European Organization For Research And Treatment Of Cancer Quality Of Life Research Articles

Understanding quality of life issues in patients with advanced melanoma: Phase 1 and 2 in the development of the EORTC advanced melanoma module

AimsWe aimed to develop a European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) module tailored for patients with advanced (resectable or unresectable stage III/IV) melanoma receiving immune checkpoint inhibitors or targeted therapy. MethodsFollowing the EORTC QoL Group module development guidelines, we conducted phases 1 and 2 of the development process. In phase 1, we generated a list of health-related (HR)QoL issues through a systematic literature review and semi-structured interviews with healthcare professionals (HCPs) and patients with advanced melanoma. In phase 2, these issues were converted into questionnaire items to create the preliminary module. ResultsPhase 1: we retrieved 8006 articles for the literature review, of which 35 were deemed relevant, resulting in 84 HRQoL issues being extracted to create the initial issue list. Semi-structured interviews with 18 HCPs and 28 patients with advanced melanoma resulted in 28 issues being added to the initial issue list. Following EORTC module development criteria, 26 issues were removed, and two issues were added after review by patient advocates.Phase 2: To ensure uniformity and avoid duplication, 16 issues were consolidated into eight items. Additionally, an independent expert contributed one new item, resulting in a preliminary module comprising 80 HRQoL items. ConclusionWe identified a range of HRQoL issues (dry skin, xerostomia, and arthralgia) relevant to patients with stage III/IV melanoma. Future module development phases will refine the questionnaire. Once completed, this module will enable standardized assessment of HRQoL in patients with (locally) advanced melanoma.

Patient-reported outcomes and hospitalization data in patients with HER2-positive metastatic breast cancer receiving trastuzumab deruxtecan or trastuzumab emtansine in the phase III DESTINY-Breast03 study

In the DESTINY-Breast03 clinical trial, trastuzumab deruxtecan (T-DXd) showed superior progression-free survival and overall survival versus trastuzumab emtansine (T-DM1) and manageable safety in patients with human epidermal growth factor receptor 2 (HER2)-positive (HER2+) metastatic breast cancer. Here, patient-reported outcomes (PROs) are reported along with hospitalization data. Patients in DESTINY-Breast03 were assessed for prespecified PRO measures, including European Organization for Research and Treatment of Cancer quality of life (EORTC-QoL) questionnaires [the oncology-specific EORTC Quality of Life Questionnaire Core 30 (QLQ-C30) and breast cancer-specific EORTC QLQ-BR45] and the generic EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L) visual analogue scale. Analyses included change from baseline, time to definitive deterioration (TDD), and hospitalization-related endpoints. EORTC QLQ-C30 baseline global health status (GHS) scores for T-DXd (n= 253) and T-DM1 (n= 260) were similar, with no clinically meaningful change (<10-point change from baseline) while on either treatment (median treatment duration: T-DXd, 14.3 months; T-DM1, 6.9 months). TDD analyses of QLQ-C30 GHS (primary PRO variable) and all other prespecified PROs (QLQ-C30 subscales, the QLQ-BR45 arm symptoms scale, and the EQ-5D-5L visual analogue scale) suggested T-DXd was numerically favored over T-DM1 based on TDD hazard ratios. Of all randomized patients, 18 (6.9%) receiving T-DXd versus 19 (7.2%) receiving T-DM1 were hospitalized, and the median time to first hospitalization was 219.5 versus 60.0 days, respectively. In DESTINY-Breast03, EORTC GHS/QoL was maintained on both therapies throughout treatment, indicating that despite the longer treatment duration with T-DXd versus T-DM1, health-related QoL did not worsen on T-DXd. Furthermore, TDD hazard ratios numerically favored T-DXd over T-DM1 in all prespecified variables of interest including pain, suggesting T-DXd may delay time until health-related QoL deterioration compared with T-DM1. Median time to first hospitalization was three times longer with T-DXd versus T-DM1. Together with reported improved efficacy and manageable toxicity, these results support the overall benefit of T-DXd for patients with HER2+ metastatic breast cancer.

