Quality-of-Life Outcomes in Patients with Relapsed or Refractory Multiple Myeloma Treated with Elotuzumab Plus Lenalidomide/Dexamethasone or Lenalidomide/Dexamethasone: Final Analysis of the Phase 3 ELOQUENT-2 Study

Introduction: The development of numerous novel therapies for the treatment of relapsed or refractory multiple myeloma (MM) has resulted in improved response rates and durable responses that prolong survival. Assessment of health-related quality of life (HRQoL) has therefore become increasingly important as HRQoL decreases with increasing lines of therapy (LoTs) (Despiégel et al. Clin Lymphoma Myeloma Leuk 2019). In the phase 3 ELOQUENT-2 study (NCT01239797), elotuzumab (E) plus lenalidomide/dexamethasone (Ld) showed a 30% reduction in the risk of progression/death versus Ld in patients with relapsed or refractory MM and 1-3 prior LoTs (median follow-up: 24.5 months; Lonial et al. N Engl J Med 2015). The initial analysis of patient-reported outcomes (PROs) from ELOQUENT-2 at a 3-year extended follow-up showed that the improvement in efficacy observed with ELd was achieved without a detriment to HRQoL (Cella et al. Ann Hematol 2018). Here we present the final analysis of PRO data from ELOQUENT-2. Methods: In ELOQUENT-2, patients with relapsed or refractory MM and 1-3 prior LoTs were randomized 1:1 to receive ELd or Ld in 28-day cycles until disease progression, unacceptable toxicity, or withdrawal of consent. The Brief Pain Inventory-Short Form (BPI-SF; pain severity, pain interference, and worst pain), the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 questionnaire (QLQ-C30; prespecified key domains were physical function, fatigue, global health status/QoL, and pain), and the myeloma-specific module (QLQ-MY20; includes assessment of symptoms and treatment side effects) were administered at baseline (BL), on Day 1 of each treatment cycle, and at the end of treatment/study withdrawal. All randomized patients with ≥1 post-BL assessment were included in each PRO analysis. Overall mean change from BL was compared between treatment groups based on a mixed-effect model for repeated measures; statistical tests for the overall population only included treatment cycles with >30 patients in each treatment group. A paired t-test was used to compare scores at each cycle with BL; an unpaired t-test compared mean values between treatment groups. BPI-SF scores range from 0-10 with lower scores representing better pain outcomes. EORTC QLQ-C30 scores range from 0-100 with higher scores representing better physical functioning and global health status/QoL, and worse fatigue and pain; EORTC QLQ-MY20 scores range from 0-100 with higher scores representing worse symptoms and problems. Results: In total, 646 patients were treated with ELd (n=321) or Ld (n=325); 319 and 311 patients had ≥1 post-BL assessment and were included in the PRO analysis, respectively (minimum follow-up: 70.6 months). BL BPI-SF mean scores for ELd versus Ld were low across all domains: pain severity (2.6 vs 2.9), pain interference (2.5 vs 2.8), and worst pain (3.6 vs 3.8). Scores for all BPI-SF domains remained stable over the course of the study (eg, pain severity: Figure A). ELd-treated patients with BL moderate/severe pain severity (score of ≥5) had significantly lower mean pain severity scores versus Ld-treated patients in Cycles 1-5. A higher proportion of clinical responders (complete or partial response per European Group for Blood and Marrow Transplantation criteria) versus non-responders had a sustained reduction in pain score across all BPI-SF domains: pain severity (18% vs 6%), pain interference (15% vs 6%), and worst pain (30% vs 13%); the difference in time to sustained improvement was not statistically significant between the clinical responders and non-responders for any pain endpoint. For both treatment groups, there was no clinically meaningful change (≥10 points) from BL scores at any cycle (>30 patients) across all key domains for EORTC QLQ-C30 (eg, global health status/QoL: Figure B) and QLQ-MY20. Conclusions: This final analysis of PROs in ELOQUENT-2 confirms that the efficacy benefits observed with addition of elotuzumab to Ld in patients with relapsed or refractory MM treated with 1-3 prior LoTs were achieved without negatively affecting HRQoL compared with Ld. Study support: BMS. Medical writing: Kenny Tran, Caudex, funded by BMS. Disclosures Cella: FACIT.org: Equity Ownership. McKendrick:PRMA Consulting Ltd.: Employment, Other: I am employed by PRMA Consulting Ltd who provide consulting services to a number of pharmaceutical companies. Davis:PRMA Consulting Ltd.: Employment, Other: I am employed by PRMA Consulting Ltd who provide consulting services to a number of pharmaceutical companies.. Vij:Sanofi: Honoraria; Karyopharm: Honoraria; Janssen: Honoraria; Genentech: Honoraria; Celgene: Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria, Research Funding; Takeda: Honoraria, Research Funding. Chen:Bristol-Myers Squibb: Employment.

Download Full-text

FOENIX-CCA2 quality of life data for futibatinib-treated intrahepatic cholangiocarcinoma (iCCA) patients with FGFR2 fusions/rearrangements.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.4097 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 4097-4097

Author(s):

Juan W. Valle ◽

Antoine Hollebecque ◽

Junji Furuse ◽

Lipika Goyal ◽

Funda Meric-Bernstam ◽

...

