Cancer-specific Health-related Quality Research Articles

Baseline financial distress and cost-related social risks among participants in the Cancer Financial Experience (CAFÉ) trial.

172 Background: Cancer Financial Experience (CAFÉ) is a multi-site, three-arm randomized controlled trial to test the impact of a novel financial navigation intervention on financial distress among cancer patients. We compared the baseline prevalence of financial distress among CAFÉ trial participants, using two instruments (InCharge and COST), and assessed cost-related social risks. Methods: Three hundred seventy one (n=371) participants were consented and randomized between August 2021-March 2023. Eligible participants (n=2033) included adults (18+ years of age), diagnosed with invasive cancer within 120 prior to a recent visit to a CAFÉ study clinic/site, members of Kaiser Permanente Northwest or Kaiser Permanente Washington, and spoke English or Spanish. Following consent, participants were randomized to one of three trial arms: enhanced usual care; brief intervention; enhanced intervention. The two primary trial outcomes were: financial distress, measured using the InCharge Financial Distress/Financial Well-Being scale, and cancer-specific health-related quality of life, measured by the FACT-G7 scale. Additionally, we collected the COST measure and cost-related social risks. All participant-reported outcomes, demographic, and socioeconomic data were collected via telephone survey at baseline and 12 months by trained interviewers. Survey data was stored in REDCap. Descriptive statistics were used to assess participant demographic, socioeconomic, and outcome data at baseline. Results: Among randomized participants (n=371), mean age was 61 years (standard deviation=14 years), 63% were female, 11% Hispanic, 9% Asian, 8% Black , 61% married or living with partner, 31% were employed full-time, 37% retired, 44% had annual income of $20000-$74999, 45% had Medicare, and 38% had breast cancer. At baseline, InCharge scores showed 31% (n=113) of participants had high, 19% had moderate, and 50% had low financial distress. Based on COST scores, 2.2% (n=16) of participants had high, 63% had moderate, and 39% had low financial distress. Forty percent (n=148) of participants reported any cost-related social risk, including heat and electricity (15%) and housing (15%). Conclusions: Baseline findings from the CAFÉ trial indicate that nearly one-third of patients with cancer may have high financial distress around the time of diagnosis, though this may vary by screening tool. The ideal screening tool for use at diagnosis is worthy of further study. Assessing and assisting patients with social risks, including financial distress, is essential to advancing cancer health equity. Clinical trial information: NCT05018000 .

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

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

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

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

Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer

The unmet needs regarding symptom management of psychological distress among patients with breast cancer must be addressed. However, little evidence exists on effective interventions, such as nurse navigation. To compare the long-term effects of the REBECCA (Rehabilitation After Breast Cancer) nurse navigation intervention vs usual care in patients with breast cancer who were psychologically vulnerable. This parallel randomized clinical trial recruited and evaluated for eligibility adult female patients with newly diagnosed breast cancer and symptoms of psychological distress (distress score of ≥7 points on Distress Thermometer) at Rigshospitalet in Copenhagen, Denmark, from August 2017 to October 2019. This study continued the work of a pilot study, extending the follow-up to 18 months. Patients who met the inclusion criteria were randomized to either standard care or the REBECCA intervention. Intention-to-treat analyses were performed from June 2021 to October 2022. Patients who were randomized to the REBECCA intervention received nurse navigation and symptom screening as well as standard care. Standard care included regular treatment, nurse support at chemotherapy and radiotherapy appointments, and municipality-based rehabilitation. The primary outcome was distress, as measured using the Distress Thermometer. The secondary outcomes included symptoms of anxiety, symptoms of depression, breast cancer-specific health-related quality of life, fear of recurrence, sleep, cognitive function, patient activation, pain, health behavior, body mass index, and need for support. Long-term effects at 6, 12, and 18 months were examined using mixed-effect models, adjusting for randomization strata of age and treatment modality. A total of 309 female patients were included in the analysis, with 153 patients randomized to the standard care group and 156 patients randomized to the REBECCA intervention group. Mean (SD) age was 56 (11) years with only small between-group differences. Patients receiving the REBECCA intervention compared with standard care had reduced (although not significant) symptoms of distress, especially at the 12-month follow-up (estimated effect = -0.51 [95% CI, -1.05 to 0.04]; effect size [ES] = -0.49). Significant effects were seen for symptoms of depression at 6 months (estimated effect = -1.39 [95% CI, -2.33 to -0.44]; ES = -0.27), and breast cancer-specific health-related quality of life at 12 months (estimated effect = 4.03 [95% CI, 1.28- 6.77]; ES = 0.31). Nonsignificant reductions were seen for symptoms of anxiety at 6 months (estimated effect = -1.00 [95% CI, -1.95 to -0.06]; ES = -0.21) and 12 months (estimated effect = -1.01 [95% CI, -1.97 to -0.04]; ES = -0.21), and a nonsignificant increase was seen for patient activation at 18 months (estimated effect = 3.52 [95% CI, -0.09 to 7.12]; ES = 0.25). Stronger intervention effects were observed for younger age, low patient activation, less education, and low social support. Results of this study indicate that patients with breast cancer who were psychologically vulnerable (ie, having moderate to high psychological distress) did not experience significant reduction in distress with nurse navigation. Further research is needed to develop the intervention's framework and investigate its potential use in clinical practice. ClinicalTrials.gov Identifier: NCT03254875.

