The impact of preoperative 5-alpha reductase inhibitors on functional outcomes and health-related quality of life following radical prostatectomy - A propensity score matched longitudinal study.

OBJECTIVES: While the impact of treatment with 5-alpha Reductase Inhibitors (5-ARI) on the risk of cancer-related mortality in men with prostate cancer (PC) has been extensively studied, little is known about the impact of preoperative 5-ARI use on patient-reported outcomes (PROs) following radical prostatectomy (RP). METHODS: Within our prospectively maintained institutional database of 5899 patients treated with RP for PC (2008- 2021), 99 patients with preoperative 5-ARI therapy were identified. A 1:4 propensity-score matched analysis of 442 men (n = 90 5-ARI, n = 352 no 5-ARI) was conducted. Primary endpoint was continence recovery using daily pad usage and ICIQ-SF. Health-related quality of life (HRQOL) was assessed using the validated EORTC QLQ-C30 and PR25 questionnaires. Multivariable Cox-regression-models tested the effect of preoperative 5-ARI treatment on continence-recovery (p < 0.05). RESULTS: Patients were followed up perioperatively, followed by annual assessments up to 60mo postoperatively. Preoperative mean ICIQ-SF score (2.2 vs. 0.9) was significantly higher in the 5-ARI cohort (p = 0.006). 24mo postoperatively, 68.6% (no 5-ARI) vs. 55.7% (5-ARI) had full continence recovery (p = 0.002). Multivariable Cox regression analysis, revealed preoperative 5-ARI treatment as an independent predictor for impaired continence recovery (HR 0.50, 95% CI 0.27-0.94, p = 0.03) In line, general HRQOL was significantly higher for patients without 5-ARI only up to 24mo postoperatively (70.6 vs. 61.2, p = 0.045). There was no significant impact of preoperative 5-ARI treatment on erectile function, biochemical recurrence-free survival and metastasis-free survival. CONCLUSIONS: Pre-RP 5-ARI treatment was associated with impaired continence outcomes starting 24mo postoperatively, suggesting that preoperative 5-ARI treatment can impair the long-term urinary function recovery following RP.

Health-related quality of life in patients with metastatic basal cell carcinoma treated with cemiplimab: Analysis of a phase 2 trial.

BACKGROUND: A phase 2 cemiplimab study (NCT03132636) demonstrated a 24.1% objective response rate in patients diagnosed with metastatic basal cell carcinoma (mBCC) who were not candidates for continued hedgehog inhibitor (HHI) therapy due to intolerance to previous HHI therapy, disease progression while receiving HHI therapy, or having not better than stable disease on HHI therapy after 9 months. Here, health-related quality of life (QoL) for this patient population is reported. METHODS: Adult patients with mBCC were treated with intravenous cemiplimab at a dose of 350 mg every 3 weeks for 5 treatment cycles of 9 weeks/cycle then 4 treatment cycles of 12 weeks/cycle. Patients completed the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (QLQ-C30) and Skindex-16 questionnaires at baseline and Day 1 of each cycle. Across Cycles 2 to 9, the overall change from baseline was analyzed using a mixed model with repeated measures. Responder analyses determined clinically meaningful improvement or deterioration (changes ≥10 points) or maintenance across all scales. RESULTS: Patients reported low symptom burden and moderate-to-high functioning at baseline. Maintenance for QLQ-C30 global health status (GHS)/QoL and across all functioning and symptom scales was indicated by overall mean changes from baseline. Clinically meaningful improvement or maintenance was reported at Cycle 2 for GHS/QoL (77%), functioning scales (77% to 86%), and symptom scales (70% to 93%), with similar proportions of improvement or maintenance at Cycles 6 and 9, excluding fatigue. On the Skindex-16, clinically meaningful improvement or maintenance was reported across the emotional, symptom, and functional subscales, in 76%-88% of patients at Cycle 2, which were generally maintained at Cycles 6 and 9. Overall mean changes from baseline showed maintenance across these subscales. CONCLUSIONS: The majority of patients treated with cemiplimab reported improvement or maintenance in GHS/QoL and functioning while maintaining a low symptom burden.

Health-related quality of life profile of newly diagnosed patients with Hodgkin and non-Hodgkin lymphomas: A real-world study including 3922 patients from the French REALYSA cohort.