Keyword(s):

Quality Of Life ◽

Health Status ◽

Global Health ◽

Global Health Status ◽

Phase 2 ◽

Life Data ◽

Eortc Qlq C30 ◽

Eortc Qlq ◽

Eq Vas

4097 Background: In FOENIX-CCA2 (NCT02052778), a pivotal phase 2 study among iCCA patients (pts) with FGFR2 fusions/rearrangements, the highly selective, irreversible FGFR1–4 inhibitor futibatinib demonstrated a confirmed objective response rate of 41.7%, with a 9.7-month median duration of response. Adverse events were manageable with dosing modifications that did not adversely impact on response. We report outcomes for the preplanned analysis of Patient-Reported Outcomes (PROs) during futibatinib treatment as a secondary objective of FOENIX-CCA2. Methods: Pts enrolled in FOENIX-CCA2 had locally advanced/metastatic unresectable iCCA with FGFR2 fusions/rearrangements, ≥1 prior line of therapy (including gemcitabine/cisplatin) and ECOG PS 0-1. Pts received oral futibatinib 20 mg continuous QD dosing per 21-day cycle. PRO measures included EORTC-QLQ-C30 (1 global health, 5 functional, 9 symptom scales), EQ-5D-3L, and EQ visual analogue scale (VAS). PROs were collected at screening, cycles 2 and 4, every 3 cycles thereafter, and end of treatment. PRO data were evaluated up to cycle 13, the last visit before data were missing for >50% of the PRO population (PRO primary assessment time point). Results: 92/103 (89.3%) pts enrolled had PRO completion data at baseline and a minimum of 1 follow-up assessment (median age 58 y, 56.5% female), with 48 pts having PRO data at cycle 13. At baseline, mean (SD) EORTC QLQ-C30 global health status score was 70.1 (19.4) and EQ VAS score 71.7 (20.3). Mean EORTC QLQ-C30 global health status scores were maintained from baseline to cycle 13, corresponding to 9.0 months on treatment, with no clinically meaningful (≥10-point) changes in individual functional measures (Table). EORTC QLQ-C30 scores across individual symptom measures were also stable from baseline through cycle 13; only constipation showed an average of 10.0-point worsening at only cycle 4. Mean EQ VAS scores were sustained from baseline to cycle 13 (mean change ranging -1.8 to +4.8 across cycles), with values maintained within the population norm range from across 20 countries. Conclusions: Quality of life data from the phase 2 FOENIX-CCA2 trial show that physical, cognitive and emotional functioning, and overall health status were maintained among pts with advanced iCCA receiving futibatinib. Clinical trial information: NCT02052778. [Table: see text]

Download Full-text

Improvements in Health-Related Quality of Life and Symptoms in Patients with Previously Untreated Chronic Lymphocytic Leukemia: Final Results from the Phase II GIBB Study of the Combination of Obinutuzumab and Bendamustine

Blood ◽

10.1182/blood-2019-123630 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 3491-3491 ◽

Cited By ~ 1

Author(s):

Alexey Danilov ◽

Habte A Yimer ◽

Michael Boxer ◽

John M Burke ◽

Sunil Babu ◽

...

Keyword(s):

