Functional Assessment Of Cancer Therapy Research Articles

Ab. No. 25 Feasibility of Structured Lymphedema Prophylactic Exercise Protocol (LPEP) in Post-Mastectomy Breast Cancer Patients: A Pilot Study

Introduction: In India breast cancer is one of the most prevalent cancers. A major complication of breast cancer treatment is lymphedema. Exercise is crucial for reducing the severity of already-developed lymphedema. The present study aimed to assess the feasibility of a structured exercise protocol- Lymphedema Prophylactic Exercise Protocol (LPEP) immediately after surgery and continuing for 12 weeks to prevent lymphedema. Methods: Total of 12 patients were included in the study. Hospitalized female participants aged between 25 to 65 years, who had undergone modified radical mastectomy were included in the study. All the patients were given structured exercises (LPEP) immediately after surgery for 12 weeks post-surgery. Primary outcome measures were the Lymphedema Quality of Life Inventory (LyQOI) and Circumferential girth measurement. Secondary outcome measures were Range of motion at the shoulder joint, Functional Assessment of Cancer Therapy – Breast (FACT-B), and Shoulder Pain And Disability Index (SPADI). Result: The pre and post-values of Shoulder ROM demonstrated statistical significance for flexion, extension, abduction, adduction, and Internal rotation (p= 0.0022). There was no statistically significant difference for circumferential girth measurement, suggesting lymphedema prophylactic exercise protocol is feasible in terms of preventing lymphedema in the participants. The study showed statistically significant differences in pre and post-test scores of LyQLI (p=0.0033), FACT-B (p=0.0012), SPADI questionnaire(p=0.0029) Conclusion: The study demonstrated the effectiveness of LPEP in post-mastectomy patients in improving shoulder ROM and lymphedema-specific quality of life, reducing shoulder pain and disability, and preventing the development of lymphedema. LPEP can be used as an effective exercise protocol for the prevention of lymphedema secondary to breast cancer surgery.

Neoadjuvant Chemotherapy Is Effective in Those Infected With SARS-CoV-2: The Real-World Experience of a Large Chinese Breast Cancer Center.

During the major shift in China's policies on coronavirus disease 2019 (COVID-19), many residents will be infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) over a short period, including a few patients with breast cancer undergoing neoadjuvant chemotherapy (NAC). Moreover, it is unknown whether this comorbidity affects the efficacy of NAC for breast cancer and the patient's psychological state and quality of life (QOL). This study aims to answer these questions. The clinical data of 2,793 patients with breast cancer who received NAC at The Affiliated Hospital of Qingdao University were retrospectively collected. The infected and non-infected groups were divided according to whether they were infected with COVID-19 during NAC. Propensity score matching was used to reduce patient selection bias. The effectiveness, psychological well-being, and QOL of the two groups were compared. No discernible differences were observed in the pathological complete response rates (p = 0.307) and major histological responses rate (p = 0.398) between the infected and non-infected groups. Following the full course of NAC, the Functional Assessment of Cancer Treatment General (p < 0.001) and Functional Assessment of Cancer Therapy for Breast Cancer (p < 0.001) were lower in the infected group than the non-infected group, the Hospital Anxiety and Depression Scale (HADS) anxiety scale (p < 0.001) and HADS depression scale (p < 0.001) were considerably higher in the infected group than the non-infected group. With timely treatment and effective medical management, SARS-CoV-2 does not appear to affect the efficacy of NAC; however, it can significantly affect the QOL of patients and increase their psychological distress. Therefore, in addition to a timely assessment of the efficacy of NAC, it is necessary to dynamically understand the patient's psychological state and QOL.

Translation and Validation of a Vietnamese Version of the Colorectal Cancer Subscale for the Functional Assessment of Cancer Therapy - Colorectal Questionnaire.

