Global Health Status Scores Research Articles

Five-year long-term functional and quality of life outcomes in total glossectomy survivors.

Total glossectomy is proven to be a superior treatment option for advanced tongue cancer. Despite its efficacy, the procedure is associated with profound morbidity, notably impacting Speech, swallowing, and overall quality of life. Limited therapeutic benefits and the potential for considerable morbidity render total glossectomy a subject of controversy. We performed a multidimensional quality of life evaluation of long-term (more than 5 yrs.) total glossectomy survivors. In this study, we evaluated 25 total glossectomy survivors with comprehensive functional and quality of life outcomes using objective measures (London Speech Evaluation Scale, FOIS, 100ml Water Challenge, FEES) and Patient-reported outcomes (SHI, PSS HN, EORTC QLQ 30 & HN35). EORTC QLQ 30 showed overall good global health status (M = 80 ± 20) and functional scale mean scores ranging from 87 to 91, despite issues in pain (M = 31.6 ± 31), swallowing (M = 23.3 ± 24), and Speech (26.1 ± 1). Speech outcomes revealed 80% with moderate to severe intelligibility impairment. Swallowing outcomes showed 84% requiring special food preparation, 24% exhibiting aspiration, and 72% having pharyngeal residue. Speech outcomes showed 88% having moderate-severe speech impairment, and Patient-reported speech outcomes indicated a mean SHI score of (M = 47.2 ± 42). Patients undergoing total glossectomy report favourable long-term outcomes in global health-related quality of life despite moderate to severe impairments in objective speech and swallowing evaluations. These positive patient-reported outcomes support the consideration of total glossectomy as a viable treatment option if and when required, underscoring the importance of evaluating treatment outcomes through the patient-perceived quality of life.

Short-term outcomes and quality of life of esophagogastrostomy versus the double-tract reconstruction after laparoscopic proximal gastrectomy

BackgroundThere is no optimal reconstruction technique after proximal gastrectomy. The esophagogastrostomy (EG) is a rather simple procedure technically, but the incidences of reflux esophagitis and anastomotic stricture are higher. While the double-tract reconstruction (DTR) can lessen postoperative reflux esophagitis, it is technically complex with a long operation time. The purpose of this study was to evaluate the quality of life (QoL) and short-term outcomes of the two reconstruction techniques.MethodsWe retrospectively collected consecutive patients with upper-third gastric adenocarcinoma and adenocarcinoma of the esophagogastric junction (AEG) at our center between 2019 June and 2023 May. Patients who underwent laparoscopic proximal gastrectomy (LPG) with EG or DTR were included in this study. A comparison was made between the clinical and pathological characteristics of patients and their surgical parameters, postoperative complications, and its 1-year QoL in two groups. The QoL of the two groups was assessed by Visick grading, the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC QLQ-STO22 scales at 1 year after operation. The nutritional status of the two groups was evaluated by BMI, hemoglobin and serum albumin.ResultsAII the qualified patients were divided EG group (n = 63) and DTR group (n = 93). Compared to the DTR group, the blood loss volume of EG group was more (p = 0.001). There were no significant differences in operation duration, number of lymph nodes dissected, and postoperative length of stay between the two groups(p > 0.05). No statistical differences were observed in terms of the incidence of early complications and Clavien-Dindo classification as well(p > 0.05). After one year, the Visick grade of the DTR group was better than EG group (p = 0.040). The multivariable logistic regression analysis showed the only independent risk factor for reflux esophagitis was the reconstruction method. According to the EORTC QLQ-C30 questionnaire, patients in the DTR group had a better global health status(p = 0.001) and complained less about nausea and vomiting(p = 0.033), and appetite loss (p = 0.022). Patients in the DTR group complained less about reflux (p = 0.030) based on the EORTC QLQ-STO22 questionnaire. The multiple linear regression analysis revealed that the reconstruction method, reflux esophagitis and age had a linear relationship with the global health status score. Regarding nutritional status, BMI of the two groups both decreased 1 year after operation, and BMI decline value of the DTR group was lower than EG group (p = 0.001). There is no statistically significant difference between the two groups as for postoperative change in hemoglobin and serum albumin.ConclusionOur findings suggest that it is possible for skilled surgeons to achieve minimal blood loss volume without significantly increasing operation duration when performing DRT, which does not raise risk. In terms of anti-reflux, postoperative QoL and BMI maintenance, 1-year postoperative follow-up outcomes reveal the DTR is superior to EG, which deserve further research and promotion.

