EORTC Quality Of Life Questionnaire Research Articles

Abstract PO2-12-05: Scalp Cooling with the Capelli System to Reduce Doxorubicin-induced Alopecia in Patients with Localized Breast Cancer: A Phase 2 Randomized Controlled Trial

Abstract Introduction: Chemotherapy-induced alopecia (CIA) is a distressing side effect of breast cancer (BC) treatment. Scalp cooling (SC) devices have shown promise in reducing the severity of CIA. However, the impact of reducing alopecia occurrence on the quality of life of Brazilian patients remains unclear. Objectives: This study aimed to assess the effectiveness of the Capelli System, a new SC device, in reducing CIA. Methods: This was a single-center, controlled, randomized phase 2 clinical trial involving women with TNM stage I to III BC undergoing neoadjuvant or adjuvant doxorubicin-based chemotherapy (AC regimen: doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m², i.v., q21 days), with or without a taxane (paclitaxel or docetaxel). Participants were randomized in a 1:3 ratio into the scalp cooling (n = 33) or control (n = 12) groups. All participants were advised to cut their hair short and avoid heat-inducing tools or processes throughout chemotherapy, using cold or lukewarm water and wide-toothed combs for hair washing. The primary efficacy endpoint was grade 2 alopecia (>50% hair loss or hair shaving due to alopecia) after 4 cycles of AC. Secondary endpoints included measures of hair loss distress (BRHL) and body image (BRBI) from the EORTC Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ-BR23), as well as symptoms of anxiety and depression from the Hospital Anxiety and Depression Scale (HADS). Fitzpatrick phototype and hair type were assessed. Statistical analyses utilized generalized linear models and Fisher's Exact test (p-value < 0.05). Results: Patients were enrolled from October 11, 2019, to January 17, 2022. Out of the 45 patients included, 8 were excluded: 2 due to intolerance, 1 with alopecia associated with COVID-19, and 5 who withdrew consent (2 with grade 2 headache, 3 without justification). The median age was 44.6 (min-max: 23-63) years, with 18 (40%) and 27 (60%) receiving adjuvant and neoadjuvant chemotherapy, respectively. Grade 2 alopecia or hair shaving occurred in 52% of scalp cooling patients and 100% of controls (p = 0.003), demonstrating a significant 48% reduction in alopecia. There were no significant differences in HADS-A, HADS-D, BRHL, or BRBI scores between the two groups. Alopecia occurrence did not show significant associations with skin or hair types. No serious adverse events related to the scalp cooling device were reported. Conclusions: SC with the Capelli System significantly reduced CIA by half. Some patients experienced discomfort or headaches and discontinued device use. Further research is needed to understand why reduced alopecia rates do not correlate with improvements in body image or reduced hair loss distress. Citation Format: Carlos Paiva, Fabiola Dias, Angelo Matthes, Bianca Paiva, Cristiano Souza, Domício Lacerda, Augusto Antoniazzi, Maria Fernanda Machado, Matheus Godinho, Crislaine de Lima, Cristiane Cárcano, Marina Zorzetto. Scalp Cooling with the Capelli System to Reduce Doxorubicin-induced Alopecia in Patients with Localized Breast Cancer: A Phase 2 Randomized Controlled Trial [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 PO2-12-05.

Return to work and psychosocial trajectories after breast cancer: a longitudinal and sequential approach.

We aimed to describe the psychosocial adjustments according to return to work (RTW) trajectories in breast cancer survivors (BCS) using a sequential and temporal approach. We used BCS data included from February 2015 to April 2016 in the Longitudinal Study on Behavioural, Economic and Sociological Changes after Cancer (ELCCA) cohort. RTW trajectories were identified using the sequence analysis method followed by a clustering. Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale and the EORTC quality of life questionnaire was used at inclusion and all follow-up visits to assess Health-Related Quality of Life (HRQoL). Fifty-two BCS were included in the study among whom four clusters of RTW trajectories were identified and labeled: slow RTW (N = 10), quick RTW (N = 27), partial RTW (N = 8), and part-time work (N = 7). Quick and slow RTW clusters showed slightly lower baseline mean levels of anxiety and higher levels of HRQoL. In the 4years following diagnosis, BCS in the quick RTW cluster tended to report higher HRQoL in terms of functioning and less symptoms of pain and fatigue while those in the partial RTW cluster showed a lower HRQoL on almost all dimensions. All clusters showed an increase in pain and fatigue symptoms until 6months followed by a tendency to recover baseline levels. The results of this study suggest that BCS who return to full-time work (slow and quick RTW patterns) recover better than patients who return to part-time work (partial and part-time RTW patterns).