INTRODUCTION: Considering the notable advances made in the treatment of lymphoma, assessment of health-related quality of life (HRQoL) of lymphoma patients has become a critical aspect to consider both in clinical research and routine practice. However, there is paucity of information about lymphoma specific HRQoL profile at diagnosis. PATIENTS AND METHODS: HRQoL at diagnosis was assessed for 3922 adult patients with newly diagnosed high-grade (HG) (n = 1994), low-grade (LG) (n = 1053) non-Hodgkin (NHL) and Hodgkin (HL) (n = 875) lymphomas included in REal world dAta in LYmphoma and Survival in Adults (REALYSA, NCT03869619), a prospective non-interventional multicentric cohort in France. Disease-specific HRQoL aspects were assessed with three validated EORTC questionnaires, namely, the QLQ-NHL-HG29, the QLQ-NHL-LG20 and the QLQ-HL27, for patients with NHL-HG, NHL-LG and HL, respectively. RESULTS: We confirmed the high-level of completion of these questionnaires in REALYSA cohort, ranging from 84 % for QLQ-HG29 to 88 % for QLQ-HL27. The proportion of patients with impaired global health status was as follows: T-cell NHL, 67 %; diffuse large B-cell (DLBCL), 62 %; Burkitt, 61 %; HL, 53 %; marginal zone, 49 %; mantle cell, 48 %; follicular, 47 %. Multivariable regression analyses for DLBCL, follicular and HL showed that gender, performance status and B symptoms were independently associated with all HRQoL dimensions. However, a variable effect of age and stage were observed among these three subtypes. CONCLUSIONS: A comprehensive analysis was made describing the HRQoL profile of newly diagnosed patients with different types of lymphomas. Our data may help to enhance the interpretation of HRQoL results in future studies using the recently validated EORTC lymphoma specific questionnaires.

Impact of oral care intervention on quality of life of patients with oral cancer undergoing radiotherapy in Sri Lanka: A quasi-experimental study.

BACKGROUND: Radiotherapy is used to treat oral cancer, yet it negatively affects patients' health-related quality of life (HRQOL). The aim was to evaluate the impact of an oral healthcare intervention on HRQOL of patients with oral cancer who receive radiotherapy with or without chemotherapy. METHODS: An oral healthcare intervention was provided to 41 patients with oral cancer before radiotherapy (fluoride varnish application, scaling, permanent restorations, adjustment of sharp teeth, and extraction of teeth with questionable prognosis, oral hygiene instructions), during, and 3 months after radiotherapy (baking soda mouthwash, artificial saliva spray). EORTC QLQ-H&N35 was used to compare the HRQOL of the intervention and control groups, with the latter having received routine oral healthcare. RESULTS: The intervention group showed lesser values for HRQOL domains and items indicating fewer side effects during the last week of radiotherapy and 3 months after, compared to the control group. Most of the changes in HRQOL were significantly less in the intervention group compared to the control group (p < 0.01). CONCLUSION: The oral healthcare intervention effectively reduced the effect of radiotherapy and positively impacted on HRQOL of patients with oral cancer.

Exploring the integration of dentistry within a multidisciplinary palliative care team: does bedside dental care improve quality of life and symptom burden in inpatient palliative care patients?

BACKGROUND: Despite the significant impact of oral problems on the quality of life of palliative care patients, comprehensive studies are lacking. This study is the first of its kind to address this gap by including both a dental examination and an intervention and assessing quality of life using the EORTC QLQ OH 15 questionnaire. OBJECTIVES: The objective of this study is to explore the impact of incorporating dentists into inpatient palliative care, with a focus on enhancing quality of life and alleviating symptom burden. METHODS: In this monocentric study, data were gathered from a palliative care unit over an 8-month period. At the beginning of the multidisciplinary treatment, T0, patients underwent both a dental examination and interviews utilizing established questionnaires, the EORTC QLQ-C30 (core, general) and OH 15 (oral health). A week later, at T1, patients underwent a follow-up examination and interview. The QLQ-C30 and OH15 are widely recognized instruments developed by the European Organisation for Research and Treatment of Cancer (EORTC) for evaluating health related quality of life in cancer patients. RESULTS: A total of n = 103 patients (48.5% women) were enrolled in the study. The median duration since their last dental visit was 1 year, and the dental condition at T0 was desolate. At T1, statistically and clinically significant changes in oral quality of life and symptom burden were observed. Noteworthy changes were noted in the OH-QoL score (median 63 vs. 92, p < 0.001), sticky saliva (median 33 vs. 0, p < 0.001), sensitivity to food and drink (median 33 vs. 0, p < 0.001), sore mouth (median 33 vs. 0, p > 0.001), and poorly fitting dentures (median 33 vs. 0 p < 0.001). Additionally, improvements were observed in xerostomia candidiasis and mucositis. CONCLUSION: The study highlights the powerful contribution of integrating a dentist in inpatient palliative care. With very little dental effort and simple ward and bedside treatments, significant improvements in the oral symptom burden of critically ill palliative patients can be achieved. This contributes to improved care status, relief of distressing symptoms, and ultimately improved quality of life. The results strongly support the consideration of dental support as an integral part of palliative care units.