Evaluation of health-related quality of life and its domains in pediatric patients with cancer

BackgroundHealth-related quality of life has emerged as a significant component in pediatric oncology research during the last several decades. Measures of health-related quality of life provide a thorough assessment of the child’s response to medical therapy, disease course, and adjustment outcomes in the context of pediatric oncology.MethodsThe aim of the present study was to assess the cancer-specific health-related quality of life in cancer pediatric patients and to evaluate the contribution of its domains and some of the anthropometric, sociodemographic, and treatment-related variables on the overall quality of life, by using the PedsQL™ 3.0 Cancer Module.ResultsThe study included 110 cases. The mean value of the PedsQL™ 3.0 Cancer Module score was 49.3 ± 12.0. The lowest mean score of quality of life was for the “procedure anxiety” (8.7 ± 23.9), followed by the “worry” domains (16.6 ± 28.5). Higher “frequency of hospital visits” was associated with increased feeling of pain and treatment anxiety yet decrease in suffering from nausea and vice versa. The longer period of hospital admission for more than half of the recommended treatment period was associated with reduced pain suffering on the expense of increase in feeling of worry as well as communication problems. The perceived physical appearance was better among those patients who spent a treatment period for 3–6 months when compared to those who spent a treatment period less than 3 months or more than 6 months. There was a highly significant association between all the eight-cancer-specific quality-of-life domains except the pain domain- and the overall quality-of-life log scores. Nausea problem followed by worry and cognitive problems was the most effective domains on the overall quality-of-life score.ConclusionCancer pediatric patients suffered low quality of life especially for anxiety procedure and worry domains with special consideration for the impact of nausea, worry, and cognitive problems on their perception of quality of life.

Impacts of the preceding cancer-specific health-related quality of life instruments on the responses to the subsequent EQ-5D-5L

BackgroundIn clinical studies, the EQ-5D-5L is often employed with disease-specific health-related quality of life instruments. The questions in the former are more general than the latter; however, it is known that responses to general questions can be influenced by preceding specific questions. Thus, the responses to the EQ-5D-5L have the possibility of being influenced by the preceding disease-specific health-related quality of life instruments. This may lead to bias in the cost-effectiveness analysis results. Therefore, this study aimed to evaluate the impact of the preceding cancer-specific health-related quality of life instruments on the EQ-5D-5L responses.MethodsWe prepared questionnaire booklets containing the EQ-5D-5L, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, and the Functional Assessment of Cancer Therapy General with different orders. Using a quasi-randomized design, they were distributed to the patients undergoing drug therapy for advanced cancer, who were classified into three groups: Groups 1, 2, and 3 (the EQ-5D-5L placed first, second, and last, respectively). We compared the EQ-5D-5L index and the missingness of EQ-5D-5L among the groups.ResultsThe mean EQ-5D-5L index was 0.796, 0.760, and 0.789 for groups 1 (n = 300), 2 (n = 306), and 3 (n = 331), respectively. The difference between Groups 2 and 1 was − 0.036 (95% CI − 0.065 to − 0.007; p = 0.015). The proportion of patients with an incomplete EQ-5D-5L was 0.11, 0.11, and 0.05 for Groups 1, 2, and 3, respectively. The difference of the proportions between group 3 and 1 and between 3 and 2 was − 0.06 (95% CI − 0.10 to − 0.02; p = 0.003) and − 0.06 (95% CI − 0.10 to − 0.02; p = 0.003), respectively.ConclusionsAlthough the EQ-5D-5L index differed according to the instrument orders, the difference size would not be considerably larger than the minimally important difference. The patients tended to complete the EQ-5D-5L when they were placed at the end of the questionnaire.