Quality Of Life ◽

Health Status ◽

Chronic Lymphocytic Leukemia ◽

Global Health ◽

Research Funding ◽

Lymphocytic Leukemia ◽

Future Health ◽

Equity Ownership

Introduction: Longitudinal changes in health-related quality of life (HRQoL) are important in patients with chronic lymphocytic leukemia (CLL). GIBB (NCT02320487) is an open-label, single-arm phase II study of obinutuzumab (GA101; G) in combination with bendamustine (G-Benda) in patients with previously untreated CLL. A previous report from the GIBB study demonstrated an investigator-assessed objective response rate of 89.2%, a complete response rate of 49.0%, and no unexpected safety signals with G-Benda (Sharman et al. J Clin Oncol 2017). Here we report the final HRQoL data over 3 years from the GIBB study. Methods: Enrolled patients received G-Benda by intravenous infusion over six 28-day cycles: G 100mg on Day (D)1, 900mg on D2, and 1000mg on D8 and D15 of Cycle (C)1, then 1000mg on D1 of C2-6; benda 90mg/m2 on D2-3 of C1, and on D1-2 of C2-6. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) includes a global health status measure, 5 functional scales (physical, emotional, cognitive, social, and role functioning), 8 symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, and diarrhea), and an item on financial difficulties (Aaronson et al. J Natl Cancer Inst 1993). The EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) is a 16-item module, specific to CLL, containing 4 multi-item scales (fatigue, treatment side effects, disease symptoms, and infection) and 2 single items (social activities and future health worries). Both questionnaires were completed by patients on C1D1 (baseline), C3D1, and C6D1, at the end of induction (EOI) treatment (defined as +28 days from C6D1 or early treatment termination visit), at the response visit (defined as 2-3 months after the EOI treatment for all patients who received study treatment and had not experienced disease progression), and every 3 months thereafter at follow-up visits for up to 2 years. In total, there were 14 timepoints where data were collected. HRQoL scores were linear transformed to a 0-100-point scale. Mean baseline scores and mean score changes from baseline at each visit were evaluated. A threshold of ≥10-point change in score represents a clinically meaningful difference. For symptoms, negative change scores from baseline reflect an improvement in symptom burden. For global health status and functioning, positive change scores from baseline reflect improvements. Results: The trial enrolled 102 patients. Median age was 61 years and 68.4% of patients were male. Ninety-eight patients (96%) completed a questionnaire at baseline and at least 1 other questionnaire during a follow-up visit. Questionnaire completion rates at 14 time points ranged from 96% at baseline to 66% at 27 months follow-up (Table 1). According to the EORTC QLQ-C30 (Figure 1), improvements were observed for global health status at all follow-up visits, and clinically meaningful improvements were observed at the response visit, 3 months follow-up, and 27 months follow-up. Clinically meaningful improvements in role functioning were observed at EOI and persisted throughout the 27-month follow-up. For fatigue, clinically meaningful improvements were observed at every visit starting from the end of treatment (EOT) visit. Improvements were also observed for insomnia with mean reductions from baseline ≥10 points at various time points during follow-up. There was no worsening in other patient-reported symptoms or functional status over time. Similarly, with the EORTC QLQ-CLL16 (Figure 2), clinically meaningful improvements in symptoms were observed for fatigue, disease symptoms, and future health worries during treatment, at the EOT and/or throughout the follow-up. The largest improvement was observed for fatigue (-24.7) at the 24-month follow-up and future health worries (-25.4) at the 27-month follow-up. Conclusions: We previously reported that G-Benda is an effective regimen for first-line treatment of CLL with no unexpected safety signals. The HRQoL data from the GIBB trial suggest that G-Benda treatment consistently improved patient HRQoL over time. Several clinically meaningful improvements were observed in HRQoL, including global health status, functioning, symptoms, and future health worries. Disclosures Danilov: AstraZeneca: Consultancy, Research Funding; Genentech: Consultancy, Research Funding; TG Therapeutics: Consultancy; MEI: Research Funding; Bristol-Meyers Squibb: Research Funding; Verastem Oncology: Consultancy, Other: Travel Reimbursement , Research Funding; Takeda Oncology: Research Funding; Genentech: Consultancy, Research Funding; Bristol-Meyers Squibb: Research Funding; Takeda Oncology: Research Funding; Aptose Biosciences: Research Funding; Aptose Biosciences: Research Funding; Janssen: Consultancy; Pharmacyclics: Consultancy; Bayer Oncology: Consultancy, Research Funding; Celgene: Consultancy; Pharmacyclics: Consultancy; Janssen: Consultancy; Curis: Consultancy; Seattle Genetics: Consultancy; Verastem Oncology: Consultancy, Other: Travel Reimbursement , Research Funding; Gilead Sciences: Consultancy, Research Funding; Bayer Oncology: Consultancy, Research Funding; Curis: Consultancy; Seattle Genetics: Consultancy; MEI: Research Funding; TG Therapeutics: Consultancy; Celgene: Consultancy; Gilead Sciences: Consultancy, Research Funding; AstraZeneca: Consultancy, Research Funding; Abbvie: Consultancy; Abbvie: Consultancy. Yimer:AstraZeneca: Speakers Bureau; Janssen: Speakers Bureau; Seattle Genetics: Honoraria; Celgene: Honoraria; Clovis Oncology: Equity Ownership; Puma Biotechnology: Equity Ownership; Amgen: Consultancy. Boxer:Gerson Lerman: Consultancy; Best Doctors: Consultancy; Takeda: Honoraria, Speakers Bureau; AbbVie: Honoraria, Speakers Bureau. Burke:Celgene: Consultancy; Gilead: Consultancy; Roche/Genentech: Consultancy. Babu:Genentech: Research Funding. Li:Genentech: Employment; Roche: Equity Ownership. Mun:Genentech: Employment, Equity Ownership. Trask:Genentech: Employment, Equity Ownership. Masaquel:Roche: Equity Ownership; Genentech: Employment. Sharman:Acerta: Consultancy, Honoraria, Research Funding; Pharmacyclics LLC, an AbbVie Company: Consultancy, Honoraria, Research Funding; AbbVie: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Research Funding; Genentech: Consultancy, Honoraria, Research Funding; TG Therapeutics: Consultancy, Honoraria, Research Funding; AstraZeneca: Consultancy, Honoraria, Research Funding. OffLabel Disclosure: GAZYVA (obinutuzumab) is a CD20-directed cytolytic antibody and is indicated: in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia; in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen

Download Full-text

OS09.7.A Quality of life outcomes in patients with incidental and operated meningiomas: the QUALMS study

Neuro-Oncology ◽

10.1093/neuonc/noab180.040 ◽

2021 ◽

Vol 23 (Supplement_2) ◽

pp. ii12-ii13

Author(s):

S M Keshwara ◽

A I Islim ◽

C P Millward ◽

C S Gillespie ◽

G E Richardson ◽

...