There is a need for a validated Vietnamese translation of the colorectal cancer subscale (CCS) of the functional assessment of cancer therapy-colorectal (FACT-C) questionnaire to assess colorectal cancer-specific concerns of Vietnamese persons with colorectal cancer post-surgery. This study aims to translate and validate the CCS of FACT-C questionnaire in Vietnamese persons with colorectal cancer post-surgery. The nine-item CCS was translated following the functional assessment of chronic illness therapy (FACIT) translation methodology guidelines. Psychometric properties of a Vietnamese version of the CCS were evaluated with a sample of 135 participants who were randomly selected from three hospitals in Vietnam, utilizing a multistage sampling method. Construct validity was examined through confirmatory factor analysis (CFA), and reliability was assessed using Cronbach's α coefficients. These measures aimed to validate the psychometric properties of the Vietnamese nine-item CCS version. Descriptive statistics were used to analyze participant demographics with SPSS. The translated version demonstrated equivalence to the original English version. CFA results for the CCS Vietnamese version indicated that all 9 items were consistent with a unidimensional questionnaire (χ2 = 69.669, p > .05, df = 27, χ2/df = 2.58, RMSEA = .074, CFI = .917, TLI = .901, SRMR = .057). The Cronbach's α coefficient was .86, indicating high reliability. The Correlated Item-Total Correlation for the 9 items ranged from .39 to .76. The nine-item CCS Vietnamese version demonstrated appropriate translation, establishing its validity and reliability in measuring colorectal cancer-related concerns within the health-related quality of life among Vietnamese persons post-surgery.

Examining patient-reported late toxicity and its association with quality of life and unmet need for symptom management among nasopharyngeal cancer survivors: a cross-sectional survey.

Alongside the improved survival of nasopharyngeal cancer (NPC), late radiation toxicities are alarmingly hampering survivors' quality of life. A patient-reported symptom burden survey is lacking to address the unmet need for symptom management among local NPC survivors. A single-center cross-sectional survey was conducted on 211 NPC survivors who had completed radiation therapy for three to 120 months. We employed the Chinese version M. D. Anderson Symptom Inventory - Head & Neck Module (MDASI-HN-C), Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN-C), and a question extracted from the Cancer Survivors' Unmet Needs Measure (CaSUN). Two hundred valid responses were collected. Participants suffered from at least four moderate to severe symptoms (mean = 4.84, SD = 4.99). The top five severe symptoms were dry mouth, mucus problems, difficulty swallowing or chewing, teeth or gum problems, and memory problems. MDASI-HN-C subscales were negatively correlated with the physical, emotional, functional, and HN-specific domains of the FACT-HN-C. The unmet need for symptom management was positively associated with symptom burden, either general symptoms (Adjusted odds ratio [ORadj] = 1.566, 95% CI = 1.282 - 1.914, p < 0.001) or top-5 symptoms (ORadj = 1.379, 95% CI = 1.185 - 1.604, p < 0.001), while negatively associated with post-RT time (ORadj = 0.981, 95% CI [0.972, 0.991], p < 0.001). Virtually all NPC survivors suffer from late toxicities, which interplay with survivors' perceptions intricately to affect their unmet needs for symptom management. Personalized supportive care strategies with regular assessments and stratifications are warranted.

Relationship between Hope and Quality of Life in Patients with Advanced Cancer in Uruguay: An Observational Analysis

Introduction: International research suggests a beneficial effect of hope on quality of life in advanced-stage cancer patients. Specific evidence for Latin America and Uruguay is limited, highlighting the need to explore this relationship for regional clinical strategies.Objective: To evaluate the correlation between hope and quality of life in Uruguayan patients with advanced cancer. Materials and Methods: This observational, analytical-descriptive, and cross-sectional study used the Herth Hope Index (HHI) and the Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life questionnaire. It included 59 patients aged 18 or older, diagnosed with advanced, non-curable cancer.

The Functional Assessment of Cancer Therapy Scale: Development and Validation of the General Measure.