A Latent Class Analysis of Nutrition Impact Symptoms in Cancer Survivors

Those with a cancer diagnosis report experiencing a wide range of nutrition impact symptoms, the prevalence of which varies by study, group, and cancer type. We aimed to identify groups of cancer survivors with specific patterns of nutrition impact symptoms. Two hundred and twenty-nine individuals attending oncology day ward and outpatient clinics completed a series of questionnaires and physical measurements. A latent class analysis was performed to identify subgroups based on 13 nutrition impact symptoms taken from the Patient Generated Subjective Global Assessment short form. The identified classes were subsequently compared using analysis of variance and chi-square tests, by sociodemographic, clinical and nutritional variables, and by the Global Health Status (GHS) and five functioning scales determined using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Three latent subtypes were identified: (1) Fatigue (n = 58, 28%); (2) Low Symptom Burden (n = 146, 64%), and (3) High Symptom Burden (n = 25, 11%). Those in the High Symptom Burden group were more likely to be female, were currently receiving some form of treatment, were diagnosed ≥two years, and had consumed less food than usual in the last month compared to those in the Low Symptom Burden group. Those in the Fatigue group were less likely to have reported their food intake to be unchanged and more likely to be diagnosed ≥two years than those in the Low Symptom Burden group. The EORTC-QLQ-C30 functioning and GHS scores were all significantly different between the three nutrition impact symptoms classes (p < 0.001). This is the first study to examine heterogeneity of nutrition impact symptoms in Irish cancer survivors. The findings of this work will inform and allow for more individualised nutrition care. By tailoring interventions to these specific groups, we can enhance the precision of care, improve prognostic accuracy, and significantly elevate the quality of life of survivors. This work underscores the critical importance of symptom management in the continuum of cancer care, ensuring that every survivor receives comprehensive support tailored to their unique journey.

Suicidal Ideation was Associated with Quality of Life Impairment of Patients with Lung Cancer: A Cross-Sectional Study in Vietnam.

This study aimed to measure the quality of life (QOL) of lung cancer patients and evaluate the relationship between QOL and suicidal ideation (SI) in a tertiary hospital in Vietnam. A cross-sectional study was conducted at Bach Mai Hospital in Hanoi, Vietnam. A total of 256 patients with lung cancer were recruited. The QOL of cancer patients was evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) version 3. Multivariate Tobit regression was employed to identify associations between SI and QOL. Overall, the mean global health status score was 58.3 ± 15.8, and those with SI had significantly higher scores than those without SI. Regarding functional scales, patients with SI had significantly lower physical functioning (82.22 ± 11.42) compared to those without SI (90.58 ± 11.90) (p<0.05). Meanwhile, regarding symptom scales, scores for fatigue, nausea and vomiting, pain, insomnia, appetite loss, constipation, diarrhea, and financial difficulties among patients with SI were significantly higher than those without SI (p<0.05). In the multivariate analysis, having SI increased the role functioning score (Coef. = 9.41, 95% CI = 0.38-18.45) and diarrhea score (Coef. = 22.33, 95% CI = 2.05-42.60). This study indicated moderate QOL and perceived the lowest social functioning in lung cancer patients. SI was associated with role functioning scores and diarrhea scores. SI should be monitored and controlled regularly in this population during treatment to improve their QOL.

The assessment of health-related quality of life in patients with polycythemia vera.

Previous studies have shown that patients with polycythemia vera (PV) have poor quality of life (QoL). Similarly, it has been shown that survival is influenced by QoL. We aimed to evaluate QoL in 88 Turkish patients with PV. This cross-sectional study included cases diagnosed with PV between January 1995 and August 2019 who attended follow-up studies in the hematology department of a tertiary hospital in Türkiye between August 2019 and July 2020. Beginning in August 2019, subjects who approved study participation applied the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) questionnaire during their routine follow-up-given that they met inclusion/exclusion criteria. Individuals with comorbidities or factors influencing QoL and those with secondary PV-related conditions were excluded. Recorded data included age, sex, history of bleeding, thrombosis, erythrocytosis, leukocytosis, thrombocytosis, obesity or splenomegaly, and cytogenetic mutation profiles such as JAK2, BCR and MPL. We also assessed whether they needed phlebotomy or erythrocyte suspensions. Data concerning comorbidities and medication use were obtained from medical records. The median age of patients was 52 (44-61) years. The majority of participants were male (67.05%). Global health status score was 75 (66.67-83.33). PV patients who had required phlebotomy demonstrated higher social functioning scores (P = .004) and lower scores for loss of appetite (P = .013) and financial difficulties (P = .020) than patients without phlebotomy. PV patients who had suffered from leukocytosis demonstrated lower physical functioning scores compared to those without leukocytosis (P = .001). Patients without JAK2 exon 14 mutations had better physical (P = .016) and cognitive functioning scores (P = .048). It was found that PV patients with splenomegaly demonstrated lower physical functioning (P = .019) and higher appetite loss scores (P = .005) than those without splenomegaly. Higher leucocyte counts were associated with decreased physical functioning and greater fatigue. In conclusion, we demonstrated deterioration of physical and emotional QoL in patients diagnosed with PV. Patients with PV require individualized, patient-specific and integrated approaches in order to minimize symptoms, improve QoL, and increase survival.

