European Organization For Research And Treatment Of Cancer Research Articles

Health-related quality of life in transplant-eligible patients with newly diagnosed multiple myeloma treated with daratumumab, lenalidomide, bortezomib, and dexamethasone: Patient-reported outcomes from GRIFFIN.

In the phase 2 GRIFFIN trial (ClinicalTrials.gov identifier: NCT02874742), daratumumab added to lenalidomide, bortezomib, and dexamethasone (D-RVd) improved depth of response and progression-free survival (PFS) versus lenalidomide, bortezomib, and dexamethasone (RVd) alone in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM). Here, we present patient-reported outcomes (PROs) collected using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30-item (QLQ-C30), EORTC Quality of Life Questionnaire Multiple Myeloma Module 20-item (QLQ-MY20), and EuroQol 5-Dimension 5-Level (EQ-5D-5L) tools on day 1 of cycles 1, 2, and 3; on day 21 of cycle 4 (end of induction therapy); on day 1 of cycle 5; on day 21 of cycle 6 (end of posttransplant consolidation therapy); and at months 6, 12, 18, and 24 of maintenance therapy. Meaningful improvements from baseline were seen in most of the PRO scales with both treatments after consolidation and were sustained for at least 2 years of maintenance treatment. Large reductions from baseline (~20 points) were especially observed in pain symptoms for both treatment groups, although these were numerically higher for patients receiving D-RVd during the majority of the time points. In addition, improvements in key scales, such as global health status, fatigue symptoms, and physical functioning, were also seen with both D-RVd and RVd. These improvements in health-related quality of life contribute to the totality of evidence supporting the improvement in clinical outcomes such as response rates and PFS with D-RVd in induction, consolidation, and maintenance therapy in TE patients with NDMM.

Long-term quality of life after hybrid robot-assisted and open Ivor Lewis esophagectomy for esophageal cancer in a single center: a comparative analysis

PurposeDue to improved survival of esophageal cancer patients, long-term quality of life (QoL) is increasingly gaining importance. The aim of this study is to compare QoL outcomes between open Ivor Lewis esophagectomy (Open-E) and a hybrid approach including laparotomy and a robot-assisted thoracic phase (hRob-E). Additionally, a standard group of healthy individuals serves as reference.MethodsWith a median follow-up of 36 months after hRob-E (n = 28) and 40 months after Open-E (n = 43), patients’ QoL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30) and the EORTC Esophagus specific QoL questionnaire 18 (QLQ-OES18).ResultsPatients showed similar clinical-pathological characteristics, but hRob-E patients had significantly higher ASA scores at surgery (p < 0.001). Patients and healthy controls reported similar global health status and emotional and cognitive functions. However, physical functioning of Open-E patients was significantly reduced compared to healthy controls (p = 0.019). Operated patients reported reduced role and social functioning, fatigue, nausea and vomiting, dyspnea, and diarrhea. A trend towards a better pain score after hRob-E compared to Open-E emerged (p = 0.063). Regarding QLQ-OES18, hRob-E- and Open-E-treated patients similarly reported eating problems, reflux, and troubles swallowing saliva.ConclusionsThe global health status is not impaired after esophagectomy. Despite higher ASA scores, QoL of hRob-E patients is similar to that of patients operated with Open-E. Moreover, patients after hRob-E appear to have a better score regarding physical functioning and a better pain profile than patients after Open-E, indicating a benefit of minimally invasive surgery.

Health related quality of life and its predictive factors on cervical cancer patients in two teaching hospitals, Addis Ababa, Ethiopia