We developed and validated a brief, yet sensitive, 33-item general cancer quality-of-life (QL) measure for evaluating patients receiving cancer treatment, called the Functional Assessment of Cancer Therapy (FACT) scale. The five-phase validation process involved 854 patients with cancer and 15 oncology specialists. The initial pool of 370 overlapping items for breast, lung, and colorectal cancer was generated by open-ended interview with patients experienced with the symptoms of cancer and oncology professionals. Using preselected criteria, items were reduced to a 38-item general version. Factor and scaling analyses of these 38 items on 545 patients with mixed cancer diagnoses resulted in the 28-item FACT-general (FACT-G, version 2). In addition to a total score, this version produces subscale scores for physical, functional, social, and emotional well-being, as well as satisfaction with the treatment relationship. Coefficients of reliability and validity were uniformly high. The scale's ability to discriminate patients on the basis of stage of disease, performance status rating (PSR), and hospitalization status supports its sensitivity. It has also demonstrated sensitivity to change over time. Finally, the validity of measuring separate areas, or dimensions, of QL was supported by the differential responsiveness of subscales when applied to groups known to differ along the dimensions of physical, functional, social, and emotional well-being. The FACT-G meets or exceeds all requirements for use in oncology clinical trials, including ease of administration, brevity, reliability, validity, and responsiveness to clinical change. Selecting it for a clinical trial adds the capability to assess the relative weight of various aspects of QL from the patient's perspective.

The biology of hope: Inflammatory and neuroendocrine profiles in ovarian cancer patients

IntroductionAlthough the concept of hope is highly relevant for cancer patients, little is known about its association with cancer-relevant biomarkers. Here we examined how hope was related to diurnal cortisol and interleukin-6 (IL-6), a pro-inflammatory cytokine previously associated with tumor biology and survival in ovarian cancer. Secondly, we examined whether hope and hopelessness are distinctly associated with these biomarkers. MethodParticipants were 292 high-grade ovarian cancer patients who completed surveys and provided saliva samples 4x/daily for 3 days pre-surgery to assess diurnal cortisol. Blood (pre-surgery) and ascites were assessed for IL-6. Hope and hopelessness were assessed using standardized survey items from established scales (Center for Epidemiological Studies Depression Scale; Profile of Mood States, Functional Assessment of Cancer Therapy). Two hopeless items were z-scored and combined into a composite for analysis. Regression models related these variables to nocturnal cortisol, cortisol slope, plasma and ascites IL-6, adjusting for cancer stage, BMI, age, and depression. ResultsGreater hope was significantly related to a steeper cortisol slope, β = −0.193, p = 0.046, and lower night cortisol, β = −0.227, p = 0.018, plasma IL-6, β = −0.142, p = 0.033, and ascites IL-6, β = −0.290, p = 0.002. Secondary analyses including both hope and hopelessness showed similar patterns, with distinct relationships of hope with significantly lower nocturnal cortisol β = −0.233,p = 0.017 and ascites IL-6, β = −0.282,p = 0.003, and between hopelessness and a flatter cortisol slope, β = 0.211, p = 0.031. ConclusionsThese data suggest a biological signature of hope associated with less inflammation and more normalized diurnal cortisol in ovarian cancer. These findings have potential clinical utility but need replication with more diverse samples and validated assessments of hope.

UnitedStates Value Set for the Functional Assessment of Cancer Therapy-General Eight Dimensions (FACT-8D), a Cancer-Specific Preference-Based Quality of Life Instrument.

To develop a value set reflecting the United States (US) general population's preferences for health states described by the Functional Assessment of Cancer Therapy (FACT) eight-dimensions preference-based multi-attribute utility instrument (FACT-8D), derived from the FACT-General cancer-specific health-related quality-of-life (HRQL) questionnaire. A US online panel was quota-sampled to achieve a general population sample representative by sex, age (≥ 18 years), race and ethnicity. A discrete choice experiment (DCE) was used to value health states. The valuation task involved choosing between pairs of health states (choice-sets) described by varying levels of the FACT-8D HRQL dimensions and survival (life-years). The DCE included 100 choice-sets; each respondent was randomly allocated 16 choice-sets. Data were analysed using conditional logit regression parameterized to fit the quality-adjusted life-year framework, weighted for sociodemographic variables that were non-representative of the US general population. Preference weights were calculated as the ratio of HRQL-level coefficients to the survival coefficient. 2562 panel members opted in, 2462 (96%) completed at least one choice-set and 2357 (92%) completed 16 choice-sets. Pain and nausea were associated with the largest utility weights, work and sleep had more moderate utility weights, and sadness, worry and support had the smallest utility weights. Within dimensions, more severe HRQL levels were generally associated with larger weights. A preference-weighting algorithm to estimate US utilities from responses to the FACT-General questionnaire was generated. The worst health state's value was -0.33. This value set provides US population utilities for health states defined by the FACT-8D for use in evaluating oncology treatments.