Eribulin versus S-1 as first or second-line chemotherapy to assess health-related quality of life and overall survival in HER2-negative metastatic breast cancer (RESQ study): a non-inferiority, randomised, controlled, open-label, phase 3 trial

Eribulin prolongs overall survival (OS) of patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC), particularly in later chemotherapy (ChT) treatment. However, the health-related quality of life (HRQoL) and efficacy of first or second-line therapy in eribulin-treated patients remain unknown. Using eribulin in the first- or second-line may demonstrate the non-inferiority of HRQoL compared to S-1, an oral 5-fluorouracil derivative, while maintaining OS. This randomised, controlled, open-label, phase III trial was conducted at 50 hospitals in Japan. Patients were enrolled from June 2016 and October 2019. Patients with HER2-negative MBC once under or no previous ChT were randomly assigned (1:1) to receive eribulin or S-1. HRQoL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) every six weeks until week 24 and every nine weeks until week 42. The primary endpoint was the deterioration defined as more than 10 points worsening of the general health score of QLQ-C30 or death within one year after randomisation. The secondary endpoints included OS. (Trial ID: UMIN000021398). Three hundred and two patients were enrolled, with 152 and 148 assigned to the eribulin and S-1 groups, respectively. The questionnaire compliance rate was 85.6%. Risk difference of global health status deterioration through one year was-0.66% (95% CI:-12.47-11.16; non-inferiority P=0.077) for eribulin compared to S-1 groups. Median time to first deterioration for global health status score was 5.64 (95% CI: 3.51-8.00) and 5.28 months (95% CI: 3.28-7.80) in the eribulin and S-1 groups, respectively. The median OS was 34.7 and 27.8 months, (HR: 0.72, 95% CI: 0.54-0.96; P=0.026); the median progression-free survival was 7.57 and 6.75 months in the eribulin and S-1 groups, (HR: 0.88, 95% CI: 0.67-1.16; P=0.35), respectively. No new adverse events occurred. The time of the first clinical deterioration was similar between the two groups and OS significantly increased in eribulin-treated patients. This study was funded by CSPOR-BC and Eisai CO., Ltd.

Short-term effects of bowel function on global health quality of life after radical cystectomy.

Radical cystectomy (RC) shows an important impact on quality of life (QoL), for various clinical aspects. The aim of our study was to evaluate the short-term bowel function in patients that underwent RC. Two hundred and six patients with MIBC underwent RC with ONB or IC urinary diversion. QoL was measured using the EORTC QLQ C30 and the Short-Form SF-36 questionnaires before surgery and at 12 months postoperatively. Baseline characteristics, including demographic profile, BMI, Charlson Comorbidity Index (CCI), modified Frailty Index (m-FI), pathological tumor stage, Clavien-Dindo grade, and neo-adjuvant chemotherapy were recorded and compared. The uni-variate and multivariate analysis (OR) were performed for constipation, diarrhea and m-FI of patients underwent RC for localized MIBC according to global health status score (poor/good vs. very good). Multivariate analysis showed that constipation medium/high was significant associated with global health status poor/good (OR=2.39; 95% CI: 1.22-4.71; P=0.01); Diarrhea medium/high was associated with global health status poor/good (OR=2.85; 95% CI:1.18-6.92; P=0.02), and m-FI ≥2 score (OR=2.13; 95% CI: 0.99-4.57; P=0.05). Diarrhea and constipation are associated with a lower QoL in cystectomized patients, both with ONB or IC urinary diversion; such association is especially significant in more fragile patients (Frailty Index ≥2).

