European Organization For Research Research Articles

The influence of delayed gastric emptying on quality of life after partial duodenopancreatectomy.

Quality of life (QoL) is temporarily compromised after pancreatic surgery, but no evidence for a negative impact of postoperative complications on QoL has been provided thus far. Delayed gastric emptying (DGE) is one of the most common complications after pancreatic surgery and is associated with a high level of distress. Therefore, the aim of this study was to analyse the influence of DGE on QoL. This single-centre retrospective study analysed QoL after partial duodenopancreatectomy (PD) via the European Organization for Research and Treatment of Cancer core questionnaire (QLQ-C30). The QoL of patients with and without postoperative DGE was compared. Between 2010 and 2022, 251 patients were included, 85 of whom developed DGE (34%). Within the first postoperative year, compared to patients without DGE, those with DGE had a significantly reduced QoL, by 9.0 points (95% CI: -13.0 to -5.1, p < 0.001). Specifically, physical and psychosocial functioning (p = 0.020) decreased significantly, and patients with DGE suffered significantly more from fatigue (p = 0.010) and appetite loss (p = 0.017) than patients without DGE. After the first postoperative year, there were no significant differences in QoL or symptom scores between patients with DGE and those without DGE. Patients who developed DGE reported a significantly reduced QoL and reduced physical and psychosocial functioning within the first year after partial pancreatoduodenectomy compared to patients without DGE.

Application of Patient-Reported Outcome Measurements in Adult Tumor Clinical Trials in China: Cross-Sectional Study.

International health policies and researchers have emphasized the value of evaluating patient-reported outcomes (PROs) in clinical studies. However, the characteristics of PROs in adult tumor clinical trials in China remain insufficiently elucidated. This study aims to assess the application and characteristics of PRO instruments as primary or secondary outcomes in adult randomized clinical trials related to tumors in China. This cross-sectional study identified tumor-focused randomized clinical trials conducted in China between January 1, 2010, and June 30, 2022. The ClinicalTrials.gov database and the Chinese Clinical Trial Registry were selected as the databases. Trials were classified into four groups based on the use of PRO instruments: (1) trials listing PRO instruments as primary outcomes, (2) trials listing PRO instruments as secondary outcomes, (3) trials listing PRO instruments as coprimary outcomes, and (4) trials without any mention of PRO instruments. Pertinent data, including study phase, settings, geographic regions, centers, participant demographics (age and sex), funding sources, intervention types, target diseases, and the names of PRO instruments, were extracted from these trials. The target diseases involved in the trials were grouped according to the American Joint Committee on Cancer Staging Manual, 8th Edition. Among the 6445 trials examined, 2390 (37.08%) incorporated PRO instruments as part of their outcomes. Within this subset, 26.82% (641/2390) listed PRO instruments as primary outcomes, 52.72% (1260/2390) as secondary outcomes, and 20.46% (489/2390) as coprimary outcomes. Among the 2,155,306 participants included in these trials, PRO instruments were used to collect data from 613,648 (28.47%) patients as primary or secondary outcomes and from 74,287 (3.45%) patients as coprimary outcomes. The most common conditions explicitly using specified PRO instruments included thorax tumors (217/1280, 16.95%), breast tumors (176/1280, 13.75%), and lower gastrointestinal tract tumors (173/1280, 13.52%). Frequently used PRO instruments included the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire-30, the visual analog scale, the numeric rating scale, the Traditional Chinese Medicine Symptom Scale, and the Pittsburgh Sleep Quality Index. Over recent years, the incorporation of PROs has demonstrated an upward trajectory in adult randomized clinical trials on tumors in China. Nonetheless, the infrequent measurement of the patient's voice remains noteworthy. Disease-specific PRO instruments should be more effectively incorporated into various tumor disease categories in clinical trials, and there is room for improvement in the inclusion of PRO instruments as clinical trial end points.

Physical function as a predictor of chemotherapy-induced peripheral neuropathy in patients with pancreatic cancer

BackgroundA growing body of research indicates that poor functional status before chemotherapy may be correlated with the severity of chemotherapy-induced peripheral neuropathy (CIPN) after the neurotoxic treatment. However, little is known about the associations between pre-chemotherapy physical function and CIPN in patients with pancreatic cancer.PurposeTo identify the predictors of CIPN in relation to pre-chemotherapy physical function in patients with pancreatic cancer.MethodsThis secondary analysis included data from patients with pancreatic cancer who participated in a longitudinal research study at National Cheng Kung University Hospital, Tainan, Taiwan. Four physical function tests (i.e., grip strength, Timed Up and Go (TUG), 2-minute step test (2MST), and Romberg test) and two questionnaires (The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQ-C30] and Chemotherapy-Induced Peripheral Neuropathy Module [CIPN20]) were assessed at baseline (i.e., before first chemotherapy session) and 2-, 3-, 4-, and 6-month follow-up. Multiple linear regression with adjustment for confounding factors was used to assess the associations between the four functional tests at baseline and the CIPN20 total score and individual subscale scores (sensory, motor, and autonomic) at 6-month follow-up.ResultsData from a total of 209 pancreatic cancer patients (mean age: 64.4 years, 54.5% male) were analyzed. The findings showed that the severity of CIPN at 6-month follow-up was significantly associated with the baseline TUG completion time (β = 0.684, p = 0.003). The TUG completion time was also positively correlated with the 6-month CIPN sensory and autonomic subscales. In addition, a baseline positive Romberg test (β = 0.525, p = 0.009) was a significant predictor of the severity of motor neuropathy at 6-month follow-up.ConclusionThe TUG completion time and positive Romberg test before chemotherapy may be predictive factors of the CIPN severity 6 months after the commencement of chemotherapy. Accordingly, the incorporation of TUG and Romberg tests into the clinical assessment protocol emerges as imperative for individuals diagnosed with pancreatic carcinoma undergoing chemotherapy regimens.

Quality-of-lifeoutcomes in metastatic spinal cord compression: findings from the SCORAD trial.