Quality of Life and Financial Impacts of Permanent Colostomy for Rectal Cancer

Abstract Introduction Returning to work is an important cancer recovery milestone. Permanent colostomy can be required for rectal cancer treatment and can significantly impact well-being. We aimed to evaluate the impact of permanent colostomy on health-related quality of life and return to work in patients with rectal cancer. Methods This was a retrospective cohort study on 23 employed patients receiving curative surgery for rectal cancer requiring permanent colostomy. Demographic and health-related quality-of-life questionnaires (the Colostomy Impact Score (CIS), the EORTC Quality of Life Questionnaire (QLQ)-C30, and the EORTC QLQ-CR29) were posted to eligible patients. Results On average, patients (10 female, 13 male, mean age 61.8 years) were 5.0 ± 3.5 years post-surgery. At the time of questioning, 73.9% had returned to work (21.7% changed their type of work), while 17.4% never returned to work. Of those that returned to work, 11.8% returned within 1 month of surgery, while 23.5% had not returned after 12 months. Comparison of CIS between patients that returned to the same work (14.6 ± 0.93), changed their work (13.0 ± 0.74), and did not return to work (14.3 ± 2.3) revealed no significant differences (p = 0.36). CIS did not correlate with days worked on return, or time to return to work (p > 0.05). Conclusion Returning to work following rectal cancer treatment with permanent colostomy is challenging, with 17.4% never returning to work. Of those who returned to work, 23.5% required more than 12 months. This was not associated with CIS in our study.

Baseline functioning scales of EORTC QLQ-C30 predict overall survival in patients with gastrointestinal cancer: a meta-analysis.

A consensus has not been reached on the value of quality of life (QoL) as a prognostic factor for survival in gastrointestinal cancer. This meta-analysis aimed to investigate the association between functioning scales of the EORTC QoL Questionnaire Core 30 (QLQ-C30) and the overall survival (OS) in patients with gastrointestinal cancer. A systematic literature search was conducted in PubMed, Web of Science, and Embase databases, until February 7, 2023. The studies included were those that investigated the association between baseline QoL measured by the functioning scales of EORTC QLQ-C30 and OS in patients with gastrointestinal cancer. The prognostic capacity of QoL was calculated by pooling the adjusted hazard ratios (HR) with 95% confidence intervals (CI). Twenty-four studies' analyses reported by 22 eligible articles involving 11,609 patients were included. When compared with good parameters of QoL, poor global QoL (HR 1.81; 95% CI 1.53-2.13), physical functioning (HR 1.51; 95% CI 1.31-1.74), social functioning (HR 1.67; 95% CI 1.30-2.15), and role functioning scale (HR 1.42; 95% CI 1.20-1.29) were significantly associated with decreased OS. For each 10-point increase in QLQ-C30 parameters, the pooled HR of OS was 0.87 (95% CI 0.83-0.92) for global QoL, 0.87 (95% CI 0.83-0.92) for physical functioning, and 0.93 (95% CI 0.88-0.97) for role functioning. However, each 10-point increase in social, emotional, or cognitive functioning scale did not significantly predict OS. Baseline health-related QoL defined by the physical functioning or global QoL scale of EORTC QLQ-C30 significantly predicts OS in patients with gastrointestinal cancer.

Nivolumab plus ipilimumab in melanoma patients with asymptomatic brain metastases: 7-year outcomes and quality of life from the multicenter phase III NIBIT-M2 trial

BackgroundThe primary analysis of the phase III NIBIT-M2 study showed a 41% 4-year overall survival (OS) of melanoma patients with asymptomatic brain metastases treated with ipilimumab plus nivolumab. MethodsHere, we report the 7-year efficacy outcomes and the Health-Related Quality of Life (HRQoL) analyses of the NIBIT-M2 study. ResultsAs of May 1, 2023, at a median follow-up of 67 months (mo), the median OS was 8.5 (95% CI: 6.6–10.3), 8.2 (95% CI: 2.1–14.3) and 29.2 (95% CI: 0–69.9) mo for the fotemustine (F) Arm A, ipilimumab plus fotemustine Arm B, and ipilimumab plus nivolumab Arm C, respectively. The 7-year OS rate was 10.0% (95% CI: 0–22.5) in Arm A, 10.3% (95% CI: 0–22.6) in Arm B, and 42.8% (95% CI: 23.4–62.2) in Arm C. HRQoL was preserved in all treatment arms. Most functional scales evaluated from baseline to W12 were preserved, with a lower mean score decrease for EORTC Quality of Life Questionnaire (QLQ)-C30 and an increase for EORTC QLQ-Brain neoplasm (BN20) in patients receiving ipilimumab plus nivolumab. ConclusionsWith the longest follow-up available to date in melanoma patients with asymptomatic brain metastases, the NIBIT-M2 study continues to show persistent therapeutic efficacy of I ipilimumab plus nivolumab while preserving HRQoL.

Younger Age and Parenchyma-Sparing Surgery Positively Affected Long-Term Health-Related Quality of Life after Surgery for Pancreatic Neuroendocrine Neoplasms.

(1) Background: Patients with pancreatic Neuroendocrine Neoplasms (PanNENs) often have a long overall survival. We evaluated determinants of quality of life (QoL) after surgery for PanNENs. (2) Methods: Patients operated on for a PanNEN in our center (1990-2021) received three EORTC QoL questionnaires (QLQ-C30, QLQ-GI.NET21, QLQ-PAN26). Six domains were selected as outcome variables (global QoL, physical function -PF, social function -SF, disease-related worries -DRWs, pain, upper-gastrointestinal (GI) symptoms) and evaluated in relation to the clinical variables. Statistical analysis was performed using R software v 4.2.2. (3) Results: One hundred and four patients enrolled showed a good global QoL (median 83.3). Old age was a determinant of worse global QoL (p 0.006) and worse PF (p 0.003). Multiple comorbidities (p 0.002) and old age (p 0.034) were associated with pain, while male gender was related to better PF (p 0.007) and less pain (p 0.012). Patients who had undergone parenchyma-sparing surgery demonstrated better PF (p 0.037), better SF (p 0.012), and less upper-GI symptoms (p 0.047). At multivariable analysis, age (p 0.005) and type of surgery (p 0.028) were confirmed as determinants of global QoL. (4) Conclusions: In patients operated on for a PanNEN, a good HRQoL is generally reported; notably, younger age and parenchyma-sparing surgery seem to positively affect HRQoL.