Quality of life assessment in diffuse large B-cell lymphoma (DLBCL) in REFLECT: a prospective, non-interventional, multicenter, German study, assessing Sandoz rituximab in combination with CHOP

Health-related quality of life (HRQoL) data are important indicators of health status in patients with lymphoma. The objective of this analysis was to assess the impact of treatment with Sandoz rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) on HRQoL in treatment-naïve adult patients with diffuse large B-cell lymphoma (DLBCL) included in the prospective, real-world REFLECT study. REFLECT is the first prospective study to assess HRQoL in patients with DLBCL treated with a rituximab biosimilar. HRQoL was assessed via the patient-reported European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire at baseline, mid-treatment (month 3), end of treatment (month 6), and follow-up (months 9 and 12). Subgroup analyses were performed to evaluate the influence of baseline characteristics on HRQoL, and associations between baseline HRQoL and treatment response. HRQoL was assessed in 169 patients. Mean global health status score remained stable from baseline (54.8) to mid-treatment (month 3; 54.7), before steadily improving through to end of treatment (month 6; 61.4), and follow-up month 9 (64.9) and month 12 (68.8). Similar trends were observed across most functional and symptom subscales. Higher cognitive, physical, or role functioning, and less appetite loss, diarrhea, fatigue, or pain at baseline, were all associated with an improved likelihood of reaching a complete versus partial response at the end of treatment. Overall, these findings confirm the HRQoL benefits of R-CHOP therapy in treatment-naïve adult patients with DLBCL, and suggest that baseline HRQoL may be predictive of treatment response.

Safety and Preliminary Efficacy of Once-Weekly Split-Dose Selinexor in Soft Tissue Sarcoma: Results of the Phase Ib METSSAR Clinical Trial.

The approved dose of Selinexor, 60 mg twice-weekly, is associated with several clinically relevant toxicities. Preclinical studies show that a sustained-release formulation of selinexor results in a lower toxicity profile. The phase 1b METSSAR trial assessed the safety and tolerability of an alternative dosing schedule of selinexor (to mimic the sustained-release formulation) in advanced soft tissue sarcoma (STS) patients. Selinexor was administered in a split-dose schedule (40 mg, 20 mg, 20 mg in the morning, afternoon, and evening, respectively) on days 1, 8, 15, and 22 of a 28-day cycle, until unacceptable toxicity or disease progression. The primary endpoint was the rate of grade ≥ 3 treatment-related adverse events (TRAEs). Secondary objectives were EORTC QLQ-C30 quality of life (QoL) assessment, and preliminary efficacy. Twenty patients with 12 STS subtypes were enrolled and received a median of four cycles of treatment. There were no grade ≥ 3 TRAEs. Dysgeusia, nausea, fatigue, and thrombocytopenia were the most common grade ≤ 2 TRAEs. No treatments were discontinued due to TRAE, but four patients (20%) required dose reduction. Median change in global health status (GHS) score from baseline to cycle 2 (by QLQ-C30 v3.0) was - 8.33, and only 39% of patients reported a clinically meaningful decline in GHS score (≥10 points). Median symptom scale scores on treatment were increased for fatigue (+12.35), nausea/vomiting (+18.52), and anorexia (+16.67), but reduced for pain (- 3.70). The median progression-free survival (PFS) was 4.0 months (95% confidence interval 1.9-7.5). Split-dose once-weekly selinexor was reasonably well tolerated in this heterogeneous group of advanced STS patients with a better, or at least similar, clinician- and patient-reported toxicity profile compared to the standard dosing regimen. Further clinical evaluation is warranted, as better dose delivery can lead to improved antitumor efficacy.

A phase 2 study of regorafenib in metastatic/unresectable, refractory synovial sarcomas.

