Health‐related quality of life in elderly, newly diagnosed multiple myeloma patients treated with VMP vs. MP: results from the VISTA trial

Introduction: Comprehensive outcome assessments after breast reconstruction (BRR) require surgery- specific Patient Reported Outcomes Measures (PROMS). Completion of early Phases I-II development resulted in a 31-item questionnaire comprising 5 hypothesised scales and (numbers of items) : Treatment /surgery related symptoms (4), body image (3), sexuality (4), cosmetic outcomes (breast, n = 7, donor site, n = 5, nipple, n = 6) and overall satisfaction (2). Current evidence shows no BRR-specific PROM, with the further validation of the BREAST-Q, currently the only PROM. The aim of this study was Phase III pre-testing of a BRR questionnaire assessing patients’ health related quality of life (HRQL) before and after BRR, in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC). Pre-testing assessed the relevance, acceptability and redundancy of questions in all types of BRRs. This PROM is intended for use alongside the EORTC QLQ-C30, and QLQ-BR23 in women treated for breast cancer before and after mastectomy and all BRR types. Methods: The EORTC BRR HRQL subgroup applied decision-making rules to each question according to eight EORTC criteria comprising 1. priority, 2. relevance and 3. difficulty /consistency across five European languages and cultures. Descriptive statistics used HRQL score criteria: 4. mean >1.5, 5. range >2, 6. floor and ceiling effects >10%, 7. prevalence ratios >30% and 8. compliance >95%. 197 patients (UK, Austria, Belgium, Italy, Sweden) were recruited: 47 prospectively completing pre- and post-BRR questionnaires, and 150 retrospectively reporting only post-BRR questionnaires. 189 patients underwent qualitative debriefing interviews. Preliminary psychometric analyses performed multi-trait scaling using EORTC QLQ-C30 and QLQ- BR23 that were used in final decisions on items and scales. Results: 31 questions /items fulfilled ‘relevance’, with none producing ‘difficulties’. Ten items were not a ‘priority’ in 10% of respondents. Of these, two questions comprising ‘muscle twitching in affected breast’ and ‘problem with donor site swelling’ were deleted, fulfilling less than 5 out of 8 criteria. Deletions of three redundant items comprised ‘weak arm’, which correlated significantly to QLQ-BR23; and ‘shape’ and ‘colour’ of affected nipple with similarities to ‘overall nipple appearance’. Descriptive statistics and clinical judgment reduced the module to 26 items conceptualized into three scales (and items): Disease Treatment /Surgery related symptoms (2), Sexuality (5), and Cosmetic outcomes (breast, n = 10, donor site, n = 4, nipple, n = 4) within the EORTC QLQ-BRR26. The body image and overall satisfaction scales were dropped, with their respective items incorporated into other scales. Discussion: The QLQ-BRR26 has completed phase III development and is available for psychometric validation in a large field international sample that aims to recruit 450 patients across 17 European centres. Psychometric testing will be finalised in Phase IV including the evaluation of the questionnaires’ responsiveness to the effects of BRR subgroups with comparisons to the BREAST-Q. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P2-19-08.

Impact of Relugolix Versus Leuprolide on the Quality of Life of Men with Advanced Prostate Cancer: Results from the Phase 3 HERO Study

Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): health-related quality-of-life results from a double-blind, randomised, controlled, phase 3 trial.

