Health-Related Quality of Life in KEYNOTE-010: a Phase II/III Study of Pembrolizumab Versus Docetaxel in Patients With Previously Treated Advanced,Programmed Death Ligand 1–Expressing NSCLC

Introduction

In the phase II/III KEYNOTE-010 study (ClinicalTrials.gov, NCT01905657), pembrolizumab significantly prolonged overall survival over docetaxel in patients with previously treated, programmed death ligand 1–expressing (tumor proportion score ≥ 1%), advanced NSCLC. Health-related quality of life (HRQoL) results are reported here.

Quality of life after total and subtotal gastrectomy for gastric carcinoma

BackgroundThere remains debate as to whether quality of life (QoL) is better for patients following sub-total gastrectomy (SG) or total gastrectomy (TG) for cancer. Both have similar survival rates provided an R0 resection is performed and in many series the morbidity and mortality after TG is higher than SG. The aim of this study was to evaluate the QoL in patients after TG and SG for cancer.MethodAll surviving patients who had undergone TG or SG between 1994 and 2009 were identified from a prospectively collected database and sent the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire (QLQ-C30 v.3) and the gastric module (QLQ-STO22).ResultsFrom a total of 261 patients who had undergone TG or SG in the study period, 91 were still alive and 53 responded. There was no significant difference between the QoL between TG and SG based on functional scales and global health status. However dysphagia and eating restrictions were significantly worse in the TG group.ConclusionThis study has demonstrated that there is no difference in overall QoL in patients with TG or SG although eating restrictions and dysphagia are worse after TG.     

Using data from studies of health-related quality of life to describe clinical issues Examples from a longitudinal study of patients with advanced stages of cervical cancer

The focus of the paper is to describe how to present data from studies on health-related quality of life (H-QoL) in a way that is simple and clinically relevant. Data from a longitudinal study of patients with advanced stages of cervix cancer are used. One hundred and eighteen patients filled out questionnaires (including EORTC QLQ-C30) 7 times over a period of 2 years. The following issues are considered: (1) The use of a panel for an initial overview of data. (2) The visual difference between using mean and median values. (3) Box-whisker plots to illustrate the variability of the data. (4) The effect of combining categorical data into fewer categories. (5) Individual patient profiles showing the wide variability among patients. (6) A table showing the change of scores over a one-year period. (7) “Prognostic plots” dividing the initial scores and the following scores. (8) Plotting changes over time. (9) Illustration of the impact of non-random drop-out. (10) The effect of drop-out for the patients who fill out two sequential assessments. (11) The use of healthy controls to help answer the question “what is normal?”.     

Responsiveness of the generic EQ-5D summary measure compared to the disease-specific EORTC QLQ C-30

Introduction: We investigated whether the sensitivity of the generic health-related quality of life (HRQoL) EQ-5D summary measure (or index) to detect changes over time in a clinical setting is comparable with that of a disease-specific HRQoL questionnaire. Methods: Patients with liver metastases (n = 75) filled out the five domains of the EQ-5D self-classifier, the EQ VAS, and the EORTC QLQ C-30 (a disease-specific (cancer) HRQoL questionnaire). The HRQoL instruments were completed before intervention, and 1/2 month and 3 and 6 months after intervention. Three analyses were performed. First, the EQ-5D index (based on self-classification) was compared to the EQ VAS. Second, the EQ-5D domains were compared to corresponding EORTC QLQ C-30 scales. Third, EQ-5D index and EQ VAS were compared with the EORTC QLQ C-30 global health-status scale. Effect size was chosen as the metric of responsiveness. Results: The EQ-5D index was slightly less responsive than the EQ VAS. Overall, the responsiveness of the EQ-5D index and EQ VAS was equal to the EORTC QLQ C-30 global health-status scale. Conclusion: Despite its generic principle and the apparent crudeness of its framework, the responsiveness of the EQ-5D proved to be comparable to that of a disease-specific HRQoL questionnaire in this specific clinical setting.     

Patient-Reported Outcome Measures Used in Routine Care Predict for Survival at Disease Progression in Patients With Advanced Lung Cancer

BackgroundPatient-reported outcome (PRO) measures have been increasingly implemented in routine care to aid in clinical decision-making. However, the prognostic value of PRO measures as a tool for decision making is not easily interpreted by clinicians. Our aims were to explore the prognostic value of PRO measures at disease progression and the changes in PRO measures between treatment start (baseline) and disease progression.Patients and MethodsSince 2014, patients with lung cancer have completed an electronic version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires C30 and LC-13 before every outpatient visit at the Department of Oncology, Hospital Unit West, Jutland, Denmark. The patients’ responses were used in routine care. Patients receiving palliative antineoplastic treatment were eligible for analysis if the questionnaire had been completed at the initiation of first-line treatment and at disease progression. The prognostic value of the scores was evaluated using a Cox proportional hazard model. A P value < .01 was considered statistically significant.ResultsA total of 94 screened patients were included. At disease progression, survival could be predicted from the absolute score of the global health scale, 3 functional scales (physical, role, emotional), and 7 symptom scales (fatigue, pain, dyspnea, hemoptysis, lung cancer dyspnea, chest pain). In addition, changes in hemoptysis, dysphagia, dyspnea, and chest pain predicted for survival at progression.ConclusionPRO measures used in routine care can provide clinicians with relevant prognostic information about patients with lung cancer at disease progression. These results show the potential value of PRO measures when used in clinical decision-making.     

