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.

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.

Health-Related Quality of Life After Robot-Assisted Distal Gastrectomy in Early Gastric Cancer

2013 ◽  
Vol 38 (5) ◽  
pp. 1112-1120 ◽  
Author(s):  
Ji Yeon Park ◽  
Bang Wool Eom ◽  
Min Jung Jo ◽  
Hong Man Yoon ◽  
Keun Won Ryu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Gastric Cancer ◽  
Early Gastric Cancer ◽  
Distal Gastrectomy ◽  
Health Related Quality ◽  
Robot Assisted ◽  
Related Quality ◽  
Health Related

Health-related quality-of-life (HRQoL) results from the FAST study: A phase II trial of epirubicin, oxaliplatin, and capecitabine with or without IMAB362 in patients with advanced CLDN18.2+ gastric and gastroesophageal junction adenocarcinoma.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 54-54 ◽  
Author(s):  
Robert Morlock ◽  
James Turnbull ◽  
Steven Blahut ◽  
Michelle R Krukas-Hampel ◽  
Emily Hawryluk ◽  
...  
Keyword(s):  
Health Status ◽  
Global Health ◽  
Repeated Measures ◽  
Mixed Model ◽  
Gastroesophageal Junction ◽  
Global Health Status ◽  
Minimally Clinically Important Difference ◽  
Gastroesophageal Junction Adenocarcinoma ◽  
Related Quality ◽  
Health Related

54 Background: In the FAST study, IMAB362 (loading dose 800 mg/m2 then 600 mg/m2 d1 qd21) plus EOX (epirubicin 50 mg/m2 and oxaliplatin 130 mg/m2 d1, and capecitabine 625 mg/m2 bid) was compared with EOX alone in patients with advanced/metastatic gastric (GA), gastroesophageal (GE), and gastroesophageal junction (GEJ) adenocarcinoma. The FAST study exhibited a clinically relevant benefit in PFS and OS with a manageable safety profile in patients treated with IMAB362. Here we present the HRQoL results from the FAST study. Methods: CLDN18.2-positive patients (intermediate/strong membrane staining in ≥40% of cells) with advanced/metastatic GA/GE/GEJ adenocarcinoma were randomized 1:1 to first-line EOX for a maximum of 8 cycles with or without 600 mg/m2 q3w IMAB362, which after 8 cycles could be continued as monotherapy until disease progression (DP). The EORTC QLQC30 and a gastric cancer specific measure EORTC STO22 were collected at baseline (BL), Cycle 5, end of EOX therapy (EOT) and post-EOT every 12 weeks until DP. Change from BL in EORTC scores over 8 cycles of EOX treatment were analyzed using mixed model repeated measures. Time to deterioration in HRQoL was defined as time from randomization to first minimally clinically important difference (MCID) decline in each HRQoL domain. Results: The HRQoL analysis included 74 EOX and 68 IMAB362 + EOX per protocol patients. There were no significant differences in mean changes from BL in EORTC QLQC30 Global Health Status/QoL Score and STO22 Total Score across the 8 cycles of treatment with EOX. The QLQC30 Nausea and Vomiting domain showed a statistical difference (p = 0.0108) in favor of EOX-only. The median time to first HRQoL MCID deterioration for the QLQC30 Global Health Status was 8.6 mo for EOX + IMAB362 and 6.0 mo for EOX alone (p = 0.008). For patients who remained on IMAB362 post EOT, HRQoL improved from BL. Conclusions: HRQoL was maintained for a longer duration in pts with advanced/metastatic GA/GE/GEJ adenocarcinoma who received EOX + IMAB362 therapy vs EOX alone. HRQoL post EOT was improved for EOX + IMAB362 therapy vs EOX alone. Clinical trial information: NCT01630083.

scholarly journals Effects of Qigong Training on Health-Related Quality of Life, Functioning, and Cancer-Related Symptoms in Survivors of Nasopharyngeal Cancer: A Pilot Study

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Shirley S. M. Fong ◽  
Shamay S. M. Ng ◽  
W. S. Luk ◽  
Louisa M. Y. Chung ◽  
Janet Y. H. Wong ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
Nasopharyngeal Cancer ◽  
Global Health Status ◽  
Control Group ◽  
European Organization ◽  
Health Related ◽  
Experimental Group

This study aimed to investigate the effects of Qigong intervention on quality of life (QOL), health-related functioning, and cancer-related symptoms in survivors of nasopharyngeal cancer (NPC). Twenty-five survivors of NPC were included in the experimental group (mean age ± SD: 55.4 ± 7.5 years) and 27 in the control group (mean age ± SD: 58.7 ± 9.5 years). The experimental group underwent a weekly 1.5-hour Qigong training program and an identical home program (three times/week) for six months. The control group received no training. Global health status/QOL, functioning, and cancer-related symptoms were assessed by the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-H&N35 questionnaires before training began, after three months of Qigong training, at the end of the six-month Qigong intervention (i.e., posttest), and six months posttest. Intention-to-treat analysis revealed no statistically (P>0.05) or clinically significant improvement in global health status/QOL, functioning, or symptoms in either group. The experimental group had 45.8% fewer sense-related (smell and taste) problems (P<0.05) but 98.6% more speech-related problems (P<0.05) than the control group after the Qigong intervention. Qigong training resulted in no apparent improvement in health-related QOL, functionality, or cancer-related symptoms in cancer-free survivors of NPC, except for a possible reduction in smell- and taste-related problems.

