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 ◽  
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.

scholarly journals Factors associated with health-related quality of life in patients with glioma: impact of symptoms and implications for rehabilitation

2020 ◽  
Vol 50 (9) ◽  
pp. 990-998
Author(s):  
Shigeko Umezaki ◽  
Yusuke Shinoda ◽  
Akitake Mukasa ◽  
Shota Tanaka ◽  
Shunsaku Takayanagi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
World Health Organization ◽  
Social Functioning ◽  
World Health ◽  
Global Health Status ◽  
Health Organization ◽  
The Impact

Abstract Objective The factors associated with health-related quality of life in patients with glioma remain unclear; particularly, the impact of symptoms on quality of life has not been studied comprehensively. This study aims to document the quality of life of patients with glioma and clarify the impact of symptoms. Methods In this cross-sectional study, participants were recruited from patients at The University of Tokyo Hospital and from patients who were registered at the Japan Brain Tumor Alliance. We included adult patients with World Health Organization grade II–IV glioma and excluded those with disturbances of consciousness or aphasia. We used the European Organization for Research and Treatment of Cancer QLQ-C30 and BN20 to evaluate quality of life and the symptoms. Multiple regression analyses were performed to investigate the impact of symptoms on European Organization for Research and Treatment of Cancer global health status and QLQ-C30 social functioning. In addition, we performed univariate subgroup analyses classified by World Health Organization grade and history of chemotherapy. Results This study included 76 patients. Seven symptoms occurred in more than 50% of the patients: fatigue, future uncertainty, drowsiness, communication deficit, financial difficulties, motor dysfunction and weakness of legs. Multiple regression analyses showed that insomnia affected their global health status, and appetite loss, financial difficulties and motor dysfunction were significantly related to their social functioning. In subgroup analysis, the number of symptom subscales that were significantly related to global health status and social functioning was larger in World Health Organization grade II patients compared with grade III/IV patients. Conclusions In addition to neurological deficits, symptoms were associated with poor quality of life in patients with glioma. This study provided the basis on further investigation of usefulness of symptom evaluation on quality of life improvement.

Quality of life and safety profile of pemetrexed-platinum doublet in Indian adult chemo-naive NSCLC patients.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19118-e19118
Author(s):  
Vikram Gota ◽  
Krunal Vasant Kavathiya ◽  
Damodaran S E ◽  
Amit Joshi ◽  
Vanita Noronha ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
Locally Advanced ◽  
Global Health Status ◽  
Significant Difference ◽  
Nsclc Patients ◽  
The Impact ◽  
Platinum Doublet

e19118 Background: Pemetrexed in combination with cisplatin or carboplatin is commonly recommended for the first-line treatment of patients with locally advanced or metastatic NSCLC of adenocarcinoma histology. The present study explores the safety and the impact of this doublet on the quality of life in adult Indian NSCLC patients. Methods: Patients were enrolled from a single tertiary care cancer hospital in India. Patients were administered pemetrexed 500 mg/m2, cisplatin 75 mg/m2or carboplatin AUC 5 every 3 weekly. All patients received standard folate and Vitamin B12 supplementation. Premedication included dexamethasone, granisetron and ranitidine. Quality of Life (QoL) data was collected at baseline and at completion of 3 cycles using EORTC QLQ-C30 (version 3) and QLQ- LC13 questionnaires. Toxicity was graded using CTCAE v. 4.03. Results: Twenty seven patients were enrolled on the study since July 2012.Twenty received carboplatin and seven received cisplatin. Mean age of the participants was 54.7 years (SD=9.58) with stage (IV=25; III A/B=2) and ECOG performance status (0=1; 1=17; and 2=9). Pemetrexed–platinum doublet caused significant improvement in Global Health Status and dyspnea score at 3 cycles compared to baseline (Table). The treatment also caused marked improvement in the physical function, emotional function, cognitive function and insomnia scales, although not statistically significant (Table). No significant difference compared to baseline was observed for other parameters. Grade 3/4 toxicities include anemia (3), neutropenia (3), hyponatremia (6), vomiting), diarrhea, and dyspnea (1 each). Conclusions: Pemetrexed-platinum doublet was well tolerated and markedly improved the global health status and dyspnoea at the end of three cycles. A higher incidence of hyponatreemia was observed in our cohort that needs to be investigated further. [Table: see text]

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

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4003-4003 ◽  
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.