Clinically Important Difference for the FACIT-Fatigue Scale in Paroxysmal Nocturnal Hemoglobinuria: A Derivation from International PNH Registry Patient Data

Background: Fatigue is a common symptom associated with paroxysmal nocturnal hemoglobinuria (PNH). Eculizumab, a C5 inhibitor approved for treatment of PNH, has been shown to significantly alleviate fatigue, as indicated by reduced scores on the Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue). FACIT-Fatigue scores range from 0-52 (higher scores indicate less fatigue); this assessment is validated for use in patients with PNH and has been used extensively both in clinical trials and in the International PNH Registry. In patients with cancer, the FACIT-Fatigue clinically important difference (CID) is estimated to be improvement of 3-5 points. This CID is commonly applied in PNH studies; however, no disease-specific CID for FACIT-Fatigue has been estimated in patients with PNH. A PNH-specific CID would be informative in evaluating changes in fatigue impact and could serve as a more robust criterion for evaluating treatment efficacy. The objective of this analysis was to determine the FACIT-Fatigue CID for patients with PNH using distribution- and anchor-based approaches and real-world data from the International PNH Registry.Methods: Adults with PNH who initiated eculizumab within 28 days of enrollment in the PNH Registry as of January 2021 with non-missing baseline FACIT-Fatigue scores were included in the analysis. FACIT-Fatigue scores were assessed at baseline and 6, 12, 24, and 36 months. Two distribution-based CID estimates were calculated using: 1) 0.5 × SD and 2) standard error of measurement (SEM). The SEM was calculated as SD−sqrt(1-α), where α represents the internal consistency measurement Cronbach's alpha. Cronbach's alpha was calculated from the 13 FACIT-Fatigue subscales. Anchor-based estimates considered 2 continuous patient-reported outcome variables: 1) European Organization for Research and Treatment of Cancer (EORTC) Global Health Status Quality of Life (QoL) summary score (quartiles; higher scores indicate better quality of life), and 2) EORTC Global Health Status Fatigue Subscale score (quartiles; lower scores indicate less fatigue). The baseline FACIT-Fatigue score was calculated for each predefined categorization of the anchors; the mean of differences in FACIT-Fatigue between adjacent categories was calculated and referenced as the anchor-based CID. Changes in anchors and high disease activity (HDA) shift from baseline to each follow-up visit were then assessed by FACIT-Fatigue score change (≤1 CID, no change, or ≥1 CID). HDA was defined as lactate dehydrogenase ratio ≥1.5 × upper limit of normal and ≥1 of the following: history of a major adverse vascular event (including a thrombotic event); anemia; or physician-reported abdominal pain, dyspnea, dysphagia, fatigue, hemoglobinuria, or erectile dysfunction.Results: 423 patients were included in the analysis (Table). The majority of patients were white or of Caucasian descent (84%); 3% were of Hispanic or Latino ethnicity. At baseline, 93% of patients had physician documentation of fatigue in their medical history (mean FACIT-Fatigue score, 29.4). The 2 distribution-based CIDs were 7 using 0.5 × SD and 5 using SEM; internal consistency was high (α=0.87). For anchor-based measurements, the CID was 8 using the EORTC QoL score and 10 using the EORTC fatigue subscale score. The percentage of patients who changed from having HDA at baseline to no HDA at eculizumab-treated follow-up visits increased over time. Using the SEM as the referent CID (owing to the high α value), the majority of these patients experienced >1 CID in FACIT-Fatigue that was sustained through 36 months (Figure). Results were similar when 0.5 × SD was used.Conclusion: Collectively, these results support the use of 5 points as the CID for FACIT-Fatigue in individual patients with PNH, which, although not necessarily the minimal value, is close to the range of CIDs reported in other diseases (3-5 points). This finding, obtained from a real-world dataset with a large number of patients, helps establish an important metric for assessment of the meaningful treatment response of patients with PNH. Of note, this CID is markedly smaller than the group average FACIT-Fatigue improvement of 10 points achieved with long-term eculizumab treatment in the pivotal blinded Phase 3 TRIUMPH study. [Display omitted] DisclosuresCella: FACIT: Membership on an entity's Board of Directors or advisory committees. Ueda: Sanofi: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Chugai Pharmaceutical: Consultancy, Honoraria, Research Funding; Alexion Pharma: Consultancy, Honoraria. Tomazos: Alexion, AstraZeneca Rare Disease: Current Employment. Gustovic: Alexion, AstraZeneca Rare Disease: Current Employment. Wang: Alexion, AstraZeneca Rare Disease: Current Employment. Patel: Alexion, AstraZeneca Rare Disease: Current Employment. Schrezenmeier: Novartis: Honoraria; Alexion, AstraZeneca Rare Disease: Honoraria, Other: Travel support, Research Funding; Roche: Honoraria; Apellis: Honoraria; Sanofi: Honoraria.