Abstract B144: Associations between experiences of discrimination and quality of life in a cohort of Black/African American breast cancer survivors

Abstract Introduction: Racism and discrimination have been associated with poorer mental and physical health, and decreased health-related quality of life (QoL) in the general population, however; there are limited studies examining the impact of discrimination in cancer survivors. We examined the relationship between experiences of discrimination and QoL in Black women diagnosed with breast cancer. Methods: Data were obtained from women enrolled in the Women’s Circle of Health Follow-up Study, a population-based cohort study of Black breast cancer survivors in New Jersey, enrolled within 10 months of diagnosis. Women included in these analyses were diagnosed between 2015-2019. Self-reported experiences of discrimination along with information on potential covariates and effect modifiers were collected during baseline in-person interviews. QoL was assessed at follow-up visits approximately 24 months post-diagnosis using a validated self-reported QoL of measure, the Functional Assessment of Cancer Therapy – Breast (FACT-B), which consists of 5 individual domains (emotional, functional, social/family, and physical wellbeing, as well as a disease specific domain for breast cancer). We examined the association of experiences of discrimination (none, low (&amp;lt;median 43%), high (≥ median 43%)) with continuous total QoL score using linear regression, adjusted for age at diagnosis, tumor stage, educational attainment, household income, smoking status, insurance, and body mass index. We also examined statistical interaction by neighborhood socioeconomic index (nSES), coping strategy (assessed using the Brief Resilient Coping Scale), and spirituality (assessed using the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp-12) scale) using cross-product terms with experiences of discrimination. Results: Of 220 study participants, 73% of participants reported experiencing any discrimination. In age adjusted models, women who reported the highest experiences of discrimination had lower QoL for overall FACT-B scores and the subscale scores (no discrimination, mean overall FACT-B:117.7, 95% confidence interval (CI): 112.4, 122.9; high discrimination, mean overall FACT-B: 106.8, 95% CI: 102.1, 111.5). Similar associations were observed in fully adjusted models, where women who reported the highest experiences of discrimination had lower QoL. For example, for women who reported no discrimination the mean overall FACT-B score was 114.7 (95% CI: 107.9, 121.4) and 100.8 (95% CI: 94.2, 107.5) for women who reported the highest level of discrimination. No evidence of statistically significant interaction was observed for nSES, spirituality, or coping strategy. Conclusions: In a population-based study of Black breast cancer survivors, experiences of discrimination were associated with poorer QoL, as measured by FACT-B. Citation Format: Nur Zeinomar, Marley M. Perlstein, Bo Qin, Hari S. Iyer, Jesse J. Plascak, Christine B. Ambrosone, Kitaw Demissie, Chi-Chen Hong, Elisa V. Bandera. Associations between experiences of discrimination and quality of life in a cohort of Black/African American breast cancer survivors [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr B144.

Quality of life and financial toxicity of hematopoietic stem cell transplant recipients in COVID-19.

to evaluate and correlate the quality of life and financial toxicity of adult patients undergoing hematopoietic stem cell transplantation during the COVID-19 pandemic. observational, analytical study, carried out with 35 patients in a reference hospital for transplantation in Latin America. For data collection, the Functional Assessment Cancer Therapy Bone Marrow Transplantation and COmprehensive Score for Financial Toxicity questionnaires were used. Spearman and Mann-Whitney correlation tests were used for data analysis. general quality of life during COVID-19 had a low score (67.09/108) with greater impairment in functional well-being (14.47/28), social well-being (16.76/28) and additional concerns (23.41/40). The means of the allogeneic group were lower than those of the autologous group in all domains, showing a significant difference in relation to additional concerns (p=0.01) and in the treatment evaluation index (p=0.04). Financial toxicity was considered to have a slight impact (22.11/44). There was a relationship, albeit not significant, between quality of life and financial toxicity (p=0.051). the quality of life of the sample was low; there is a correlation between quality of life and financial toxicity, although not significant. The higher the financial toxicity, the lower the quality of life.