This article reports detailed quality-of-life data including preferred and actual place of care from SCORAD, the only large prospective randomized trial in metastatic spinal cord compression (MSCC). SCORAD compared 2 doses of radiotherapy in patients with MSCC: 8 Gy single fraction and 20 Gy in 5 fractions. In total, 686 patients were randomized, of whom 590 had Health-Related Quality of Life (HRQoL) data collected at baseline and at least 1 later time point. HRQoL was measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 supplemented with the QLU-C10D and data on place of care at weeks 1, 4, 8, and 12 postrandomization. Quality-of-Life Adjusted Survival was computed by multiplying Kaplan-Meier survival probabilities with the UK utility weights obtained from the QLU-C10D. Patients with a baseline physical functioning score of above 50 demonstrated a 28% reduction in the risk of death (hazard ratio [HR] = 0.72, 99% confidence interval [CI] = 0.54 to 0.95; P = .003). An increased risk of death was associated with fatigue (HR = 1.35, 99% CI = 1.03 to 1.76; P = .0040), dyspnea (HR = 1.61, 99% CI = 1.24 to 2.08; P < .001), and appetite loss (HR = 1.25, 99% CI = 0.99 to 1.59; P = .014). The preferred place of care for the majority was at home or with relatives (61%-74% across the 12 weeks) but achieved by only 53% at 8 weeks. Prolonged survival in patients with MSCC was associated with better HRQoL. More than 60% of patients preferred to be cared for at home or with relatives, but only half were able to achieve this. There was no difference in HRQoL between the multifraction and single-fraction groups. ISRCTN97555949 and ISRCTN97108008.

Effectiveness of early palliative care in patients with head and neck cancer in Taiwan

Background: Early palliative care (EPC) benefits some cancers, but its clinical outcomes differ depending on patients’ racial and ethnic disparities, and customs. To determine whether EPC improves symptoms, emotional distress, and quality of life among Taiwanese patients with early or advanced-stage head and neck cancer (HNC). Methods: Based on participants’ pathological stages, they were categorized as having early and advanced-stage HNC. Those willing and unwilling to undergo EPC were assigned to the EPC and standard groups, respectively. Their daily cancer-related symptoms were assessed using the Distress Thermometer (DT) and MD Anderson Symptom Inventory (MDASI), whose scores’ concurrent validity was evaluated using the European Organization for Research and Treatment of Core Quality of Life (EORTC-QLQ-C30) and Head and Neck 35 (EORTC-QLQ-H&amp;N35) questionnaires. Results: Patients (n=93) diagnosed with HNC at Taiwan’s Chia-Yi Christian Hospital from November 2020 to October 2022 were recruited. The patients voluntarily split into two groups: EPC groups and standard groups (23 and 11 in early-stage; 46 and 13 in advanced-stage, respectively). DT assessment showed significant emotional distress improvements for all patients with HNC who received EPC. The EORTC-QLQ-C30 questionnaire indicated that, compared to standard interventions, EPC groups significantly improved the quality of life and some symptoms for both early and advanced-stage HNC patients. However, the EORTC-QLQ-H&amp;N35 questionnaire found no significant difference between the two groups. Furthermore, advanced-stage patients’ anti-cancer treatment completion rates with EPC and standard interventions were 95.35% and 75%, respectively. Conclusion: EPC improves symptoms, emotional distress, quality of life, and treatment completion rates in Taiwanese patients with early or advanced-stage HNC. Nonetheless, further extensive clinical studies are required for validation.

Role of Radiotherapy in Improving Quality of Life in Patients with Hepatocellular Carcinoma and Liver Metastasis

Background: Hepatocellular carcinoma (HCC) and liver metastases (LM) are often associated with significant symptoms such as pain and abdominal discomfort, impacting the quality of life (QoL) of affected patients. Current treatments vary in effectiveness and often leave a substantial unmet medical need in symptom management. Objective: This study aimed to assess the efficacy of external radiation therapy (ERT) in alleviating symptoms and improving the QoL in patients with HCC and LM, focusing on those presenting primarily with pain or abdominal discomfort. Methods: After institutional review board approval, patients with HCC or painful LM, not previously treated with tumor resection, radiofrequency ablation, or systemic therapy, were included. Eligible participants exhibited symptoms such as pain, nausea, and fatigue, and had a performance status of 0-2. A single fraction dose of ERT was administered, and symptom relief was evaluated using the Brief Pain Inventory (BPI) and QoL using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30). Completion rates of these questionnaires were tracked at baseline, one week, and one month post-treatment. Results: Of the 43 patients enrolled (23 HCC, 20 LM), significant improvement in the FACT-G TOI was observed in 34% of patients at one month post-ERT. When focusing on those with pain or abdominal discomfort, 59% reported clinically significant symptom relief. However, QoL improvement was noted in only about one quarter of patients, with one third experiencing worsening QoL at one month. Questionnaire completion rates were high initially but decreased over time, reflecting the challenging nature of the patient population. Conclusion: ERT demonstrated potential benefits in symptom relief, particularly for pain and abdominal discomfort in patients with HCC and LM. Nonetheless, the impact on overall QoL was mixed, highlighting the need for further research into optimizing therapeutic strategies for this patient group.

Abstract PO5-04-14: Quality of Life (QoL) among metastatic hormone receptor positive, HER2 negative breast cancer patients during first line systemic treatment

Abstract Background Current international guidelines recommend endocrine therapy combined with a CDK4/6 inhibitor as the preferred first line systemic treatment in patients diagnosed with metastatic hormone receptor positive (HR), HER2 negative breast cancer (BC). Randomized controlled trials that led to the approval of these agents in the first line disease setting are derived from controlled environments and selected patients. We aimed to assess real-world patients’ characteristics, safety and health related quality of life in a non-select cohort of patients being managed in a Brazilian private Cancer Center. Methods: We performed a cross sectional study at Beneficencia Portuguesa de Sao Paulo evaluating quality of life among patients with metastatic HR+/HER2 negative treated in the first line disease setting. Inclusion criteria included patients that received the combination of a CDK4/6i with any endocrine therapy (ET) between January 2018 and April 2023. Primary endpoint was quality of life assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC QLQ-BR23, it is baseline, there is only one measurement for each patient. Results: We analyzed 72 patients who meet the inclusion criteria. Median age at diagnosis was 49 years old (ranging from 31 to 91). Approximately half of the population was premenopausal (51%). Palbociclib and abemaciclib were the most commonly used CDK4/6i, with 42 and 35% of patients, respectively. ECOG performance status was zero or one in almost the entire patient population analyzed (97%). 53% of the patients were diagnosed as de novo metastatic BC. Table 1 and 2 summarize the patients characteristics. Mean global health status was 75.4, with social and cognitive functioning scoring the highest (Mean 78.6 and 79.1, respectively). The most distressing symptom among the symptom scale was fatigue (Mean 27.2). Most symptoms and functioning scales did not meet the threshold for clinically meaningful differences between the different CDK4/6 inhibitors. Conclusion: Real-world data from our study is consistent with the historical expected health related quality of life among patients diagnosed with HR+/HER2 negative metastatic BC in the first line disease setting. Table. Citation Format: Débora Gagliato, Julio Antonio Araujo, Bianca Milena Verboski, Guilherme William Marcelino, Fabiana Nogueira Momberg, Gilmara Silveira da Silva, Rozana Mesquita Ciconelli, Antônio Buzaid. Quality of Life (QoL) among metastatic hormone receptor positive, HER2 negative breast cancer patients during first line systemic treatment [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-04-14.