Depressive Symptoms and Quality of Life Associated With the Use of Monoclonal Antibodies in Breast Cancer Treatment.

To assess the relationship between (a) chemotherapy and monoclonal antibody (mAb) treatments and (b) depressive symptoms and quality of life (QOL) in patients with breast cancer. 182 women with breast cancer in Spain who were undergoing chemotherapy with or without mAbs. An observational, cross-sectional study was carried out. The European Organisation for Research and Treatment of Cancer (EORTC) QOL Questionnaire-Core 30 and the EORTC QOL Questionnaire-Breast Cancer were used to assess QOL. Patients were screened for depressive symptoms using the Beck Depression Inventory-II. No relationship was found between the use of mAbs with chemotherapy and QOL, except for incidence of diarrhea. However, depressive symptoms had a negative and highly significant influence on the majority of the QOL parameters. The presence of depressive symptoms negatively affects QOL. Used concurrently, mAbs and chemotherapy do not negatively influence QOL, but some adverse effects, such as diarrhea, are common.

Real-World (RW) Treatment Patterns and Patient-Related Factors Including Quality of Life (QoL), Medication Adherence, and Actigraphy in Community Patients (pts) with Newly Diagnosed Multiple Myeloma (NDMM) Transitioning from Bortezomib (btz) to Ixazomib: The US MM-6 Community-Based Study

Real-World (RW) Treatment Patterns and Patient-Related Factors Including Quality of Life (QoL), Medication Adherence, and Actigraphy in Community Patients (pts) with Newly Diagnosed Multiple Myeloma (NDMM) Transitioning from Bortezomib (btz) to Ixazomib: The US MM-6 Community-Based Study

Mitchell–Hoole–Kanatas (MHK) questionnaire: the first to measure patient-reported outcomes relating to problems with intimacy after diagnosis and treatment of head and neck cancer

Patient-reported outcomes are increasingly used by clinical teams as indicators of quality when assessing treatment after a diagnosis of head and neck cancer. About a third of patients report reduced sexual interest or enjoyment after such treatment but, despite that, there is no questionnaire about intimacy that has been developed specifically for them. The aim of this study was to develop such a questionnaire, to gain an indication of the relative incidence of individual items, and to compare characteristics such as age, stage, treatment, time since treatment for an established head and neck cancer, and a health-related quality of life (QoL) measure (European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 with the Head and Neck 35 module). The development of the new instrument was based on an exploratory observational study that included quantitative and qualitative methods. The qualitative element was achieved by the generation of items - from published studies, the comments of patients and carers, and a cross-sectional survey of patients with head and neck cancer who were alive and free of disease. The quantitative element comprised analysis of exploratory and confirmatory factors, internal reliability assessment (Cronbach’s alpha), and a correlation analysis. Forty-two patients were included in the focus groups, and 101 patients participated in the cross-sectional survey (both male and female, in a relationship and single, age range 30–70 years for the focus group, and 62–117 in the cross-sectional survey). All treatments were included. We found that the ability to enjoy a sex life had been adversely affected in about half the sample and that this had significantly changed from before their cancer in a third. The qualitative part of the study resulted in 22 items that covered a range of domains from dry mouth and thick saliva to loss of sensation (lips, fingertips), restricted head/neck movement, fatigue, and pain. The exploratory analysis covered four domains (physical, sensation, movement, and communication) from 12 of 22 items. Cronbach’s alphas ranged from 0.62 to 0.84, and the correlation analysis indicated “good fit” statistics for these domains. In terms of the EORTC QoL Questionnnaire – Head and Neck 35, the four MHK domains showed good levels of association with anticipated domains. Head and neck cancer and its associated treatments significantly adversely affect intimacy and sexuality in half the population sampled. The MHK tool may be used to identify specific issues related to intimacy in patients with a history of diagnosis and treatment of head and neck cancer. Further work is essential to identify its precise role and to help develop specific interventions.