e23551 Background: Current therapeutic options for advanced synovial sarcomas remain limited. Adoptive T-cell therapies against NY-ESO-1 and MAGE-4 benefit a subset of patients, but is of limited value in Asian patients due to the absence of the HLA-A*02 genotype. Methods: The trial had a single arm, Simon two-stage design that included patients with advanced synovial sarcomas who had progressed on 2 lines of therapy, one of which could be an anti-VEGF therapy. Regorafenib was administered orally in a continuous regimen with 80mg and 120 mg doses on alternate days. The primary end point was 3-month progression-free rate (PFR). A 3-month PFR of greater than 40% was taken to be a marker of drug efficacy. Secondary end points included median PFS, OS and safety analysis. Quality of life assessment was carried out at baseline and at 3 months using the EORTC C-30 questionnaire. Radiological responses were assessed using RECIST 1.1 criteria after independent review by 2 radiologists. Results: A total of 22 patients were included in the study during the period from January 2022 to December 2023 with baseline characteristics as shown in Table 1. 18 patients were eligible for assessment of the primary outcome. The 3-month PFR with regorafenib was 57% with an ORR of 5%. At a median follow up of 9 months, the median PFS was 5.0 (2.9-7.0) months, and the median OS was 10.0 (7.8-11.2) months. In an exploratory analysis, the subset of patients previously exposed to pazopanib showed a 3-month PFR of 46% and a median PFS of 3 months. The grade ¾ toxicities seen included HFSR (52%), diarrhea (5%) and oral mucositis (5%). The quality-of-life analysis showed symptom burden to be highest in the fatigue, pain and financial difficulties domain at baseline. No worsening of symptom burden scores was seen over the study period. The global health status score showed a numerical improvement at 3 months. Conclusions: The study had a significant number of patients with poor PS. Regorafenib in the above-mentioned dosing regimen demonstrated meaningful clinical activity in a heavily pre-treated population of patients with synovial sarcoma, including those previously exposed to pazopanib, with a preserved quality of life. The treatment was associated with manageable toxicities and no new safety signals, albeit with higher HFSR rates. [Table: see text]

IMPROVEMENT IN QUALITY OF LIFE FOLLOWING PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE FOR MALIGNANT OBSTRUCTIVE JAUNDICE: AN INSTITUTION-BASED OBSERVATIONAL STUDY

Purpose: Long-term prognosis of patients with obstructive jaundice due to malignant biliary disease is very dismal. These patients are treated mainly for palliation of symptomatic jaundice and related complications. To alleviate symptomatic jaundice, three modalities of treatment are generally employed – bilio-enteric bypass, Percutaneous Transhepatic Biliary Drainage (PTBD) and Endoscopic Retrograde Cholangiopancreatography guided stenting. However, minimal data is available comparing the pre-procedure and post-procedure Quality of Life (QOL) of these patients. Aims of the Study: To study the pre-procedure &amp; post-procedure QOL of patients undergoing PTBD. Methodology: We studied patients who underwent PTBD in between January 2017 and June 2021, attending our tertiary-care hospital with malignant obstructive jaundice, with high-up biliary obstruction. An observational study was conducted to compare the QOL before and after procedure using the EORTC-QLQ-30 Symptom Scale Score. Results:The majority (80%) had the diagnosis of carcinoma gallbladder. Maximum number of patients (75%) presented with a pre-procedure bilirubin value of more than 15 mg/dl. These patients showed significant bilirubin decrement by day 7. Follow-up at 1 month and 3 months following PTBD demonstrated significant improvement in global health status, physical status, emotional, cognitive and social QOL score. Some deterioration in the QOL score was noted at 6 months follow-up, which might be related to recurrence or stent blockade. Conclusion: Overall improvement in post-procedure QOL was observed during follow-up analysis of the subjects. The increase in financial burden could be attributed to the maintenance of drainage catheter (wound management bags, treatment of infections) and cost of frequent hospital visits after the procedure.

Real-world treatment patterns and quality of life among patients with locally advanced or metastatic urothelial carcinoma living in Saudi Arabia, South Korea, Taiwan, and Turkey.

To evaluate demographic and clinical characteristics, treatment patterns, and quality of life in patients with locally advanced or metastatic urothelial carcinoma in Asia. Data were drawn from the Adelphi Real World Metastatic Urothelial Carcinoma Disease Specific Programme™, a cross-sectional survey of medical oncologists/urologists and their adult patients in Saudi Arabia, South Korea, Taiwan, and Turkey. Exploratory patient-reported outcomes included the EQ-5D visual analog scale, European Organisation for Research and Treatment of Cancer Quality of Life of Patient Questionnaire global health, and Brief Pain Inventory. Analyses were descriptive. Overall, 175 physicians reported data for 988 patients. Mean (standard deviation) patient age was 66.3 (10.8) years, 77% were men, and 82% had bladder tumors at diagnosis. Of patients receiving first- (n = 988), second- (n = 290), and third-line (n = 87) treatments, 81%, 35%, and 59% received chemotherapy, respectively, and 17%, 63%, and 34% received programmed cell death protein 1/ligand 1 inhibitors, respectively. Patient-reported (n = 319) mean (standard deviation) EQ-5D visual analog scale score was 51.8 (15.6), European Organisation for Research and Treatment of Cancer Quality of Life of Patient Questionnaire global health status score was 44.6 (19.9), and Brief Pain Inventory score was 6.5 (1.9; n = 315). The most common first- and second-line treatments for locally advanced or metastatic urothelial carcinoma were chemotherapy and programmed cell death protein 1/ligand inhibitors, respectively. At third line, 10% of patients received best supportive care alone, underscoring an unmet need for effective third-line treatment options. Patients in all regions reported quality-of-life impairment.