BackgroundCervical cancer is the second most prevalent and the leading cause of cancer related deaths among Ethiopian women; and about three fourth are diagnosed at advanced stages. Cervical cancer can affect the health-related quality of life (HRQOL) in multiple ways. The main aim of this study was to describe the HRQOL of cervical cancer patients and the predictive factors using validated tools.MethodsInstitution based cross-sectional study was conducted among 264 cervical cancer patients using the validated Amharic version of European Organization for Research and Treatment of Cancer (EORTC) modules; QLQ-C30 and QLQ CX24. Descriptive statistics were used to summarize the raw data. One way ANOVA was used to determine the significance of mean differences between the dependent and independent variables. Binary and multivariable regression analysis were used to measure the association between Global Health Status and independent factors. The level of significance was set at p-value < 0.05.ResultsOn EORTC QLQ-C30 scales, the mean Global Health Status (GHS) was 42.57 ± 23.31. The least and highest affected functions were physical and social, mean (SD) = 76.39 ± 23.24 and 50.40 ± 32.19, respectively. The financial difficulty was the most affected among the symptom scales, 57.83 ± 35.34. Only physical function and financial difficulty have shown an independent association with GHS, (AOR = 0.21, 95% CI = 0.05–0.84), (AOR = 0.21 95% CI = 0.07–0.59), respectively. Illiterate, can read and write, were among the predictor factors that showed an independent association with the Global Health Status. Among the EORTC QLQ-CX24 symptom scales, the highest affected score was for sexual worry, mean (SD) = 51.81 + 32.197.ConclusionsIn an effort to improve the Global Health Status of cervical cancer patients in Ethiopia; physical function and financial difficulty should be the priority areas. The Illiterate and those who lack formal education need due attention in order to improve the health-related quality-of-life.

EORTC QLQ-C30 general population normative data for the United States

ObjectiveThe European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 is a frequently used cancer-specific health-related quality of life (HRQoL) questionnaire. To aid interpretation of data obtained via EORTC QLQ-C30, general population norm data have been published for many countries. However, despite its frequent use in the United States, no normative data by sex and age exist to date. Therefore, this study aimed to generate sex- and age-specific EORTC QLQ-C30 normative data for the United States. MethodsRecruitment and data collection were carried out via online panels as part of a larger cross-sectional study. For the recruitment, the sample was stratified by sex and age (18–39, 40–49, 50–59, 60–69, ≥ 70 years) to achieve a balanced distribution, with n = 100 per subgroup. Descriptive statistics are presented by age and age/sex. ResultsA total of N = 1009 respondents completed the survey (n = 508 females, n = 501 males). More than two thirds of participants (72.5%) reported at least one health condition, e.g., arthritis (26%). Across EORTC QLQ-C30 scales, women and men 60 years and older reported generally better/higher functioning and better/lower symptom scores compared to the younger age groups. ConclusionTo date, no specific EORTC QLQ-C30 general population normative data have been published for the United States. This paper provides these important normative data, which will greatly support the interpretation of EORTC QLQ-C30 scale scores obtained from US cancer patients, and also enable comparison with European norms.

Longitudinal patient-reported outcomes after minimally invasive McKeown esophagectomy for patients with esophageal squamous cell carcinoma

PurposeSurgery for esophageal squamous cell carcinoma (ESCC) is characterized by a poor prognosis and high complication rate, resulting in a heavy symptom burden and poor health-related quality of life (QOL). We evaluated longitudinal patient-reported outcomes (PROs) to analyze the correlations between symptoms and QOL and their changing characteristics during postoperative rehabilitation.MethodsWe investigated patients with ESCC who underwent minimally invasive McKeown esophagectomy at Sichuan Cancer Hospital between April 2019 and December 2019. Longitudinal data of the clinical characteristics and PROs were collected. The MD Anderson Symptom Inventory and European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaires were used to assess symptoms and QOL and compare the trajectories of PROs during the investigation.ResultsA total of 244 patients with ESCC were enrolled in this study. Regarding QOL, role and emotional functions returned to baseline at 1 month after surgery, and cognitive and social functions returned to baseline at 3 months after surgery. However, physical function and global QOL did not return to baseline at 1 year after surgery. At 7 days and 1, 3, 6, and 12 months after surgery, the main symptoms of the patients were negatively correlated with physical, role, emotional, cognitive, and social functions and the overall health status (P < 0.05).ConclusionPatients with ESCC experience reduced health-related QOL and persisting symptoms after minimally invasive McKeown esophagectomy, but a recovery trend was observed within 1 month. The long-term QOL after esophagectomy is acceptable.