The Promoting Resilience in Stress Management (PRISM) intervention for adolescents and young adults receiving hematopoietic cell transplantation: a randomized controlled trial protocol

BackgroundPsychological distress is prevalent among adolescents and young adults (AYAs) receiving hematopoietic cell transplantation (HCT). The Promoting Resilience in Stress Management (PRISM) intervention is a resilience-coaching program that has been shown to mitigate distress and improve quality of life among AYAs receiving chemotherapy for newly diagnosed or advanced cancer. This article describes the protocol of an ongoing randomized-controlled trial (RCT) examining the efficacy of PRISM among AYAs receiving HCT for cancer and/or blood disorders.Methods/designThe goal of this multi-site, parallel, RCT is to evaluate the effect of PRISM compared to psychosocial usual care (UC) among AYAs receiving HCT. Our primary hypothesis is that AYAs who receive PRISM will report lower depression and anxiety 6-months following enrollment compared to those who receive UC. The PRISM program includes four scripted coaching sessions targeting skills in stress-management, goal setting, cognitive-restructuring, and meaning-making, followed by a facilitated family meeting. Sessions are delivered one on one, 1–2 weeks apart, in-person or via videoconference. We aim to recruit 90 AYAs from 4 US pediatric AYA oncology centers. Eligible AYAs are aged 12–24 years; receiving HCT for malignancy or a bone marrow failure syndrome associated with cancer predisposition; < 4 weeks from their HCT date; able to speak English and read in English or Spanish; and cognitively able to complete sessions. Enrolled AYAs are randomized 1:1 within each site to receive PRISM+UC or UC alone. AYAs on both study-arms complete patient-reported outcome surveys at baseline, 3- and 6-months. Age-valid instruments assess depression and anxiety, overall and cancer-specific health-related quality of life, symptom burden, resilience, and hope. Covariate-adjusted regression models will compare AYA-reported depression and anxiety at 6-months in the PRISM versus UC groups. Secondary and exploratory objectives include assessments of PRISM’s cost-effectiveness and its impact on (i) parent and caregiver quality of life and mental health, (ii) pharmaco-adherence to oral graft-versus-host disease (GVHD) prophylaxis, (iii) biologic outcomes such as transplant engraftment and graft-versus-host disease, and (iv) biomarkers of stress such as heart rate variability and the Conserved Transcriptional Response to Adversity (CTRA) gene expression profile.DiscussionIf successful, this study has the potential to address a critical gap in whole-patient care for AYAs receiving HCT.Trial registrationClinicalTrials.gov Identifier NCT03640325, August 21, 2018.

Transcultural adaptation and validation of the Serbian version of the colorectal-specific quality of life questionnaire FACT-C.

ObjectiveTranscultural adaptation and validation of the FACT-C questionnaire to Serbian language.MethodsThe study included 131 patients with colorectal cancer. Translation included standard forward and backward translation from original language to Serbian and back. Pilot testing of the questionnaire was conducted on 10 patients with diagnosed colorectal cancer. The questionnaires EORTC-QLQ-C30 and DASS will be used as validated tools to evaluate validity of examined, FACT-C questionnaire.ResultsThe FACT-C demonstrated satisfactory construct validity using Cronbach’s alpha. Satisfactory concurrent validity was demonstrated using correlations with EORTC-QLQ-C30 and DASS questionnaires. High reproducibility was demonstrated using repeated questionnaires on 30 patients two weeks after the first interview.ConclusionThe Serbian version of the FACT-C was demonstrated to have satisfactory applicability, reliability and validity in Serbian patients with colorectal cancer. It can be considered as a valid colorectal cancer specific health related quality of life tool for the Serbian population.

AdvanTIG-203: A randomized phase 2 study comparing anti-TIGIT ociperlimab plus tislelizumab versus tislelizumab plus placebo as second-line treatment in patients with advanced or recurrent esophageal squamous cell carcinoma (ESCC) expressing programmed death-ligand 1 (PD-L1).

TPS370 Background: The programmed death-1 (PD-1)/PD-L1 pathway plays an important role in tumor induced immunosuppression. PD-L1 overexpression is observed in approximately 30–60% of esophageal cancers and is associated with poor prognosis. Anti-PD-1 agents demonstrate moderate efficacy in PD-L1-positive esophageal cancer in terms of response rate and overall survival, however, long-term outcomes remain poor due to primary and secondary resistance driven by tumor immune escape. The T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain (TIGIT) is upregulated on T-cells and natural killer cells in multiple solid tumors, which can inhibit anticancer immune responses. Ociperlimab (BGB-A1217) is a novel, humanized, monoclonal antibody that binds TIGIT with high specificity and affinity, blocking the interaction with its ligands on tumor cells. Preclinical and clinical studies suggest that dual targeting with anti-TIGIT and anti-PD-1 antibodies produces synergistic immune cell activation and enhanced antitumor activity. Methods: AdvanTIG-203 is a Phase 2, global, randomized, double-blind, placebo-controlled study (NCT04732494) of patients with unresectable, locally advanced, recurrent or metastatic ESCC, who progressed on or after 1st line systemic therapy and whose tumors express PD-L1 (visually-estimated combined positive score ≥ 10%). After stratification by Eastern Cooperative Oncology Group performance status (0 or 1), number of metastatic sites (≤ 1 or ≥ 2) and region (Asian or non-Asian), 280 patients will be randomized (1:1) to either ociperlimab 900 mg intravenous (IV) plus tislelizumab 200 mg IV every 3 weeks (Q3W), or tislelizumab plus placebo Q3W, until disease progression (per RECIST v1.1), unacceptable toxicity, death or withdrawal of consent. Co-primary endpoints are investigator-assessed overall response rate (ORR) and overall survival (OS) in the intention-to-treat population. A sample size of 280 patients was estimated to provide approximately 94.8% power to detect a 20% difference in ORR at a one-sided significance level of 0.025. With 198 deaths, the study was estimated to provide approximately 86% power to detect a hazard ratio of 0.65 for OS. Secondary endpoints are ORR by independent review, progression-free survival, duration of response, disease control rate, and clinical benefit rate per investigator and independent assessment, cancer-specific health-related quality of life (HRQoL), and safety. Exploratory endpoints include but are not limited to expression of TIGIT, CD226, CD155, CD112, and PD-L1, pharmacokinetics, immunogenicity, and generic HRQoL measures. Clinical trial information: NCT04732494.