The impact of hereditary multiple exostoses on quality of life, satisfaction, global health status, and pain

2016 ◽  
Vol 137 (2) ◽  
pp. 209-215 ◽  
Author(s):  
Riccardo D’Ambrosi ◽  
Vincenza Ragone ◽  
Camilla Caldarini ◽  
Nicola Serra ◽  
Federico Giuseppe Usuelli ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Life Satisfaction ◽  
Health Status ◽  
Global Health ◽  
Global Health Status ◽  
Hereditary Multiple Exostoses ◽  
Multiple Exostoses ◽  
The Impact

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

Blood ◽  
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.

Quality of Life In Adult De Novo Acute Leukemia Patients

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4747-4747
Author(s):  
Stijn Verleden ◽  
Lucien Noens ◽  
Kurt Audenaert
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
Acute Leukemia ◽  
De Novo ◽  
Well Being ◽  
Global Health Status ◽  
Subjective Well Being

Abstract Abstract 4747 Introduction: Recent advances in the treatment of patients with acute leukemia have increased their long-term survival. However, the side effects of aggressive chemotherapy can have a significant impact on different dimensions of quality of life and various aspects of psychological well-being. Objective: To assess depression, emotional well-being, and quality of life before and after induction treatment in de novo acute leukemia patients. Methods: Current longitudinal-prospective study of adult de novo acute leukaemia patients, treated with induction chemotherapy at Hematology Department, UZ Ghent, Belgium. After enrollment, eligible patients are administered a number of self-report questionnaires, within five days after admission (pre-induction) and after completion of induction (pre-consolidation). We used the CES-D, the shortened version of the POMS, and the EORTC QLQ-C 30, to measure depression, emotional aspects of subjective well-being, and quality of life. Results: Twenty adult de novo acute leukemia patients were enrolled between 01/2009 and 06/2010. The median age was 43 years, 50% were male, 80% had AML (20% ALL), and their median years of education was 12 years. At baseline, patients had a low quality of life, and low role functioning, but also a high level of fatigue. Global health status related with social functioning (r=0.76, p=0.000), and role functioning related with fatigue (r=-0.58, p=0.008). A positive correlation was found between fatigue and nausea (r=0.55, p=0.011), but also pain (r=0.52, p=0.020). Diagnosis of de novo acute leukemia had a clear influence on different aspects of subjective well-being, in particular sixty-five percent of the patients had significant levels of depression (i.e. CES-D≥16) at baseline. Depressed patients had a significant lower global health status, emotional and social functioning (EORTC QLQ-C 30), but also less emotional vigor and more emotional tension (POMS) compared to non-depressed patients. Change in self-assessed measures was found in global health status (p=0.000), emotional functioning (p=0.000), and symptom scales fatigue (p=0.051) and nausea (p=0.005), all five scales of the POMS, and depression (all p<0.05). At follow-up, global health status related with four of the five functional scales, except for cognitive functioning (r=0.15, p=0.553), and also with one symptom scale fatigue (r=-0.64, p=0.003). Global health status related with the POMS vigor subscale (r=0.06, p=0.008) and CES-D depression (r=-0.54, p=0.018). Fatigue related with the POMS fatigue (r=0.62, p=0.005), vigor (r=-0.78, p=0.000), tension (r=0.62, p=0.004), and CES-D depression (r=0.72, p=0.000). At follow-up, thirty-five percent of patients had still significant levels of depression. Multiple regression analysis showed that the POMS subscale vigor had the highest predictive value of depression, of emotional well-being, and patient characteristics to explain quality of life at follow-up. Conclusion: Adult de novo acute leukemia patients have at baseline low quality of life, high levels of depression, and a high negative emotional status of subjective well-being. Changes between two time points were observed across global health status, and some dimensions of quality of life, depression, and all subscales of emotional status of subjective well-being. Psychological follow-up during and after induction treatment with focus on depression, vigor, and fatigue could improve quality of life of these patients. Disclosures: No relevant conflicts of interest to declare.