Quality of Life after Mastectomy with or without Breast Reconstruction and Breast-Conserving Surgery in Breast Cancer Survivors: A Cross-Sectional Study at a Tertiary Hospital in Ghana.

(1) Background: Breast cancer is the leading malignancy worldwide, and in Ghana, it has a poor overall survival rate. However, approximately 50% of cases are cases of early-stage disease, and with advances in breast cancer treatment and improvements in survival, quality of life (QOL) is becoming as important as the treatment of the disease. (2) Methodology: This was a cross-sectional study of survivors who had breast-conserving surgery (BCS), mastectomy only (M) and mastectomy with breast reconstruction (BRS) from 2016 to 2020 at a tertiary hospital in Ghana, comparatively assessing their QOL using EORTC QLQ C-30 and EORTC QLQ BR-23. (3) Results: The study participants had an overall global health status (GHS) median score of 83.3 [IQR: 66.7-91.7] with no significant differences between the surgery types. The BRS group had statistically significant lower median scores for the functional scale (82.8 and 51.0) and the highest scores for the symptomatic scale (15.7 and 16.5). Body image was significantly lowest for the BRS group (83.3) [68.8-91.7] and highest (100) [91.7-100] for the BCS group (p < 0.001). (4) Conclusion: There is a need to develop support systems tailored at improving the QOL of breast cancer survivors taking into consideration the type of surgery performed.

Unravelling Quality of Life for Head and Neck Cancer Patients after VMAT Radiation Therapy: Insights from Toxicity, Dosimetry and Symptoms Correlation.

(1) Background: Head and neck cancer treatment, including advanced techniques like Volumetric Modulated Arc Therapy (VMAT), presents challenges for maintaining patient quality of life (QoL). Thus, thoroughly investigating how radiation therapy (RT) affects patients has been proved essential. Derived by that, this study aims to understand the complex interactions between not only RT and QoL but also symptom severity, and treatment-related toxicities in three distinct time points of patient's treatment; (2) Methods: To achieve that, EORTC-QLQ-C30 and EORTC QLQ-H&N35 questionnaires were used in combination with EORTC_RTOG scoring criteria and Spearman's rho statistical analysis for 74 patients with cancer undergoing VMAT radiation therapy; (3) Results: The results revealed a significant improvement in the Overall Health Index post-treatment, indicating a temporary decline during therapy followed by subsequent recovery, often surpassing pre-treatment QoL levels. Concurrently a reduction in symptomatology was observed, notably in pain, swallowing difficulties, and dry mouth, aligning with prior research indicating decreased symptom burden post-treatment. However, Spearman's correlation coefficient analysis at two distinct time points during therapy uncovered varying degrees of correlation between dosimetric data at Organs at Risk (OARs) and reported symptoms, highlighting potential limitations in using QoL questionnaires as sole indicators of treatment efficacy. Our investigation into the correlation between dosimetric data, toxicity, and symptoms focused on the relationship between radiation doses and oral mucositis levels, a common toxicity in head and neck cancer patients. Significant associations were identified between toxicity levels and dosimetric parameters, particularly with OARs such as the parotid glands, oral cavity, and swallowing muscles, underlining the utility of the EORTC method as a reliable toxicity assessment tool; (4) Conclusions: To summarize, current research attempts to underscore the importance of refining QoL assessments for enhanced patient care. The integration of dosimetric data, symptom severity, and treatment-related toxicities in the QoL outcomes of head and neck cancer patients undergoing VMAT radiation therapy, can lead towards the optimization of treatment strategies and the improvement of patient outcomes in future patient-centered radiation therapy practices.

A Pilot Study to Show Longitudinal Trends in Health-Related Quality of Life (HRQOL) in a Cohort of Breast Cancer Patients Under Treatment at a Tertiary Healthcare Facility in Bhubaneswar, India.