Synergy of de-walled Ganoderma Lucidum spore powder (GLSP) on targeted therapy in advanced non-squamous non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutant: protocol for a randomized, double-blind, placebo-controlled study

BackgroundOsimertinib is regarded as a promising third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for advanced non-squamous non-small cell lung cancer (NSCLC) patients who developed T790M. However the adverse effects, primarily fatigue, remain an overwhelming deficiency of Osimertinib, hindering it from achieving adequate clinical efficacy for such NSCLC. Ganoderma lucidum has been used for thousands of years in China to combat fatigue, while Ganoderma Lucidum spores powder (GLSP) is the main active ingredient. The aim of this study is to investigate whether GLSP is sufficiently effective and safe in improving fatigue and synergizing with Osimertinib in non-squamous NSCLC patients with EGFR mutant.Method/designA total of 140 participants will be randomly assigned to receive either de-walled GSLP or placebo for a duration of 56 days. The primary outcome measure is the fatigue score associated with EGFR-TKI adverse reactions at week 8, evaluated by the Chinese version of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer Patients (QLQ-C30). Secondary outcomes include evaluation of treatment effectiveness, assessment of quality of life (QoL), and exploration of immune indicators and gut microbiota relationships. Following enrollment, visits are scheduled biweekly until week 12.Trial registrationChina Clinical Trial Registry ChiCTR2300072786. Registrated on June 25, 2023.

Performance of the EORTC and CUETO Models to Predict Recurrence and Progression in High-risk Non-muscle-invasive Bladder Cancer Patients.

To evaluate the performance of the European Organization for Research and Treatment of Cancer (EORTC) and the Spanish Urological Club for Oncological Treatment (CUETO) risk scoring models in non-muscle-invasive bladder cancer (NMIBC) patients defined as high risk according to European Association of Urology guidelines and managed based on current recommendations. Data from 187 high-risk NMIBC patients treated at a tertiary center between July 2010 and November 2021 were analyzed retrospectively. One- and five-year recurrence- and progression-free survival were assessed for each patient using the EORTC and CUETO risk scores. The patients were divided into four risk groups according to their risk scores as low, medium-low, medium-high and high risk, as indicated in the models. Discriminative ability was evaluated with the Harrell's concordance index (c-index). Both risk scoring models overestimated the risk of recurrence and progression at one and five years. Only the prediction of recurrence at five years in the high risk group according to the CUETO model was compatible with our cohort. CUETO (c-indices for recurrence and progression were 0.802 and 0.834, respectively) exhibited better discrimination than EORTC (0.722 for recurrence and 0.752 for progression) in the prediction of disease recurrence and progression. The CUETO model was superior to the EORTC model in predicting recurrence and progression and stratifying patients with different prognoses in our high-risk NMIBC patient population treated according to current guideline recommendations. However, both models overestimated the probability of disease recurrence and progression. Only the probability of recurrence at five years in the high-risk group of the CUETO model was compatible with our cohort.

Changes in Quality of Life and Sexual Function After Luteinizing Hormone-Releasing Hormone (LHRH) Agonists and Orchiectomy in Men With Metastatic Prostate Cancer: Results From a Randomized Trial.

Purpose To examine changes in quality of life (QoL) in men diagnosed with metastatic prostate cancer undergoing androgen deprivation therapy (ADT). Methods This was a phase IV trial where patients were randomized to either triptorelin or subcapsular orchiectomy. We report changes in QoL, functional and symptom scales, and sexual function. These were assessed using the validated questionnaires, namely, the European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (EORTC-QLQ-C30), European Organization of Research and Treatment of CancerQuality of Life Questionnaire Prostate Cancer 25 (EORTC-QLQ-PR25), and Erectile Hardness Scale (EHS) before treatment and at 12, 24, and 48 weeks, respectively. Data were analyzed using linear mixed models for repeated measures. Results Fifty-seven men with a median age of 74 years were randomized. The pooled analyses showed that QoL (p=0.003), emotional function (p<0.001), urinary symptoms (p=0.011), and hormonal treatment-related symptoms (p<0.001) changed significantly between visits. Improvement from baseline in QoL (mean change: 6.8 points (95% confidence interval (CI 95% CI): 2.1; 11.5)), emotional function (6.9 points: 3.3, 10.6), and urinary symptoms (-7.7 points (-12.3; -3.0)) was most pronounced at 24 weeks. Hormonal treatment-related symptoms (8.9 points (95% CI: 5.9; 12.0)) worsened. No significant differences between treatment groups were observed. At baseline, 29 men (51%) reported interest in sex, 18 were sexually active, and 12 had erections hard enough for penetration. At 48 weeks seven reported interest in sex, five were sexually active, and one man had a hard enough erection for penetration. Conclusions Men with newly diagnosed metastatic prostate cancer experience improved QoL and emotional function after starting ADT. Urinary symptoms improved, while hormonal treatment-related symptoms worsened. Interest in sex and sexual activity was retained in a proportion of men despite ADT.