Keyword(s):

Quality Of Life ◽

Global Health ◽

Cognitive Functioning ◽

Emotional Health ◽

Health Score ◽

Sf 36 ◽

Eortc Qlq

Abstract BACKGROUND Long-term Health-Related Quality of Life (HRQoL) is an important measure of patient wellbeing. There is a paucity of studies evaluating HRQoL in meningioma patients. MATERIAL AND METHODS Cross-sectional study of adult patients with an incidental or symptomatic intracranial meningioma. Patients with less than 5 years of follow-up, a history of craniospinal radiation or neurofibromatosis type 2 were excluded. HRQoL was evaluated with SF-36, EORTC QLQ-C30 and EORTC QLQ-BN20 questionnaires. Outcome determinants were evaluated using a multi-variable linear regression analysis, adjusted for patient, tumour and treatment characteristics, and duration of follow-up. RESULTS 699 patients were invited to participate and 246 responded: 118 (48%) had an incidental meningioma. Mean age at diagnosis was 56.8 years (SD=13) and 81% were female. Median time from diagnosis to completion of questionnaire was 8.5 years (IQR 6.8–11.5). During follow-up, 158 patients (64.2%) had at least one operation for their meningioma and 47 patients (19.1%) had radiotherapy. Of those operated, 126 (79.7%) had WHO grade 1 and 24 (15.2%) had grade 2 meningiomas. Compared to normative population values, meningioma patients reported a worse SF-36 general health score (mean 61.9 vs 56.5, P=0.003) but a similar QLQ-C30 global health score (mean 62.3 vs 65.8, P=0.039), worse SF-36 and QLQ-C30 physical functioning scores (mean 74.1 vs 64.6, P<0.001 and mean 81.8 vs 76.5, P=0.007) and similar SF-36 and QLQ-C30 emotional health scores (mean 72.2 vs 70.9, P=0.367 and mean 71.0 vs 71.9, P=0.960). QLQ-C30 cognitive functioning was worse (mean 80.5 vs 71.4, P<0.001). Compared to the meningioma literature, QLQ-BN20 seizure burden was similar (mean 2.0 vs 1.6, P=0.760). A worse performance status at diagnosis was associated with an inferior QLQ-C30 global health score (β-coefficient=-4.9 [95% CI -9.1-(-)0.6] P=0.024). Number of surgeries was significantly associated with a worse QLQ-C30 cognitive functioning score (β-coefficient=-7.0 [95% CI -13.2-(-)0.9], P=0.025). Anti-epileptic drug use was associated with a significantly worse QLQ-C30 emotional health score (β-coefficient=-10.9 [95% CI -21.7-(-)0.01], P=0.050). CONCLUSION Meningioma patients have long-term HRQoL impairments affecting their physical and cognitive functions. An understanding that multiple surgeries affects cognitive function, and the need for anti-epileptic drugs equate to poorer emotional health, could help target appropriate therapies and support in the future.

Download Full-text

Patient-Reported Outcomes (PRO) Data from Patients (Pts) with Essential Thrombocythemia (ET) Enrolled in the MOST Study

Blood ◽

10.1182/blood-2019-124527 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 1665-1665

Author(s):

Ellen K. Ritchie ◽

Anas Al-Janadi ◽

Philomena Colucci ◽

Patricia Kalafut ◽

Dilan Paranagama ◽

...

Keyword(s):