Thyroid Cancer-Specific Health-Related Quality of Life Questionnaire: Psychometric Properties of the Persian Version.

Background:Adverse effects related to treatment negatively affect the quality of life of patients with thyroid cancer. The current study aimed to evaluate the psychometric properties of the Persian version of the thyroid-cancer-specific health-related quality of life (TC-specific HRQoL) questionnaire among patients with thyroid cancer in Kerman province, Iran.Methods:This research was a cross-sectional study conducted on 240 patients with thyroid cancer in Kerman province from 2000 to 2015. The patients were selected through the census method and were asked to complete the thyroid-cancer-specific quality of life questionnaire. Data were analyzed by SPSS version 19.0 and LISREL version 8.80. The reliability of the Persian version was determined by Cronbach's α coefficient and the intraclass correlation coefficient (ICC). Exploratory and confirmatory factor analysis (CFA) was also conducted.Results:The Cronbach's α and ICCs were determined as 0.92 and 0.88, respectively. Five factors were extracted in the exploratory factor analysis with a total of 55.76% explained variance. Acceptable goodness of fit indices were found in CFA.Conclusions:The Persian version of the TC-specific HRQoL has sufficient psychometric properties and can be used to assess HRQoL among patients with thyroid cancer.

Comparison of Quality of Life of Patients with Papillary Thyroid Microcarcinoma Treated by Different Modalities

Objective To compare the health-related quality of life(HRQoL)of patients with papillary thyroid microcarcinoma(PTMC)treated by different modalities. Methods The PTMC patients after treatment who came to our department for follow-up from October to December in 2019 were enrolled and assigned into three groups according to treatment modalities:radiofrequency ablation(RFA)group(n=80), hemithyroidectomy(HT)group(n=34), and total thyroidectomy(TT)group(n=35).All patients completed three scales:short form 36-item health survey(SF-36), thyroid cancer-specific health-related quality of life questionnaire(THYCA-QoL), and fear of progression questionnaire-short form(FoP-Q-SF).Multivariate linear regression analysis was employed to adjust for confounders and the quality of life scores were compared among the three treatment modalities. Results In the SF-36, physical component summary(PCS)(P=0.006, P=0.033)and role-physical(RP)(P=0.003, P=0.001)scores of patients in the RFA and HT groups were significantly higher than those in the TT group, whereas PCS(P=1.000)and RP(P=1.000)showed no significant difference between the RFA group and the HT group.In addition, the mental component summary(MCS)score in RFA group was higher than that in TT group(P=0.034).The THYCA-QoL demonstrated that the patients in TT group complained more about scar than the patients in HT(P=0.003)and RFA(P<0.001)groups, and the patients in the RFA group complained less about weight gain than those in the HT(P=0.028)and TT(P<0.001)groups.In the FoP-Q-SF, the scores of the quality of life of patients concerned about disease progression had no significant difference among the three groups(P> 0.05).Conclusion Compared with traditional open surgery, ultrasound-guided RFA has unique advantages in improving patients' quality of life and can be used as an alternative to open surgery for PTMC.

AdvanTIG-202: A phase 2 study investigating anti-TIGIT monoclonal antibody ociperlimab plus anti-PD-1 monoclonal antibody tislelizumab in patients with previously treated recurrent or metastatic cervical cancer.