Health-related quality of life (HRQOL) is a critical aspect to consider when making treatment decisions for patients with non-Hodgkin-lymphoma (NHL). This international study by the European Organisation for Research and Treatment of Cancer (EORTC) tested the psychometric properties of two newly developed measures for patients with high-grade (HG)- and low-grade (LG)-NHL: the EORTC QLQ-NHL-HG29 and the EORTC QLQ-NHL-LG20 to supplement the core questionnaire (EORTC QLQ-C30). Overall, 768 patients with HG-NHL (N=423) and LG-NHL (N=345) from 12 countries completed the QLQ-C30, QLQ-NHL-HG29/QLQ-NHL-LG20 and a debriefing questionnaire at baseline, and a subset at follow-up for either retest (N=125/124) or responsiveness to change (RCA; N=98/49). Confirmatory factor analysis showed an acceptable to good fit of the 29 items of the QLQ-NHL-HG29 on its five scales (symptom burden [SB], neuropathy, physical condition/fatigue [PF], emotional impact [EI], and worries about health/functioning [WH]), and of the 20 items of the QLQ-NHL-LG20 on its four scales (SB, PF, EI, and WH). Completion took on average 10minutes. Test-retest reliability, convergent validity, known-group comparisons, and RCA find satisfactory results of both measures. A total of 31%-78% of patients with HG-NHL and 22%-73% of patients with LG-NHL reported symptoms and/or worries (e.g., tingling in hands/feet, lack of energy, and worries about recurrence). Patients reporting symptoms/worries had substantially lower HRQOL compared to those without. The use of the EORTC QLQ-NHL-HG29 and QLQ-NHL-LG20 questionnaires in clinical research and practice will provide clinically relevant data to better inform treatment decision-making. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group developed two questionnaires. These questionnaires measure health-related quality of life. The questionnaires are for patients with high-grade or low-grade non-Hodgkin lymphoma. They are called the EORTC QLQ-NHL-HG29 and QLQ-NHL-LG20. The questionnaires are now internationally validated. This study demonstrates that the questionnaires are reliably and valid, which are important aspects of a questionnaire. The questionnaires can now be used in clinical trials and practice. With the information gathered from the questionnaires, patients and clinicians can better evaluate treatments and discuss the best choice for a patient.

PCN385 - QUALITY OF LIFE OF PATIENTS LIVING WITH METASTATIC COLORECTAL CANCER (MCRC): EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER (EORTC) QUESTIONNAIRE RESULTS FROM A REAL WORLD EUROPEAN SURVEY

Health-related quality of life (HRQL) is a fundamental outcome in oncology patients and quality of life (QOL) assessment requires clinically relevant questionnaires. The purpose of this study was translation and definition of measurement properties and the clinical validity of Quality of Life Questionnaire (QLQ) -OG25 module in Persian patients with oesophagus, oesophagogastric junction (OGJ) or gastric cancers. The translation procedure followed European Organization for Research and Treatment of Cancer (EORTC) guidelines. Both EORTC QLQ-OG25 and a core questionnaire (EORTC QLQ-C30) were administered to patients with oesophagus (150), OG junction (93) and gastric (32) cancer undergoing multi-modal treatments. Convergent and discriminant validity, Cronbach's alpha coefficient and known-groups comparisons were used to examine reliability and validity. In all, 275 patients (mean age 62 years) completed both questionnaires. Compliance rate was high and the questionnaire module was well accepted. We found good reliability for multi-item subscales of QLQ-OG25 (Cronbach's alpha coefficients 0.76-0.89). About 73% had TNM staging and scales distinguished between clinically distinct groups of patients. However, patients in palliative group experienced compromised functional status and worse treatment-associated symptoms than those in the potentially curative group. Test-retest scores were consistent. Multi-trait scaling analysis demonstrated good convergent and discriminant validity. Overall, the Persian version of QLQ-OG25 demonstrated psychometric and clinical validity that supports its application as a supplement to the original tool (EORTC QLQ-C30) when assessing HRQL in patients with upper-gastrointestinal (GI) cancer both in curative and palliative phases.

Patient-reported outcomes with belantamab mafodotin, bortezomib, and dexamethasone versus daratumumab, bortezomib, and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-7): results from a phase 3, open-label, randomised controlled trial.

Standardising the Assessment of Patient-reported Outcome Measures in Localised Prostate Cancer. A Systematic Review

P04 - Body Mass Index (BMI) e quality of life (QoL) in cancer patients – the ‘Tor Vergata’ Observational study in oNCOlogy– TV-ONCO study

Quality of life after successful treatment of early-stage Hodgkin's lymphoma: 10-year follow-up of the EORTC–GELA H8 randomised controlled trial

Head-and-neck cancers (HNCs) are one of the major public health problems for both patients and the health-care providers in India. The clinical manifestations of HNC and its treatment can lead to negative effects on the quality of life (QoL) of the patient. The study is aimed to explore the QoL using the European Organization for Research and Treatment of Cancer (EORTC) QoL questionnaires among HNC patients in Western part of India. A cross-sectional prospective study was conducted among 400 HNC patients attending the tertiary cancer center. The QoL was assessed by using the EORTC core questionnaire (EORTC QLQ-C30) and EORTC head- and neck-specific questionnaire (EORTC QLQ-H and N35). The data were explored using means, standard deviation, medians, ranges, and proportions. All the 400 patients had completed the questionnaire having a compliance rate of 100%. There was no missing data at the item level for the EORTC QLQ-C30 questionnaire. While the missing items for EORTC QLQ-H and N35 were: problems while swallowing food, problems with teeth, and sexuality. The mean functional score ranged from 74.22 to 93.49 for EORTC QLQ-C30. The mean symptoms score was found in the range from 3.25 to 81.50 for EORTC QLQ-H and N35. Both questionnaires were comprehensive and well accepted by the patients. These questionnaires provided the information-related disease-specific QoL data, which otherwise is often missed. Health-care providers should not only focus on the clinical effects of treatment but also on QoL issues because it will improve overall patient care and survival.