Quality Of Life ◽

Global Health ◽

Research Funding ◽

Symptom Burden ◽

Advisory Board ◽

Employment Equity ◽

Scale Scores ◽

Equity Ownership ◽

Eortc Qlq

Introduction: ET is a chronic myeloproliferative neoplasm (MPN) characterized by thrombocytosis and an increased risk for thrombotic and hemorrhagic events. ET can be associated with substantial symptom burden, impaired quality of life (QoL), and reduced survival. PRO data pertaining to the impact of ET on QoL and symptom burden in these pts are limited. The ongoing Myelofibrosis and Essential Thrombocythemia Observational STudy (MOST) was designed to collect data about the demographics, disease burden, PROs, and management of pts with ET or myelofibrosis (MF) in clinical practices throughout the United States. This analysis describes PROs from pts with ET enrolled in MOST. Methods: MOST is a longitudinal, multicenter, noninterventional, prospective, observational study (NCT02953704). Eligible adults with ET were ≥60 years of age, had a history of thrombotic events, or were receiving ET-directed therapy. PROs were collected in conjunction with usual-care visits approximately every 6 months over a planned observation period of 36 months. Patient-reported symptom burden was assessed with the disease-specific MPN Symptom Assessment Form Total Symptom Score (MPN-SAF TSS), composed of 10 items (fatigue, early satiety, abdominal discomfort, inactivity, concentration problems, night sweats, itching, bone pain, fever [>100oF], weight loss). The MPN-SAF numbness/tingling item was also included in the questionnaire but was not included in the TSS calculation. Symptom severity was graded from 0 (absent) to 10 (worst imaginable), with a possible TSS ranging from 0 to 100. Health-related QoL was evaluated with the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 v3.0), composed of 5 functional scales, 3 symptom scales, 6 additional single-symptom items, and a global health/QoL scale. For functional and global health/QoL scales, higher scores indicate higher functioning and better global health/QoL, respectively. For symptom scales/items, higher scores indicate greater symptom burden. High-risk pts and low-risk pts receiving ET-directed therapy (excluding aspirin only) with baseline PRO data were included in this analysis. Data were summarized with descriptive statistics. Results: The MOST study enrolled 1234 pts with ET between Nov 29, 2016 and March 29, 2019 at 124 sites. Of these pts, 794 qualified for this analysis (data cut-off date, June 17, 2019); median age was 70 (range, 19-93) years, 80% were ≥60 years of age, 68% were women, 90% were white, 42% were working full or part-time, and 4% had a documented family history of MF, ET, or polycythemia vera. The majority of pts (87%) had high-risk ET. At enrollment, 768 pts completed the MPN-SAF. Mean (SD) TSS was 17.1 (15.6); 33% of pts had TSS ≥20. Women had higher mean (SD) TSS than men (18.5 [15.8] vs 14.2 [14.9]) and had higher mean individual symptom scores, except for weight loss and fever. The highest mean (SD) individual symptom scores were fatigue (3.4 [2.7]), numbness/tingling (2.3 [3.0]), inactivity (2.3 [2.8]), and early satiety (2.3 [2.7]) (Fig A). The most frequently reported severe symptoms (ie, score ≥7) were fatigue (17% [127/746]), numbness/tingling (14% [107/767]), and inactivity (11% [86/762]). At enrollment, 794 pts completed the EORTC QLQ-C30. The highest mean (SD) symptom scale scores (score ≥15) were fatigue (29.6 [25.8]), insomnia (28.6 [30.6]), pain (22.1 [27.9]), dyspnea (17.2 [25.5]), and constipation (15.7 [25.2]) (Fig B). The mean (SD) global health status/QoL score was 72.7 (21.9); functional scores ranged from 79.9 (21.9) for emotional functioning to 85.2 (24.1) for social functioning (Fig C). The average functional scale scores and symptom scale scores indicate higher functioning and less symptom burden, respectively, in men vs women. Conclusion: Pts with ET experienced a high symptom burden; fatigue was the most common and highest in severity. Symptom burden and quality of life scores in the current study were similar to prior reports (Emanuel J Clin Oncol 2012; Scherber Blood 2011). Women reported higher symptom burden than men in both the MPN-SAF and EORTC QLQ-30. Of note, numbness/tingling, which is not included in the MPN-SAF TSS calculation, was one of the most frequently reported severe symptoms for pts with ET in MOST. Future analyses from this trial will continue to increase understanding of the symptom burden and its impact on QoL in pts with ET. Disclosures Ritchie: Celgene, Incyte, Novartis, Pfizer: Consultancy; Genentech: Other: Advisory board; Tolero: Other: Advisory board; Pfizer: Other: Advisory board, travel support; agios: Other: Advisory board; Celgene: Other: Advisory board; Jazz Pharmaceuticals: Research Funding; Celgene, Novartis: Other: travel support; AStella, Bristol-Myers Squibb, Novartis, NS Pharma, Pfizer: Research Funding; Ariad, Celgene, Incyte, Novartis: Speakers Bureau. Al-Janadi:Incyte: Honoraria, Other: Travel, Accommodations, Expenses, Research Funding; Celgene: Honoraria, Other: Travel, Accommodations, Expenses, Research Funding, Speakers Bureau; Genentech/Abbvie: Honoraria, Other: Travel, Accommodations, Expenses, Speakers Bureau; Genentech/Roche: Honoraria, Other: Travel, Accommodations, Expenses, Speakers Bureau; Gilead Sciences: Consultancy, Honoraria, Other: Travel, Accommodations, Expenses; Sandoz-Novartis: Consultancy, Honoraria; Alexion Pharmaceuticals: Consultancy, Honoraria, Other: Travel, Accommodation, Expenses, Research Funding, Speakers Bureau; Takeda: Consultancy, Honoraria, Other: Travel, Accommodations, Expenses, Research Funding, Speakers Bureau; MEI Pharma: Research Funding; Seattle Genetics: Consultancy, Honoraria, Other: Travel, Accommodations, Expenses. Colucci:Incyte: Employment, Equity Ownership. Kalafut:Incyte: Employment, Equity Ownership. Paranagama:Incyte: Employment, Equity Ownership. Mesa:Genotech: Research Funding; Promedior: Research Funding; Sierra Onc: Consultancy; Celgene: Research Funding; AbbVie: Research Funding; Novartis: Consultancy; La Jolla Pharma: Consultancy; CTI Biopharma: Research Funding; Samus: Research Funding; Incyte: Research Funding.

Download Full-text

Allogeneic Transplantation from an HLA-Matched Family Donor in First Complete Remission of Acute Myeloid Leukemia Had an Adverse Impact on Quality of Life in Patients Followed for at Least Five Years after Treatment: A Survey of the German AML Intergroup on 525 Patients.

Blood ◽

10.1182/blood.v106.11.747.747 ◽

2005 ◽

Vol 106 (11) ◽

pp. 747-747

Author(s):

Dorle Messerer ◽

Jutta Engel ◽

Jörg Hasford ◽

Markus Schaich ◽

Silke Soucek ◽

...