TPS5595 Background: Women with recurrent/metastatic cervical cancer represent a poor prognostic group with high unmet clinical needs. T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibition motif domains (TIGIT) is a co-inhibitory, immune checkpoint receptor expressed on immune cells and upregulated on T-cells and natural killer cells in multiple solid tumors, inhibiting anticancer immune responses. Ociperlimab (BGB-A1217) is a novel, humanized, monoclonal antibody that binds TIGIT with high specificity and affinity, blocking the interaction with its ligands on tumor cells. Tislelizumab is an anti-PD-1 antibody engineered to minimize binding to FcγR on macrophages to abrogate antibody-dependent phagocytosis, a mechanism of T-cell clearance and potential resistance to anti-PD-1 therapy. Preclinical and clinical studies suggest that dual targeting with anti-TIGIT and anti-PD-1 antibodies produces synergistic immune cell activation and enhanced antitumor activity. Methods: AdvanTIG-202 is a Phase 2, randomized, multicenter, open-label study (NCT04693234). Approximately 167 pts with cervical squamous cell or adenosquamous carcinoma or adenocarcinoma, recruited from 100 centers, whose disease progressed on or after ≥ 1 prior line of chemotherapy for recurrent/metastatic disease will be included in this 2-Part study. In Part 1, approximately 80 pts will be randomized (1:1) to either ociperlimab 900 mg intravenously (IV) in combination with tislelizumab 200 mg IV every 3 weeks (Q3W) (Arm 1), or tislelizumab monotherapy 200 mg IV Q3W (Arm 2), until disease progression, unacceptable toxicity, or withdrawal of consent. In Part 2, Arm 1 will be expanded by approximately 87 additional pts whose tumors are evaluable for PD-L1 expression. The primary endpoint is overall response rate (ORR) (RECIST v1.1) assessed by Independent Review Committee (IRC) in Arm 1. Secondary endpoints are investigator-assessed ORR in Arm 2, IRC-assessed and investigator-assessed ORR in Arm 1, IRC-assessed and investigator-assessed duration of response, progression-free survival, time to response, disease control rate, clinical benefit rate and overall survival, cancer-specific health-related quality of life (HRQoL), safety, pharmacokinetics and immunogenicity in Arms 1 and 2. Exploratory endpoints are generic HRQoL and the association of biomarkers with patient prognosis, response or resistance. Clinical trial information: NCT04693234.

AdvanTIG-203: A randomized phase 2 study comparing anti-TIGIT ociperlimab plus tislelizumab versus tislelizumab plus placebo as second-line treatment in patients with advanced or recurrent esophageal squamous cell carcinoma (ESCC) expressing programmed death-ligand 1 (PD-L1).

TPS4150 Background: The programmed death-1 (PD-1)/PD-L1 pathway plays an important role in tumor induced immunosuppression. PD-L1 overexpression is observed in approximately 30–60% of esophageal cancers and is associated with poor prognosis. Anti-PD-1 agents demonstrate moderate efficacy in PD-L1-positive esophageal cancer in terms of response rate and overall survival, however, long-term outcomes remain poor due to primary and secondary resistance driven by tumor immune escape. The T-cell immunoglobulin and immunoreceptor tyrosine-based inhibition motif domain (TIGIT) is upregulated on T-cells and natural killer cells in multiple solid tumors, which can inhibit anticancer immune responses. Ociperlimab (BGB-A1217) is a novel, humanized, monoclonal antibody that binds TIGIT with high specificity and affinity, blocking the interaction with its ligands on tumor cells. Preclinical and clinical studies suggest that dual targeting with anti-TIGIT and anti-PD-1 antibodies produces synergistic immune cell activation and enhanced antitumor activity. Methods: AdvanTIG-203 is a phase 2, global, randomized, double-blind, placebo-controlled study (NCT04732494) of patients with unresectable, locally advanced, recurrent or metastatic ESCC, who progressed on or after 1st line systemic therapy and whose tumors express PD-L1 (visually estimated combined positive score ≥10%). After stratification by Eastern Cooperative Oncology Group performance status (0 or 1), number of metastatic sites (≤1 or ≥2) and region (Asian or non-Asian), 280 patients will be randomized (1:1) to either ociperlimab 900 mg intravenous (IV) plus tislelizumab 200 mg IV every 3 weeks (Q3W), or tislelizumab plus placebo Q3W, until disease progression (per RECIST v1.1), unacceptable toxicity, death or withdrawal of consent. Co-primary endpoints are investigator-assessed overall response rate (ORR) and overall survival (OS) in the intention-to-treat population. A sample size of 280 patients was estimated to provide approximately 94.8% power to detect a 20% difference in ORR at a one-sided significance level of 0.025. With 198 deaths, the study was estimated to provide approximately 86% power to detect a hazard ratio of 0.65 for OS. Secondary endpoints are ORR by independent review, progression-free survival, duration of response, disease control rate, and clinical benefit rate per investigator and independent assessment, cancer-specific health-related quality of life (HRQoL), and safety. Exploratory endpoints include but are not limited to expression of TIGIT, CD226, CD155, CD112, and PD-L1, pharmacokinetics, immunogenicity, and generic HRQoL measures. Clinical trial information: NCT04732494.