Comparison of Quality of Life after Robotic, Video-Assisted, and Open Surgery for Lung Cancer.

Post-operative quality of life (QOL) has become crucial in choosing operative approaches in thoracic surgery. However, compared to VATS and thoracotomy, QOL results post-RATS are limited. We compared QOL before and after RATS and between RATS, VATS, and thoracotomy. We conducted a retrospective review of lung cancer surgical patients from 2015 to 2020. Patients completed validated EORTC QOL questionnaires (QLQ-C30 and QLQ-LC13). Results were analysed using the EORTC Scoring Guide, with statistical analysis. A total of 47 (94%) pre- and post-RATS questionnaires were returned. Forty-two patients underwent anatomical lung resections. In addition, 80% of patients experienced uncomplicated recovery. All global and functional QOL domains improved post-operatively, as did most symptoms (13/19). Only four symptoms worsened, including dyspnoea (p = 0.017), with two symptoms unchanged. Of the 148 returned questionnaires for all approaches (open-22/VATS-79/RATS-47), over 70% showed a high pre-operative performance status. Most patients underwent anatomical lung resection, with only VATS patients requiring conversion (n = 6). Complications were slightly higher in RATS, with one patient requiring re-intubation. RATS patients demonstrated the highest global and functional QOL. Physical QOL was lowest after thoracotomy (p = 0.002). RATS patients reported the fewest symptoms, including dyspnoea (p = 0.046), fatigue (p < 0.001), and pain (p = 0.264). Overall, RATS results in a significantly better post-operative QOL and should be considered the preferred surgical approach for lung cancer patients.

Combined Couple Therapy Based on Acceptance and Commitment and Schema Therapy for Quality of Life and Recovery Process of Patients With Breast Cancer During Medical Treatment

Introduction: Cancer can affect the process of recovery and the quality of life (QoL) of individuals. This study determined the effectiveness of combined couple therapy based on acceptance and commitment and schema therapy on the QoL and recovery process of patients with breast cancer (BC) during medical treatment. Methods: The research method is semi-experimental with pre-test, post-test, follow-up, and control group. The study’s statistical population included all married patients with BC (stage one) who received treatment in Mashhad in 2019. A total of 30 samples were selected through the convenience sampling method and then randomly assigned to the control and treatment groups. The exceptional EORTC QoL questionnaire (QLQ-C30) was used in patients with cancer to collect data, and the recovery symptoms were checked according to medical records and the relevant specialist’s opinion. The data were also analyzed by repeated measures analysis of variance to analyze the obtained data. Results: The findings demonstrated that the combined couple therapy based on Acceptance and commitment therapy (ACT) had a significant effect on the QoL and recovery process of patients with cancer during medical treatment (P&gt;0.01). Conclusion: The results imply that couple schema therapy-based ACT could positively affect the QoL and treatment processes among cancer patients.

Abstract 4370: How much time is needed to complete quality of life assessments in oncology trials? - Metadata analysis

Abstract Introduction: Digitalization in clinical trials introduced electronic data collection. Participants in diverse environments can use electronic devices to report their experiences with the drug by completing patient reported outcome assessments (ePROs). Quality of life (QOL) reports describe how a patient feels or functions during a treatment with a new drug. For oncology trials, QOL data is needed to prove the treatment effect and support a labeling claim. Methods: The literature search in the Web of Science for articles containing QOL keyword found ten articles with the highest number of citations. QOL instruments relevant to cancer research were identified based on the literature search. Form completion times corresponding to the cancer-specific instruments were identified and analyzed using a metadata of 948 instruments and 17,234,458 assessment submissions. Results: Three general QOL measures in oncology trials were identified: the EORTC Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30), Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), and SF-36 Health Survey (SF-36). Median times of form completion in seconds (s) increased in the following order: FACIT-F &amp;lt; EORTC QLQ-C30 &amp;lt; SF-36v2 and were equal to 105 s &amp;lt; 213 s &amp;lt; 386 s. Metadata analysis showed that participants spent less than two minutes on completion of the FACIT-F assessment, which is only 18% of the estimated completion time of 10 minutes. Metadata analysis showed that it took participants three and a half minutes to complete the EORTC QLQ-C30 assessment, which is roughly one third of the estimated completion time of 11 minutes. The completion time for SF-36v2 fell within the estimated range of 5 to 10 minutes. Conclusions: Properly selected QOL instruments facilitate collection of the right data for demonstration of a treatment benefit. It is recommended to include a general oncology and a disease specific QOL instrument to show the treatment’s success of improving patient’s QOL. At the same time, the completion of the instruments should not be burdensome considering disease progression characteristic for oncology studies. Citation Format: Jowita Marszewska, Lindsay Hughes. How much time is needed to complete quality of life assessments in oncology trials? - Metadata analysis. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 4370.