Radiotherapy Combined with a Radiosensitizer for Bacillus Calmette-Guérin–unresponsive Non–muscle-invasive Carcinoma In Situ Bladder Cancer: An Open-label, Single-arm, Multicenter, Phase 2 European Organisation for Research and Treatment of Cancer Trial

Radical cystectomy with pelvic lymph node dissection and urinary diversion is the standard of care for patients with bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive bladder cancer (NMIBC). However, many patients are unwilling or unable to undergo such major surgery associated with high morbidity and a negative impact on quality of life. Chemoradiotherapy is an established treatment option for muscle-invasive bladder cancer. However, it has not been investigated adequately in NMIBC until now. The European Organisation for Research and Treatment of Cancer (EORTC) 2235 study (NCT06310369) is designed as a multicenter, prospective, international, phase 2 trial of moderate hypofractionated radiotherapy combined with a radiosensitizer in BCG-unresponsive NMIBC patients with carcinoma in situ (CIS) who are not eligible for or declined to undergo radical cystectomy. Patients who have received nadofaragene firadenovec or TAR-200 are eligible. The primary endpoint is the 6-mo complete response (CR) rate defined by the absence of CIS proven by a control biopsy of the bladder. The secondary endpoints include overall survival, progression-free survival, durability of CR, grade 3–4 adverse events rate, patients’ quality of life, and organ preservation rate. Patient summaryIntravesical instillation of bacillus Calmette-Guérin is the standard treatment of non–muscle-invasive, also coined as superficial, bladder cancer. In case the cancer recurs, even superficially, there is no other proven treatment than a radical cystectomy—the surgical removal of the bladder. Although the surgical technique has improved dramatically over the past few years, it remains contraindicated in patients with severe comorbidities. In addition, because it affects the quality of life, patients may reject this option. This study will assess the efficacy of external beam radiotherapy, a robust alternative to surgery in muscle-invasive bladder cancer. Radiotherapy will be administered 5 d a week for 4 wk. It will be associated with a “radiosensitizer,” an intravenous or oral drug, during the radiotherapy treatment. The study will measure the proportion of patients remaining recurrence free at 6 mo and thereafter. It will also evaluate the safety of the treatment and its impact on quality of life.

Outcomes of extracranial stereotactic body radiation therapy for induced oligometastatic non-small cell lung cancer on novel systemic therapy.

Stereotactic body radiation therapy (SBRT) is often delivered in patients with oligometastatic disease (OMD). However, the specific subset of patients with polymetastatic non-small cell lung cancer (NSCLC) on novel systemic therapies who develop induced oligopersistant disease (OpersisD) or oligoprogressive disease (OprogD), as defined by the European Organisation for Research and Treatment of Cancer (EORTC) OMD classification, has not been well described. This study explores the outcomes of patients treated with this strategy. Patients with stage IV NSCLC being treated with osimertinib or immune checkpoint inhibitors (ICIs) who received extracranial SBRT for OpersisD or OprogD were identified in our retrospective analysis. Outcomes reported include progression-free survival (PFS), time to change of systemic treatment (TTCST), overall survival (OS), local control (LC) and treatment-related toxicity. Forty-nine patients received SBRT for OpersisD (34.7%) or OprogD (65.3%) at a median of 5.8 and 15.3 months after start of systemic therapy, respectively. 55.1% received concurrent osimertinib and 44.9% received ICI. Seventy-seven extracranial lesions were treated with various fractionation schemas. At a median of 18.8 months follow-up from first SBRT, LC was achieved in 92.2% of total lesions treated (71). The 1-year OS was 91.7% for OpersisD and 83.3% for OprogD. OpersisD compared to OprogD had a longer median PFS (18.3 vs. 6.1 months) and longer median TTCST (23.6 vs. 13.5 months), median OS was not reached for either cohort. On multivariate analysis, patients treated with osimertinib had shorter PFS (HR: 2.20; 95% CI: 1.01-4.82; P=0.048) and shorter TTCST (HR: 2.83; 95% CI: 1.09-7.33; P=0.032). One patient (2%) experienced grade 3 pneumonitis after SBRT, and no grade 4-5 toxicities were reported with SBRT treatment. This study indicates that SBRT for OpersisD or OprogD in Stage IV NSCLC patients on osimertinib or ICIs is safe, very well tolerated, and may prolong the time before needing a shift in systemic therapy. Further prospective research is needed to validate and expand upon these findings.