Quality of Life in Patients with Low-Risk Papillary Thyroid Microcarcinoma: Active Surveillance Versus Immediate Surgery

This study aimed to compare the quality of life (QoL) and psychological issues of patients with papillary thyroid microcarcinoma (PMC) who were under active surveillance (AS) and those who underwent immediate surgery (OP). This was a cross-sectional study conducted on 347 patients with low-risk PMC who were under AS (n = 298) or who underwent OP (n = 49). They were asked to complete two questionnaires (thyroid cancer-specific health-related QoL [THYCA-QoL] and the Hospital Anxiety and Depression Scale [HADS]). The results between the AS and OP groups were compared. The mean ages of patients in the AS and OP groups were 58.6±12.5 and 58.4±13.1 years (P =.94), respectively, and the male ratios were 34/298 (11%) and 2/49 (4.1%) (P =.14), respectively. The median follow-up periods from diagnosis in the AS and OP groups were 56.5 months (interquartile range [IQR], 32 to 88 months) and 84 months (IQR, 64 to 130 months) (P<.001), respectively. In the THYCA-QoL questionnaire, the OP group had more complaints about "voice" (P<.001), "psychological" (P =.025), "problems with scar" (P<.001), and "gained weight" (P =.047) than the AS group. Other scales of the THYCA-QoL were comparable in the two groups. In the HADS questionnaire, the AS group had significantly better anxiety (P =.020), depression (P =.027), and total scores (P =.014) than the OP group. PMC patients in the OP group had more complaints and were more anxious and depressed than the AS group. These findings suggest that AS is a reasonable alternative to surgery for patients with low-risk PMC from the point of view of QoL and psychology. AS = active surveillance; CI = confidence interval; HADS = Hospital Anxiety and Depression Scale; LT4 = levothyroxine; OP = immediate surgery; PMC = papillary microcarcinoma; PTC = papillary thyroid carcinoma; QoL = quality of life; STAI = State-Trait Anxiety Inventory; THYCA-QoL = thyroid cancer-specific health-related quality of life; TSH = thyrotropin.

Factors Affecting Quality of Life of Patients Undergoing Radiofrequency Ablation for Papillary Thyroid Microcarcinoma

Objective To evaluate the factors affecting health-related quality of life (HRQoL) of patients with thyroid papillary microcarcinoma (PTMC) after ultrasound-guided radiofrequency ablation (RFA).Methods The clinical data of 100 patients with PTMC who underwent reexamination after RFA in the Ultrasound Department of our center from October to December 2019 were retrospectively analyzed.Demographic information was collected.SF-36 and Thyroid Cancer-specific Health-related Quality of Life Questionnaire scales were used to assess patients' quality of life and thyroid-related specific symptoms.The SF-36 scale includes two general domains including physical component summary (PCS) and mental component summary (MCS).The impacts of demographic characteristics and thyroid-related symptoms after RFA on PCS and MCS scores were further analyzed.Results Univariate analysis and correlation analysis showed that the PCS scores in quality of life of PTMC patients were related to sex, neuromuscular, voice, concentration, sympathetic nerve, and throat/mouth complaints, psychological state, sensory symptoms, scar, chills, tingling, and headache (all P<0.1);and the MCS scores were associated with education level, residence, neuromuscular, voice, concentration, sympathetic nerve, and throat/mouth complains, psychological state, sensory symptoms, scar, chills, tingling, and headache (all P<0.1).Multivariate regression analysis showed that the PCS scores were only associated with sex and the neuromuscular and throat/mouth complains and the psychological state.The regression equation was:PCS=110.367-8.025×sex-0.213×psychological state-0.280×neuromuscular complain-0.278×throat/mouth complain.In contrast, the MCS scores were only associated with the psychological state and the throat/mouth and concentration complains, with the regression equation being:MCS=91.323-0.237×psychological state-0.437×throat/mouth-0.304×concentration.Conclusions The main risk factors affecting the quality of life of PTMC patients after ultrasound-guided RFA were female gender, psychological burden, lack of attention, and symptoms in neuromuscular system and throat/mouth.Therefore, preoperative explanations should be made according to the relevant symptoms that the patients may report, and psychological interventions should be offered after RFA to improve the quality of life of PTMC patients after treatment.

87P Patient-reported and cancer-specific health-related quality of life among patients with early stage HR+/HER2- breast cancer (BC)

87P Patient-reported and cancer-specific health-related quality of life among patients with early stage HR+/HER2- breast cancer (BC)

Effects of dietary and physical activity interventions on generic and cancer-specific health-related quality of life, anxiety, and depression in colorectal cancer survivors: a randomized controlled trial