Quality of life in QUILT 3.032 study: Patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) receiving IL-15RαFc superagonist N-803 plus BCG.

495 Background: Patients (pts) with BCG-unresponsive NMIBC have limited treatment options and are at an increased risk for cystectomy. Nogapendekin alfa inbakicept (NAI, also known as N-803), is an interleukin-15 superagonist (IL-15RαFc), which synergizes with BCG to elicit innate immune memory resulting in durable complete responses (CRs) in this patient population. In an open-label, 3-cohort, multicenter Phase 2/3 study of intravesical BCG plus NAI in BCG-unresponsive high-grade NMIBC (QUILT 3.032; NCT03022825), pts with carcinoma in situ (CIS; Cohort A) have a CR rate of 71% (median duration 26.6 months), 89.2% cystectomy avoidance and 100% bladder cancer specific survival at 24 months. We submit here the first quality of life (QOL) data report in the same pts cohort. Methods: Cohort A: 86 pts (median age 73 years; 87% male) with histologically confirmed BCG-unresponsive CIS with or without Ta/T1 disease, treated with intravesical BCG 50 mg plus NAI 400 μg. Mean baseline ECOG score was 0.183, with 82% of pts having score = 0. QOL was measured by the EORTC QOL Questionnaire Core 30 (QLQ-C30) and QOL NIMBC-Specific 24 Questionnaire (QLQ-NMIBC24). Results: Multivariate analyses have shown no significant changes over time for any of the measured QOL domains. Mild worsening vs. baseline in feeling ill was reported by 6% and 3% of pts by week 27 and 52, while 4% and 6% reported improvement. By week 78 and 104, 7% and 9% of pts reported improvement vs. baseline in their wellbeing with the majority being stable (non-significant). No statistically significant variations were detected in the physical function (PF) score (baseline vs. week 27, 52, 78 and 104). Higher PF scores were observed in pts responding to the therapy vs. non-responders; however, baseline value of PF was also higher in responders vs. non-responders. In contrast to historical results of BCG alone, week 27 physical function scores were numerically higher than baseline, with a subsequent nadir at week 78 and recovery to baseline by week 104 (non-significant). Hospitalizations for any reason remained low (0% - 6% per assessments) during the study. Conclusions: QOL measurement supports good tolerability of the intravesical NAI plus BCG in BCG-unresponsive, high-grade NMIBC pts with CIS. These results further strengthen the evidence of a favorable benefit: risk ratio of this novel combination immunotherapy, in a challenging disease. Clinical trial information: NCT03022825 .

Are there sustained psychological impacts in women diagnosed with in-situ or early invasive breast cancers?

The detection of a ductal carcinoma in-situ (DCIS) or an early invasive breast cancer (EIBC), particularly by population-wide mammography-screening-programs, is controversial as an unknown proportion of these cases may be due to overdiagnosis. We investigated whether women with such potentially overdiagnosed breast cancers suffer from sustained adverse psycho-social consequences. Standardized questionnaires were mailed to 900 survivors, diagnosed with either DCIS or EIBC, requesting self-reports on quality of life using EORTC Quality of Life Questionnaire C-30. Levels of anxiety and depression were assessed using the HADS questionnaires. Item score values in the study group were compared to reference data obtained from normative studies in the German female reference population. The 577 women who returned completed questionnaires had a mean age of 65.1 years, 387 (67%) had been diagnosed by mammography screening. Median time since diagnosis was 5.9 years. There were no substantial differences between the study sample and the reference population for most of the items. While most score values were even slightly more favorable in the study group, the scores for cognitive function were moderately lower, especially among younger patients. Score values for anxiety were generally higher among younger women (50 to 59 years) from the study group, while depression scores were lower irrespective of age. This study indicates that the diagnosis of DCIS or EIBC, which is predominantly a result of screening, does not seem to induce sustained, adverse psychological impacts in affected women when compared with the respective general female population. Only anxiety levels remained elevated among younger women.

Dynamic Change in Patient Reported Quality of Life is a Predictor for Survival in Localized Prostate Cancer: Exploratory Analysis from a Phase III Randomized Controlled Trial