Abstract PO5-11-10: Quality of life in Brazilian women with early breast cancer on adjuvant endocrine therapy

Abstract Background: There is a significant scarcity of quality of life (QOL) data among the Brazilian population with breast cancer. This study aims to evaluate QOL in Brazilian women with early breast cancer treated with adjuvant endocrine therapy (ET) and to explore its relationships with patients’ clinical and social characteristics, type and duration of endocrine therapy and type of healthcare insurance. Methodology: Women with a history of early-stage estrogen-receptor positive invasive carcinoma of the breast on adjuvant endocrine therapy for at least 6 months were invited to participate of this study. QOL assessment was conducted using the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires. Demographic and medical information were collected from medical records. Data collection performed using 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 Multiple linear regression models with Stepwise procedure. 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. A total of 233 women (50.54%) were treated in private institutions. Mean age was 56.02 years (range 22-93), 47.69% were non-white and 38.7% were premenopausal. A total of 62.34% had prior lumpectomy, 43.1% had tumor stage II, 61.69% received prior chemotherapy and 15.18% were HER2 positive. Regarding ET, 45.2% were on aromatase inhibitors (AI), 40.61% on tamoxifen (TMX) and 14.19% on ovarian function suppression plus ET (OFS). Median duration of ET use was 2.78 years. From the adjustment of the multiple regression model, it was found that the variable patients with a higher educational level were a significant predictor for the Physical Functioning score (p &amp;lt; 0.0001). The Role Functioning score had the variables treatment in a private hospital (p = 0.0462) and a higher educational level (p = 0.0357) as significant predictors. The variables age &amp;gt; 60 years (p = 0.0006) and marital status: single (p = 0.0267) were significant predictors for the Emotional Functioning score. Cognitive Functioning was correlated with the variables age &amp;gt; 60 years (p &amp;lt; 0.0001) and treatment duration &amp;lt; 2 years (p = 0.0475). Social Functioning had significant predictors such as hormone therapy with AI (p = 0.0305) and hormone therapy with TMX (p = 0.0267) when compared to OFS, as well as treatment duration &amp;lt; 2 years (p = 0.0175). The variable age &amp;gt; 60 years was a predictor for the Fatigue score (p = 0.0233). The Pain score correlated with variables such as higher educational level (p = 0.0003) and treatment duration &amp;lt; 2 years (p = 0.0032). The variables treatment in a public hospital (p = 0.0066), age &amp;lt; 60 years (p = 0.0471), and treatment duration &amp;lt; 2 years (p = 0.0054) were predictors for a higher Arm Symptoms score. Regarding the Breast Symptoms score, the variables treatment in a public hospital (p = 0.0005), Caucasian ethnicity (p = 0.0006), radiation therapy (p = 0.0098), and treatment duration &amp;lt; 2 years (p = 0.0203) were predictors for the total score. Body Image correlated with variables such as age &amp;gt; 60 years (p = 0.0322), surgical approach: mastectomy (p = 0.0445), tumor size &amp;lt; 50mm (p = 0.0446), and radiation therapy (p = 0.0405). The Global health status score did not correlate with any variable. Conclusion: Lower educational level, age&amp;lt; 60 years, duration of ET less than 2 years had a significant impact in many domains of QOL. Radiotherapy was the treatment modality with more impact in QOL scores. The identification of modifiable factors related to QOL in this study provides valuable insights for the development of a customized intervention in Brazilian population. Citation Format: Danielle Santos, Cristiano Souza, Maria Cristina Magalhães, Daniela Pereira, Fernanda Moura, Sulene Oliveira, Anna Luiza Galvão, Bruno Souza, Amanda Castro, Monalisa Andrade, Andrea Shimada, Yuri Beckedorff, Carlos Paiva, Heloísa Resende, Angelica Rodrigues, Daniela Rosa, Daniele Assad-Suzuki, Romualdo Barroso-Sousa. Quality of life in Brazilian women with early breast cancer 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 PO5-11-10.