Keyword(s):

Quality Of Life ◽

Health Status ◽

Global Health ◽

Odds Ratio ◽

Cardiac Insufficiency ◽

Global Health Status ◽

Concomitant Disease ◽

The Impact

Abstract The impact of allogeneic blood stem cell transplantation (Allo-SCT) in comparison to conventional chemotherapy (CCT) in AML on quality of life remains unclear mainly due to a lack of studies with long term follow-up. Therefore the German AML-Intergroup initiated a survey on quality of life for patients treated within 1 of 8 German prospective multicenter treatment trials. All patients completed a self-report questionnaire either when they returned for follow-up outpatient visits or by mail. Patients completed the EORTC Quality of Life-Core Questionnaire (QLQ-C30) supplemented by self-assessed concomitant diseases, late treatment effects and demographic details including percentage of disability. 525 patients (median age: 46 years at diagnosis; median follow up period: 9 years) returned their questionnaires, 244 after SCT in 1. CR (189 allo; 55 auto) and 281 after CCT. Recovery-rate of the questionnaires was 55% ranging from 40% to 79% in the different trial cohorts. Due to low numbers after auto-SCT these patients were excluded from further analysis. The ECOG activity index revealed normal activity in 40% and 58% and disabled person card in 63% and 37% of the patients in the allo-SCT and CCT groups, respectively. Impaired vision, cataract surgery, chronic skin disorders and treatment of hormonal disorders were reported significantly more often in allo-SCT-patients, whereas osteoarthritis, cardiac insufficiency and unspecific back pain were slightly more frequent in CCT patients, mainly due to a higher median age in the CCT-group. All QLQC-30 functions except physical functioning and pain were in favor of CCT (p<0.001 in each variable). Problems in leisure-time activity, evenness and social life (friends and family) as well as financial management were significantly more frequent in patients after Allo-SCT than in patients after CCT, whereas the general assessment of positive attitude in life showed no difference between the two groups (62% CCT and 64% Allo-SCT). Multivariate logistic regression models on global health status and fatigue were performed. Actually concomitant disease (odds ratio 6.68 95%-CI 3.83–11.66), age > 45 years (odds-ratio 2.57 95%-CI 1.47–4.50) and Allo-SCT (odds ratio 2.10 95%-CI 1.20 – 3.69) showed significant adverse effect on global health status. Similarly unfavorable effects were evaluated for actually concomitant disease and Allo-SCT on fatigue. These results indicate that Allo-SCT compared to intensive chemotherapy had a significant negative impact on quality of life and this needs to be considered when reviewing treatment options.

Download Full-text

Quality of Life Assessment in Patient who Underwent Chemotherapy in Gynaecologic Oncology Division

Indonesian Journal of Obstetrics and Gynecology ◽

10.32771/inajog.v8i4.1353 ◽

2020 ◽

pp. 244-248

Author(s):

Hariyono Winarto ◽

William Halim

Keyword(s):

Quality Of Life ◽

Health Status ◽

Global Health ◽

Life Assessment ◽

Global Health Status ◽

Life Questionnaire ◽

European Organization ◽

Quality Of Life Questionnaire ◽

Eortc Qlq

Abstract Objective: To determine the quality of life in cancer patients who underwent chemotherapy treatment.Methods: A cross-sectional study was conducted from June to August 2019. Patients with cancer, who had undergone chemotherapy and willing to participate were included in this study. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ–30) questionnaire was used as the measurement tool. The patients were grouped into three groups based on the cycles of chemotherapy.Results: Sixty three responders participated in the study. As the treatment progressed, there was a signifi cant decrease in Global Health Status (GHS) and social function. In symptom scales, there was a signifi cant increase in nausea and vomiting, pain, and insomnia.Conclusions: There was a decrease in the quality of life in patients with gynecological cancer who underwent chemotherapy in dr. Cipto Mangunkusumo National General Hospital. This result should be an evaluation for the healthcare provider to implement a holistic approach in managing cancer patients.Keywords: chemotherapy, gynaecological cancer, quality of life. Abstrak Tujuan: Untuk menilai kualitas hidup pasien kanker yang menjalani kemoterapi.Metode: Penelitian dilakukan dengan metode potong lintang, dilakukan dari Juni hingga Agustus 2019. Semua pasien dengan kanker yang menjalani kemoterapi dan bersedia mengikuti penelitian diikutsertakan dalam penelitian ini. Penilaian dilakukan menggunakan kuisioner dari The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ- 30) digunakan. Pasien dikelompokkan menjadi 3 kelompok berdasarkan siklus kemoterapinya.Hasil: Terdapat 63 pasien yang berpartisipasi dalam penelitian ini. Seiring pengobatan, terdapat penurunan signifikan pada global health status (GHS) dan fungsi sosial. Gejala yang meningkat secara signifi kan antara lain mual dan muntah, nyeri, dan insomnia.Kesimpulan: Terdapat penurunan kualitas hidup pada pasien kanker ginekologi yang menjalani kemoterapi di Rumah Sakit Dr. Cipto Mangunkusumo. Hasil penelitian ini menjadi evaluasi untuk penyedia layanan kesehatan agar dapat menangani pasien kanker secara holistik.Kata kunci: kanker ginekologi, kemoterapi, kualitas hidup.

Download Full-text

Impact on quality of life of adding cetuximab to irinotecan in patients who have failed prior oxaliplatin-based therapy: The EPIC trial

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.4003 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 4003-4003 ◽

Cited By ~ 15

Author(s):

C. Eng ◽

J. Maurel ◽

W. Scheithauer ◽

L. Wong ◽

M. Lutz ◽

...