Introduction: Breast cancer incidence has overtaken that of cervical cancer among women in India according to the Globacon 2020 reports. Cancer management is also being streamlined at the Center and district levels, such that comprehensive integrated management is offered to cases to optimize the best results. In breast cancer, there are two modes of surgery namely Breast Conservation Surgery(BCS) and Modified Radical Mastectomy (MRM) now over 2 decades, with recommended Chemo radiation depending on the extent of the disease. HRQOL (Health-related Quality of Life) studies have been done in these groups of patients, due to their added relevance in terms of the loss of a vital organ like the breast. EORTC 30 and BR23 are standardized and detailed tools that have been seen to estimate QOL, keeping in mind a whole array of domains that are affected by the disease. Objective: To evaluate the "Body Image" and "Quality of life" (QOL) in operated breast cancer patients using BR -23 and EORTC - QLQ- questionnaire at 1month (after surgery) and then 3 to 4 months after surgery. Methods: This article attempts to draw a comparison among of EORTC30 and BR 23 scores calculated for 46 breast cancer patients operated during the pandemic time in one center and consenting to repeat the measures at pre-decided three time periods during the course of management. Results: No significant differences are noted in the mean scores for EORTC 30 and BR23 for the two types of surgeries. Visit 1 scores for both modes of surgery are over 75 and by Visit 3 become less than 55 for EORTC. BR 23 (which measures the symptoms core to Breast cancer) at all 3 visits are between 45 to 55. Friedman's test shows that the scores are not significant for age groups, the number of living children, or lifestyle factors like alcohol or tobacco chewing, though quadratic graphs depict the distinct variations in the scores at the 3 times reinforcing the need for follow-up of mental health in these subjects at intervals. The study largely brings out a strong need for repeated follow-up and counseling at regular and short intervals, post-surgery in breast cancer patients. EORTC 30 and BR 23 tools are excellent to use to essay information on the mental health of patients with breast cancer.

Internal Responsiveness of EQ-5D-5L and EORTC QLQ-C30 in Dutch Breast Cancer Patients during the First Year Post-Surgery: A Longitudinal Cohort Study.

The EuroQoL 5-Dimension 5-Level questionnaire (EQ-5D-5L) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) are commonly used Patient-Reported Outcome Measures (PROMs) for breast cancer. This study assesses and compares the internal responsiveness of the EQ-5D-5L and EORTC QLQ-C30 in Dutch breast cancer patients during the first year post-surgery. Women diagnosed with breast cancer who completed the EQ-5D-5L and EORTC QLQ-C30 pre-operatively (T0), 6 months (T6), and 12 months post-surgery (T12) were included. Mean differences of the EQ-5D-5L and EORTC QLQ-C30 between baseline and 6 months (delta 1) and between baseline and 12 months post-surgery (delta 2) were calculated and compared against the respective minimal clinically important differences (MCIDs) of 0.08 and 5. Internal responsiveness was assessed using effect sizes (ES) and standardized response means (SRM) for both deltas. In total, 333 breast cancer patients were included. Delta 1 and delta 2 for the EQ-5D-5L index and most scales of the EORTC QLQ-C30 were below the MCID. The internal responsiveness for both PROMs was small (ES and SRM < 0.5), with greater internal responsiveness for delta 1 compared to delta 2. The EQ-5D-5L index showed greater internal responsiveness than the EORTC QLQ-C30 Global Quality of Life scale and summary score. These findings are valuable for the interpretation of both PROMs in Dutch breast cancer research and clinical care.

Longitudinal Assessment of the Quality of Life in Oral Squamous Cell Carcinoma Patients.