Abstract PO3-10-10: Are we adequately integrating patient reported outcomes in breast cancer clinical trials?

Abstract Background: Integrating patient reported outcomes (PROs) in cancer care enhances clinical outcomes and creates a paradigm shift in providing patient-centered care. Several studies performed in the past 15 years have demonstrated that systematic monitoring of patients using PROs through surveys improve patient-clinician communication, clinician awareness of symptoms, symptom management, patient satisfaction, quality of life, and overall survival. There has been uncertainty over the type of PRO system to implement in cancer care, how to evaluate PRO in clinical trials, and how to compare this to the clinician common terminology criteria for adverse events (CTCAE). The PRO concept was first introduced in 1975 with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) survey. In May 2018, the National Cancer Institute established the PRO-CTCAE to be utilized for cancer patients to report and grade their treatment related adverse events, like that of clinician reported CTCAE. The goal of our study was to evaluate frequency of PRO incorporation in phase III breast cancer clinical trials. Methods: New England Journal of Medicine, Journal of Clinical Oncology, and Lancet were systematically searched to identify phase III breast cancer clinical trials published between January 2018 and June 2023. A total of 113 phase III studies were identified, 87 of which had reported protocols. Studies that did not demonstrate protocols on these search engines were not included in the review. Of these 87 clinical trials, 36 studies documented evaluation of PRO. These studies were segregated by year of publication. For each year, the number of total phase III breast cancer clinical trials that were published were compared to those that were published and evaluated PRO. A percentage was generated and allowed for a longitudinal trend to be analyzed over a 5-year period to assess if there was improved frequency of PRO integration into breast cancer clinical trials. Summary statistics were calculated using SAS 9.4. Results: 36 of 113 trials demonstrated PRO use and 26 utilized EORTC-QoL, 1 used PRO-CTCAE, and 9 used another measure of PRO assessment within their study protocol (such as FACT-B and PHQ-9. Additionally, in 2018, 33% of published breast cancer studies included PRO data. Since then, there have been fluctuations in breast cancer studies collecting PRO; 2019: 33%, 2020: 47%, 2021: 43%, 2022: 73%, and since the start of 2023: 9%. Conclusions: Our data suggests a trend towards improvement in frequency of PRO data collection in breast cancer clinical trials over the past 5 years, exemplified by the marked increase in 2022. There remains a need to incorporate PROs in clinical trials and routine care to improve patient experience and provide patient-centered care. Citation Format: Yadav Rina, Zhengyan Huang, Jessica Moss, Garima Gupta. Are we adequately integrating patient reported outcomes in breast cancer clinical trials? [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-10-10.

Abstract PO3-11-05: Sexual dysfunction among Brazilian women with early breast cancer on adjuvant endocrine therapy (ET)

Abstract Background: Sexual dysfunction is a common health problem in women, and it can occur during breast cancer treatment and survivorship. This study aims to determine the frequency of sexual disfunction among Brazilian women with early breast cancer on adjuvant endocrine therapy and to explore its relationships with patients’ clinical and social characteristics, adherence to ET, quality of life, return to work and healthcare insurance. Methodology: Women with history of early-stage ER+ invasive carcinoma of the breast on adjuvant endocrine therapy for at least 6 months were invited to participate of this study. Sexual dysfunction was evaluated using the Female Sexual Function Index questionnaire (FSFI). A score of &amp;lt; 26.55 in FSFI indicates sexual dysfunction. We evaluated sexually active patients (women should have at least one sexual intercourse in the previous four weeks). Demographic and medical information, site of treatment (private versus public), degree of education (completed high school vs not) were reviewed from medical records. Quality of life was assessed using EORTC QLQ C30 and BR-23 forms and adherence to ET was assessed by the Morisky Medication Adherence Scale (MMAS-8). Additionally, patients were interviewed about return to work. Data collection was performed using RedCap software and statistical analyzes were performed on the software R (R Core Team (2022). Qualitative variables were compared between groups using the Chi-square or exact Chi-square test and for quantitative variables the non-parametric Mann-Whitney test was used. Multivariable analysis was performed using Poisson regression. P &amp;lt; 0.05 was considered significant. Analyzes were performed in SAS 9.4. Results: From June 2021 to May 2023, a total of 461 women with ER+ early-stage breast cancer from 12 Brazilian institutions were included in this analysis. The mean age was 56.0 years (range 22-93 ), 47.7% were non-white and 38.7% were premenopausal. A total of 233 women (50.6%) had private insurance and the remaining were treated in public institutions. Median duration of ET use was 2.78 years (range 6 months- 9.61 years).Only 249 (54%) out of 461 patients who accepted to participate in this study declared to have sexual intercourse in the previous 4 weeks before evaluation and composes the population of this analysis. Sexual disfunction according results of FSFI questionnaire was found in 113 (53.3%) participants. Age was significantly associated with sexual dysfunction with women &amp;gt; 40 years-old having higher rates (95.3%) compared with versus younger patients (4.71% p=0.0069). Patients without sexual dysfunction had significantly higher EORTC QLQ C30 Global health status, Physical Functioning, Emotional Functioning, Sexual Functioning and Sexual Enjoyment scores than those with sexual dysfunction (p = 0.0060, p = 0.0242, p = 0 .0353, p = 0.0002 and p &amp;lt; 0.0001 respectively). ET duration between 2 and 5 years vs &amp;lt; 2 years, higher vs lower education level, EORTC QLQ-BR23 breast symptom and sexual functioning higher scores were significantly associated with the occurrence of sexual dysfunction in multivariated analysis (p &amp;lt; 0.05). Conclusion: In our study, only 54% of women evaluated had sexual intercourse in the previous four weeks and from those women 53.3% reported sexual dysfunction. Factors related to sexual dysfunction were higher education level, ET duration between 2 and 5 years, breast symptom and sexual functioning higher scores. div style=margin-top:10px; margin-bottom:20px;&amp;gt;Characteristic with adjusted prevalence ratios for the occurrence of sexual disfunction XX XX PR: prevalence ratio, EORTC: European Organisation for Research and Treatment of Cancer Citation Format: Daniele Assad-Suzuki, Fernanda Moura, Danielle Santos, Sulene Oliveira, Cristiano Souza, Heloísa Resende, Andrea Shimada, Anna Luiza Galvão, Bruno Souza, Amanda Castro, Monalisa Andrade, Yuri Beckedorff, Maria Cristina Magalhães, Carlos Paiva, Angelica Rodrigues, Daniela Pereira, Daniela Rosa, Romualdo Barroso-Sousa. Sexual dysfunction among Brazilian women with early breast cancer on adjuvant endocrine therapy (ET) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-11-05.