Keyword(s):

Quality Of Life ◽

Health Status ◽

Global Health ◽

Progression Free Survival ◽

Phase Iii ◽

Global Health Status ◽

Significant Difference ◽

Eortc Qlq ◽

The Impact

4003 Background: EPIC, a multinational phase III clinical trial examined the impact of cetuximab on survival in pretreated EGFR- expressing metastatic colorectal (MCRC) patients (pts). Pts were randomized to either cetuximab 400 mg/m2 followed by 250 mg/m2 weekly and irinotecan 350 mg/m2 q 3 weeks or irinotecan alone. The primary endpoint was overall survival (OS) with quality of life being one of the secondary endpoints. Methods: Health Related Quality of life (HRQoL) of pts in this trial was assessed through the EORTC QLQ-C30 questionnaire, version 3.0. Pts completed the questionnaire pretreatment, every second cycle, and at first follow-up visit. HRQoL was compared between treatment arms using a Wei-Lachin test. Results: Baseline demographics were balanced between the arms. Cetuximab plus irinotecan (n=648) was superior to irinotecan alone (n=650) in progression-free survival (HR 0.69, p<.0001) and response rate (16.4 vs 4.2%, p<.0001). OS was comparable between the arms, but may have been influenced by subsequent therapy: 46% of subjects in the irinotecan alone arm received cetuximab, 89% of them in combination with irinotecan. Baseline HRQoL scores did not significantly differ between treatment arms for 11 of the 15 scales. For 4 scales (Social Functioning, Fatigue, Dyspnea, and Appetite Loss), there were statistically significant differences in baseline scores, in favor of the cetuximab plus irinotecan arm. Non- compliance rates (missing questionnaires) were similar between the arms. A statistically significant difference was noted for pts in the cetuximab plus irinotecan arm in HRQoL on 10 of the 15 scales as compared to patients in the irinotecan arm, with the scores of the cetuximab plus irinotecan arm consistently higher, as noted by the scales of Global Health Status (p=.047), pain (p< .0001), and nausea (p<.0001). Conclusions: In addition to statistically significant improvements in PFS and RR in patients receiving cetuximab plus irinotecan compared with irinotecan alone, HRQoL was better preserved on the combination arm with less deterioration in symptom scores (pain, nausea, insomnia), as well as global health status scores. No significant financial relationships to disclose.

Download Full-text

An Evaluation of Half-Body Irradiation in the Treatment of Widespread, Painful Metastatic Bone Disease

Tumori Journal ◽

10.1177/030089160809400607 ◽

2008 ◽

Vol 94 (6) ◽

pp. 813-821 ◽

Cited By ~ 7

Author(s):

Leszek Miszczyk ◽

Andrzej Tukiendorf ◽

Aleksandra Gaborek ◽

Jerzy Wydmański

Keyword(s):

Quality Of Life ◽

Health Status ◽

Global Health ◽

Pain Intensity ◽

Observation Time ◽

Global Health Status ◽

Pain Level ◽

Eortc Qlq C30 ◽

Eortc Qlq

Aims Evaluation of analgesic uptake, pain intensity, and quality-of-life changes after half-body irradiation of patients with bone metastases. Material and Methods Ninety-five patients (97 irradiations) were treated with single half-body irradiation fraction (3–8 Gy). Thirty-three patients had upper-half-body irradiation, 55 lower-half-body irradiation and 9 middle-half-body irradiation. The patients were examined on the day of irradiation, 2 and 4 weeks later, and then once a month. The intake of analgesics, pain level (from 0 to 10), and the quality of life (EORTC QLQ-C30) were evaluated. The fluctuations of pain levels and the particular scaling values of QLQ-C30 during a one-year period were analyzed (Kendall t correlation). Results Over the course of 5 months, the incidence of patients using strong opioids decreased from 43.8% to 33.3%, and the incidence of patients who did not need to resort to analgesics increased from 6.7% to 25%. The mean pain level decreased from 6.1 points (half-body irradiation) to 3.1 points 2 weeks later. An inverse correlation between pain level readings and time was statistically significant. An increase was observed in the values of the five functional scales as reflected on the EORTC QLQ-C30 questionnaire (four of which correlated significantly with the observation time). A similar situation prevailed with respect to global health status. A decrease was observed in most of the values on the symptoms scales; 6 saw a significant decrease, in correlation with the follow-up. Correlations were also found between pain intensity and functionality, and between symptoms scales readings and global health status. Conclusions Half-body irradiation of cancer patients suffering from painful multiple bone dissemination is an effective and simple treatment modality that affords significant quality-of-life improvement and pain relief, thus allowing for a reduction in the use of strong analgesics.

Download Full-text

The Effect of Chemotherapy on Quality of Life of the Patients with Metastatic Gastric and Colorectal Cancer

The Journal of Tepecik Education and Research Hospital ◽

10.5222/terh.2021.77598 ◽

2021 ◽

Author(s):

Selda Çakın Ünnü ◽

Ilkay Tugba Unek ◽

Ömercan Topaloğlu

Keyword(s):