Background Studies evaluating the quality of life (QoL) among oral cancer patients in the Indian population are scarce. Regular follow-ups and QoL assessment in oral squamous cell carcinoma (OSCC) patients can aid in comprehensive support strategies to improve their QoL outcomes. Aim and objectives This study aimed to assess the QoL of oral cancer patients and correlate the QoL with demographic and treatment parameters.  Materials and methods The study included oral cancer patients who had previously reported to the Department of Oral and Maxillofacial Surgery. QoL assessment was done using the EORTC QLQ-C30 and QLQ-HN43 questionnaires before and after treatment. The clinico-demographic details, treatment data, follow-up data, and recorded mean QoL were procured from the patient records in Dental Information Archival Software. Assessment of QoL was done before treatment and at intervals of one month, three months, six months, 12 months, 24 months, and 36 months postoperatively after treatment. Statistical analysis was performed using IBM SPSS Statistics for Windows, Version 23 (released 2015; IBM Corp., Armonk, New York, United States). A repeated measures analysis of variance (ANOVA) was utilized for comparing the average QoL scores and frequency of follow-ups across various intervals. Chi-square tests assessed differences in mean QoL among genders, across different sites, and between primary closure and graft placement. The significance was set at a p-value of less than 0.05. Results A total of 90 OSCC patients had reported to the department. A preoperative assessment of QoL was done for 90 (100%) patients. Out of these patients, surgery has been performed on 41 (45%). Twenty-five out of 41 (60%) patients had responded to regular follow-up, and QoL was assessed for these patients. After the immediate postoperative phase, only 12 (48%) had reported after three months. Only six (24%) had a 12-month follow-up, five (20%) had a two-year follow-up, and one (4%) had a three-year follow-up. There was a constant decrease in the number of follow-ups after the treatment of OSCC (p=0.00). Prior to treatment, the mean QoL index was 4.64. Females had a slightly higher preoperative QoL of 4.76 compared to males, with a score of 4.67 (p=0.157). Immediately after the treatment of OSCC, a decline in QoL scores was noted, with a mean score of 4.25 (p=0.32). Patients who underwent primary closure after excision had a mean post-op QoL score of 4.9, while patients who underwent graft placement had a mean score of 4.6 (p=0.157). Conclusion This study highlights the enduring impact of oral cancer on a patient's quality of life and emphasizes the need for ongoing research to explore specific interventions that can contribute to sustained improvement in QoL. It emphasizes personalized, holistic care approaches for such patients.

The EORTC QLQ43 and FACT H&N questionnaires of quality of life at 1 and 5 years after treatment and dental care in head and neck cancer patients: a pilot study.

PURPOSE: This study aimed to examine health-related quality of life (HRQoL) in head and neck cancer patients at 1 and 5 years after successful treatment of their tumors, and to explore the usefulness of 2 instruments for assessing the need of dental care services. METHODS: This cross-sectional pilot study included 20 adult patients with head and neck cancer who completed the Functional Assessment of Cancer Therapy-Head and Neck (FACT H&N) Symptom Index and the European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-H&N43) after 1 and 5 years of treatment. RESULTS: Mean (standard deviation, SD) scores of the FACT H&N Symptom Index were higher (better HRQoL) at 5 years than at 1 year (24.1 [4.4] vs. 21.1 [6.4]; p = 0.236). Only three of the ten items of FACT H&N (swallow, pain in mouth/throat or neck, and solid foods) evaluated oral health. In the EORTC QLQ-H&N43 questionnaire, scores were lower at 5 years (better HRQoL) in almost all multi- and single-item symptoms. This questionnaire includes four multi-item scales (pain in the mouth, social eating, swallowing, and problems with teeth) measuring dental and orthodontic needs. CONCLUSION: HRQoL in patients with head and neck cancer improved with the length of follow-up. The EORTC QLQ-H&N43 has more items addressing oral health compared to the FACT H&N Symptom Index and may be more adequate to assess the need of dental therapy in clinical practice.

The impact of online yoga on sleep and quality of life in women with breast cancer: a randomized trial.

INTRODUCTION: There is growing evidence of the benefit of physical activity and mindfulness in breast cancer patients (HC et al. in BMC Complement Altern Med, 2017). Yoga offers a combination of both. The aim of this study was to establish an online yoga program for breast cancer patients and survivors. As the project was launched during the (COVID) pandemic restrictions, we intended to prove effective online yoga as a way to access supportive therapy independently of sanitary issues and geographic locations in rural regions. METHODS: The two main outcomes were quality of life and sleep quality, and both were evaluated by standardized questionnaires (EORTC-QLQ 30 BR 23 and PSQI). Participants (n = 173) had breast cancer or a history of breast cancer and were randomized to either 6 weeks online yoga, twice a week for 45 min or a waiting control group. RESULTS: Our results show improved sleep quality in the PSQI score and improved subitems (dyspnea and physical activity) in the EORTC quality of life score. DISCUSSION: Online yoga seems to be a valid option in supportive therapy for breast cancer patients, as it improves physical fitness, dyspnea and overall sleep quality. It is also safe and cost effective as a remote intervention. TRIAL REGISTRATION: Trial registration number and date of registration for prospectively registered trials: DRKS00029548, 07.07.2022.WHO International clinical trials registry platform number: DRKS00029548. The registration number of the ethical committee CAU in Kiel: D 589/20.