Abstract PO3-11-06: Return to work in Brazilian women on adjuvant endocrine therapy

Abstract Background: Breast cancer is the most common cancer in women and its diagnosis and treatment may adversely impact the return to work (RTW). Previous work showed that RTW varies from as low at 27% to as high as 93%. There are few data about RTW in Latin America population. This study aims to investigate the RTW in Brazilian woman with early breast cancer treated with adjuvant endocrine therapy (ET) and its relations to patients’ characteristics, duration of ET, healthcare insurance, quality of life (QOL), sexual disfunction and adherence. Methodology: Women with a past history of early-stage estrogen receptor-positive (ER+) invasive carcinoma of the breast on adjuvant endocrine therapy for at least 6 months were invited to participate in this study and evaluated about RTW. We interviewed patients and asked about employment before cancer diagnosis and about absence from work (yes/no) after diagnosis, return to work (yes/no), time off (&amp;lt; 06 months, 6-12 months, 13-24 months, &amp;gt; 24 months), and difficulties in RTW (yes/no). EORTC QLQ C30 and BR-23, female sex function index questionnaires (FSFI) and adherence to endocrine therapy (MMAS-8) were evaluated. Demographic and medical information, having or not private health insurance (yes versus public), degree of education (completed high school vs not) were reviewed from medical records. Data collection was done with RedCap software. Qualitative variables were compared between groups using the Chi-square or exact Chi-square test and for quantitative variables the non-parametric Mann-Whitney test was used. Multivariable analysis was performed using Poisson regression. P &amp;lt; 0.05 was considered significant. Analyzes were performed in SAS 9.4. Results: From June 2021 to May 2023, a total of 461 women with ER+ early-stage breast cancer from 12 Brazilian institutions were included in this analysis. The mean age was 56.02 years (range 22-93 ), 47.7% were non-white and 38.7% were premenopausal. A total of 233 women (50.6%) had private insurance and the remaning were treated in public institutions. Median duration of ET usewas 2.78 years (range 6 months- 9.61 years). A total of 266 (64.88%) of women worked before cancer diagnosis and were evaluated about RTW. RTW rates at 6 months, 12 months and 24 months after diagnosis were 32.7%, 53% and 69.9% respectively. A total of 31.2% of women did not RTW at 2 years. A total of 53 (37.5%) of woman reported to face difficulties to RTW. Characteristics associated with RTW were age &amp;gt;60 years (p=0.004), white race (p=0.014), higher education level (p&amp;lt; 0.0001), stage I disease (p=0.018), private healthcare insurance (p&amp;lt; 0.0001). In the multivariable analysis, not having private health insurance, yonger age, lower EORTC QLQ-C30 physical functioning score and higher EORTC QLQ-BR23 arm symptoms scores were associated with not returning to work in this population (p &amp;lt; 0.05). Conclusion: Almost one third of the patients who were employed before cancer diagnosis did not RTW after treatment in Brazil. At 12 months, RTW rate was 53% higher than previous data in Latin America. Healthcare insurance, age and quality of life were related to RTW. It is crucial to identify the barriers and improve work conditions to increase RTW after breast cancer treatment as RTW have been shown to be beneficial to patients’ physical, mental health and quality of life. Variables with adjusted prevalence ratios for the occurrence of absence from work XX XX PR: Prevalence ratio; EORTC : European Organisation for Research and Treatment of Cancer XX XX Citation Format: Daniele Assad-Suzuki, Andrea Shimada, Danielle Santos, Cristiano Souza, Fernanda Moura, Sulene Oliveira, Anna Luiza Galvão, Bruno Souza, Amanda Castro, Monalisa Andrade, Yuri Beckedorff, Maria Cristina Magalhães, Carlos Paiva, Heloísa Resende, Daniela Pereira, Angelica Rodrigues, Daniela Rosa, Romualdo Barroso-Sousa. Return to work in Brazilian women on adjuvant endocrine therapy [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-11-06.

Abstract PO2-12-04: Suboptimal adherence to adjuvant endocrine therapy (ET) in Brazilian women with early-stage estrogen receptor-positive (ER+) breast cancer

Abstract Background: Adjuvant ET reduces breast cancer recurrence and increases overall survival among patients with early-stage ER+ breast cancer, however a suboptimal number of patients in fact takes oral medicine as prescribed. In Brazil, there is a paucity of data about adherence to adjuvant ET. This study aims to evaluate adherence to adjuvant ET in Brazilian women with early breast cancer and to evaluate clinical and sociodemographic characteristics associated with higher or lower adherence. Methods: Women with history of early-stage ER+ invasive carcinoma of the breast on adjuvant ET for at least 6 months were invited to participate of this study. Adherence was assessed with questionnaire Morisky Medication Adherence Scale (MMAS-8) and high adherence was defined by a MMAS-8 score=8. Demographic and medical information, site of treatment (private versus public), degree of education (completed high school vs not) were reviewed from medical records. Quality of life was assessed using EORTC QLQ C30 and BR-23 forms, sexuality was evaluated with the Female Sex Function Index questionnaire. Additionally, patients were interviewed about return to work. Data collection was done with RedCap software. Qualitative variables were compared between groups using the Chi-square or exact Chi-square test and for quantitative variables the non-parametric Mann-Whitney test was used. Multivariable analysis was performed using Poisson regression. P &amp;lt; 0.05 was considered significant. Analyzes were performed in SAS 9.4. Results: From June 2021 to May 2023, a total of 461 women with ER+ early-stage breast cancer from 12 Brazilian institutions were included in this analysis. The mean age was 56.0 years (range 22-93), 47.7% were non-white and 38.7% were premenopausal. A total of 233 women (50.6%) had private insurance and the remaining were treated in public institutions. Median duration of ET use was 2.78 years (range 6 months- 9.61 years). High adherence to adjuvant endocrine therapy was present in 55.7% of patients. Median age of high adherent woman was higher than low adherent (p=0.005). Factors significantly associated with high adherence were no use of ovarian suppression (p=0.0095), use of anti-Her2 therapy (p=0.0462). Furthermore, higher scores for EORTC QLQ-C30 global health status (p=0.017) and in specific domains, including role functioning (p=0.007), emotional functioning (p&amp;lt; 0.0001), cognitive functioning (p&amp;lt; 0.001), social functioning (p = 0,0005), higher scores for EORTC BR23 body image (p&amp;lt; 0.001) and future perspective (p = 0.0198) were also associated with high adherence. Higher EORTC QLQ-C30 cognitive function score was the only variable associated with high adherence (p &amp;lt; 0.0001) to ET in multivariate model. Conclusion: Using the MMAS-8, only 55.7% of Brazilian women with stage I-III ER+ breast cancer reported high adherence to endocrine therapy. This suboptimal adherence rate leads to important questions such as the impact on the prognosis of this population Charactheristic with adjusted prevalence ratio for the occurrence of High adherence PR: Prevalence ratio; EORTC: European Organisation for Research and Treatment of Cancer Citation Format: Daniele Assad-Suzuki, Heloísa Resende, Danielle Santos, Fernanda Moura, Sulene Oliveira, Andrea Shimada, Anna Luiza Galvão, Bruno Souza, Amanda Castro, Monalisa Andrade, Yuri Beckedorff, Maria Cristina Magalhães, Cristiano Souza, Carlos Paiva, Daniela Pereira, Angelica Rodrigues, Daniela Rosa, Romualdo Barroso-Sousa. Suboptimal adherence to adjuvant endocrine therapy (ET) in Brazilian women with early-stage estrogen receptor-positive (ER+) breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-12-04.