Health-related quality of life in patients with triple-class exposed relapsed and refractory multiple myeloma treated with idecabtagene vicleucel or standard regimens: patient-reported outcomes from the phase 3, randomised, open-label KarMMa-3 clinical trial

Chimeric antigen receptor T-cell therapy idecabtagene vicleucel (ide-cel) showed significantly improved progression-free survival compared with standard regimens in adults with relapsed and refractory multiple myeloma who had received two to four previous regimens in the ongoing phase 3 KarMMa-3 trial (NCT03651128). This study analysed patient-reported outcomes (PROs), a KarMMa-3 secondary endpoint. In the randomised, open-label, phase 3 KarMMa-3 trial, 386 patients in hospitals (≥18 years of age, with measurable disease and an Eastern Cooperative Oncology Group performance status score of 0 or 1, who had received two to four previous regimens-including an immunomodulatory agent, a proteasome inhibitor, and daratumumab-and had documented disease progression after receiving their last dose of the last therapy) were randomly assigned to ide-cel (n=254) or standard regimens (daratumumab, pomalidomide, and dexamethasone; daratumumab, bortezomib, and dexamethasone; ixazomib, lenalidomide, and dexamethasone; carfilzomib and dexamethasone; or elotuzumab, pomalidomide, and dexamethasone; n=132). Patients were expected to complete the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life C30 Questionnaire (QLQ-C30), Multiple Myeloma Module (QLQ-MY20), EQ 5 dimensions (EQ-5D), and EQ-5D visual analogue scale (VAS) at baseline and follow-up timepoints (data cutoff April 18, 2022). PROs included nine prespecified primary domains: EORTC QLQ-C30 GHS-quality of life (QoL), physical functioning, cognitive functioning, fatigue, and pain; QLQ-MY20 disease symptoms and side effects of treatment; and five-level EQ-5D (EQ-5D-5L) index score and EQ-5D visual VAS. Differences in overall least-squares mean changes from baseline to month 20 were analysed using post-hoc constrained longitudinal data analysis. Time to confirmed improvement or deterioration from baseline was analysed using Cox proportional hazard models. Patients were randomly assigned between May 6, 2019, and April 8, 2022. Overall, the median age was 63 years (IQR 55-68); 151 (39%) patients were female; and 250 (65%) patients were White, 36 (9%) Black or African American, 19 (5%) Hispanic or Latino, 12 (3%) Asian, and seven (2%) of other race. The median follow-up was 18·6 months (IQR 14·0-26·4). PRO compliance was higher than 75% throughout. Overall least-squares mean changes from baseline favoured ide-cel with Hedges' g effect sizes from 0·3 to 0·7 for most domains. Patients in the ide-cel group showed statistically significant and clinically meaningful improvements across the primary PRO domains of interest, with the exception of QLQ-MY20 disease symptoms, side effects of treatment, and EQ-5D-5L index score, which showed improvement across assessment visits but did not exceed the within-group minimally important difference thresholds. The ide-cel group had shorter times to clinically meaningful improvement than the standard regimens group in QLQ-C30 domains except in role functioning, diarrhoea, and financial difficulties; in QLQ-MY20 domains except body image; and in EQ-5D-VAS. Ide-cel offers improved health-related quality of life compared with standard regimens for patients with relapsed and refractory multiple myeloma after previous lines of therapy. The PRO data highlight the extended QoL benefits of a one-time infusion with ide-cel compared with continuous treatment with standard regimens in the treatment of triple-class exposed patients with relapsed and refractory multiple myeloma. 2seventy bio and Celgene, a Bristol Myers Squibb Company.