Understanding the quality of life (QOL) issues in survivors of cancer: towards the development of an EORTC QOL cancer survivorship questionnaire

BackroundThe number of cancer survivors is growing steadily and increasingly, clinical trials are being designed to include long-term follow-up to assess not only survival, but also late effects and health-related quality of life (HRQOL). Therefore it is is essential to develop patient-reported outcome measures (PROMs) that capture the full range of issues relevant to disease-free cancer survivors. The objectives of this project are: 1) to develop a European Organisation for Research and Treatment of Cancer (EORTC) questionnaire that captures the full range of physical, mental and social HRQOL issues relevant to disease-free cancer survivors; and 2) to determine at which minimal time since completion of treatment the questionnaire should be used.MethodsWe reviewed 134 publications on cancer survivorship and interviewed 117 disease-free cancer survivors with 11 different types of cancer across 14 countries in Europe to generate an exhaustive, provisional list of HRQOL issues relevant to cancer survivors. The resulting issue list, the EORTC core questionnaire (QLQ-C30), and site-specific questionnaire modules were completed by a second group of 458 survivors.ResultsWe identified 116 generic survivorship issues. These issues covered body image, cognitive functioning, health behaviors, negative and positive outlook, health distress, mental health, fatigue, sleep problems, physical functioning, pain, several physical symptoms, social functioning, and sexual problems. Patients rated most of the acute symptoms of cancer and its treatment (e.g. nausea) as no longer relevant approximately one year after completion of treatment.ConclusionsCompared to existing cancer survivorship questionnaires, our findings underscore the relevance of assessing issues related to chronic physical side effects of treatment such as neuropathy and joint pain. We will further develop a core survivorship questionnaire and three site-specific modules for disease-free adult cancer survivors who are at least one year post-treatment.

Gender differences in pain and patient reported outcomes: a secondary analysis of the NCIC CTG SC. 23 randomized trial.

Gender differences may contribute to variations in disease presentations and health outcomes. To explore the gender difference in pain and patient reported outcomes in cancer patients with bone metastases undergoing palliative radiotherapy on the National Cancer Institute of Canada (NCIC) SC.23 randomized trial. Patients completed the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) bone metastases module (QLQ-BM22) and EORTC QOL Core-15-Palliative (QLQ-C15-PAL) before treatment and at days 10 and 42 after a single 8 Gy radiation treatment. Patient demographics, performance status, analgesic consumption, BM22 and C15 were compared between males and females using the 2-sample t-test for continuous variables or the Chi-squared test for categorical variables. Multiple linear regression models were used to check the difference between gender groups adjusting for the baseline demographics and primary disease sites. There were 298 patients (170 male, 128 female) with median age of 69 years. The most common primary cancer sites were lung, prostate and breast. At baseline, there were no differences in BM22 and C15 scores, except a worse nausea and vomiting score (P=0.03) in females on the C15. In patients with moderate baseline worst pain scores (WPS), females reported worse scores in painful sites of BM22. At day 42, there was no significant difference in response to radiotherapy. Among the responders, females reported better improvement in emotional aspect. In cancer patients with bone metastases undergoing palliative radiotherapy, the majority of symptom presentations, patient reported outcomes, and response to radiation was not significantly different between genders. NCT01248585.