Quality-of-life findings in patients with midgut neuroendocrine tumors: Results of the NETTER-1 phase III trial.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 348-348 ◽  
Author(s):  
Jonathan R. Strosberg ◽  
Edward M. Wolin ◽  
Beth Chasen ◽  
Matthew H. Kulke ◽  
David L Bushnell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Global Health Status ◽  
High Dose ◽  
Eortc Qlq ◽  
The Impact

348 Background: Neuroendocrine tumor progression is associated with decline in quality of life, both due to tumor and hormone-related symptoms. The Phase III NETTER-1 trial randomized patients with advanced, progressive midgut NETs to receive treatment with 177Lu-DOTATATE (177Lu; Lutathera) versus high-dose (60 mg) Octreotide LAR (Oct). EORTC questionnaires C30 and GINET21 were assessed during the trial in order to determine the impact of treatment on health-related quality of life (HRQoL). Methods: Patients completed EORTC QLQ-30 and QLQ-G.I.NET21 questionnaires at baseline and every 12 weeks thereafter until disease progression. Raw scores were converted to a 100-point scale and individual changes from baseline scores were assessed. Clinically relevant ( ≥ 10 point) deterioration/improvement was considered clinically significant. Results: Clinically and statistically significant improvements in QoL were observed in the 177Lu arm versus the Oct arm at certain time points in key domains of HRQoL including global health status and diarrhea. In mean, global health status improved in 28% of patients on 177Lu arm vs. 15% on Oct, and worsened in 18% of patients on 177Lu vs. 26% on Oct. Diarrhea improved in 39% of patients on 177Lu vs. 23% on Oct, and worsened in 19% of patients on 177Lu vs. 23% on Oct. There was a trend towards improvement in pain that was not statistically significant. Flushing appeared to improve compared to baseline in both arms of the study with no clear advantage to treatment with 177Lu vs. Oct. Conclusions: QoL analysis suggests benefit in important domains associated with 177Lu treatment compared to high-dose octreotide in patients with advanced midgut NETs, and confirms the treatment value of 177Lu on patient QoL, in addition to the meaningful increase in progression-free survival already reported. Clinical trial information: NCT01578239.

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

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]

scholarly journals 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 ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3491-3491 ◽  
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

scholarly journals Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With 177Lu-Dotatate in the Phase III NETTER-1 Trial

2018 ◽  
Vol 36 (25) ◽  
pp. 2578-2584 ◽  
Author(s):  
Jonathan Strosberg ◽  
Edward Wolin ◽  
Beth Chasen ◽  
Matthew Kulke ◽  
David Bushnell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
Phase Iii ◽  
High Dose ◽  
Health Related Qol ◽  
Health Related ◽  
Phase Iii Study ◽  
The Impact

Purpose Neuroendocrine tumor (NET) progression is associated with deterioration in quality of life (QoL). We assessed the impact of 177Lu-Dotatate treatment on time to deterioration in health-related QoL. Methods The NETTER-1 trial is an international phase III study in patients with midgut NETs. Patients were randomly assigned to treatment with 177Lu-Dotatate versus high-dose octreotide. European Organisation for Research and Treatment of Cancer quality-of-life questionnaires QLQ C-30 and G.I.NET-21 were assessed during the trial to determine the impact of treatment on health-related QoL. Patients completed the questionnaires at baseline and every 12 weeks until tumor progression. QoL scores were converted to a 100-point scale according to European Organisation for Research and Treatment of Cancer instructions, and individual changes from baseline scores were assessed. Time to QoL deterioration (TTD) was defined as the time from random assignment to the first QoL deterioration ≥ 10 points for each patient in the corresponding domain scale. All analyses were conducted on the intention-to-treat population. Patients with no deterioration were censored at the last QoL assessment date. Results TTD was significantly longer in the 177Lu-Dotatate arm (n = 117) versus the control arm (n = 114) for the following domains: global health status (hazard ratio [HR], 0.406), physical functioning (HR, 0.518), role functioning (HR, 0.580), fatigue (HR, 0.621), pain (HR, 0.566), diarrhea (HR, 0.473), disease-related worries (HR, 0.572), and body image (HR, 0.425). Differences in median TTD were clinically significant in several domains: 28.8 months versus 6.1 months for global health status, and 25.2 months versus 11.5 months for physical functioning. Conclusion This analysis from the NETTER-1 phase III study demonstrates that, in addition to improving progression-free survival, 177Lu-Dotatate provides a significant QoL benefit for patients with progressive midgut NETs compared with high-dose octreotide.

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