Social support during re-entry period and long-term quality of life in breast cancer survivors: a 10-year longitudinal cohort study.

This study evaluated the association between social support during the re-entry period and long-term health-related quality of life (HRQoL) in breast cancer survivors using a longitudinal cohort study. This is a prospective cohort study with 275 breast cancer survivors who reported HRQoL at 5 and 10years after diagnosis. Social support for the re-entry period was measured 3years after diagnosis using the Medical Outcome Study Social Support Survey (MOS-SSS). HRQoL was evaluated using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and Breast Cancer-Specific Module (BR-23). Multivariable linear regression analysis was performed to evaluate HRQoL at 5 and 10years after diagnosis by level of social support during the re-entry period. The mean (SD) of social support during re-entry period was 68.5. The low social support (LSS, score < 55) group during the re-entry period had a significantly lower HRQoL (mean difference =  - 12.93) compared to moderate or high social support (MHSS, score ≥ 55) group. 5 and 10years after diagnosis, the LSS group continued to demonstrate lower HRQoL (5years: - 7.17; 10years: - 7.85) compared to the MHSS group. The LSS group were more likely to have lower role and social function scores, and higher fatigue, pain, and financial problems compared to the MHSS group at 10years after diagnosis. Breast cancer survivors who received lower social support during the re-entry period were more likely to experience poorer HRQoL in the long term than those who did not.

Long-term health-related quality of life in head and neck cancer survivors: A large multinational study.

Head and neck cancer (HNC) patients suffer from a range of health-related quality of life (HRQoL) issues, but little is known about their long-term HRQoL. This study explored associations between treatment group and HRQoL at least 5 years' post-diagnosis in HNC survivors. In an international cross-sectional study, HNC survivors completed the European Organization for Research and Treatment of Cancer (EORTC) quality of life core questionnaire (EORTC-QLQ-C30) and its HNC module (EORTC-QLQ-H&N35). Meaningful HRQoL differences were examined between five treatment groups: (a) surgery, (b) radiotherapy, (c) chemo-radiotherapy, (d) radiotherapy ± chemotherapy and neck dissection and (e) any other surgery (meaning any tumour surgery that is not a neck dissection) and radiotherapy ± chemotherapy. Twenty-six sites in 11 countries enrolled 1105 survivors. They had a median time since diagnosis of 8 years, a mean age of 66 years and 71% were male. After adjusting for age, sex, tumour site and UICC stage, there was evidence for meaningful differences (10 points or more) in HRQoL between treatment groups in seven domains (Fatigue, Mouth Pain, Swallowing, Senses, Opening Mouth, Dry Mouth and Sticky Saliva). Survivors who had single-modality treatment had better or equal HRQoL in every domain compared to survivors with multimodal treatment, with the largest differences for Dry Mouth and Sticky Saliva. For Global Quality of Life, Physical and Social Functioning, Constipation, Dyspnoea and Financial Difficulties, at least some treatment groups had better outcomes compared to a general population. Our data suggest that multimodal treatment is associated with worse HRQoL in the long-term compared to single modality.

EORTC QLQ-C30 normative data for the United Kingdom: Results of a cross-sectional survey of the general population

ObjectiveThe cancer-specific health-related quality of life (HRQoL) questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC), the EORTC QLQ-C30, is a frequently applied questionnaire to assess cancer patients’ self-reported health used as part of research and clinical practice. Normative data obtained from the general population can facilitate the interpretation of these data. Despite its frequent application, no detailed EORTC QLQ-C30 normative data have yet been published for the United Kingdom (UK). This study presents detailed EORTC QLQ-C30 normative data for the United Kingdom overall and by sex and age. MethodsThe data are drawn from a larger published, international, cross-sectional online survey. For the recruitment, the sample was stratified by sex (males, females) and age in five age groups with a sample size of n = 100 per subgroup. ResultsA total of N = 1026 UK respondents completed the survey (n = 517 females, n = 509 males). There were no clear subgroup patterns by sex or age; however, older patients tended to show higher (i.e., better) scores in emotional and social functioning; they also reported some of the lowest (i.e., best) scores for symptoms, such as insomnia, appetite loss, diarrhoea, nausea/vomiting or financial difficulties. ConclusionThis paper provides EORTC QLQ-C30 general population normative data for the UK, further stratified by sex and age. These data will greatly support the interpretation of EORTC QLQ-C30 scale scores obtained from UK cancer patients, and also enable comparison with other detailed national normative datasets collected in the same project, across several other European countries and the US.