Qualidade de vida e toxicidade financeira dos transplantados de células-tronco hematopoéticas na COVID-19

Objective: to evaluate and correlate the quality of life and financial toxicity of adult patients undergoing hematopoietic stem cell transplantation during the COVID-19 pandemic. Method: observational, analytical study, carried out with 35 patients in a reference hospital for transplantation in Latin America. For data collection, the Functional Assessment Cancer Therapy Bone Marrow Transplantation and COmprehensive Score for Financial Toxicity questionnaires were used. Spearman and Mann-Whitney correlation tests were used for data analysis. Results: general quality of life during COVID-19 had a low score (67.09/108) with greater impairment in functional well-being (14.47/28), social well-being (16.76/28) and additional concerns (23.41/40). The means of the allogeneic group were lower than those of the autologous group in all domains, showing a significant difference in relation to additional concerns (p=0.01) and in the treatment evaluation index (p=0.04). Financial toxicity was considered to have a slight impact (22.11/44). There was a relationship, albeit not significant, between quality of life and financial toxicity (p=0.051). Conclusion: the quality of life of the sample was low; there is a correlation between quality of life and financial toxicity, although not significant. The higher the financial toxicity, the lower the quality of life.

Sustained Efficacy, Safety, and Improved Quality of Life in Adult and Pediatric Patients with Transfusion-Dependent β-Thalassemia up to 9 Years Post Treatment with Betibeglogene Autotemcel (Beti-cel)

Introduction: Beti-cel gene therapy addresses the underlying cause of transfusion-dependent β-thalassemia (TDT) by adding functional copies of a modified β-globin gene to autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) via a third-generation, self-inactivating lentiviral vector (LVV), BB305, which produces functional adult hemoglobin (Hb), HbA T87Q, in red blood cells (RBCs). Here, we report efficacy, safety, and quality of life (QOL) data from adult and pediatric patients treated with beti-cel who were followed for up to 9 years after treatment. These outcomes may inform patient selection for real-world treatment with beti-cel. Methods: Patients with TDT who completed either a phase 1/2 (HGB-204 [NCT01745120]; HGB-205 [NCT02151526]) or phase 3 (HGB-207 [NCT02906202]; HGB-212 [NCT03207009]) beti-cel parent study and subsequently participated in the long-term, 13-year follow-up study LTF-303 (NCT02633943) were included in this analysis. Analyses were performed with data collected through January 30, 2023. Efficacy (including transfusion independence [TI], defined as a weighted average Hb ≥9 g/dL without packed RBC transfusions for ≥12 months) and safety are reported through last follow-up. QOL data are reported for studies HGB-204, HGB-207, and HGB-212 through month 36. Statistical analyses were conducted to examine key outcomes in subgroups based on patient age at enrollment (pediatric: &amp;lt;18 years; adult: ≥18 years). Results:As of January 30, 2023, 63 patients (median [range] age: 17 [4-35] years) had received beti-cel in a phase 1/2 or 3 study and enrolled in LTF-303, with a median (range) follow-up of 60.1 (23.8-109.5) months. Phase 3 studies used the commercial drug product manufacturing process. Ninety percent (37/41) of phase 3 patients achieved and maintained TI through last follow-up (up to 6 years; Table 1). TI rates by study, genotype, and age for phase 3 patients are also presented in Table 1. In phase 1/2 studies that used an older drug manufacturing process, 68.2% (15/22) of patients achieved TI; 14 of these patients sustained TI through last follow-up (up to 9 years). One patient no longer meets protocol-defined TI as a result of Hb level &amp;lt;9g/dL at year 6 due to acute health events unrelated to β-thalassemia, which were not attributed to loss of beti-cel treatment effect. Approximately 80% of pediatric and adult patients required only one mobilization cycle to achieve the drug product dose. The median percentage of drug product cells transduced with the BB305 LVV was comparable between adult and pediatric populations (78% and 80%, respectively), as were the month 6 median peripheral blood vector copy number (1.4 c/dg and 1.1 c/dg) and HbA T87Q (9.4 g/dL and 8.3 g/dL). Adult patients reported improvements in QOL up to month 36 as assessed by the Short Form-36 Health Survey Questionnaire mental and physical component summary scores, Functional Assessment of Cancer Therapy, and EuroQol ( Table 2). Pediatric Quality of Life Inventory scores will be reported at the time of presentation. Overall, 19% (12/63) of patients experienced ≥1 beti-cel-related adverse event (AE); the most common beti-cel-related AEs (occurring in ≥3 patients) were abdominal pain (experienced in 5/63 [7.9%] patients) and thrombocytopenia (3/63 [4.8%] patients). Five patients experienced serious veno-occlusive liver disease; all 5 received defibrotide and recovered. No malignancies, insertional oncogenesis, or vector-derived replication-competent lentivirus were reported. Age subgroup safety analysis as of last follow-up will be reported in the final presentation. Conclusion: Beti-cel is a potentially curative gene therapy for patients with TDT across ages and genotypes through achievement of TI and normal or near-normal Hb. These data will inform real-world beti-cel treatment decisions for patients with TDT and providers.

