Health-Related Quality-of-Life Analysis From KEYNOTE-045: A Phase III Study of Pembrolizumab Versus Chemotherapy for Previously Treated Advanced Urothelial Cancer

2018 ◽  
Vol 36 (16) ◽  
pp. 1579-1587 ◽  
Author(s):  
David J. Vaughn ◽  
Joaquim Bellmunt ◽  
Yves Fradet ◽  
Jae Lyun Lee ◽  
Lawrence Fong ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
Urothelial Cancer ◽  
Phase Iii ◽  
Global Health Status ◽  
Life Score ◽  
Related Quality ◽  
Advanced Urothelial Cancer

Purpose In the phase III KEYNOTE-045 study ( ClinicalTrials.gov identifier: NCT02256436), pembrolizumab significantly prolonged overall survival compared with investigator’s choice of chemotherapy in patients with previously treated advanced urothelial cancer. Here, we report the results of health-related quality-of-life (HRQoL) analyses from the KEYNOTE-045 trial. Patients and Methods Patients were randomly assigned 1:1 to pembrolizumab 200 mg or investigator’s choice of docetaxel 75 mg/m2, paclitaxel 175 mg/m2, or vinflunine 320 mg/m2 administered intravenously every 3 weeks. Key prespecified HRQoL analyses were time to deterioration (TTD) and mean change from baseline to week 15 in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 global health status/quality-of-life score. Results Of 542 patients who were randomly assigned, 519 were included in HRQoL analyses (pembrolizumab, n = 266; chemotherapy, n = 253). HRQoL compliance was > 95% at baseline and approximately 88% at week 15 for both groups. Pembrolizumab prolonged TTD in global health status/quality-of-life score compared with chemotherapy (median, 3.5 months v 2.3 months; hazard ratio, 0.72; nominal one-sided P = .004). Mean (95% CI) change from baseline to week 15 in global health status/quality-of-life score was 0.69 (−2.40 to 3.77) with pembrolizumab and −8.36 (−11.84 to −4.89) with chemotherapy (mean difference, 9.05 points; 95% CI, 4.61 to 13.50; nominal two-sided P < .001). Conclusion Pembrolizumab prolonged TTD in HRQoL compared with chemotherapy. Patients who were treated with pembrolizumab had stable or improved global health status/quality of life, whereas those who were treated with investigator’s choice of chemotherapy experienced declines in global health status/quality of life. Combined with efficacy and safety outcomes, these data support pembrolizumab as standard of care for patients with platinum-refractory advanced urothelial cancer.

scholarly journals Deterioration of Health-Related Quality of Life Scores under Treatment Predicts Longer Survival

2020 ◽  
Vol 2020 ◽  
pp. 1-10 ◽  
Author(s):  
Maike Jörling ◽  
Sandra Rutzner ◽  
Markus Hecht ◽  
Rainer Fietkau ◽  
Luitpold V. Distel
Keyword(s):  
Quality Of Life ◽  
Overall Survival ◽  
Health Status ◽  
Global Health ◽  
Cox Regression ◽  
Global Health Status ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

Objectives. Baseline health-related quality of life (HRQoL) scores predict survival, which has already been demonstrated in various studies. However, we were interested in whether changes in baseline scores during treatment are also significant predictors of survival. Methods and Materials. We analysed the data of 400 consecutive cancer patients receiving radiochemotherapy. Leading diagnoses were head and neck cancer (34.5%), rectal cancer (24.5%), and lung cancer (13%). HRQoL was studied at baseline, six weeks after therapy and after each completed year after the start of therapy until drop out of the study using the EORTC QLQ-C30 questionnaire. The change score was calculated as the baseline score subtracted from the score after therapy. Statistics included Kaplan-Meier estimates and Cox regression. Results. High global health status (p=0.005) and low pain scores (p=0.040) at baseline were related to favourable overall survival. Change scores of role functioning (p=0.027), global health status (p<0.018), and pain (p<0.001) were predictive of overall survival. Pain was the superior predictor of survival (p=0.001) among all variables and QoL scores studied by multivariate analysis. A deterioration in pain was associated with a 2.8 times higher chance of survival (HR 0.36). Conclusions. Deterioration of HRQoL baseline pain score by cancer treatment is a favourable and superior prognostic factor for survival.