<h3>Purpose/Objective(s)</h3> Patient reported quality of life (QOL) outcomes are pivotal endpoints to determine treatment efficacy and safety. However, it remains unknown if treatment induced change in patient reported QOL outcomes correlate with survival in localized prostate cancer (LPCa). We performed an exploratory analysis of a phase III randomized controlled study to determine the association of treatment induced dynamic change in patient reported global QOL with long-term overall survival (OS) and disease-free survival (DFS) in LPCa treated with radiotherapy (RT) and androgen deprivation therapy (ADT). <h3>Materials/Methods</h3> LPCa patients with Gleason score ≤7, clinical stage T1b-T3a, and PSA <30 ng/mL were randomized to neoadjuvant and concurrent ADT for 6 mos starting 4 mos before prostate RT or concomitant and adjuvant ADT for 6 mos starting concurrently with RT. Patient reported QOL outcomes were collected using EORTC QOL questionnaires. We used the global QOL (G-QOL) score from C30 questionnaire. Increase in G-QOL score indicated improvement in global QOL. To capture the association between the dynamic change in the G-QOL of each patient and the hazard of outcome, we utilized the framework of multivariate joint modeling for longitudinal and survival outcomes. For the time-to-event submodel, a Cox proportional hazard regression model was built with covariables including treatment arm, baseline PSA, tumor stage, Gleason score, and age. For the longitudinal submodel, a linear mixed effect model was built with an interaction term for treatment arm and time of evaluation in addition to fixed covariables - treatment arm, time of evaluation, baseline G-QOL score and age. Time of assessment was included as a random slope while patients were included as random intercepts in the mixed models. The two submodels were linked through a random effect. Baseline hazard was modeled using penalized splines. A two-sided p-value <0.025 was chosen to be the threshold for statistical significance. <h3>Results</h3> A total of 388 patients were eligible for this study – 191 belonged to the neoadjuvant arm while 197 to the adjuvant arm. At a median follow-up of 148 mos, a total of 133 deaths were recorded. On joint modelling, an increase in G-QOL score by 10 units (the threshold for clinically meaningful change) was associated with a 11.2% decrease in the hazard of death (hazard ratio [HR] per 1 unit increase G-QOL: 0.988, 95% CI: 0.980-0.996; p=0.007). An increase in G-QOL score by 10 units was associated with 10% decrease in the hazard of progression or death (HR per 1 unit increase in G-QOL: 0.990; 95% CI: 0.984-0.999; p=0.023). <h3>Conclusion</h3> Treatment induced improvement in global QOL is a predictor for improved DFS and OS in LPCa. This suggests a significant interplay of patient-reported quality of life and quantity of life in LPCa which could mainly be driven by the non-cancer specific mortality in this patient population. Judicious use of these QOL metrics could guide risk stratification and potentially inform treatment decision in these patients

Phase 3 ENABLAR-2 study to evaluate enobosarm and abemaciclib combination compared to estrogen-blocking agent for the second-line treatment of AR+, ER+, HER2- metastatic breast cancer in patients who previously received palbociclib and estrogen-blocking agent combination therapy.

TPS1121 Background: Targeting the androgen receptor (AR) may be the next important endocrine therapy for advanced breast cancer. The AR has been demonstrated to be a tumor suppressor when activated. Enobosarm is an oral selective AR targeting agonist that activates the AR in breast cancer. Preclinical studies in CDK4/6 inhibitor resistant PDX models demonstrated combinatorial synergistic activity of enobosarm plus CDK 4/6 inhibitors. An open-label, Phase 2 study, was conducted in 136 women with heavily pretreated ER+ HER2- metastatic breast cancer that were randomized to oral daily enobosarm at a dose of 9 or 18 mg. The efficacy evaluable (EE) group were patients that were AR positive (&gt; 10% AR nuclear staining). In the EE population with measurable disease at baseline, 10 patients had received prior endocrine therapy + a CDK 4/6 inhibitor. Subsequent treatment with enobosarm resulted in a clinical benefit rate of 50% and the best overall response rate (ORR) was 30% (2CRs and 1 PR). Of the 10 patients, 7 had AR nuclear staining ≥40%. None of the patients with AR nuclear staining &lt; 40% responded to enobosarm. Although a small subset of the study, it appears that enobosarm has activity in patients who had ≥40% AR staining and who had progressed on standard endocrine therapy with a CDK 4/6 inhibitor. Overall, treatment with enobosarm was well tolerated with significant positive effects on quality-of-life measurements. Methods: The ENABLAR-2 trial is an ongoing Phase 3, randomized, open-label, efficacy and safety study in patients with AR+ ER+ HER2- MBC with AR nuclear staining of ≥40%, who have progressed after one line of systemic therapy comprising estrogen blocking agent and palbociclib. The planned sample size is 186 patients randomized 1:1 to enobosarm + abemaciclib OR fulvestrant if the first line of therapy for MBC was a non-steroidal AI plus palbociclib, until disease progression, toxicity, or loss of clinical benefit. If first line therapy for metastatic breast cancer was fulvestrant plus palbociclib, then the patient will be randomized 1:1 to either enobosarm + abemaciclib OR an AI. Randomization will be stratified by AR% nuclear staining, ≥60% versus &lt; 60%, as well as by estrogen blocking agent such that each cohort will have the same number of subjects previously receiving fulvestrant + palbociclib in first line therapy. The key objectives are to determine the safety and efficacy of enobosarm and abemaciclib combination versus an alternative estrogen blocking agent with the primary endpoint of PFS. Secondary endpoints include ORR, duration of response, overall survival, change from baseline in Short Physical Performance Battery (SPPB), change in EORTC Quality of Life Questionnaire (EORTC-QLQ) and change in body composition as measured by DEXA. Clinical trial information: NCT05065411.

Health-related quality of life in patients treated with gemcitabine/cisplatin and durvalumab ± tremelimumab in chemotherapy-naïve advanced biliary tract cancer.