Health-Related Quality of Life (HRQL) in Cutaneous T-Cell Lymphoma: Psychological Burden and Influencing Factors from Mycosis Fungoides and Sézary Syndrome Patients in China

Introduction: Mycosis fungoides (MF) and Sézary syndrome (SS) are the most common subtypes of cutaneous T-cell lymphomas (CTCL). However, beyond the clinical and economic burden, psychological burden from CTCL patients in China has not been reported and requires further evaluation. Methods: The analysis used data from adults (≥18 years) clinically diagnosed with MF or SS, and have been receiving or have received disease-related treatment in the past year. MF patients with stage IA-IIA, patch or plaque phase were categorized into early stage, while stage IIB-IVA, tumor phase were late stage. All SS patients are late stage. HRQL data from the EQ-5D-5L, Skindex-29 and Functional Assessment of Cancer Therapy - General (FACT-G) were analysed at the item level and scored according to instrument guidelines. Multivariate analyses were used to identify factors associated with poor HRQL. Results: Data were collected from a quantitative survey of 56 MF patients and 5 SS patients residing in 38 cities of 21 provinces across China: 56% were male, with a mean (SD) age of 39 (13) years (median was 38, ranged 19 to 74 years old). 51% were late stage. Based on emotional domain questions of Skindex-29, among all patients, 39% always or often worried about the disease progression, while 45% of late-stage patients were always and often worried. 36% of all patients often or always felt CTCL was annoying. Based on FACT-G, in physical well-being domain, 39% of all patients, and 48% of late-stage patients felt they were ill in “quite a bit” or “very much” scale, respectively. In social well-being domain, 35% of all, and 39% of early-stage patients felt “not at all” or only “a little bit” satisfied with their sex life. In emotional well-being domain, 38% of all patients were “not at all” or “a little bit” satisfied with their coping with the disease, while 36% of all patients “quite a bit” or “very much” worried about the condition getting worse. In the functional well-being domain, 29% of all patients felt they were “not at all” or “a little bit” able to work. In multivariate analysis, regression on EQ-5D-5L score showed that younger patients were more likely to report severe anxiety and depression. Skindex-29 score showed that female patients worried more that the disease get more serious and causing scars on their skin. Conclusions: In China, psychological burden with MF and SS, included anxiety, depression, worrying about disease progression, unable to work, and unsatisfied sex life. Younger patients and female patients reported greater psychological impact of the disease. Optimal medical management of MF and SS should address psychological impacts of the disease.