Abstract PO1-05-06: Health-related QOL and physical activity collected via wearable device in patients with HR+/HER2− advanced breast cancer in Japan treated with palbociclib+endocrine therapy (ET) or ET alone: 6-month longitudinal study (JBCRG-26)

Abstract Background: Palbociclib (PAL) is a first-in-class cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) for the treatment of HR+/HER2− advanced breast cancer (ABC). In phase 3 clinical trials, PAL+ET prolonged progression-free survival and maintained health-related quality of life (HRQOL) compared with placebo+ET. However, few studies have evaluated the day-to-day effects of PAL+ET treatment on patients’ HRQOL and daily activities in a real-world setting. Here, we report the daily life of the patients treated with PAL+ET or ET alone evaluated with a mobile application and wearable device. Methods: This is a prospective, observational, multicenter study conducted in Japanese women with HR+/HER2- ABC initiating PAL+ET (Group 1) or ET alone (Group 2) in first- or second-line setting. HRQOL was assessed with the EORTC-QLQ-C30 at baseline and Day 15 of each cycle via a smartphone-based application for 6 treatment cycles (24 weeks). Physical activity (PA) data were collected via wearable device (CentrePoint Insight Watch®, ActiGraph LLC, the USA). Patients were instructed to wear the device at all-times, except of while bathing and sleeping, during the baseline period (at least 4 days prior to treatment initiation was recommended) and 6 cycles. PA metrics were averaged on a weekly basis. Patient data, including baseline characteristics, treatment, and adverse events, were collected via electronic case report forms. As primary endpoints, change in Global health status (GHS) of EORTC-QLQ-C30 and “sedentary time” from baseline were evaluated at each time point. No formal hypothesis testing or comparisons between groups was planned. Results: Ninety-nine patients were enrolled (Group 1: 78 patients, Group 2: 21 patients). Patients had a median age of 56/52 years (Group 1/Group 2); 51%/33% had visceral metastases; 86%/86% had ECOG performance status of 0; 76%/91% initiated first-line treatment; 36%/33% were fully employed. Seventy-four of 78 patients (95%) in Group 1 and 20 of 21 patients (95%) in Group 2 completed the 6-cycle observation period. Baseline mean GHS score was 60.9 and 64.3 in Group 1 and 2, respectively. The change from baseline to Cycle 6 in GHS score was 4.6 and 1.2 in Group 1 and 2, respectively, not reaching the deterioration-threshold of 8 points in either treatment group. Results for each functional subscale are summarized in Table 1. Baseline mean “sedentary time” was 580.7 and 565.1 min/day in Group 1 and 2, respectively. The change from baseline to Cycle 6 in “sedentary time” was —67.2 and —139.4 min/day in Group 1 and 2, respectively. Results of other PA metrics are summarized in Table. No new safety signals were identified. Conclusion: In this study, PAL+ET or ET alone did not have any significant adverse impact on HRQOL and PA measured by wearable devices in patients with HR+/HER2- ABC. (NCT04736576) Citation Format: Hiroko Bando, Mari Oba, Aya Ueda, Kaori Terata, Mihoko Doi, Shigenori Nagai, Masaya Hattori, Ken-Ichi Watanabe, Nobuko Tamura, Manabu Futamura, Kei Koizumi, Naoki Niikura, Tempei Miyaji, Yasuaki Muramatsu, Linghua Xu, Norikazu Masuda, Shigehira Saji. Health-related QOL and physical activity collected via wearable device in patients with HR+/HER2− advanced breast cancer in Japan treated with palbociclib+endocrine therapy (ET) or ET alone: 6-month longitudinal study (JBCRG-26) [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 PO1-05-06.

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 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.

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.

The Utility of [18]F-Fluorocholine Positron Emission Computed Tomography and [18]F-Fluorodeoxyglucose Positron Emission Tomography-Computed Tomography in Evaluating Breast Cancer Phenotypes: A Pilot Study.