4117 Background: In the phase 2 (NCT03046862), gemcitabine/cisplatin (GemCis) and durvalumab (D) ± tremelimumab (T) in chemotherapy-naïve advanced biliary tract cancer (BTC) showed a high objective response rate and durable clinical benefit. Based on this study, phase 3 trial (TOPAZ-1, NCT03875235) has been conducted and the positive result for adding D to GemCis has been reported. Health-related quality of life (HRQoL) for adding immunotherapy to cytotoxic chemotherapy in BTC has not been reported yet. We present HRQoL results from the phase 2 study. Methods: In this study, treatment-naïve patients with unresectable or recurrent BTC were enrolled into three cohorts. Patients received one cycle of GemCis followed by GemCis plus D and T (cohort 1) or, starting with the first cycle, received GemCis plus D (cohort 2) or GemCis plus D and T (cohort 3). The EORTC Quality of Life Questionnaire (QLQ)-C30 and BIL21 were administered at baseline and every cycle throughout treatment. Change from baseline to post-2 cycles and deterioration of HRQoL (≥10 points change) were analysed. Results: At data cut-off (March 22, 2021), 126 patients (32 in cohort 1, 47 in cohort 2, 47 in cohort 3) were included for this analysis. Compliance for QLQ was very high ( &gt; 90 %) at all time points. C30 global health status (GHS) scores remained stable at all time points and from baseline to post 2 cycles (mean [95% CI] change, 2.66 [-1.10‒6.42]), with greater improvements observed in patients with responder (a best response of complete response (CR) or partial response (PR)) (3.60 [-1.27 to 8.47]) compared to non-responder (stable disease (SD) or progressive disease (PD) (0.66 [-5.19 to 6.51]). For the overall cohort, functioning scales also remained stable from baseline to post 2 cycles. Nausea/vomiting (8.4 [4.45 to 12.36]), dyspnea (7.28 [2.17 to 12.4]), constipation (9.24 [3.35 to 15.13]), financial difficulties (5.53 [1.65 to 9.41]) in C30 and eating (5.53 [1.65 to 9.41]), tiredness (5.42 [1.23 to 9.6]), treatment side effects (7.98 [1.15 to 14.81] in BIL21 were worse at post 2 cycles. However, pain (-7.14 [-12.24 to -2.04]), diarrhea (-4.48 [-8.86 to -0.1]) in C30 and jaundice (-5.51 [-9.26 to -1.76]), pain (-6.02 [-9.7 to -2.34] in BIL21 were improved and more improvement was shown in responder compared to non-responder. Regarding deterioration of C30 GHS, median deterioration-free survival (months [95% CI]) was 4.14 (2.66-6.47) in all cohorts and there was no difference between responder (3.68 [2.27-7.92]) and non-responder (5.59 [2.73-9.46], Hazard ratio = 1.00 [95% CI, 0.62-1.61], p = 0.997). There was no difference among 3 cohorts. Conclusions: GemCis plus D ± T in chemotherapy-naïve advanced BTC generally preserved HRQoL and improved some symptom scales such as jaundice and pain although chemotherapy related symptom scales were worse.

CoRInTH: A phase Ib/II trial of checkpoint inhibitor, pembrolizumab (PD-1 antibody [Ab]) plus standard intensity modulated chemoradiotherapy (IMCRT) in HPV-induced stage III squamous cell carcinoma (SCC) of the anus.

TPS3630 Background: SCC of anus (SCCA) are considered rare tumours, but the incidence is increasing. Only 65% patients with later stage T3/T4 +/-N1 SCCA remain disease free at 3 years (Gunderson 2013, James 2013). The cytotoxicity of IMCRT enhances tumour antigen presentation and promotes cytokine release as well as enhancing the MHC (Demaria 2004, Reits 2006). Immune therapy, against PD-1, have been approved for patients with SCC arising from other primary sites eg. head and neck, lung cancer. The addition of such checkpoint inhibitors might also result in improved PFS and OS for higher risk SCCA patients. Methods: A multicentre, single arm, open-label, non-randomised study to evaluate the safety and tolerability of different schedules of exposure to pembrolizumab (P) with standard IMCRT in 50 patients with locally advanced T3/4 anal cancer. The first cohort of 6 patients commenced standard IMCRT and received P 200mg every 21d beginning at Week 5 day 1 of the IMCRT schedule. If this is considered safe and tolerable with not more than 3/6 SAEs within first 6 weeks after completion IMCRT, a second cohort of 6 patients will be recruited where P is introduced on Week 1 Day 1 with standard IMCRT. Pembrolizumab monotherapy will be continued for a total of 6 months. Primary endpoint is safety and tolerability by assessing AEs and protocol adherence. Secondary endpoints include feasibility, clinical response assessment by RECIST (MRI) for ORR at 3, 6 and 12 months, imaging response assessments by TRG MRI using changes in Apparent Diffusion Coefficient (ADC) on diffusion weighted sequences and patient reported outcomes, using EORTC quality of life questionnaires. Patients are being asked to contribute to translational endpoints with the donation of tissue and blood samples. Eligible patients will have Stage IIIA/B (T3/4, any N, M0) SCCA, performance status 0 or 1 and be suitable for IMCRT. Patents with anal tumours of non-epithelial origin, metastatic disease or a diagnosis of immunodeficiency are excluded. Single phase IMRT with a simultaneous integrated boost to achieve 53.2Gy in 28 fractions over 5.5 weeks to PTV_A, according to the UK consensus is mandated. Concomitant chemotherapy can either be cisplatin 60mg/m2/ or mitomycin 12mg/m2 with either 5FU 1000mg/m2 or capecitabine 825mg/m2 at investigator discretion. The first cohort has completed recruitment with Safety Review Committee / IDMC review planned for April 2022. Patients will then be sought to start P on Week 1 Day 1 with IMCRT. Further safety review will be undertaken following the first 6 patients entered into the second cohort but recruitment will continue in an expansion phase to a maximum of 44 patients. Clinical trial information: NCT04046133.

