Symptom Control and Quality of Life in LUX-Lung 3: A Phase III Study of Afatinib or Cisplatin/Pemetrexed in Patients With Advanced Lung Adenocarcinoma With EGFR Mutations

2013 ◽  
Vol 31 (27) ◽  
pp. 3342-3350 ◽  
Author(s):  
James Chih-Hsin Yang ◽  
Vera Hirsh ◽  
Martin Schuler ◽  
Nobuyuki Yamamoto ◽  
Kenneth J. O'Byrne ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Health Status ◽  
Global Health ◽  
Lung Adenocarcinoma ◽  
Phase Iii ◽  
Egfr Mutations ◽  
Health Related ◽  
Over Time

Purpose Patient-reported symptoms and health-related quality of life (QoL) benefits were investigated in a randomized, phase III trial of afatinib or cisplatin/pemetrexed. Patients and Methods Three hundred forty-five patients with advanced epidermal growth factor receptor (EGFR) mutation–positive lung adenocarcinoma were randomly assigned 2:1 to afatinib 40 mg per day or up to six cycles of cisplatin/pemetrexed. Lung cancer symptoms and health-related QoL were assessed every 21 days until progression using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and Lung Cancer-13 questionnaires. Analyses of cough, dyspnea, and pain were preplanned, including percentage of patients who improved on therapy, time to deterioration of symptoms, and change in symptoms over time. Results Questionnaire compliance was high. Compared with chemotherapy, afatinib significantly delayed the time to deterioration for cough (hazard ratio [HR], 0.60; 95% CI, 0.41 to 0.87; P = .007) and dyspnea (HR, 0.68; 95% CI, 0.50 to 0.93; P = .015), but not pain (HR, 0.83; 95% CI, 0.62 to 1.10; P = .19). More patients on afatinib (64%) versus chemotherapy (50%) experienced improvements in dyspnea scores (P = .010). Differences in mean scores over time significantly favored afatinib over chemotherapy for cough (P < .001) and dyspnea (P < .001). Afatinib showed significantly better mean scores over time in global health status/QoL (P = .015) and physical (P < .001), role (P = .004), and cognitive (P = .007) functioning compared with chemotherapy. Fatigue and nausea were worse with chemotherapy, whereas diarrhea, dysphagia, and sore mouth were worse with afatinib (all P < .01). Conclusion In patients with lung adenocarcinoma with EGFR mutations, first-line afatinib was associated with better control of cough and dyspnea compared with chemotherapy, although diarrhea, dysphagia, and sore mouth were worse. Global health status/QoL was also improved over time with afatinib compared with chemotherapy.

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.

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.

scholarly journals P139 What impact does JIA have on health-related quality of life over time and by gender?

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Andrew Smith ◽  
Bishma Saqib ◽  
Rebecca Lee ◽  
Wendy Thomson ◽  
Lis Cordingley
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Child Health ◽  
Reference Population ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
Over Time ◽  
Domain Scores

Abstract Background Juvenile idiopathic arthritis (JIA) is a heterogeneous group of arthritic conditions presenting in children and young people, in which physical limitations and associated complications can have detrimental effects on physical and psychosocial wellbeing. This study aims to investigate the impact of living with JIA on different aspects of health-related quality of life (HRQoL) and to explore how this changes over time, using data from the Childhood Arthritis Prospective Study (CAPS). Methods Longitudinal data collected as part of CAPS were analysed. HRQoL was assessed at baseline, 1 year and 3 years’ post-diagnosis using the Child Health Questionnaire (CHQ), a parent-completed form for children from 5 years of age. The CHQ measures physical, emotional and social components of child health status. Raw domain scores were transformed via algorithm into values ranging from 0-100, with higher scores indicating better health status. Mean (standard deviation) and median (interquartile range) for each domain were determined, both for the full cohort and by gender. Differences between median scores at baseline and 3 years were assessed using the Wilcoxon signed-rank test. Mean scores of each domain were visually compared with a reference population sample of healthy children from the United States. Results 184 participants completed the questionnaire at all 3 time points. At baseline, compared to the reference population, children with JIA scored lower in every domain although scores were closer between the 2 groups at 3 years. Median scores improved over time, the exception being the general health perceptions domain which decreased after baseline. Domains with the greatest improvement were physical functioning,“bodily pain and social-physical. The largest changes occurred from baseline to 1 year. Statistically significant differences between baseline and 3-year scores were found for all domains. Domain scores for male and female participants were very similar at baseline, though scores for male participants indicated slightly better health at 1 and 3 years for both physical and psychosocial domains. Conclusion JIA has significant impact on HRQoL, which improves within 3 years of diagnosis with the greatest improvement occurring within the first year. Physical health domains show greater improvement over time than psychosocial domains, although psychosocial scores were generally higher throughout the study. Male participants tend to score slightly higher than female participants in both physical and psychosocial domains after baseline. Further research should explore measurable patient, age or disease-related drivers of HRQoL. Disclosures A. Smith None. B. Saqib None. R. Lee None. W. Thomson None. L. Cordingley None.