PurposeTo assess the effects of dietary and physical activity (PA) interventions on generic and cancer-specific quality of life (QoL), anxiety, and depression levels among adult Chinese colorectal cancer (CRC) survivors.MethodsTwo-hundred twenty-three adult CRC survivors within 1 year of completion of primary cancer treatment were randomized to receive dietary, PA or combined intervention, or usual care for a 12 monthduration, under a 2 (diet vs usual care) × 2 (PA vs usual care) factorial design. Generic and cancer-specific QoL was assessed using a Chinese version 12-Item Short Form Health Survey (SF-12) and the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) scale, respectively. Anxiety and depression was assessed using the Hospital Anxiety and Depression Scale at baseline, 6, 12, 18, and 24 months. Linear mixed models were used for examining the intervention effects.ResultsParticipants receiving dietary intervention experienced a significant improvement in the generic measure of QoL (SF-6D utility scores, mean difference 0.042, 95%CI 0.03 to 0.081) at 12 months, the cancer-specific QoL scores (mean difference 3.09, 95%CI 0.13 to 6.04), and levels of depression (P = 0.015) at both 12 and 24 months follow-up. Participants receiving PA intervention only demonstrated a significant improvement in SF-6D utility index (mean difference 0.039, 95%CI 0.002 to 0.077) and physical functioning (mean difference 2.85, 95%CI 1.00 to 4.70) at 6 months.ConclusionsDietary intervention improved the generic and cancer-specific QoL and depression in CRC survivors.Trial registrationThe study was prospectively registered on 17 October 2012 at ClinicalTrials.gov (NCT01708824).Implications for Cancer SurvivorsCRC survivors can benefit from dietary interventions in alleviating depression and improving overall health-related QoL.

Health-related Quality of Life and Pain in a Real-world Castration-resistant Prostate Cancer Population: Results From the PRO-CAPRI Study in the Netherlands.

The purpose of this study was to determine generic, cancer-specific, and prostate cancer-specific health-related quality of life (HRQoL), pain and changes over time in patients with metastatic castration-resistant prostate cancer (mCRPC) in daily practice. PRO-CAPRI is an observational, prospective study in 10 hospitals in the Netherlands. Patients with mCRPC completed the EQ-5D, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and Brief Pain Inventory-Short Form (BPI-SF) every 3 months and European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Cancer Module (EORTC QLQ-PR25) every 6 months for a maximum of 2 years. Subgroups were identified based on chemotherapy pretreatment. Outcomes were generic, cancer-specific, and prostate cancer-specific HRQoL and self-reported pain. Descriptive statistics were performed including changes over time and minimal important differences (MID) between subgroups. In total, 151 included patients answered 873 questionnaires. The median follow-up from the start of the study was 19.5 months, and 84% were treated with at least 1 life-prolonging agent. Overall, patients were in good clinical condition (Eatern Cooperative Oncology Group performance status 0-1 in 78%) with normal baseline hemoglobin, lactate dehydrogenase, and alkaline phosphatase. At inclusion, generic HRQoL was high with a mean EQ visual analog score of 73.2 out of 100. The lowest scores were reported on role and physical functioning (mean scores of 69 and 76 of 100, respectively), and fatigue, pain, and insomnia were the most impaired domains. These domains deteriorated in > 50% of patients. Although most patients were treated with new treatments during follow-up, mCRPC has a negative impact on HRQoL with deterioration in all domains over time, especially role and physical functioning. These domains need specific attention during follow-up to maintain HRQoL as long as possible by timely start of adequate supportive care management.

687P - Evaluation of minimal important difference (MID) for the European organisation for research and treatment of cancer (EORTC) pancreatic cancer module (PAN26) in patients with surgically resected pancreatic adenocarcinoma