Comparison of different target volume delineation strategies based on recurrence patterns in adjuvant radiotherapy for glioblastoma

Abstract Background Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC) recommendations are commonly used guidelines for adjuvant radiotherapy in glioblastoma. In our institutional protocol, we delineate T2-FLAIR alterations as gross target volume (GTV) with reduced clinical target volume (CTV) margins. We aimed to present our oncologic outcomes and compare the recurrence patterns and planning parameters with EORTC and RTOG delineation strategies. Methods Eighty-one patients who received CRT between 2014 and 2021 were evaluated retrospectively. EORTC and RTOG delineations performed on the simulation computed tomography and recurrence patterns and planning parameters were compared between delineation strategies. Statistical Package for the Social Sciences (SPSS) version 23.0 (IBM, Armonk, NY, USA) was utilized for statistical analyses. Results Median overall survival and progression-free survival were 21 months and 11 months, respectively. At a median 18 month follow-up, of the 48 patients for whom recurrence pattern analysis was performed, recurrence was encompassed by only our institutional protocol’s CTV in 13 (27%) of them. For the remaining 35 (73%) patients, recurrence was encompassed by all separate CTVs. In addition to the 100% rate of in-field recurrence, the smallest CTV and lower OAR doses were obtained by our protocol. Conclusions The current study provides promising results for including the T2-FLAIR alterations to the GTV with smaller CTV margins with impressive survival outcomes without any marginal recurrence. The fact that our protocol did not result in larger irradiated brain volume is further encouraging in terms of toxicity.

The impact of CDK4/6 inhibitors on the quality of life of working-age women with metastatic breast cancer: a population-based cohort study from Portugal

Background Breast cancer frequently leads to reduced work capacity and increased absenteeism among working-age women diagnosed with this condition. In this study, we aimed to assess the effect of CDK4/6i combined with aromatase inhibitors (AIs) or fulvestrant on quality of life (QoL) and work activity in a cohort of Portuguese patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer who started this treatment regimen. Methods This unicentric prospective observational cohort study was conducted in 35 Portuguese women with stage IV HR+/HER2- breast cancer receiving CDK4/6i combined therapy. The objectives of the study were evaluated using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 version 3 (QLQ-C30) and the breast cancer-specific Questionnaire (EORTC QLQ-BR23), and the Work Productivity and Activity Impairment questionnaire - General Health (WPAI:GH) questionnaires at four different time points throughout treatment. Results The results obtained revealed a significant improvement in EORTC QLQ-C30 score from baseline in emotional functioning, social functioning, pain, dyspnea, insomnia, and financial difficulties, as well as in future perspective and breast symptoms, as assessed by EORTC QLQ-BR23 score. However, a significant deterioration from baseline in systemic therapy side effects was also observed. Despite the limitations regarding the cohort size, an increase in work absenteeism was also observed, as determined by WPAI:GH scores. This can possibly be attributed to pain-related bone metastases observed in those patients. Conclusions To the best of our knowledge, this is the first study to assess the impact of combined CDK4/6i therapy on the QoL and work activity of Portuguese patients with metastatic breast cancer. Our results indicate that although patients’ QoL did not appear to be affected, there was a significant decrease in work activity, as evidenced by preliminary results of the increased rate on work absenteeism.

Safety and effectiveness of CIMAvax-EGF administered in community polyclinics.

https://rpcec.sld.cu/trials/RPCEC00000205-En, identifier RPCEC00000205.