A planned, prospective comparison of short-term quality of life outcomes among older patients with breast cancer treated with standard chemotherapy in a randomized clinical trial vs. an observational study: CALGB #49907 and #369901

Patients ≥ 65 years old ("older") are often not included in randomized clinical trials (RCT), but when they are, care in an RCT might improve quality of life (QoL). We conducted a prospective comparison of QoL among older women receiving standard chemotherapy from the same cooperative group physicians in an RCT vs. an observational study ("off-trial"). Older women with invasive, non-metastatic breast cancer (n=150 RCT; 530 off-trial) were included. Linear mixed-effects models tested associations between chemotherapy on- vs. off-trial and changes in EORTC (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) QoL scores over 24 months, controlling for pre-treatment QoL, age, education, tumor factors, comorbidity, and other covariates. Anthracycline regimens were used by 58% of women treated on-trial vs. 54% of those treated off-trial. Women in the RCT reported an adjusted mean increase of 13.7 points (95% CI 10.2, 17.1) in global QoL at 24 months (vs. mid-treatment), while women treated off-trial had only an adjusted improvement of 7.0 points (95% CI 3.5, 10.4; p=.007 for difference in mean changes). Women in the RCT had significantly greater improvement in emotional function than those treated off-trial, controlling for baseline; they also had greater reductions in therapy side effects and fatigue at 24 months than women off-trial, controlling for covariates. There may be different QoL trajectories for older women undergoing breast cancer chemotherapy on- vs. off-trial. If confirmed, the results suggest that the extra monitoring and communication within an RCT could provide the infrastructure for interventions to address symptoms and improve QoL for the growing older cancer population.

A comparison between surgery plus radiotherapy and exclusive chemoradiation therapy regimes in oral and oropharyngeal cancer: Long-term functional and psychological impact.

5575 Background: Treatment of head and neck tumors negatively affects speech, swallowing, and quality of Life (QoL). Our aim was the evaluation of QoL and psychological functioning comparing surgery + radiotherapy (S+RT) and exclusive chemo-radiation therapy (CH-RT) regimes. Methods: Seventy-two patients, homogeneous for demographic and TNM characteristics were affected by a tumor of oral cavity and oropharynx; 36 underwent S+RT and 36 received exclusive CH-RT. Late effects of treatment and psycho-oncological assessment included: Radiation Therapy Oncology Group (RTOG)-European Organisation for Research and Treatment of Cancer (EORTC) late radiation morbidity scoring system, DISCHE morbidity recording scheme, Hospital Anxiety and Depression Scale (HADS), Montgomery Asberg Depression Rating Scale (MADRS), Mini Mental Adjustment to Cancer (MINI MAC), EORTC QoL Head and Neck35, Karnofky performance status, Visual Analogue Scales for dysphonia, dysphagia, dysmorphism and pain and Goodenough-Harris Draw a Person Test (DAP). Results: After median follow-up of 63 months, moderate-severe DISCHE score in S+RT vs. CT+RT was: taste impairment (64% vs. 89%), salivary function (59% vs. 79%), subcutaneous fibrosis (97% vs. 75%). Long term dysphagia: some discomfort (22% vs. 39%), soft diet required (42% vs. 28%), fluids only and naso-gastric tube feeding (11% vs. 4%); patients with severe dysphagia and taste impairment showed higher levels of anxiety (p<0.05): dysphagia influences the QoL, fatigue and physical-social functioning. Severe salivary function impairment is related only with troubles in social eating and contacts, without effects on QoL. MADRS depression was 56% vs. 46%, HADS anxiety was 22% vs. 21%. Just fair concordance in rate of depression between self-reported and clinician-rated scales was observed, with higher rates relieved in MADRS scale compared to HADS depression subscale (using 8 or 10 cut-off, Cohen's k test=0.401). Conclusions: A different pattern of long term toxicity was observed in S+RTvsCT+RT. Anxiety rate is lower, depression is present in half of patients and is statistically related with dysphagia. No significant financial relationships to disclose.