Japanese value set for the EORTC QLU-C10D: A multi-attribute utility instrument based on the EORTC QLQ-C30 cancer-specific quality-of-life questionnaire.

PURPOSE: This study aimed to develop a Japanese value set for the EORTC QLU-C10D, a multi-attribute utility measure derived from the cancer-specific health-related quality-of-life (HRQL) questionnaire, the EORTC QLQ-C30. The QLU-C10D contains ten HRQL dimensions: physical, role, social and emotional functioning, pain, fatigue, sleep, appetite, nausea, and bowel problems. METHODS: Quota sampling of a Japanese online panel was used to achieve representativeness of the Japanese general population by sex and age (≥ 18 years). The valuation method was an online discrete choice experiment. Each participant considered 16 choice pairs, randomly assigned from 960 choice pairs. Each pair included two QLU-C10D health states and life expectancy. Data were analyzed using conditional logistic regression, parameterized to fit the quality-adjusted life-year framework. Preference weights were calculated as the ratio of each dimension-level coefficient to the coefficient for life expectancy. RESULTS: A total of 2809 eligible panel members consented, 2662/2809 (95%) completed at least one choice pair, and 2435/2662 (91%) completed all choice pairs. Within dimensions, preference weights were generally monotonic. Physical functioning, role functioning, and pain were associated with the largest utility weights. Intermediate utility weights were associated with social functioning and nausea; the remaining symptoms and emotional functioning were associated with smaller utility decrements. The value of the worst health state was - 0.221, lower than that seen in most other existing QLU-C10D country-specific value sets. CONCLUSIONS: The Japan-specific QLU-C10D value set is suitable for evaluating the cost and utility of oncology treatments for Japanese health technology assessment and decision-making.

The Use of Diets to Improve the Quality of Life of Women With Breast Cancer.

INTRODUCTION: There has been an increase in the incidence of breast cancer cases in the last decade, and despite the treatment increasing the chances of survival, it reduces the quality of life. In this context, diets could decrease the adverse effects of treatment and improve quality of life. METHODOLOGY: A form with the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire, which contains specific scores for physical, cognitive, emotional, symptomatic, and functional performance, was made available in a Facebook support group. Afterward, the data were analyzed using linear regression and a t-test of independent samples using Jamovi version 2.3.24 (retrieved from https://www.jamovi.org). RESULTS: There was a low number of participants who followed the ketogenic diet or intermittent fasting. In general, adherence to the diets was good. In the t-test, diets showed improvement in physical performance. Linear regression correlated treatment with chemotherapy, metastases, and bad diet adherence with worse symptomatic scores. CONCLUSION: There is evidence that diets can improve the symptoms of these patients; however, there is no consensus about which diet produces the best effect, requiring further studies on this subject.

General population normative values for the EORTC QLQ-C30 by age, sex, and health condition for the French general population.

BACKGROUND: General population normative values for the widely used health-related quality of life (HRQoL) measure EORTC QLQ-C30 support the interpretation of trial results and HRQoL of patients in clinical practice. Here, we provide sex-, age- and health condition-specific normative values for the EORTC QLQ-C30 in the French general population. METHODS: French general population data was collected in an international EORTC project. Online panels with quota samples were used to recruit sex and age groups. Number and type of comorbidities were assessed. Descriptive statistics were used to calculate general population values for each QLQ-C30 scale, separately for sex, age, and presence of one- and more chronic health conditions. A multivariate linear regression model has been developed to allow estimating the effect of sex, age, and the presence for one- and more chronic health conditions on EORTC QLQ-C30 scores. Data was weighted according to United Nation statistics adjusting for the proportion of sex and age groups. RESULTS: In total, 1001 French respondents were included in our analyses. The weighted mean age was 47.9 years, 514 (51.3%) participants were women, and 497 (52.2%) participants reported at least one health condition. Men reported statistically significant better scores for Emotional Functioning (+9.6 points, p = 0.006) and Fatigue (-7.8 point; p = 0.04); women reported better profiles for Role Functioning (+8.7 points; p = 0.008) and Financial Difficulty (-7.8 points, p = 0.011). According to the regression model, the sex effect was statistically significant in eight scales; the effect of increasing age had a statistically significant effect on seven of the 15 EORTC QLQ-C30 scales. The sex- and age effect varied in its direction across the various scales. The presence of health conditions showed a strong negative effect on all scales. CONCLUSION: This is the first publication of detailed French normative values for the EORTC QLQ-C30. It aims to support the interpretation of HRQoL profiles in French cancer populations. The strong impact of health conditions on QLQ-C30 scores highlights the importance of considering the impact of comorbidities in cancer patients when interpreting HRQoL data.

