 95% NC). In the mental component the differences were significant at 3 months (C) (p = 0.0012, NC 95%) as well as the differences at 6 months (D) after ASCT (p = 0.0007, NC 95%). Conclusions The study suggests that ASCT is a feasible and safe therapeutic alternative to improve the quality of life in patients with multiple sclerosis. Figure Disclosures No relevant conflicts of interest to declare.

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