scholarly journals Prophylactic Cranial Irradiation in Extensive Disease Small-Cell Lung Cancer: Short-Term Health-Related Quality of Life and Patient Reported Symptoms—Results of an International Phase III Randomized Controlled Trial by the EORTC Radiation Oncology and Lung Cancer Groups

2009 ◽  
Vol 27 (1) ◽  
pp. 78-84 ◽  
Author(s):  
Berend J. Slotman ◽  
Murielle E. Mauer ◽  
Andrew Bottomley ◽  
Corinne Faivre-Finn ◽  
Gijs W.P.M. Kramer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Health Status ◽  
Global Health ◽  
Global Health Status ◽  
Life Questionnaire ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

Purpose Prophylactic cranial irradiation (PCI) in patients with extensive-disease small-cell lung cancer (ED-SCLC) leads to significantly fewer symptomatic brain metastases and improved survival. Detailed effects of PCI on health-related quality of life (HRQOL) are reported here. Patients and Methods Patients (age, 18 to 75 years; WHO ≤ 2) with ED-SCLC, and any response to chemotherapy, were randomly assigned to either observation or PCI. Health-related quality of life (HRQOL) and patient-reported symptoms were secondary end points. The European Organisation for the Research and Treatment of Cancer core HRQOL tool (Quality of Life Questionnaire C30) and brain module (Quality of Life Questionnaire Brain Cancer Module) were used to collect self-reported patient data. Six HRQOL scales were selected as primary HRQOL end points: global health status; hair loss; fatigue; and role, cognitive and emotional functioning. Assessments were performed at random assignment, 6 weeks, 3 months, and then 3-monthly up to 1 year and 6-monthly thereafter. Results Compliance with the HRQOL assessment was 93.7% at baseline and dropped to 60% at 6 weeks. Short-term results up to 3 months showed that there was a negative impact of PCI on selected HRQOL scales. The largest mean difference between the two arms was observed for fatigue and hair loss. The impact of PCI on global health status as well as on functioning scores was more limited. For global health status, the observed mean difference was eight points on a scale 0 to 100 at 6 weeks (P = .018) and 3 months (P = .055). Conclusion PCI should be offered to all responding ED SCLC patients. Patients should be informed of the potential adverse effects from PCI. Clinicians should be alert to these; monitor their patients; and offer appropriate support, clinical, and psychosocial care.

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.

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 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.

High-Dose Therapy and Autologous Hematopoietic Stem Cell Transplantation (ASCT) Has a Significant but Transient Impact on Quality of Life: Lessons From the Chronic Lymphocytic Leukemia (CLL) ASCT Study by the CLL Subcommittee of the Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 1989-1989
Author(s):  
Liesbeth C. de Wreede ◽  
Maggie Watson ◽  
Donald Milligan ◽  
Mauricette Michallet ◽  
Peter Dreger ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
Social Functioning ◽  
Physical Functioning ◽  
Global Health Status ◽  
First Year ◽  
High Dose ◽  
High Dose Therapy