The quality of life outcome in patients with head and neck squamous cell cancer treated using chemoradiotherapy.

OBJECTIVE: Organ preservation is a goal of head and neck squamous cell cancer (HNSCC) treatment. chemoradiotherapy remains one of the main treatment options and is widely recognized as a method with organ-preserving potential and outcomes comparable to those of surgery. However, few studies have investigated the quality of life (QOL) of patients with HNSCC treated using chemoradiotherapy, therefore, we aimed to retrospectively evaluate how QOL changes pre and post-chemoradiotherapy. METHODS: We evaluated QOL outcomes in patients who underwent initial radical chemoradiotherapy for HNSCC at the Department of Otolaryngology and Head and Neck Surgery Kitasato University Hospital from 2018 to 2021. We used the Cancer Fatigue Scale (CFS) and the combined European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-H&N35 questionnaires at pre-treatment, three months and six months post-treatment. RESULTS: We obtained 37 and 29 responses from the CFS and EORTC QLQ-C30/H&N35 questionnaire, respectively. From the CFS, the physical fatigue score at three months post-treatment deteriorated more than that at pre-treatment, and significantly improved by six months post-treatment. The total score worsened significantly at three months and there was a trend toward improvement at six months. In the EORTC QLQ-C30, physical and social functioning declined in three months and did not improve within six months. Fatigue was substantially worse at three months and significantly improved at six months but did not reach the same level as that before treatment. Appetite loss was also significantly worse at three months. In the QLQ-H&N35 questionnaire, sensory issues, trouble with social contact, and dry mouth were significantly worse at three months and did not improve within six months. Sticky saliva also worsened at three months and significantly improved at six months. CONCLUSION: There were some problems associated with chemoradiotherapy. Some patients showed an improvement, while others continued to have challenges. In Japan, chemoradiotherapy was shown to have a long-term impact on the patient's life.

Validation of the Mexican version of the EORTC QLQ-CR29 in patients with colorectal cancer.

BACKGROUND: The evaluation of the quality of life (QoL) of patients with colorectal cancer (CRC) is an essential measure to measure the impact of the disease and treatments on the lives of patients. However, in Latin America there is no validated and reliable instrument to assess this construct. OBJECTIVES: This study aims to validate the EORTC QLQ-CR29 instrument in the Mexican population with CRC. METHODS: This study aims to validate the EORTC QLQ-CR29 instrument in the Mexican population with CRC. The study used an instrumental design and a nonprobabilistic sample due to availability, made up of 251 patients with CRC, with an average age of 54.7 ± 12.28 years. Exploratory and confirmatory factor analyses were performed, as well as concurrent validity tests. RESULTS: The exploratory factorial analysis yielded 4 factors that explained 51.64% of the variance, with a Cronbach reliability coefficient of .766 and an Omega index of .725. The confirmatory factor analysis indicated that the proposed theoretical model fits the data almost perfectly, with an error close to 0, which shows that it is a balanced and parsimonious instrument to measure the QoL of the patients with CRC. SIGNIFICANCE OF RESULTS: The EORTC QLQ-CR29 instrument proved to be a valid and reliable instrument for use in clinical care and research directed at patients with CRC in Mexico. Its use is recommended by multidisciplinary health teams in oncology in Mexico, since it allows knowing the patient's perspective on the impact of CRC on their life, guiding therapeutic decision-making and being a primary outcome measure.

Health-related quality of life with sacituzumab govitecan in HR+/HER2- metastatic breast cancer in the phase III TROPiCS-02 trial.