Quality of Life of Long-Term Survivors after a Distal Subtotal Gastrectomy

The aim of this study was to investigate the impact of a distal subtotal gastrectomy on the quality of life (QoL). The QoL data of 126 patients were obtained on their 5th annual follow-up visit after a curative distal subtotal gastrectomy for gastric cancer (Group A). The QoL data of 130 age- and gender-adjusted healthy population were obtained from the individuals who visited the health screening center for a medical check-up (Group B). There were 42 women and 84 men in the study group and their mean age was 56.0±11.1 years. QoL was assessed using the Korean versions of the European Organization for Research and Treatment of Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30) and QLQ-STO22. The EORTC QLQ-C30 global health status and QoL scores of Group A and Group B were 63.9±22.7 and 61.3±22.1, respectively (p=0.361). Group A revealed a better score for emotional functioning (84.1±16.1 and 75.2±21.4, respectively; p<0.001), cognitive functioning (82.0±16.4 and 75.0±21.4, respectively; p=0.004) and fatigue (27.7±20.8 and 33.8±23.2, respectively; p=0.028). However, Group A revealed a worse score for nausea and vomiting (14.8±20.0 and 10.2±16.0, respectively; p=0.042), financial difficulties (14.8±22.9 and 7.1±16.1, respectively; p=0.002), reflux (16.7±17.7 and 10.1±17.0, respectively; p=0.003), eating restrictions (13.6±15.2 and 6.6±10.2, respectively; p<0.001) and body image (23.3±25.4 and 16.2±24.6, respectively; p=0.023). The QoL of long-term survivors after a distal subtotal gastrectomy is still influenced by the surgery itself even though they are considered to be free of disease.

Mental and Physical Stressors in the Diagnosis of Breast Cancer: An Analysis of Distress and Systemic Biomarkers in Patients Referred for Biopsy of a Suspected Breast Cancer Lesion.

Abstract Background: Women diagnosed and treated for breast cancer will experience significant symptom distress including, fatigue, depression, anxiety and alterations in sleep. Inflammatory cytokines have been implicated in the symptom distress experienced by these women. There is little research of symptom distress related to the experience and results of breast biopsy. The current study is a multidisciplinary analysis of distress and systemic biomarkers in patients referred for biopsy of a suspected breast cancer lesion.Methods: 42 of 100 planned patients have been prospectively studied with blood samples and behavioral assessments at two time points; when first referred to a breast surgeon for a suspect imaging or clinical exam and post biopsy after the results are known. Behavioral assessments include the Hospital Anxiety and Depression Scale (HADS), the Brief Fatigue Inventory (BFI), the Pittsburgh Sleep Quality Index (PSQI), the European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QOL) and the PANAS questionnaire. Scores were determined for each patient and correlated using Pearson's analysis. Plasma samples were analyzed with XMap bead multiplex assays for VEGF, EGF, INFγ, TNF, IL-1Β, IL-2, IL-6, FGF-2. The mean ± standard deviation was calculated for each biomarker at each time point.Results: When looking at the entire population and their test performances pre- and post-biopsy, there were highly significant (p&amp;lt;.01) correlations between scores for depression (HADS-D), fatigue (BFI) and quality of life (EORTC-QOL). Of 42 patients studied, 13 had a positive cancer diagnosis (31%). There were no significant differences noted in scores between the patients with a cancer (+) versus a benign (-) diagnosis, however trends were present. QOL scores declined in 9/13 (69%) (+) patients and 10/29 (34%) (-) patients while QOL scores improved in 1/13 (8%) (+) patients and 9/29 (31%) (-) patients. Anxiety mood disorder was present at baseline (HADS) in 3/9 (+) patients tested (34%) versus 4/23 (-) patients (17%). The average pre-biopsy scores for anxiety were higher for the (+) patient group, yet both patient groups had similarly reduced anxiety levels after diagnosis. 17% of (-) patients developed a significant anxiety mood disorder after diagnosis while none of those in the positive group did. Depression was less of a problem in both groups with little change in scores pre- and post-diagnosis. Mild fatigue (BFI)was noted in 69% of all patients (77% of those with + diagnosis) with little change after diagnosis. Serum biomarkers did not significantly correlate with cancer diagnosis. but IL-6 levels were inversely related to the fatigue symptom portion of ETORC.Conclusions: There is significant impact of a possible cancer diagnosis on a patients' sense of well being and functioning. Perceived risk may impact on this greatly and may be self imposed and/or a result of patient-healthcare system interaction. This will only increase as screening for breast cancer includes newer, more sensitive modalities for cancer detection that increase the detection of suspect lesions. Increasing awareness and interventions should be considered even when cancer is not diagnosed. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 1070.