Abstract PS02-02: Patient-reported outcomes from the Phase 3 CAPItello-291 trial investigating capivasertib and fulvestrant for patients with aromatase inhibitor-resistant HR-positive/HER2-negative advanced breast cancer

Abstract Background: In the Phase 3 CAPItello-291 trial, adding capivasertib (C), a pan-AKT inhibitor, to fulvestrant (F) in patients (pts) with aromatase inhibitor-resistant, HR+/HER2− (HER2− defined as IHC 0, or 1+ or IHC2+/ISH–) advanced breast cancer significantly improved PFS vs placebo (P) + F in the overall (HR 0.60, 95% CI 0.51, 0.71, p&amp;lt; 0.001) and AKT pathway-altered populations (HR 0.50, 95% CI 0.38, 0.65, p&amp;lt; 0.001). The safety profile of C-F was manageable; diarrhea (mostly grade 1) was the most frequent adverse event. Global health status (GHS)/health-related quality of life (HRQoL) was maintained from baseline in both arms; time to deterioration (TTD) favored C-F. We report results from additional patient-reported outcomes (PRO). Methods: Pts were randomized 1:1 to receive F (500 mg IM on days 1 and 15 of cycle 1 and day 1 of each subsequent 28-day cycle) with either P or C (400 mg BID; 4 days on, 3 days off). PRO measures assessed HRQoL, disease-related symptoms, functioning, and patient-reported treatment tolerability using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), EORTC QLQ Breast Cancer 23 items (EORTC QLQ-BR23), PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and Patient Global Impression of Treatment Tolerability (PGI-TT). PROs were assessed at pre-specified timepoints. Change from baseline was assessed using Mixed Model Repeat Measures (on-treatment scores) for EORTC QLQ-C30 and summarized for EORTC QLQ-BR23; TTD was assessed using the stratified log-rank test for both. Results: Overall, 708 pts were randomized to C-F (n=355) or P-F (n=353). Overall compliance rates with EORTC QLQ-C30 and PGI-TT were 84.5% and 80.6% with C-F and 81.8% and 81.7% with P-F, respectively. Baseline compliance rates with the EORTC QLQ-C30 and PGI-TT were 88.2% and 82.8% with C-F and 87.3% and 83.1% with P-F, respectively. Mean changes from baseline in EORTC QLQ-C30 functional and symptom domain scores were maintained with C-F and P-F, except for diarrhea in the C-F arm, where scores worsened by &amp;gt;10 points (table). TTD analysis showed that HRs favored C-F vs P-F for all functional and symptom domains, except diarrhea (HR 2.75; 95% CI 2.01, 3.81), which favored P-F (table). Median TTD of diarrhea was shorter with C-F vs P-F in line with the C-F safety profile. Diarrhea with C-F was generally manageable, and discontinuations due to diarrhea were low (2.0%; n=7/355). For PGI-TT, most pts reported that they were ‘not at all’ or ‘a little bit’ bothered by the side effects of cancer therapy. Over the first 6 months, the proportion of pts reporting to be ‘somewhat’, ‘quite a bit’, or ‘very much’ bothered by side effects was higher for C-F vs P-F, with between-arm differences being highest in the first 2 cycles. Results from EORTC QLQ-BR23 domains will be presented at the meeting. Conclusions: Pts treated with C-F maintained HRQoL for longer than pts treated with P-F on all EORTC QLQ-C30 functional and symptom domain scores, except diarrhea. Worsening of diarrhea was observed with C-F, consistent with the safety profile of C, but events appeared tolerable and did not negatively impact GHS/HRQoL. Together with the clinical efficacy and manageable safety profile of C-F, the PRO results from the CAPItello-291 trial further support a positive benefit–risk profile of the combination in this population. https://clinicaltrials.gov/: NCT04305496. Funding: CAPItello-291 is sponsored by AstraZeneca. Editorial acknowledgment: AstraZeneca-funded medical writing support was provided by Suzanne Patel, Ph.D., from BOLDSCIENCE Inc. Capivasertib was discovered by AstraZeneca subsequent to a collaboration with Astex Therapeutics (and its collaboration with the Institute of Cancer Research and Cancer Research Technology Limited). Citation Format: Hope Rugo, Mafalda Oliveira, Sacha Howell, Florence Dalenc, Javier Cortés, Henry Gómez, Xichun Hu, Komal Jhaveri, Petr Krivorotko, Sibylle Loibl, Serafin Morales Murillo, Meena Okera, Yeon Park, Joo Hyuk Sohn, Eriko Tokunaga, Masakazu Toi, Samih Yousef, Lyudmila Zhukova, Marta Fulford, Haylee Andrews, Ian Wadsworth, Celina D’Cruz, Nicholas Turner. Patient-reported outcomes from the Phase 3 CAPItello-291 trial investigating capivasertib and fulvestrant for patients with aromatase inhibitor-resistant HR-positive/HER2-negative advanced breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PS02-02.

Cancer-Specific Health Utilities: Evaluation of Core Measurement Properties of the EORTC QLU-C10D in Lung Cancer Patients-Data from Four Multicentre LUX-Lung Trials, Applying Six Country Tariffs.