Quality of Life and Global Response Score in Cutaneous T-Cell Lymphoma

Background: Cutaneous T-cell lymphoma (CTCL) encompasses a heterogenous group of conditions that are typically incurable and managed as chronic, life-long diseases. Clinically, CTCL is associated with pruritus, and skin lesions that can cause pain and cosmetic discomfort, resulting in reduced health-related quality of life (HRQoL) for patients. As these patients often receive life-long therapy, any proposed therapy should maximize therapeutic safety and efficacy as well as patient HRQoL. Improvement in HRQoL may provide an indication to continue therapy, even for patients with partial response. Clinical trial response assessments for CTCL utilize a global response score, which includes skin, nodal and blood assessments (Olsen et al, JCO 2011). Dermatology-specific instruments, such as Skindex-29 (Chren 2012, Dermatol Clin 30), and oncology-specific instruments such as the Functional Assessment of Cancer Therapy - General (FACT-G) (Cella et al, JCO 1993), have been used to assess quality of life in this population. Disease entity, stage, age, sex, education, and treatment regimen are related to the extent of HRQOL impairment in patients with CTCL (Porkert et al, EJC 2018). Correlation between clinical response and HRQoL response has been reported in other cancers, such as renal cell carcinoma (Grimm Oncol Ther 2017) and other dermatologic conditions such as psoriasis (Acta Derm Venereol 2017), but has not been reported in CTCL. We evaluated changes in HRQoL in relation to the global response score in CTCL. Methods: Global response data, as well as Skindex-29 and FACT-G scores, were obtained from the phase III MAVORIC study (Kim et al, Lancet Oncol 2018). Patients with stage IB-IVB mycosis fungoides or S ézary syndrome were prospectively enrolled. Global response score was assessed every 8 weeks. Skindex-29 and FACT-G questionnaires were administered every 8 weeks. Patients with at least a baseline value for Skindex-29 or FACT-G score, at least one subsequent visit with both Skindex-29 or FACT-G value, and an overall response value were included. Changes in scores were calculated from baseline to the first visit with best overall response. A higher score in Skindex-29 indicated worse HRQoL. A higher score on FACT-G indicated improvement in HRQoL. Wilcoxon rank-sum test was performed. Correlation was calculated by Pearson coefficient. Results: 324 patients were evaluable for total Skindex-29 analysis. First visit with best overall response for patients with PD/SD occurred at a median of 1.26 cycles (IQR; 1.26, 14.26); 5.98 cycles (IQR; 1.26, 48.98) for PR; and 10.98 cycles (IQR; 3.98, 36.98) for CR. Patients with CR/PR as best response (n=121) had median change in Skindex-29 of -16 (IQR; -31, -8) and patients with SD/PD as best response rate had median change in Skindex-29 of -4 (IQR; -12, 3) (p &amp;lt;0.001) (Table 1). 333 patients were evaluable for total FACT-G analysis. Patients with CR/PR as best response rate had median change in FACT-G of 6 (IQR; -2, 16) and patients with SD/PD as best response rate had median change in FACT-G of 2 (IQR; -6, 8) (p &amp;lt;0.001) (Table 1). Skindex-29 correlates with global response score overall and across all domains. FACT-G correlates with global response score overall and across all domains, with the exception of social well-being. There was a moderate reverse correlation between change in total Skindex-29 and change in total FACT-G score (R=-0.61, p&amp;lt;0.001) (Figure 1). Conclusion: HRQoL as measured by the Skindex-29 and FACT-G correlate with complete or partial response to therapy in the global response score in patients with CTCL. There is moderate correlation between skin-specific quality of life and general quality of life in this population. Further exploration of factors affecting social well-being in patients with CTCL is warranted. Incorporation of QOL scales in global response score criteria should be considered.

Neurocognitive Outcomes over the First 3 Months after Chimeric Antigen Receptor T-Cell (CAR T) Therapy: Preliminary Findings from a Longitudinal Study