Functional and psychological evaluation after exclusive chemoradiation therapy in oral and oropharyngeal cancer

e17012 Purpose: The treatment of head and neck tumours often negatively affects speech, swallowing, body image and quality of life (QoL). Aim of this study was the evaluation of the impact of exclusive chemoradiation therapy (CH-RT) on QoL and psychological functioning. Patients and Methods: Twenty-eight patients, affected by a carcinoma of the oral cavity and oropharynx received exclusive CH-RT. Late effects of CH-RT and psycho-oncological assessment included: Radiation Therapy Oncology Group (RTOG) - European Organisation for Research and Treatment of Cancer (EORTC) late radiation morbidity scoring system, DISCHE morbidity recording scheme, Hospital Anxiety and Depression Scale (HADS), Montgomery Asberg Depression Rating Scale (MADRS), Mini Mental Adjustment to Cancer (MINI MAC), and EORTC QoL Head and Neck 35. Results: After a median follow-up of 42 months (range 12–60 months) moderate-severe late toxicity was as follows: taste impairment (89.20%), salivary function (82.12%), subcutaneous tissue (7.08%). Concerning dysphagia 39% of patients complained some discomfort, 28% had a more severe toxicity whereas 7% could not have an oral feeding; patients with severe dysphagia showed higher levels of anxiety (p &lt; 0.05): dysphagia influences the QoL, fatigue and physical-social functioning. Rates of depression and anxiety were generally low: 78.6% of our sample did not show clinical relevant anxious symptoms and 82.1% of patients did not reach the threshold of an overt depression. Just a fair concordance in rate of depression between self- and hetero-evaluated scale was observed, with higher rates relieved by MADRS compare to HADS depression subscale using 8 or 10 cut-off (Cohen's k test = 0.401) Conclusions: Our data suggest low rates of anxiety and depression, in patients treated with CH-RT, with a different evaluation between self-evaluative and hetero-evaluative scales. No significant financial relationships to disclose.

The European Organisation for Research and Treatment of Cancer (EORTC) translation procedure for standardized quality of life questionnaires

16033 Background: The EORTC Quality of Life (QoL) Group has developed a modular approach to QoL measurement for use in clinical trials in cancer. Questionnaires are used in international trials and standardized translation procedures are therefore required. This report summarizes the EORTC translation procedure, its accomplishments and translation problems. Methods: Translations follow a forward-backward procedure, independently carried out by two native-speakers of the target language. Discrepancies are arbitrated by a third consultant, and solutions are reached by consensus. Translated questionnaires undergo pilot-testing. Suggestions (by patients and users) are incorporated into the final questionnaire version. Most translations are performed by professional translators. The translation procedure is managed and supervised by the Translation Committee within the EORTC QoL Group. Results: To date, the core EORTC QoL questionnaire, the QLQ-C30, has been translated and validated into 62 languages, with a further 12 translations in progress. Translations include all major Western languages, East European languages, Asian languages and also remote languages, such as Xhoza (Africa).The validated, condition-specific questionnaire modules have been translated in up to 37 languages. The following major translation problems were encountered: lack of expressions for specific symptoms in various languages, the quest for formal versus informal versions, recent spelling reforms in several European countries, and different weights of social issues between Western and Eastern cultures. The EORTC measurement system is now registered for use in over 9000 clinical studies in 80 countries worldwide. Conclusions: The EORTC provides a strong infrastructure and methodology to produce high quality translations of their QoL questionnaires for use in international clinical trials. Translation problems have been identified and it will be an important topic for future research to specify whether these problems arise out of procedural/methodological shortcomings or are due to subtle cross-cultural differences in concepts of health, illness and QoL. No significant financial relationships to disclose.