The utility of the [18]F fluorodeoxyglucose positron emission tomography-computed tomography ([18]F FDG PET-CT) marker for breast cancer is well established. Given its limitations in localizing FDG-negative malignant tumors, the expression of [18]F-fluorocholine ([18]-FCH) may potentially be helpful to improve the overall accuracy in evaluating breast cancer. This study determined the potential of [18]- FCH PET CT as a potential marker in assessing breast cancer phenotypes. We recruited consecutive patients with biopsy-proven breast carcinoma who underwent [18] F-FCH PET-CT following the [18]F-FDG PET-CT imaging. The subjects were dichotomized into human epidermal growth factor receptor 2 (HER2)-negative and HER2-positive genotypes. The maximum standardized uptake value (SUVmax; g/dL) was used to predict the two groups of variables. Global health status (GHS) score based on the EORTC quality of life questionnaire (QLQ) was used to evaluate the outcome of the cohort subjects at 6, 12, and 24 months. There were 21 females with a mean age of 54.48 ± 12.17 years. Eighteen patients had invasive ductal carcinoma (18/21;85.8%) on histology, with 11 (52.4%) were HER2-negative genotype. There was higher sensitivity and specificity of [18]-FCH-PET/CT in breast lesions at 40% and 68.8% compared to [18]FDGPET/CT with 33.3% and 66.7%, respectively. There were significant differences between [18]F-FCH SUVmax (g/dL) of the HER-negative as compared to the HER2- positive group (1.99 g/dL vs. 0.2 g/dL; P < .05). High SUVmax (g/dL) of [18]F-FCH had predicted the HER-negative genotype at the cutoff value of 0.75 (P < .05). High [18]F-FCH showed significantly poor scoring of GHS parameters compared to low FCH at 6 months (mean SUVmax 8.06 vs. 5.40 respectively; P < .05). [18]F-FCH PET-CT is a potential marker in localizing and predicting aggressive breast carcinoma phenotypes.

Quality of Life Analysis of Patients Treated with Percutaneous Hepatic Perfusion for Uveal Melanoma Liver Metastases

PurposePercutaneous hepatic perfusion with melphalan (M-PHP) is a minimally invasive therapy with proven efficacy in patients with uveal melanoma (UM) liver metastases. M-PHP is associated with a short hospital admission time and limited systemic side effects. In this study, we assessed quality of life (QoL) in UM patients treated with M-PHP.Materials and MethodsA prospective, single-center study including 24 patients treated with M-PHP for UM metastases to the liver. QoL questionnaires were collected at baseline, on day 2/3 after M-PHP, and on day 7 and day 21 after M-PHP, according to study protocol. The results were scored according to EORTC-QLQ C30 global health status (GHS), functional scales, and symptom scales. The difference in scores at baseline and subsequent time points was analyzed with the Wilcoxon signed-rank test and multiple testing Bonferroni correction. Adverse events (AE) were registered up to 30 days after M-PHP according to CTCAE v5.0.ResultsTwenty-four patients (14 males; median age 63.0 years) completed 96 questionnaires. Most scores on all scales declined on day 2/3 after M-PHP. On day 21 after M-PHP, 12 out of 15 scores returned to baseline, including median GHS scores. Three variables were significantly worse on day 21 compared to baseline: fatigue (6–33; p = 0.002), physical functioning (100 vs 86.7; p = 0.003), and role functioning (100 vs 66.7; p = 0.001). Grade 3/4 AEs consisted mainly of hematological complications, such as leukopenia and thrombopenia.ConclusionM-PHP causes fatigue and a decline in physical and role functioning in the 1st weeks after treatment, but GHS returns to baseline levels within 21 days.Level of Evidence 3Cohort study.Graphical

Impact of Preoperative LUTS on Health-related Quality of Life Following Radical Prostatectomy: A Propensity Score Matched Longitudinal Study

To assess the impact of preoperative lower urinary tract symptoms (LUTS) on long-term health-related quality of life (HRQOL) up to 10 years after radical prostatectomy (RP) for prostate cancer (PC). Within our prospective institutional database of 6487 patients treated with RP for PC (2008-2020), 2727 patients with preoperative LUTS (IPSS score of ≥8) were identified. A 1:1 propensity-score matched analysis of 3056 men (n=1528 LUTS, n=1528 no LUTS) was conducted. Primary endpoint was HRQOL (based on EORTC QLQ-C30 and PR25). Linear regression models tested the effect of preoperative LUTS on the net change in general HRQOL (P<.05). Median follow-up was 48 months. Preoperative mean global health status (GHS) score (67.4 vs75.7) was significantly lower in the LUTS cohort (P<.001). Post-RP the difference in general HRQOL between the LUTS cohort and the no-LUTS cohort became smaller (65.7 vs67.8), however, remaining statistically significant (P=.037). In long-term follow-up, general HRQOL was comparable between both subcohorts (P-range 0.716-0.876). Multivariable linear regression analysis revealed increased preoperative IPSS as an independent predictor for increased perioperative improvement of IPSS (P<.001) CONCLUSION: For patients undergoing RP, preoperative LUTS were associated with a postoperative improvement of HRQOL outcomes. In long-term follow-up, HRQOL was comparable to patients without preoperative LUTS. Hence, RP is an efficient option to treat PC as well as LUTS in those patients.