BackgroundPAN26 was developed as a supplement to the EORTC QLQ-C30 to assess pancreatic cancer–specific health-related quality of life (HRQoL) issues. Despite its use in clinical trials, PAN26 MID has not been established. In undertaking the most comprehensive evaluation to date of PAN26’s measurement properties in patients with surgically resected pancreatic cancer receiving adjuvant therapy, we used distribution-based minimum detectable change (MDC) and anchor-based methods to determine PAN26 scale MIDs using the data collected during the Adjuvant Pancreatic Adenocarcinoma Clinical Trial (APACT).Table687P PAN26 anchor (QLQ-C30 overall health) and distribution-derived MIDTableScale/ItemAnchorDistributionEstimateSE1/2 BLSDSEMAltered bowel habit–a12.511.8Body image6.40.313.113.5Digestive symptoms6.00.313.416.2Hepatic– a7.611.4Pancreatic pain5.60.29.79.7Satisfaction with health care– a12.115.3Sexual dysfunction5.40.417.319.7Bloated4.90.312.815.9Dry mouth5.10.313.415.6Gas– a14.516.2Indigestion4.80.312.815.7Limited activities8.00.315.421.7Low weight5.30.314.820.5Taste different7.50.313.619.7Troubled by tx adverse events8.80.312.615.8Weak arms/legs9.10.313.115.7Worried about future health6.30.315.516.3BLSD, baseline standard deviation; SE, standard error; SEM, standard error of measurement (based on intraclass correlation).aLow r (< 0.3) with overall health. MethodsPAN26 and QLQ-C30 scores were assessed in 12-week intervals at screening (BL), middle and end of treatment, and up to 2.5 years of follow-up. MDC values were calculated via BL standard deviation (SD) and reliability-biased standard error of measurement approaches. Anchor-based values were determined via a linear mixed model in which QLQ-C30 overall health (OH; Item 29) served as a serial patient global impression of severity anchor for predicting PAN26 scores. Pattern-mixture models (PMM) were fit to assess the impact of attrition on estimates. ResultsMDC values were in the 12 to 15 range (Table). These findings were consistent with SD-based values inferred from earlier studies, although our results extended to standalone items. Anchor-based MIDs were almost twice as sensitive as MDC, with values in the 5 to 9 range (PMM values almost identical). Anchor values could not be inferred for the PAN26 bowel, hepatic, and healthcare scales and gas item due to their low (r<0.30) correlation with OH. ConclusionsThe MID estimates for PAN26 subscales can help clinicians and researchers interpret the changes in HRQoL and determine sample sizes in the design of future clinical trials. Editorial acknowledgementPharmerit International. Legal entity responsible for the studyThe authors. FundingCelgene Corporation. DisclosureM. Reni: Non-remunerated activity/ies, Personal Fees: Celgene, Baxalta, Shire, Eli Lilly, Pfizer, Novocure, Novartis, AstraZeneca. J. Braverman: Full / Part-time employment: Celgene Corporation. T. Macarulla Mercade: Honoraria (self): Roche, Sanofi, Tesaro, Shire, Genzyme; Advisory / Consultancy: Baxalta, Celgene, H3B, QED, Shire; Speaker Bureau / Expert testimony: Celgene, Sanofi/Aventis, Shire; Research grant / Funding (self): Agios, Aslan, AstraZeneca, Bayer, Celgene, Genetech, Hallozyme, Immunomedics, Lilly, Merimarck, Millennium, Novartis, Novocure, Pfizer, Pharmacyclics, Roche; Travel / Accommodation / Expenses: Bayer, H3B, Merck, Sanofi. D. Oh: Advisory / Consultancy: Genentech/Roche, AstraZeneca, Novartis, Merck Serono, Bayer, Taiho, ASLAN, Halozyme, Zymeworks; Research grant / Funding (institution): AstraZeneca, Novartis, Array, Eli Lilly. H. Riess: Non-remunerated activity/ies, Personal Fees: Celgene, Roche, Shire. M.A. Tempero: Advisory / Consultancy: AbbVie, Advance Medical, BioPharm Communications, BMS, Celgene, Eisai, Ignyta, Pharmacyslics, Pharmcyte Biotech, Tocagen; Advisory / Consultancy: AstraZeneca, CPRIT, Immunovia; Research grant / Funding (institution): Halozyme. B. Lu: Shareholder / Stockholder / Stock options, Full / Part-time employment: Celgene Corporation. J. Marcus: Full / Part-time employment: Pharmerit international; Advisory / Consultancy, Research grant / Funding (self): Celgene Corporation. N. Joshi: Full / Part-time employment: Pharmerit International; Advisory / Consultancy: Celgene Corporation. M. Botterman: Honoraria (institution): Celgene, Bayer, Daiichi, BMS. All other authors have declared no conflicts of interest.

Utility Estimation of Health Status of Cancer Patients by Mapping for Cost-Utility Analysis

Background: It is important to obtain accurate information about the preferences of people for measuring quality-adjusted life years (QALYs), because it is necessary for cost-utility analysis. In this regard, mapping is a method to access this information. Therefore, the purpose of this study was to map Functional Assessment of Cancer Therapy – General (FACT-G) onto Short Form Six Dimension (SF-6D) in breast cancer patients to provide appropriate conditions for a detailed cost-utility analysis. Methods: This descriptive analytical study was conducted on 416 patients with breast cancer. The SF-6D and FACT-G questionnaires were completed for patients selected by consecutive sampling from the Imam Khomeini Cancer Institute in Tehran in 2018. The Ordinary Least Squares model was used to estimate the value of utility and the models' goodness of fit was evaluated using R2. In addition, models' predictive performance was assessed by Mean Absolute Error (MAE), Root Mean Square Error (RMSE), and Minimal Important Difference (MID) conducted between the observed and predicted SF-6D values. Models were validated using a 10-fold cross validation method. Results: Given the criteria of goodness of fit, model 2 was the best (R2 = 41.19 %). Moreover, findings of the predictive performance of models showed that model 2 was the best (MAE = 0.06943, RMSE = 0.09031, and MID = 0.0003). Conclusions: Findings showed that the developed algorithm had a good predictive ability. So, it can enable the policymakers and researchers to convert cancer-specific health-related quality of life instruments to preference-based instruments.