Patient-reported outcomes with belantamab mafodotin, pomalidomide, and dexamethasone versus bortezomib, pomalidomide, and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-8): a phase 3, open-label, randomised controlled trial.

Improved Quality of Life (QOL) Outcomes in Patients With Head-and-Neck Squamous Cell Carcinoma (HNSCC) Treated With Intensity Modulated Radiation Therapy (IMRT) Compared to 3-dimensional Conformal Radiation Therapy (3D-CRT): Evidence From a Prospective Randomized Study

Overall survival of patients with anaplastic oligodendroglial tumors has been improved due to the addition of procarbazine, lomustine and vincristine (PCV) chemotherapy to radiotherapy (RT), especially in 1p/19q-codeleted tumors. With improved survival, quality of survival becomes pivotal. We evaluated cognitive functioning and health-related quality of life (HRQOL) in a cohort of long-term anaplastic oligodendroglioma survivors. Thirty-two out of 37 long-term survivors included in European Organisation for Research and Treatment of Cancer (EORTC) study 26951 in the Netherlands and France participated. Cognition was assessed using neuropsychological tests for 6 domains, and HRQOL with the EORTC Quality of Life Questionnaire (EORTC QLQ-C30) and Brain Cancer Module (EORTC QLQ-BN20). Fatigue and mood were evaluated. Results were compared to healthy controls and to patients' own HRQOL 2.5 years following initial treatment. At the time of assessment, median survival for the patients was 147 months, 27 were still progression-free since initial treatment. Of progression-free patients, 26% were not, and 30% were severely cognitively impaired; 41% were employed and 81% could live independently. Patients' HRQOL was worse compared to controls, but similar to 2.5 years after initial treatment. Initial treatment (RT versus RT + PCV) was not correlated with cognition or HRQOL. In conclusion, cognitive functioning in long-term anaplastic oligodendroglioma survivors is variable. However, most patients function independently. In progression-free patients, HRQOL is relatively stable during the disease course. In this small sample, no effect of the addition of PCV on cognition or HRQOL was identified.

Colorectal cancer management may require an ostomy formation; however, a stoma may negatively impact health-related quality of life (HRQoL). This study aimed to compare generic and stoma-specific HRQoL in patients with a permanent colostomy after rectal cancer across different countries. A cross-sectional cohorts of patients with a colostomy after rectal cancer in Denmark, Sweden, Spain, the Netherlands, China, Portugal, Australia, Lithuania, Egypt, and Israel were invited to complete questionnaires regarding demographic and socioeconomic factors along with the Colostomy Impact (CI) score, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and five anchor questions assessing colostomy impact on HRQoL. The background characteristics of the cohorts from each country were compared and generic HRQoL was measured with the EORTC QLQ-C30 presented for the total cohort. Results were compared with normative data of reference European populations. The predictors of reduced HRQoL were investigated by multivariable logistic regression, including demographic and socioeconomic factors and stoma-related problems. A total of 2557 patients were included. Response rates varied between 51-93 per cent. Mean time from stoma creation was 2.5-6.2 (range 1.1-39.2) years. A total of 25.8 per cent of patients reported that their colostomy impairs their HRQoL 'some'/'a lot'. This group had significantly unfavourable scores across all EORTC subscales compared with patients reporting 'no'/'a little' impaired HRQoL. Generic HRQoL differed significantly between countries, but resembled the HRQoL of reference populations. Multivariable logistic regression showed that stoma dysfunction, including high CI score (OR 3.32), financial burden from the stoma (OR 1.98), unemployment (OR 2.74), being single/widowed (OR 1.35) and young age (OR 1.01 per year) predicted reduced stoma-related HRQoL. Overall HRQoL is preserved in patients with a colostomy after rectal cancer, but a quarter of the patients interviewed reported impaired HRQoL. Differences among several countries were reported and socioeconomic factors correlated with reduced quality of life.