Quality Of Life ◽

Colorectal Cancer ◽

Health Status ◽

Global Health ◽

Palliative Chemotherapy ◽

Global Health Status ◽

Symptom Scores ◽

Eortc Qlq C30 ◽

Eortc Qlq

Objective: The self-administered questionnaires by the patients are among the most important methods to evaluate the patient’s health related quality of life. The objective of the study was to evaluate the effect of chemotherapy on quality of life of the patients receiving palliative chemotherapy with the diagnosis of metastatic gastric and colorectal cancer by using EORTC QLQ-C30. Methods: This study included 100 patients who were treated with palliative chemotherapy for the diagnosis of metastatic gastric or colorectal cancer in İzmir Tepecik Education and Research Hospital Department of Medical Oncology between 2011-2012. The EORTC QLQ-C30 questionnaire was filled twice by the patients before chemoterapy started and after chemotherapy completed. Results: When the two questionnaires were compared, it was found that global health status and physical functioning did not change after the chemotherapy. Role functioning, cognitive functioning, and social functioning impaired but emotional functioning improved (p<0.05). After the chemoterapy, scores of fatigue and constipation decreased but financial difficulties increased (p<0.05). The symptom scores of nausea-vomitting, pain, dyspnea, insomnia, anorexia, diarrhea did not change. Conclusion: The results of this study suggested that a quality of life assessment with the EORTC QLQ-C30 questionnaire would be beneficial in patients with metastatic gastric and colorectal cancer. In this way, impairments in functional scores, global health status and symptom scores that may occur after chemotherapy can be detected, clinicians can be helped to decide on the switch to chemotherapy regimens that are similar in effectiveness but have different side effects profile, the patients’ quality of life can be improved as a result of the application of the necessary palliative treatments.

Download Full-text

Health-Related Quality of Life in Waldenstrom Macroglobulinemia (WM) and IgM Monoclonal Gammopathy of Undeterminated Significance (IgM-MGUS)

Blood ◽

10.1182/blood-2018-99-111444 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 3593-3593

Author(s):

Anna Maria Frustaci ◽

Michele Nichelatti ◽

Marina Deodato ◽

Maddalena Mazzucchelli ◽

Marco Montillo ◽

...

Keyword(s):

Quality Of Life ◽

Health Status ◽

Global Health ◽

Global Health Status ◽

Emotional Function ◽

Vas Score ◽

Eortc Qlq C30 ◽

Eortc Qlq ◽

The Impact

Abstract The clinical course of WM widely differs among patients, with some manifesting symptoms as a consequence of the monoclonal IgM component or lymphoma infiltration. IgM-MGUS is generally asymptomatic while, in some cases, paraprotein-related manifestations may occur. Patients with IgM-MGUS should perform a regular follow-up as they are at risk of developing WM or other B-cell lymphoproliferative disorders (1.5-2% per year). Although WM typically afflicts the elderly, there are no studies addressing the impact of ECOG performance status and comorbidities on patients' outcome. Furthermore, to our knowledge health-related quality of life (HRQOL) has never been evaluated in this category. The aim of this study is to analyze the impact of diagnosis and patients' characteristics on quality of life. From October 2017, HRQOL was assessed in 103 patients (37 WM with previous or ongoing treatment [tWM]; 29 asymptomatic MW [aWM]; 37 IgM-MGUS) by the administration of EORTC QLQ-C30, HADS, FACT-GOG neurotoxicity and EQ-5D-5L questionnaires. Demographic anamnestic and disease-related data were also collected for each patient. The same questionnaires continue to be administered every 6 months for 3 years, in order to capture changes in HRQOL over time. Patients features are reported in table 1. No significant differences in terms of age, sex distribution, age at diagnosis, months from diagnosis, ECOG performance status, CIRS or number of concomitant medications, were detected among the 3 groups (table 1). As regards CIRS, the organ systems mainly involved resulted: vascular and genitourinary for tWM, genitourinary for aWM and vascular, respiratory and genitourinary for IgM-MGUS. Among the 3 groups no statistical differences were reported when analyzing: EORTC QLQ-C30 global health status, functional scales (physical, role, emotional, cognitive and social functioning) and symptoms scale, EQ-5D VAS score, HADS anxiety and depression scores or FACT-GOG neurotoxicity score. Males had higher global health status and emotional function when compared to females both in IgM-MGUS and WM patients. Higher CIRS score and ECOG status negatively impacted on global health status, physical function, EQ-5D VAS score and anxiety both in WM and IgM-MGUS. WM patients with longer time from diagnosis showed a significantly worse emotional function. Patients-reported symptoms that could be referred to peripheral neuropathy (PN, 39 patients) resulted the only significant parameter negatively impacting on HRQOL (global health status, functional and symptoms scales according to EORTC QLQ-C30 and EQ-5D VAS score) and also affecting HADS anxiety score. The diagnosis of PN was confirmed by neurologic tests only in 16/39 subjects that, compared with the rest of the population, showed older age (p .019), older age at diagnosis (p . 015) and higher ECOG status (p .005). In these patients, EORTC QLQ-C30 detected a reduced cognitive function (p .0031), while HADS a greater perception of anxiety (p .0015). No differences were recorded for EQ-5D VAS score or HADS depression scale. In conclusion, in our series diagnosis per se didn't seem to affect HRQOL which was negatively influenced by high ECOG status and comorbidities. Emotional function meaningfully deteriorated as the time lapse from diagnosis became longer. Quality of life was significantly altered in patients reporting symptoms of PN and this was confirmed by all the questionnaires. Longer follow up is needed to confirm these preliminary data. Disclosures Montillo: Roche: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria, Speakers Bureau; Gilead: Consultancy, Honoraria, Speakers Bureau. Tedeschi:Janssen: Consultancy, Speakers Bureau; AbbVie: Consultancy; Gilead: Consultancy.

Download Full-text