Abstract Abstract 1989 Objective: High-dose therapy (HDT) and ASCT is the standard of care in a variety of hematologic malignancies. Whereas for some indications a survival advantage for HDT and ASCT has been demonstrated, a benefit only in terms of better progression-free survival has been shown for CLL. Because of this the quality of life (QoL) deserves particular attention. QoL assessment was a major focus of a randomized controlled EBMT-Intergroup trial on the value of HDT compared to observation in first or second remission of CLL (Michallet, Blood, 2011). Methods: 222 patients were enrolled into the study and allocated to either ASCT or observation. In the transplant arm, 72% received HDT and ASCT (for those median time from randomization to transplant was 3.01 months); in the observation arm 9% received ASCT. QoL was assessed with the EORTC QLQ C30 version 3.0, a questionnaire that has to be filled in by the patients. The answers to the questions yielded 15 scores, each on a scale from 0 to 100. The scores represent 15 domains: global health status/QoL, 5 functional scales (100 representing perfect health) and 9 symptom scales (0 representing no complaints). QoL forms had to be completed at randomization and at months 4, 8, 12, and 24. Data on 56%, 53%, 54%, 61%, and 50% of the baseline patients are available for the respective periods. Missing forms were not systematically related to baseline variables or relapse. The numbers of drop out due to death at 2 years were 5 patients in the HDT arm and 4 patients in the control arm. All QoL outcomes were analyzed with mixed models according to the intent to treat principle. Time (as factor), age, gender, treatment arm and the interaction of time and treatment arm were modelled as fixed effects, whereas individual random effects were added for the intercept. Results: The mean values for global health status/QoL, physical functioning, role functioning and social functioning over time for the transplant and the observation group are shown in Figure 1. Global health status/QoL at 4 months (estimated effect from the multivariate model −7.15, p=0.034) was significantly inferior in the transplant cohort compared to the control group. At 8 months the estimated effect of HDT on global health status/QoL was −3.06 (p=0.36). This difference further diminished over the first year (estimate at 1 year −0.53, p=0.87). QoL did not decrease independently from the treatment during the first 2 years. The same global pattern of change over time was observed for physical functioning, role functioning and social functioning; however, the treatment impact was still significant at 8 months for physical functioning (-6.58; p=0.025) and social functioning (-11.18; p=0.014). No significant covariate effects could be delineated for either of these scales apart from age having a beneficial effect on social functioning. Conclusions: Quality of life is affected multi-dimensionally in the first year after high-dose therapy and autologous stem cell support. The negative impact of HDT on QoL has disappeared after two years. Patients should be informed that HDT followed by ASCT impairs quality of life in the first year after transplantation. Disclosures: No relevant conflicts of interest to declare.

Health-related quality-of-life results from JCOG0912: A phase III noninferiority trial comparing open and laparoscopy-assisted distal gastrectomy for stage I gastric cancer.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 293-293
Author(s):  
Takaki Yoshikawa ◽  
Masahiko Ando ◽  
Junki Mizusawa ◽  
Hitoshi Katai ◽  
Takanobu Yamada ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Health Status ◽  
Global Health ◽  
Distal Gastrectomy ◽  
Stage I ◽  
Global Health Status ◽  
Related Quality ◽  
Health Related ◽  
Hrqol Assessment

293 Background: Laparoscopy-assisted distal gastrectomy (LADG) was non-inferior to open (ODG) in patients with stage I gastric cancer in randomized phase 3 non-inferiority trial (JCOG0912). Here, we present the results of health-related quality of life (HRQoL) which was a secondary endpoint in JCOG0912. Methods: Among 33 institutions participated in JCOG0912, 4 major cancer centers were selected for HRQOL assessment. HRQoL was assessed using EORTC QLQ-C30 and the EORTC-STO22 before (baseline) and at 1, 3, 12, and 36 months after surgery. The primary HRQOL scale was QLQ-C30 global health status. We defined clinically meaningful decrease of HRQoL as decrease in 10 points or more from the baseline. Missing data were regarded as decrease. Assuming that expected %decrease of global health status at 3 months was 61% in ODG and 45% in LADG with 80% power and two-sided alpha of 0.05, sample size for HRQOL assessment was calculated to be 304. When this hypothesis at 3 months was confirmed, statistical comparison was tested in turn at 12 and 36 months. Results: Among 921 enrolled patients in JCOG0912 from Mar 2010 to Nov 2013, 592 were enrolled from the 4 centers in this HRQoL study. The %decrease of global health status at 3 months was different between ODG and LADG (37.2% (109/293) in ODG vs 29.2% (86/295) in LADG, odds ratio [OR] 0.65 (95% CI: 0.45-0.93, p = 0.020)), but was not different in 1 month (56.0% (164/293) vs 55.3% (163/295), OR 0.92 (0.61-1.32)), 12 months (26.3% (77/293) vs 27.8% (82/295) (OR 1.07 (0.73-1.56))and 36 months (31.4% (91/293)vs 30.8% (91/295) (odds ratio, 0.96 (0.67-1.37))). Among the other subscales, LADG had significantly better symptom scores for pain at 1 and 3 months, constipation at 3 and 12 months, and eating restrictions at 3 months. Conclusions: Decrease of HRQoL was less frequently observed in LADG than ODG especially in the early phase after surgery. Considering non-inferiority and better HRQoL of LADG, LADG is strongly recommended for stage I gastric cancer. However, we have to be careful to expand the indication of LADG for advanced gastric cancer until a solid evidence is obtained. Clinical trial information: UMIN000003319.

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