Development of an EORTC disease-specific quality of life questionnaire for use in patients with liver metastases from colorectal cancer

Quality of life (QL) is an important outcome measure within clinical trials. This paper describes the development of a QL module for patients with liver metastases from colorectal cancer (CRC) to supplement the European Organization for Research and Treatment of Cancer (EORTC) core QL questionnaire, the EORTC QLQ-C30. Phases 1–3 of the EORTC QL Group guidelines for developing QL modules were followed. The literature search generated 71 QL issues. Semi-structured interviews with eight healthcare professionals and 47 patients from the United Kingdom, France, Germany and Austria reduced the list to 23 issues. Questionnaire items were formulated to be compatible with the EORTC QLQ-C30. The provisional module was further tested in 102 patients resulting in a 21-item module, the QLQ-LMC21 (Liver Metastases Colorectal). A combination of the core questionnaire and the QLQ-LMC21 will provide essential QL information regarding the use of treatments in both the curative and palliative settings.

The challenges and achievements involved in implementing Quality of Life research in cancer clinical trials

Over the last decade, Quality of Life (QOL) research has become an important aspect of cancer clinical trials. A dramatically increasing number of published studies, both randomised and non-randomised, report QOL outcomes. There is increasing evidence that QOL results impact on both future research and treatment decisions for clinicians. The rising number of studies with QOL components is mirrored within the European Organization for Research and Treatment of Cancer (EORTC), one of the largest cancer clinical trial organisations in Europe. Clinical trial groups have frequently reported on the difficulties and challenges of implementing QOL research. In the following paper, we therefore examine past experience in EORTC QOL studies, with a focus on the challenges presented and the improved approaches that are being implemented to obtain more meaningful outcomes.

Development of an EORTC disease-specific quality of life module for use in patients with gastric cancer

Quality of life (QL) is an important outcome in clinical trials in oncology. There is currently no valid international QL measure for gastric cancer. This paper describes the development of a QL module for gastric cancer to supplement the European Organization for Research and Treatment of Cancer (EORTC) Quality of life (QLQ-C30) questionnaire. Phases I to III of module development were conducted in the United Kingdom, France, Germany and Spain according to EORTC QL Group guidelines. Twenty relevant QL issues were generated from the literature and interviews with health professionals (n=24) and patients (n=58). This produced a 24 item provisional module. Further testing in 115 patients resulted in the QLQ-STO22, containing 22 questions, conceptualised into five scales and four single items, related to disease symptoms, treatment side-effects and emotional issues specific to gastric cancer. The use of the QLQ-C30 supplemented by the QLQ-STO22 will provide a comprehensive QL measure for international trials in gastric cancer.

Quality of life in patients with prostatic cancer a feasibility study

In recent years, there has been a growing recognition of the need to include parameters representing the patients' view of their conditions that, therefore, are more subjective in nature. As a first effort to introduce quality-of-life (QOL) assessment in prostatic cancer clinical trials, the European Organization for Research and Treatment of Cancer (EORTC) Genitourinary Group, in cooperation with the EORTC QOL Group, activated Protocol 30853 (orchiectomy versus goserelin acetate and flutamide in previously untreated patients with Stage M+ disease. Study Coordinator: Louis Denis). The use of patient-administered QOL questionnaires was optional, and of 327 patients, only 22% underwent pretreatment assessments. Psychologic distress, fatigue, social and family life, and pain are the most important to the patient on a subjective basis, and these were confirmed in relation to objective parameters. There was a discrepancy between the doctors' evaluations and the patients' opinions about subjective morbidity, namely, in regard to sexual status and pain. This EORTC trial revealed the reluctance of clinicians to do QOL research, partly related to feasibility problems and partly to the doctors' doubts about the value of such efforts. QOL assessment should become a mandatory part of clinical trials in prostatic cancer.