Health-related quality of life in patients treated with pembrolizumab for microsatellite instability–high/mismatch repair–deficient advanced solid tumours: Results from the KEYNOTE-158 study

BackgroundIn the KEYNOTE-158 study (NCT02628067), pembrolizumab showed a high objective response rate and durable clinical benefit for patients with previously treated, unresectable/metastatic microsatellite instability−high (MSI-H)/mismatch repair‒deficient (dMMR) non-colorectal solid tumours. We present health-related quality of life (HRQoL) results from the MSI-H/dMMR population (cohort K). Patients and methodsEligible patients had previously treated MSI-H/dMMR advanced non-colorectal solid tumours, measurable disease per RECIST v1.1, and ECOG performance status ≤1. Patients received pembrolizumab 200 mg Q3W for 35 cycles (2 years). The EORTC Quality of Life Questionnaire (QLQ-C30) and EQ-5D-3L were administered at baseline, at regular intervals throughout treatment, and 30 days after treatment discontinuation. Prespecified analyses (exploratory endpoints) included the magnitude of change from baseline to post-baseline timepoints in all patients and by the best overall response for QLQ-C30 global health status (GHS)/QoL, QLQ-C30 functional/symptom scales/items, and EQ-5D-3L visual analogue scale (VAS) score. ResultsAt data cutoff (October 5, 2020), 351 patients were enrolled, of whom 311 and 315 completed baseline QLQ-C30 and EQ-5D-3L questionnaires, respectively. QLQ-C30 GHS/QoL scores improved from baseline to week 9 (mean [95% CI] change, 3.07 [0.19–5.94]), then remained stable or improved by week 111, with greater improvements observed in patients with a best response of complete response (CR) or partial response (PR) (10.85 [6.36–15.35]). Patients with CR/PR showed improvements in physical (5.58 [1.91–9.25]), role (9.88 [3.80–15.97]), emotional (5.62 [1.56–9.68]), and social (8.33 [2.70–13.97]) functioning, and stable cognitive functioning (1.74 [−1.45 to 4.94]). ConclusionsPembrolizumab generally improved or preserved HRQoL in patients with previously treated MSI-H/dMMR advanced non-colorectal solid tumours.

Body Image Scale: Evaluation of the Psychometric Properties in Three Indian Head and Neck Cancer Language Groups.

BackgroundBody image is a subjective concept encompassing a person’s views and emotions about their body. Head and neck cancer (HNC) diagnosis and treatment affects several psychosocial concepts including body image. Large numbers of HNC patients are diagnosed each year in India but there are no suitable measures in regional languages to assess their body image. This study assessed the psychometric properties of the Body Image Scale (BIS), a measure suitable for clinical and research use in HNC populations, translated into Tamil, Telugu and Hindi and compared body image distress between language groups.MethodsTranslated versions of BIS were completed by HNC patients recruited from three cancer centers across India one time only. Psychometric evaluation was conducted including factor analysis using principal component analysis and internal consistency reliability using Cronbach’s alpha. Patients completed the EORTC Quality of Life Questionnaire (QLQ) C-30 and EORTC QLQ HN-35 measures to enable exploration of convergent and discriminant validity. ANOVA was used to calculate difference in mean values for body image.ResultsOur sample included 621 HNC patients (Tamil = 205, Telugu = 216, Hindi = 200). Factor analysis revealed a one-factor solution and Cronbach’s alpha coefficients ranged between 0.891 and 0.969 indicating good reliability. Hypothesized correlations between similar and different constructs were as expected, supporting construct validity. On the BIS, we found a statistically significant difference (F = 11.0954, P < 0.05) between means of Tamil, Telugu, and Hindi groups, with higher body image scores in Telugu (M = 12.86; SD = 7.65) and Hindi groups (M = 12.52; SD = 7.36) indicating more symptoms/body image distress, when compared to Tamil population (M = 9.28; SD = 10.04).ConclusionThe reliability and validity of the three translated Indian versions of the BIS were maintained, providing a method for assessing body image of HNC population worldwide speaking Tamil, Telugu, and Hindi across the illness trajectory.