BACKGROUND: The TROPiCS-02 study (NCT03901339) demonstrated that sacituzumab govitecan (SG) has superior clinical outcomes over treatment of physician's choice (TPC) chemotherapy in patients with hormone receptor-positive, human epidermal growth factor 2 receptor-negative (HR+/HER2-) metastatic breast cancer (mBC). Here, we present health-related quality of life (HRQoL) patient-reported outcome (PRO) findings from this study. PATIENTS AND METHODS: Eligible adults with HR+/HER2- mBC who previously received a taxane, endocrine-based therapy, a CDK4/6 inhibitor, and 2-4 lines of chemotherapy were randomized 1:1 to receive SG or TPC until progression or unacceptable toxicity. PROs were assessed at baseline and on day 1 of each cycle, using the European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 (EORTC QLQ-C30), EQ-5D-5L, and PRO Common Terminology Criteria for Adverse Events (PRO-CTCAE). RESULTS: Compared to TPC, overall least square mean change from baseline was significantly better for SG for physical functioning and dyspnea, but worse for diarrhea. Time to first clinically meaningful worsening or death was significantly longer for SG in global health status/quality of life, physical functioning, fatigue, emotional functioning, dyspnea, insomnia, and financial difficulties of the EORTC QLQ-C30 and the EQ-VAS, but longer for TPC in diarrhea. Few patients in both arms reported experiencing any worsening to level 3 or 4 treatment-related symptomatic events during treatment, as assessed by 16 PRO-CTCAE items, except for diarrhea frequency and amount of hair loss, which favored TPC. CONCLUSIONS: SG was associated with an HRQoL benefit in most symptoms and functioning, compared with TPC. This supports the favorable profile of SG as a treatment option for patients with pretreated HR+/HER2- mBC.

Assessing the Predictive Accuracy of EORTC, CUETO and EAU Risk Stratification Models for High-Grade Recurrence and Progression after Bacillus Calmette-Guérin Therapy in Non-Muscle-Invasive Bladder Cancer.

The currently available EORTC, CUETO and EAU2021 risk stratifications were originally developed to predict recurrence and progression in non-muscle-invasive bladder cancer (NMIBC). However, they have not been validated to differentiate between high-grade (HG) and low-grade (LG) recurrence-free survival (RFS), which are distinct events with specific implications. We aimed to evaluate the accuracy of available risk models and identify additional risk factors for HG RFS and PFS among NMIBC patients treated with Bacillus Calmette-Guérin (BCG). We retrospectively included 171 patients who underwent transurethral resection of the bladder tumor (TURBT), of whom 73 patients (42.7%) experienced recurrence and 29 (17%) developed progression. Initially, there were 21 low-grade and 52 high-grade recurrences. EORTC2006, EORTC2016 and CUETO recurrence scoring systems lacked accuracy in the prediction of HG RFS (C-index 0.63/0.55/0.59, respectively). EAU2021 risk stratification, EORTC2006, EORTC2016, and CUETO progression scoring systems demonstrated low to moderate accuracy (C-index 0.59/0.68/0.65/0.65) in the prediction of PFS. In the multivariable analysis, T1HG at repeat TURBT (HR = 3.17 p < 0.01), tumor multiplicity (HR = 2.07 p < 0.05), previous history of HG NMIBC (HR = 2.37 p = 0.06) and EORTC2006 progression risk score (HR = 1.1 p < 0.01) were independent predictors for HG RFS. To conclude, available risk models lack accuracy in predicting HG RFS and PFS in -NMIBC patients treated with BCG.

Symptomatic adverse events of chemotherapy in breast cancer patients:Using CTCAE, PRO-CTCAE, and EORTC QLQ-C30.

BACKGROUND: The Common Terminology Criteria for Adverse Events (CTCAE) is used as a tool to evaluate the adverse events (AE) of chemotherapy in cancer patients. Since CTCAE by medical providers underestimates AE more than patient-reported outcomes (PRO), the National Cancer Institute developed PRO-CTCAE. The present study investigated differences between symptoms detected using CTCAE by medical providers and PRO-CTCAE by breast cancer patients. METHODS: Patients received chemotherapy comprising epirubicin and cyclophosphamide pre- or postoperatively. AE were evaluated using 4 questionnaires:PRO-CTCAE, CTCAE, the European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC-QLQ-30), and Hospital Anxiety and Depression Scale (HADS) after 1, 2, and 3 courses of chemotherapy. RESULTS: Forty-two patients were registered. Regarding the recognition of psychological symptoms, such as fatigue, anxiety, and discouragement, and subjective symptoms, including heart palpitations and shortness of breath, PRO using PRO-CTCAE was significantly higher than medical provider-recognized outcomes using CTCAE. Concerning the recognition of regimen-specific symptoms, such as vomiting, nausea, and decreased appetite, medical provider- recognized outcomes were the same or higher than PRO. In QLQ-C30, the physical and role functions, fatigue and dyspnea significantly worsened after 2 and 3 courses of chemotherapy. J. Med. Invest. 71 : 82-91, February, 2024.