Development of standard computerised adaptive test (CAT) settings for the EORTC CAT Core

AimsComputerised adaptive test (CAT) provides individualised patient reported outcome measurement while retaining direct comparability of scores across patients and studies. Optimal CAT measurement requires an appropriate CAT-setting, the set of criteria defining the CAT including start item, item selection criterion, and stop criterion. The European Organisation for Research and Treatment of Cancer (EORTC) CAT Core allows for assessing the 14 functional and symptom domains covered by the EORTC QLQ-C30 questionnaire. The aim was to present a general approach for selecting CAT-settings and to use this to develop a portfolio of standard settings for the EORTC CAT Core optimised for different purposes and populations.MethodsUsing simulations, the measurement properties of CATs of different length and precision were evaluated and compared allowing for identifying the most suitable settings. All CATs were initiated with the most informative QLQ-C30 item. For each domain two fixed-length and two fixed-precision standard CATs were selected focusing on efficiency (brief version) and precision (long), respectively.ResultsThe brief fixed-length CATs included 3–5 items each while the long versions included 5–8 items. The fixed-precision CATs aimed for reliability of 0.65–0.95 (brief versions) and 0.85–0.98 (long versions), respectively. Median sample size savings using the CATs compared to the QLQ-C30 scales ranged 20%-31%, although savings varied considerably across the domains.ConclusionThe EORTC CAT Core standard settings simplify selection of relevant and appropriate CATs. The CATs prioritise either brevity and efficiency or precision, but all provide increased measurement precision and hence, reduced sample size requirements compared to the QLQ-C30 scales. The CATs may be used as they are or modified to accommodate specific requirements.

Danish value sets for the EORTC QLU-C10D utility instrument

PurposeIn this study, we developed Danish utility weights for the European Organisation for Research and Treatment of Cancer (EORTC) QLU-C10D, a cancer-specific utility instrument based on the EORTC QLQ-C30.MethodsFollowing a standardized methodology, 1001 adult participants from the Danish general population were quota-sampled and completed a cross-sectional web-based survey and discrete choice experiment (DCE). In the DCE, participants considered 16 choice sets constructed from the key 10 dimensions of the QLU-C10D and chose their preferred health state for each one. Utility weights were calculated using conditional logistic regression with correction for non-monotonicity.ResultsThe sample (n = 1001) was representative of the Danish general population with regard to age and gender. The domains with the largest utility decrements, i.e., the domains with the biggest impact on health utility, were physical functioning (− 0.224), pain (− 0.160), and role functioning (− 0.136). The smallest utility decrements were observed for the domains lack of appetite (− 0.024), sleep disorders (− 0.057), and fatigue (− 0.064). Non-monotonicity of severity levels was observed for the domains sleep disturbances, lack of appetite, and bowel problems. Deviations from monotonicity were not statistically significant.ConclusionThe EORTC QLU-C10D is a relatively new multi-attribute utility instrument and is a promising cancer-specific health technology assessment candidate measure. The country-specific Danish utility weights from this study can be used for cost-utility analyses in Danish patients and for comparison with other country-specific utility data.

Enhanced Recovery after Surgery (ERAS) in Postoperative Lung Cancer Patients: A Novel Perioperative Strategy for Preventing Venous Thromboembolism and Improving Quality of Life.

This study aimed to assess the impact of enhanced recovery after surgery (ERAS) intervention in preventing venous thromboembolism (VTE) among postoperative lung cancer patients. Conducted from January 2022 to January 2023, the research involved 125 lung cancer patients randomly assigned to either a control group (n = 60) receiving routine care, or an ERAS group (n = 65) which received both routine care and ERAS interventions. The ERAS program comprised a comprehensive series of interventions meticulously implemented throughout the preoperative, intraoperative, and postoperative phases. Thrombotic risk assessment using the Caprini Risk Assessment Model (RAM) was conducted preoperatively and on postoperative day 5 (POD 5), with plasma D-dimer levels measured preoperatively, on POD 1, POD 3, and POD 5. Quality of life and patient satisfaction were assessed at discharge using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer Module 13 (QLQ-LC13) and The Newcastle Satisfaction with Nursing Scale (NSNS), respectively. The ERAS group demonstrated significantly lower Caprini RAM scores on POD 5 compared to the control group, with lower D-dimer levels on POD 3 and POD 5. The incidence of VTE was lower in the ERAS group (1.54%) compared to the control group (11.67%) during hospitalization. At discharge, the ERAS group showed improved quality of life, with higher satisfaction scores for nursing care and their hospital stay. ERAS nursing interventions effectively mitigate thrombotic risk, improve D-dimer levels, enhance postoperative quality of life, and elevate patient satisfaction among individuals undergoing lung cancer surgery.