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 Comparison of health-related quality of life with different antitumor agents for advanced soft tissue sarcoma

2020 ◽  
Author(s):  
Kayo Suzuki ◽  
Taketoshi Yasuda ◽  
Kenta Watanabe ◽  
Masahiko Kanamori ◽  
Yoshiharu Kawaguchi
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Global Health ◽  
Antitumor Agents ◽  
Second Line ◽  
Advanced Soft Tissue Sarcoma ◽  
Health Related

Abstract Background During cancer treatment, maintenance and improvement of quality of life (QOL) are important, as is prolongation of overall survival. As the disease progresses, patients may experience a decline in QOL due to physical or mental changes. However, few studies have evaluated QOL longitudinally in advanced soft tissue sarcoma (STS) patients according to the antitumor agent. The purpose of this study was to compare health-related QOL (HRQOL) in patients with advanced STS receiving the combination regimen of doxorubicin and ifosfamide (AI) or three novel antitumor agents (pazopanib, trabectedin, eribulin). Methods Twelve patients diagnosed with advanced STS who started chemotherapy between 2010 and 2017 at our hospital were enrolled. HRQOL was assessed using the European Organization on Research and Treatment of Cancer Quality-of-Life Core Questionnaire-30 (EORTC QLQ-C30) after three cycles of chemotherapy before assessing the effect of treatment. Global health status, a functional scale, and a symptomatic scale were compared for the AI regimen and the three novel antitumor agents. Results The mean global health status score of the patients treated with the AI regimen was significantly different from that of those treated with one of the three novel antitumor agents (37.9 and 56.8, respectively). No significant differences were found in the five functional scores. The nausea and vomiting score was significantly different between the AI regimen and eribulin. The constipation score was significantly higher with the AI regimen, and the diarrhea score was significantly higher with pazopanib. Conclusions Compared to the AI regimen, patients can continue treatment with one of the three innovative antitumor agents while maintaining QOL, even with progressive disease. In particular, of the three innovative antitumor agents compared to the AI regimen, patients treated with pazopanib were able to maintain social activities during treatment. In the second-line and subsequent treatments, we could not clearly show a different effect on maintenance of a better QOL among the three innovative drugs, so additional work in the future is needed. If we clarify which of the three drugs most affects QOL, recommendations can be made regarding treatment selection for the second-line and subsequent treatments.

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.

Does change in health-related quality of life (HRQoL) score predict survival? Analysis of a lung cancer RCT.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 7607-7607
Author(s):  
Divine Ewane Ediebah ◽  
Corneel Coens ◽  
Efstathios Zikos ◽  
Chantal Quinten ◽  
Jolie Ringash ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Performance Status ◽  
Health Related Quality ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq ◽  
Over Time

7607 Background: Over 60 cancer clinical trials have shown that baseline health-related quality of life (HRQoL) scores are prognostic for patient survival. Few studies have investigated the added value of change in HRQoL scores. Our aim was to investigate if change in HRQoL scores from baseline over time is also associated with survival. Methods: We analyzed data from an EORTC 3-arm randomized clinical trial (RCT) in advanced non-small-cell lung cancer (NSCLC) patients, comparing gemcitabine+cisplatin, versus paclitaxel+gemcitabine, versus standard arm paclitaxel+cisplatin. HRQoL was measured in 394 patients using the EORTC QLQ-C30 at baseline and after each chemotherapy cycle. The prognostic significance of sex, age and WHO performance status (0-1 vs. 2) and the 15 QLQ-C30 subscales were assessed with Cox proportional hazard models stratified for treatment (level of significance 0.05). Changes in HRQoL scores from baseline to each chemotherapy cycle assessment were categorized as “improved”, “stable” and “worsened” using a threshold of 10 points difference. Due to expected attrition, the analysis was limited to changes from baseline up to cycle 3. Results: There were 248 patients in cycle 1, 212 in cycle 2 and 196 in cycle 3. We performed analyses separately using data at cycle 1, cycle 2, and cycle 3. In all analyses, HRQoL in various subscales and socio-demographic and clinical variables (physical functioning (hazard ratio [HR] 0.91, 95% CI 0.85-0.98; p=0.0103), pain (1.11, 1.05-1.17; p= 0.0004), age (0.98, 0.97-1.00, p=0.0413) and WHO performance status (1.77, 1.09-2.89; p=0.0218) at cycle 1; pain (1.11, 1.03-1.20; p=0.0016), age (0.98, 0.96-1.00; p=0.0217) and sex (0.63, 0.42-0.95; p=0.0081) at cycle 2; and role functioning (0.93, 0.88-1.00; p=0.0128) and age (0.98, 0.96-1.00; p=0.0081) at cycle 3) predicted survival; however, change in HRQoL was only an independent predictor for improvement at cycle 1. Conclusions: Our findings suggest that change from baseline over time in HRQoL, as measured on subscales of the EORTC QLQ-C30, contains added prognostic value for survival independent of baseline HRQoL scores. Further work is needed to assess the robustness and sensitivity of these findings.

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