Assessment of Psychosocial Effect and Quality of Life in Breast Cancer Patients

Psychological factors and quality of life influence the breast cancer patient (Khan et al., 2010). The aim of this retrospective study is to evaluate the breast cancer patients’ self-esteem, perceived social support, and quality of life. Sixty patients were taken in this, whose age was between twenty to sixty years. A self-esteem scale, social support questionnaire, and EORTC quality of life questionnaires were used to assess breast cancer patients. All statistical analyzes were completed via SPSS 16.0. The majority of the patients (93%) had high self-esteem and social support (90%). There was a significant association was found between self-esteem and social support (.001). Global health status and functional scores were high. Patients had increased complaints of fatigue, systemic therapy side-effect, and arm symptoms. Participants had suffered increased financial difficulties. It was observed that the sexual activity and sexual enjoyment of the participants had decreased. Breast cancer patients’ self-esteem and social support were high. The overall quality of life in breast cancer patients appeared to be good. The participants had felt more tired, difficulty lifting their arms. Therefore, Higher Self- esteem and social support were strongly associated with a good overall quality of life.

Quality-of-life analysis of pembrolizumab vs brentuximab vedotin for relapsed/refractory classical Hodgkin lymphoma

AbstractKEYNOTE-204 (NCT02684292) demonstrated a progression-free survival advantage for pembrolizumab over brentuximab vedotin (BV) in patients who had relapsed or refractory classical Hodgkin lymphoma (R/R cHL) following, or who were ineligible for, autologous stem cell transplantation (ASCT). Health-related quality of life (HRQoL), measured by patient-reported outcomes (PROs) from KEYNOTE-204, are reported from patients who received ≥1 dose of study treatment and completed ≥1 PRO assessment. The EORTC QoL Questionnaire Core 30 (QLQ-C30) and EuroQoL EQ-5D were administered at baseline, every 6 weeks until week 24, and every 12 weeks thereafter. Prespecified end points included least squares mean (LSM) changes from baseline to week 24 and time to true deterioration (TTD; ≥10-point decline from baseline). Comparisons were evaluated using 2-sided P values uncontrolled for multiplicity. High compliance at baseline (>90%) and through week 24 (>80%) was demonstrated across treatment groups (PRO analysis set: pembrolizumab, n = 146; BV, n = 150). The EORTC QLQ-C30 global health status (GHS)/quality of life (QoL) score improved from baseline to week 24 on pembrolizumab and worsened on BV and demonstrated significant LSM differences at 24 weeks (GHS/QoL: 8.60 [95% confidence interval, 3.89-13.31]; P = .0004). Significant improvements were observed in each QLQ-C30 domain except emotional and cognitive functioning. Compared with BV, pembrolizumab prolonged TTD for GHS/QoL (hazard ratio, 0.40 [95% CI, 0.22-0.74]; P = .003) and each QLQ-C30 domain except cognitive functioning. In conclusion, pembrolizumab demonstrated overall improvements in PROs of HRQoL measures over BV in the KEYNOTE-204 study. These data and previously reported efficacy results support pembrolizumab as the preferred treatment option for patients with R/R cHL who are ineligible for or experience relapse after ASCT.

OS09.6.A Cognition and health-related quality of life in long time survivors of high-grade glioma

Abstract BACKGROUND Although prognosis is poor in high-grade glioma (HGG) patients, some become a long-term survivor (LTS). Health-related quality of life (HRQOL) and cognition are seen as indicators for quality of survival in HGG but data in LTS and their caregivers are scarce. We aim to investigate cognition and HRQOL in LTS with evaluation by their proxies. MATERIAL AND METHODS We included LTS with initial HGG-diagnosis between 1999–2014. Cognition was assessed with: Boston Naming Test, shortened Token Test, verbal (Category and Letter) Fluency, Diagnostic Instrument of Mild Aphasia, Hopkins Verbal Learning Test and Trail Making Test (A, B, B/A) and HRQOL with: EORTC Quality of Life Questionnaire (C30) and Brain Cancer Module (BN20). 15 Proxies evaluated patients’ HRQOL with: C30, BN20 and they filled in a burden scale: Caregiver Strain Index (CSI). RESULTS 21 patients with grade III or IV glioma and 7 years (range 5–20 years) median survival after diagnosis participated. Compared to normative data patients deviated significantly on HVLT (direct recall, delayed recall, recognition true positives), TMT (A, B and B/A), BNT and CF (p&amp;lt;0.05) which was not affected by hemispheric localization (left/right) or tumor grade (III/IV). HVLT delayed recall was significantly worse in patients with &amp;gt;12 years survival compared to patients with &amp;lt;12 years survival. Average QoL rating in patients was 75%, proxy’s evaluation about patients’ QoL was similar. Moderate correlations (p&amp;lt;0.05) were found between impaired scores on TMT and CF and C30 cognition subscale and between impaired scores on CF, HVLT delayed recall and BNT and BN20 language subscale. At individual level only one patient had intact scores on all administered tests. Other patients had mild impairments on 1–5 subtests and severe impairment on 1–8 subtests. Five out of 14 (36%) proxies reported a great level of caregiver strain on CSI. CONCLUSION Most LTS suffer from cognitive impairments. Despite worse prognosis and cognitive impairments, at group level patients report relatively intact QoL, which is supported by their proxies. However, at the individual level severity of impairments is variable and high caregiver strain is reported in one-third of the proxies. Objective cognitive functioning was only modestly associated with subjective experience in patients. A patient-tailored approach is recommended to investigate individual impairments and needs for rehabilitation and support for patients and also for their carers.