胃大部切除术后3年胃癌患者生活质量的EORTC QLQ-C30与QLQ-STO22联合评价

目的:采用欧洲癌症研究与治疗组织(EORTC)生活质量核心30问卷调查(QLQ-C30)和QLQ-STO22评价胃癌术后3年患者的生活质量(QOL).方法:对96名胃大部切除术后3年的胃癌患者和90名年龄和性别相匹配的门诊体检健康者进行研究.胃癌患者和健康者平均年龄分别为53.2岁±8.1岁和54.8岁±7.9岁.88.5%患者为I期胃癌术后.患者自行完成QLQ-C30量表和QLQ-STO22量表,对各评分进行统计分析.结果:胃癌患者和健康者EORTC QLQ-C30整体健康状况和QOL评分无显著差异.胃癌患者的认知功能、情绪功能和疲劳要优于对照健康者.但胃癌患者恶心和呕吐评分、经济困难、反流、进食受限和体型评分较健康者差.其他评分未见显著差异.结论:胃癌术后3年,患者的QOL整体评分基本恢复至正常水平,但在某些方面,特别是与上消化道相关的症状(如恶心呕吐、反流、进食受限等)与健康者存在差距.有必要基于这些差异采取针对性的措施进行治疗和护理.     

Quality of life in elderly patients with localized breast cancer treated with radiotherapy. A prospective study

PurposeThere is a debate on the role of adjuvant Radiotherapy (RT) in elderly breast cancer patients.The aim is to study Quality of Life (QL) throughout the treatment and follow-up periods in early stages breast cancer patients who have started radiotherapy, and to compare the QL of axillary surgery groups.Methods173 patients, ≥65 years completed the EORTC QLQ-C30 and QLQ-BR23, and the Interview for Deterioration in Daily Living Activities in Dementia(IDDD) questionnaires three times throughout treatment and follow-up periods. Linear mixed effect models were used to evaluate longitudinal changes in QL, and whether these changes differed among axillary surgery groups.ResultsQL scores were high (>70/100 points) in most QL areas, with moderate limitations (>30) in sexual functioning and enjoyment, future perspective and global QL.In six areas there was a decline at the RT sessions end, that after 6 weeks was recovered. For three areas, there was an improvement in the follow-up measurement compared to the previous assessments. Changes in seven areas were <5 points.Axillary node dissection patients had a body image decrease (6 points) in the follow up period. The lymphadenectomy group had more fatigue (10 points, p = 0.078) than the other two axillary surgery groups.ConclusionsResults orientate towards good patients' adaptation to their disease and treatments, and to administering RT in early stages breast cancer patients. QL differences between the axillary surgery groups and in their evolutions were few but have appeared in key QL areas.     

Validation and Reliability Testing of the EORTC QLQ-NMIBC24 Questionnaire Module to Assess Patient-reported Outcomes in Non–Muscle-invasive Bladder Cancer

Background

Well-developed and well-tested patient-reported outcome measures for non–muscle-invasive bladder cancer (NMIBC) are required.

Objective

To test and adapt the scale structure and explore the psychometric properties of the European Organisation for Research and Treatment of Cancer (EORTC) questionnaire for NMIBC.

Design, setting, and participants

A total of 433 patients in the Bladder COX-2 Inhibition Trial (BOXIT) completed the EORTC QLQ-C30 and NMIBC questionnaires. BOXIT is evaluating the addition of celecoxib to standard treatment in high- and intermediate-risk NMIBC.

Outcome measurements and statistical analysis

Multitrait scaling investigated and adapted the questionnaire scale structure and evaluated the reliability and validity of the revised scales, as well as responsiveness to change.

Results and limitations

A total of 410 patients (94.7%) (79.3% men, 74.6% high risk) returned baseline forms, and the questionnaire response rate was 88.2%. Multitrait scaling confirmed six scales and five single items. Scales and items demonstrated significant differences between patients with good and poor performance status scores (p < 0.001). Men reported better sexual function than women (p < 0.001). Scale and single-item module scores were not highly correlated with QLQ-C30 scores (evidence of discriminant validity), and the module was responsive to changes in health over time. International and test–retest data are required.

Conclusions

This study demonstrates the evidence-driven adapted scale structure and psychometric data of the EORTC QLQ-NMIBC24 module to use in clinical trials of patients with high- or intermediate-risk bladder cancer.