Cost-utility analysis generally requires valid preference-based measures (PBMs) to assess the utility of patient health. While generic PBMs are widely used, disease-specific PBMs may capture additional aspects of health relevant for certain patient populations. This study investigates the construct and concurrent criterion validity of the cancer-specific European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Utility-Core 10 dimensions (QLU-C10D) in non-small-cell lung cancer patients. We retrospectively analysed data from four multicentre LUX-Lung trials, all of which had administered the EORTC Quality of Life Questionnaire (QLQ-C30) and the EQ-5D-3L. We applied six country-specific value sets (Australia, Canada, Italy, the Netherlands, Poland, and the United Kingdom) to both instruments. Criterion validity was assessed via correlations between the instruments' utility scores. Correlations of divergent and convergent domains and Bland-Altman plots investigated construct validity. Floor and ceiling effects were assessed. The comparison of the EORTC QLU-C10D and EQ-5D-3L produced homogenous results for five of the six country tariffs. High correlations of utilities (r > 0.7) were found for all country tariffs except for the Netherlands. Moderate to high correlations of converging domain pairs (r from 0.472 to 0.718) were found with few exceptions, such as the Social Functioning-Usual Activities domain pair (max. r = 0.376). For all but the Dutch tariff, the EORTC QLU-C10D produced consistently lower utility values compared to the EQ-5D-3L (x̄ difference from -0.082 to 0.033). Floor and ceiling effects were consistently lower for the EORTC QLU-C10D (max. 4.67% for utilities). The six country tariffs showed good psychometric properties for the EORTC QLU-C10D in lung cancer patients. Criterion and construct validity was established. The QLU-C10D showed superior measurement precision towards the upper and lower end of the scale compared to the EQ-5D-3L, which is important when cost-utility analysis seeks to measure health change across the severity spectrum.

Abstract PO2-05-02: Real-world experience of patients receiving treatment for hormone receptor-positive/human epidermal growth factor receptor-2 negative metastatic breast cancer: A global analysis of symptoms and side effects

Abstract Background: Advances in treatment for patients (pts) with hormone receptor-positive (HR+)/human epidermal growth factor receptor-2 negative (HER2–) metastatic breast cancer (mBC) have improved overall survival, but treatment resistance is common and median survival remains only a few years. These pts usually need chronic therapy and often experience symptoms and side effects. There is limited knowledge on pts’ experiences outside the clinical trial setting, largely because this information is not routinely reported. This analysis leverages a unique database of physician- and pt-reported data to describe symptoms and side effects among a real-world, geographically diverse population of pts receiving treatment for HR+/HER2– mBC. Methods: This retrospective cohort study used Adelphi Disease Specific Programme Real World Data, comprising validated, linked pt and physician questionnaire data from the US, France, Germany, Italy, Spain, and UK. Eligible pts were ≥18 y, currently receiving treatment for advanced BC and not enrolled in a clinical trial. Data were collected between August 2022 and February 2023. Physician surveys provided data on individual pt demographics and disease characteristics, comorbidities, treatment history, and treatment (including adherence). Physicians also reported presence or absence of symptoms and side effects after treatment initiation for each pt they considered. A subset of pts completed one-time validated quality of life (QOL) instruments, including the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) and EORTC QLQ-breast (BR23). Results: Data from 1578 pts receiving treatment for HR+/HER2– mBC were analyzed. Mean age was 65-y, 91% were white, 71% had de novo mBC, and 82% had ECOG performance status 0-1 at the start of current treatment. Across all lines of therapy, 71% of pts were receiving endocrine-based therapy, 16% were receiving chemotherapy only, and 13% were receiving other therapies; 40% of all pts were receiving second or later lines of any systemic therapy (2L+). Among all pts, the most common physician-reported symptoms and side effects (in ≥10% of pts) were bone pain (30%), change in appetite (13%), weight loss (12%), neutropenia (11%), and joint/muscle pain (11%). Pts on 2L+ therapy experienced a greater frequency of symptoms and side effects than those on first-line therapy (Table). Of 220 pts who completed QOL questionnaires, the most commonly reported symptoms and side effects (in ≥70% of pts) were feeling tired (87%), worry about future health (80%), general worrying (79%), needing to rest during the day (74%), feeling weak (74%), having trouble doing strenuous activity (71%), and trouble taking a long walk (71%). These were common irrespective of pt age, disease state (recurrent vs de novo), current treatment regimen, and line of therapy. Conclusions: This real-world analysis shows that both physicians and pts identified substantial symptoms and side effects during treatment. These were pervasive across the population and more common in those receiving 2L+ therapy, although it remains unclear which were due to treatment or disease. Thus, it is important to continue to develop treatments and supportive care to improve both clinical outcomes and pt QOL. Citation Format: MK Rehnquist, Ann Partridge, Annabel Lambert, Allison Kurian, Natalia Sadetsky, Emily Freeman, Lisa Carey. Real-world experience of patients receiving treatment for hormone receptor-positive/human epidermal growth factor receptor-2 negative metastatic breast cancer: A global analysis of symptoms and side effects [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-05-02.

Efficacy of ferric carboxymaltose on haemoglobin response among older patients with gastrointestinal bleeding: a randomised clinical trial.

Acute gastrointestinal bleeding (AGIB) is common in older patients but the use of iron in this context remains understudied. This study aimed to evaluate prospectively the efficacy of ferric carboxymaltose to treat anaemia in older patients after AGIB. This randomised double-blinded placebo-controlled clinical trial was conducted in 10 French centres. Eligible patients were 65years or more, had controlled upper or lower gastrointestinal bleeding and a haemoglobin level of 9-11g/dl. Patients were randomly assigned, in a 1:1 ratio, to receive either one intravenous iron injection of ferric carboxymaltose or one injection of saline solution. The primary endpoint was the difference in haemoglobin level between day 0 and day 42. Secondary endpoints were treatment-emergent adverse events, serious adverse events, rehospitalisation and improvement of quality of life (QOL) at day 180. From January 2013 to January 2017, 59 patients were included. The median age of patients was 81.9 [75.8, 87.3] years. At day 42, a significant difference in haemoglobin level increase was observed (2.49g/dl in the ferric carboxymaltose group vs. 1.56g/dl in the placebo group, P = 0.02). At day 180, QOL, measured on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, improved by 10.5 points in the ferric carboxymaltose group and by 8.2 points in the placebo group (P = 0.56). Rates of adverse events and rehospitalisation were similar in the two groups. Intravenous iron seems safe and effective to treat anaemia in older patients after AGIB and should be considered as a standard-of-care treatment. ClinicalTrials.gov (NCT01690585).

Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): patient-reported outcomes from a randomised, open-label, multicentre, phase 3 trial

In DESTINY-Breast02, patients with HER2-positive unresectable or metastatic breast cancer who received trastuzumab deruxtecan demonstrated superior progression-free and overall survival compared with those receiving treatment of physician's choice. We present the patient-reported outcomes (PROs) and hospitalisation data. In this randomised, open-label, phase 3 trial conducted at 227 clinical sites globally, enrolled patients had to be aged 18 years or older with HER2-positive unresectable or metastatic breast cancer that had progressed on trastuzumab emtansine and had an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were randomly assigned (2:1) using block randomisation (block size of 3) to receive trastuzumab deruxtecan (5·4 mg/kg intravenously once every 21 days) or treatment of physician's choice by an independent biostatistician using an interactive web-based system. Patients and investigators remained unmasked to treatment. Treatment of physician's choice was either capecitabine (1250 mg/m2 orally twice per day on days 1-14) plus trastuzumab (8 mg/kg intravenously on day 1 then 6 mg/kg once per day) or capecitabine (1000 mg/m2) plus lapatinib (1250 mg orally once per day on days 1-21), with a 21-day schedule. The primary endpoint, which was progression-free survival based on blinded independent central review, has previously been reported. PROs were assessed in the full analysis set (all patients randomly assigned to the study) using the oncology-specific European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), breast cancer-specific EORTC Quality of Life Questionnaire Breast 45 (QLQ-BR45), and the generic HRQoL EQ-5D-5L questionnaire. Analyses included change from baseline and time to definitive deterioration for PRO variables of interest and hospitalisation-related endpoints. This study is registered with ClinicalTrials.gov, NCT03523585, and is closed to recruitment. Between Sept 6, 2018, and Dec 31, 2020, 608 patients were randomly assigned to receive either trastuzumab deruxtecan (n=406; two did not receive treatment) or treatment of physician's choice (n=202; seven did not receive treatment). Overall, 603 patients (99%) were female and five (<1%) were male. The median follow-up was 21·5 months (IQR 15·2-28·4) in the trastuzumab deruxtecan group and 18·6 months (IQR 8·8-26·0) in the treatment of physician's choice group. Median treatment duration was 11·3 months (IQR 6·2-20·5) in the trastuzumab deruxtecan group and approximately 4·5 months in the treatment of physician's choice group (4·4 months [IQR 2·5-8·7] with trastuzumab; 4·6 months [2·1-8·9] with capecitabine; and 4·5 months [2·1-10·6] with lapatinib). Baseline EORTC QLQ-C30 global health status (GHS) scores were similar with trastuzumab deruxtecan (n=393) and treatment of physician's choice (n=187), and remained stable with no clinically meaningful change (defined as ≥10-point change from baseline) over time. Median time to definitive deterioration was delayed with trastuzumab deruxtecan compared with treatment of physician's choice for the primary PRO variable EORTC QLQ-C30 GHS (14·1 months [95% CI 10·4-18·7] vs 5·9 months [4·3-7·9]; HR 0·5573 [0·4376-0·7099], p<0·0001) and all other prespecified PROs (EORTC QLQ-C30 subscales, EORTC QLQ-BR45 arm and breast symptoms, and EQ-5D-5L visual analogue scale). Patient hospitalisation rates were similar in the trastuzumab deruxtecan (92 [23%] of 406) and treatment of physician's choice (41 [20%] of 202) groups; however, median time to hospitalisation was 133 days (IQR 56-237) with trastuzumab deruxtecan versus 83 days (30-152) with treatment of physician's choice. Overall, GHS and quality of life were maintained for both treatment groups, with prespecified PRO variables favouring trastuzumab deruxtecan over treatment of physician's choice, suggesting that despite a longer treatment duration, there was no detrimental impact on patient health-related quality of life with trastuzumab deruxtecan. When considered with efficacy and safety data from DESTINY-Breast02, these results support the overall benefit of trastuzumab deruxtecan for patients with HER2-positive unresectable or metastatic breast cancer previously treated with trastuzumab emtansine. Daiichi Sankyo and AstraZeneca.

Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer (TOPAZ-1): patient-reported outcomes from a randomised, double-blind, placebo-controlled, phase 3 trial

In the ongoing, randomised, double-blind phase 3 TOPAZ-1 study, durvalumab, a PD-L1 inhibitor, plus gemcitabine and cisplatin was associated with significant improvements in overall survival compared with placebo, gemcitabine, and cisplatin in people with advanced biliary tract cancer at the pre-planned intermin analysis. In this paper, we present patient-reported outcomes from TOPAZ-1. In TOPAZ-1 (NCT03875235), participants aged 18 years or older with previously untreated, unresectable, locally advanced, or metastatic biliary tract cancer with an Eastern Cooperative Oncology Group performance status of 0 or 1 and one or more measurable lesions per Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1) were randomly assigned (1:1) to the durvalumab group or the placebo group using a computer-generated randomisation scheme. Participants received 1500 mg durvalumab or matched placebo intravenously every 3 weeks (on day 1 of the cycle) for up to eight cycles in combination with 1000 mg/m2 gemcitabine and 25 mg/m2 cisplatin intravenously on days 1 and 8 every 3 weeks for up to eight cycles. Thereafter, participants received either durvalumab (1500 mg) or placebo monotherapy intravenously every 4 weeks until disease progression or other discontinuation criteria were met. Randomisation was stratified by disease status (initially unresectable vs recurrent) and primary tumour location (intrahepatic cholangiocarcinoma vs extrahepatic cholangiocarcinoma vs gallbladder cancer). Patient-reported outcomes were assessed as a secondary outcome in all participants who completed the European Organisation for Research and Treatment of Cancer's 30-item Quality of Life of Cancer Patients questionnaire (QLQ-C30) and the 21-item Cholangiocarcinoma and Gallbladder Cancer Quality of Life Module (QLQ-BIL21). We calculated time to deterioration-ie, time from randomisation to an absolute decrease of at least 10 points in a patient-reported outcome that was confirmed at a subsequent visit or the date of death (by any cause) in the absence of deterioration-and adjusted mean change from baseline in patient-reported outcomes. Between April 16, 2019, and Dec 11, 2020, 685 participants were enrolled and randomly assigned, 341 to the durvalumab group and 344 to the placebo group. Overall, 345 (50%) of participants were male and 340 (50%) were female. Data for the QLQ-C30 were available for 318 participants in the durvalumab group and 328 in the placebo group (median follow-up 9·9 months [IQR 6·7 to 14·1]). Data for the QLQ-BIL21 were available for 305 participants in the durvalumab group and 322 in the placebo group (median follow-up 10·2 months [IQR 6·7 to 14·3]). The proportions of participants in both groups who completed questionnaires were high and baseline scores were mostly similar across treatment groups. For global health status or quality of life, functioning, and symptoms, we noted no difference in time to deterioration or adjusted mean changes from baseline were observed between groups. Median time to deterioration of global health status or quality of life was 7·4 months (95% CI 5·6 to 8·9) in the durvalumab group and 6·7 months (5·6 to 7·9) in the placebo group (hazard ratio 0·87 [95% CI 0·69 to 1·12]). The adjusted mean change from baseline was 1·23 (95% CI -0·71 to 3·16) in the durvalumab group and 0·35 (-1·63 to 2·32) in the placebo group. The addition of durvalumab to gemcitabine and cisplatin did not have a detrimental effect on patient-reported outcomes. These results suggest that durvalumab, gemcitabine, and cisplatin is a tolerable treatment regimen in patients with advanced biliary tract cancer. AstraZeneca.