scholarly journals Health-related quality of life of carfilzomib- and daratumumab-based therapies in patients with relapsed/refractory multiple myeloma, based on German benefit assessment data

2019 ◽  
Vol 29 (1) ◽  
pp. 69-79 ◽  
Author(s):  
Katja Weisel ◽  
Heinz Ludwig ◽  
Achim Rieth ◽  
Andrea Lebioda ◽  
Hartmut Goldschmidt
Keyword(s):  
Quality Of Life ◽  
Multiple Myeloma ◽  
Health Status ◽  
Global Health ◽  
Health Related Quality ◽  
Descriptive Assessment ◽  
Refractory Multiple Myeloma ◽  
Related Quality ◽  
Health Related

Abstract Background Carfilzomib and daratumumab are licensed in relapsed/refractory multiple myeloma (RRMM), but no head-to-head trials have been conducted. Methods We used data from dossiers prepared for the German Federal Joint Committee based on two phase III randomized trials of carfilzomib-based therapies (ASPIRE, ENDEAVOR) and two of daratumumab-based therapies (POLLUX, CASTOR) to conduct a descriptive assessment of health-related quality of life (HRQoL). HRQoL was assessed using the European Organisation for Research and Treatment of Cancer 30-item HRQoL Questionnaire, with hazard ratios calculated for carfilzomib- and daratumumab-based therapy versus comparators for time to HRQoL deterioration of ≥ 10 points. Analyses were also conducted on data from the EORTC 20-item myeloma-specific questionnaire, the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale, and the visual analog scale of the EuroQoL 5-dimension, 5-level questionnaire, where results for these instruments were available. As the designs and patient population of the four trials were similar but not identical, the analysis included only indirect, descriptive comparisons. Results Compared with lenalidomide/dexamethasone, median time to deterioration in global health status/QoL was longer for carfilzomib-based therapy versus control, but similar for daratumumab-based therapy and control. Compared with bortezomib/dexamethasone, time to deterioration was significantly longer for carfilzomib-based therapy versus control for global health status/QoL and numerous functional and symptom subscales. HRQoL measurement is feasible in large RRMM populations. Conclusion Descriptive assessment of HRQoL data suggests potential benefits for carfilzomib-based over daratumumab-based therapy.

Health-related quality of life in the early-access phase IIIb study of trifluridine/tipiracil in pretreated metastatic colorectal cancer (mCRC): Results from PRECONNECT study.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 638-638 ◽  
Author(s):  
Julien Taieb ◽  
Timothy Jay Price ◽  
Fortunato Ciardiello ◽  
Marc Peeters ◽  
Lucjan Wyrwicz ◽  
...  
Keyword(s):  
Health Status ◽  
Global Health ◽  
Utility Score ◽  
Global Health Status ◽  
Early Access ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq ◽  
Ecog Ps

638 Background: Pivotal RECOURSE trial assessed efficacy and safety of trifluridine/tipiracil (FTD/TPI) in mCRC patients (pts) without collecting QoL data. Here we describe a preliminary analysis of QoL in mCRC pts treated with FTD/TPI in the ongoing phase 3b PRECONNECT study (NCT03306394). Methods: Eligible pts had histologically mCRC previously treated with available therapies and an ECOG-PS of 0/1. Pts received FTD/TPI (35 mg/m2 twice daily) orally on days 1–5 and 8–12 of each 28-day cycle. ECOG-PS and QoL were assessed at baseline, every 4 weeks on FTD/TPI and at discontinuation. QoL was measured with EORTC QLQ-C30, EQ-5D index and VAS questionnaires. Utility score was based on EQ-5D index and values from Germany, UK and Spain. For QLQ-C30, clinical relevance was assessed using a 10 point threshold. Changes in utility score and VAS were deemed clinically relevant if ≥ 9 and ≥ 7, respectively. Only results where ≥ 10% of the initial cohort completed the questionnaires were assessed, corresponding to 7 cycles of treatment. Results: 464 pts were included at cutoff (1 November 2017). Median FTD/TPI treatment duration was 2.96 months (range 0.4–14.7). Median time to ECOG-PS ≥ 2 was 8.7 months with 74.3% of pts remaining at ECOG-PS 0/1 at discontinuation. At baseline mean QLQ-C30 global health status was 62.75 (SD = 20.50; median 66.67) with values for all scales in line with EuroQoL reference for mCRC (variation < 10 points on function and < 5 on symptom scales). Baseline EQ-5D VAS was 65.55 (SD = 20.11; median 70.00) and utility score 73.11 (SD = 20.71; median 75.27). There was no clinically relevant difference in mean change from baseline at any time point on global health status score nor any of functional or symptom scales. Similar results were obtained for utility score and VAS. QoL was maintained on FTD/TPI in all subgroups based on age and ECOG-PS for all scales except for appetite loss increase at cycle 5 in pts ≥ 65 and in ECOG-PS 0 in whom the score increased by 12.2 and 10.4, respectively. Conclusions: The first prospective data on QoL suggest that mCRC pts can maintain their QoL while on FTD/TPI treatment. Clinical trial information: NCT03306394.

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.

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