Pretreatment Patient-reported Overall Health: A Prognostic Factor for Early Overall Mortality After Primary Curative Treatment of Prostate Cancer

Background and objectiveRegistry-based studies for prostate cancer (PCa) document higher overall mortality (OM) after high-dose radiotherapy (RT) than after radical prostatectomy (RP). Our aim was to explore the association between pretreatment patient-reported health (“OverallHealth”: OH) and curative treatment type, and the impact on early OM. MethodsNew PCa patients registered between 2017 and 2019 in the Cancer Registry of Norway (n = 1949) completed the European Organisation for Research and Treatment of Cancer Quality-of-Life Core 30 (QLQ-C30) questionnaire before RP (n = 592) or RT (n = 610) or after allocation to active surveillance (AS; n = 747). We dichotomised the QLQ-C30 summary score to classify patients with un-impaired versus impaired OH. Standard univariable and multivariable analyses with treatment type or OM as the outcome were conducted. The mean observation time was 4.7 years (standard deviation 1.0). Statistical significance was set at p < 0.05. Key findings and limitationsImpaired OH was more frequent in the RT group (38%) than in the RP (25%) or AS (28%) group (p < 0.001). Higher age, higher risk group, and impaired OH increased the probability of undergoinRT rather than RP (p < 0.001). Impaired OH was associated with a twofold higher early OM rate in the RT group (16% vs 8%; p = 0.009) and fourfold higher OM rate in the AS group (13% vs 3%; p < 0.001). These findings remained significant in Cox regression analyses controlled for age and risk group. After RP, only locally advanced high-risk tumours were significantly associated with OM. Unknown psychometrics for the OH variable is the main study limitation. Conclusions and clinical implicationsPretreatment patient-reported impaired OH, measured as the QLQ-C30 summary score, was positively associated with allocation to RT or AS and is a prognostic factor for early OM. Before allocation to RT or AS, elderly patients with PCa should be screened and treated for health problems that can be remedied. Future studies should determine the psychometrics of the QLQ-C30 summary score in comparison to established frailty screening instruments. Patient summaryPatient-reported scores reflecting their overall health can help in choosing curative treatment for prostate cancer and are associated with survival during the first 5 years after treatment.

Rhinoplasty Health Inventory and Nasal Outcomes (RHINO) Scale: Translation, Cross-Cultural Adaptation and Validation for Hebrew-Speaking Patients.

Patient-reported outcomes questionnaires are accepted measurement tools to evaluate procedures results. The Rhinoplasty Health Inventory and Nasal Outcomes (RHINO) scale is an English-language validated and reliable quality-of-life instrument that evaluates both functional and aesthetic outcomes after rhinoplasty, and is not available in Hebrew. We followed the forward-and-back-translation method, defined by the European Organization for Research and Treatment of Cancer. Translation of the RHINO scale and merging it into one version were performed, following back-translation and validation on native Hebrew-speaking patients who underwent rhinoplasty and control healthy group. Lastly, we review and analyzed the results. The translated questionnaire had high reliability measures, demonstrating homogeneity (α value 0.800 in the rhinoplasty group and 0.896 in the control group), test-retest reproducibility with no significant difference (p = 0.5), and high agreement scores represented by the Bland-Altman plot (95% limits of agreement ranged from 8.78 to 9.80). Validity demonstrated by significant differences between the two study groups' mean questionnaire scores (p < 0.001 for rhinoplasty vs. controls, p < 0.001 for preoperative vs. postoperative, and p = 0.002 for postoperative vs. control group) and also between the aesthetic scores and functional scores of the rhinoplasty group before and after the surgery (p < 0.001). There were no reported understanding problems. The Hebrew version of the RHINO scale is a reliable and valid tool for pre- and post-rhinoplasty surgery outcomes measuring among Hebrew-speaking patients, and can improve coordination of expectations, follow-up, and quantify subjective evaluation of the surgery. Level of evidence: IV.

Long‐term quality of life after open and laparoscopic total gastrectomy for stage I gastric cancer: A prospective multi‐institutional study (CCOG1504)

AbstractBackgroundLittle information is available from prospective clinical trials on the influences of surgical approaches on postoperative quality of life (QOL). We aimed to prospectively compare chronological changes in postoperative body weight and QOL between laparoscopic and open total gastrectomy for stage I gastric cancer (GC).MethodsWe conducted a multi‐institutional prospective study (CCOG1504) of patients who undergo laparoscopic or open total gastrectomy. Body weight was measured at the baseline and at the 1st, 2nd, and 3rd postoperative years (POY). QOL using the European Organization for Research and Treatment of Cancer quality of life questionnaire‐C30 (EORTC QLQ‐C30) and the Post‐Gastrectomy Syndrome Assessment Scale‐37 (PGSAS‐37) questionnaires were measured at the baseline and at the 1st, 3rd, 6th, 12th, and 36th postoperative months (POM).ResultsWe enrolled 84 patients from 15 institutions, and finally 43 patients for the laparoscopic group and 16 for the open group were eligible for data analysis. There were no significant differences in body weight change between the two groups. The role functioning score among the EORTC QLQ‐C30 tended to be higher (i.e., better QOL) in the laparoscopic group at POM 1 and 12 after surgery compared to the open group. The dissatisfaction at working score among the PGSAS‐37 at 1 month after surgery was lower (i.e. better QOL) in the laparoscopic group compared to the open group.ConclusionsThe results of CCOG1504 indicated that laparoscopic approach for total gastrectomy was associated with a more favorable dissatisfaction at working score (PGSAS‐37).