Introduction People treated with systemic therapies for cancer may exhibit changes in neurocognitive functioning over time, affecting domains such as memory, processing speed, and executive functioning. There is a need for prospective data regarding neurocognitive outcomes among patients treated with Chimeric Antigen Receptor T-Cell (CAR T) therapy. The purpose of this study was to investigate the trajectory of neurocognitive performance and self-reported cognitive functioning over the first 3 months of CAR T therapy. Methods As part of a larger cohort study of patients treated with CAR T, neurocognitive outcomes were assessed prior to starting CAR T and again at 1- and 3- months post-CAR T. Neurocognitive performance was measured using standardized neuropsychological tests including measures of verbal memory (Hopkins Verbal Learning Test-Revised (HVLT-R) - immediate recall, delayed recall, retention), processing speed (Trail-making Test - Part A (TMT-A)) and executive functioning (Trail-making Test Part B (TMT-B), Controlled Oral Word Association Test (COWAT)). Raw test scores were converted to z-scores (Mean 0, SD 1) based on norms adjusted for age, sex, and education, where applicable. Impairment on individual tests was defined by a z score ≤ -1.64. Participants were categorized as showing overall impairment if they had at least two tests with a z-score of ≤ -1.5 or a z-score ≤ -2.0 on one test. Self-reported cognitive functioning was measured using the Functional Assessment of Cancer Therapy - Cognition, Perceived Cognitive Impairment score (FACT-Cog3 PCI) and the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire C-30, Cognitive Functioning scale (EORTC QLQ-C30 CF). Demographic and clinical data were collected through self-report and patient records. Frequencies of impairment were determined at each time point, with clinically significant changes on individual test scores in the first month determined based on z-score changes of ≥1.0 or minimal clinically important differences for self-report questionnaires. Linear mixed models were generated to estimate the trajectory of neurocognitive performance and self-reported cognitive functioning over time from baseline to 3 months. Results Neurocognitive outcomes were available for 37 participants at baseline, with follow-up data available for 29 patients at 1 month and 17 patients at 3 months. Participants were 54% male, had a mean age 58.4 years (sd 11.3) and a mean 15.5 years (sd 3.2) education. All patients had a diagnosis of non-Hodgkin lymphoma (53% diffuse large B-cell lymphoma (DLBCL), 31% transformed DLBCL from follicular lymphoma). Immune effector cell-associated neurotoxicity syndrome (ICANS) affected 32% of patients (5% Grade 4, 3% Grade 3, 8% Grade 2, 16% Grade 1). Cytokine release syndrome (CRS) affected 97% of patients (3% Grade 3, 76% Grade 2, 19% Grade 1). Frequency of overall impairment at each time point was 10/37 (27%) at baseline, 12/29 (41.4%) at 1 month, and 3/17 (17.6%) at 3 months. At each time point, impairment was most common on tests of executive functioning and memory. Based on individual test score changes between baseline and 1 month, rates of decline on individual tests of neurocognitive performance ranged from 11.5% (TMT-A) to 34.6% (COWAT). Decline on self-reported cognitive functioning was observed for 14.3% (FACT-Cog PCI) and 28.6% (EORTC QLQ-C30 CF) of participants. Based on mixed models (Table 1), there was a statistically significant decline in estimated mean z-scores on a test of executive function (COWAT: -0.52, 95% CI -0.89-(-0.16), p=0.007) at 1-month compared to baseline. At three months, there was a statistically significant improvement in estimated mean z-scores on memory (HVLT-R immediate recall: 0.56, 95% CI 0.11-1.01, p=0.017) and executive functioning (TMT-B: 0.87, 95% CI 0.17-1.57, p=0.019; COWAT: 0.68, 95% CI 0.19-1.16, p=0.009) compared to baseline. Conclusions Impairment is present in a subgroup of patients prior to starting CAR T therapy. Patients may demonstrate declines on performance-based measures and report worsening cognitive symptoms in the first month after CAR T therapy, but also improved performance in some domains by three months. Enrollment and long-term follow-up of patients in this study is ongoing. Future analyses will explore differences in trajectories among subgroups, such as those who have experienced ICANS and CRS.

Financial Toxicity and Quality of Life in Patients Taking Oral Therapy for Hematologic Malignancies

Background There has been an increase in the use of oral agents for the treatment of hematologic malignancies. Though clinically efficacious and convenient, oral therapies often have higher out-of-pocket cost than intravenous medications due to differences in insurance coverage. High financial burden and sequelae thereof, known as financial toxicity (FT), can negatively impact patient mood, adherence, quality of life (QoL), and outcomes. We present cross-sectional data from a longitudinal survey to evaluate the economic, psychosocial, and QoL impact of oral anti-cancer medications (OAMs) in the treatment of hematologic malignancies. Methods We used database query to identify patients at a midwestern, tertiary care, academic medical center who were 18 years or older and were prescribed Enasidenib, Ivosidenib, Venetoclax, Gilteritinib, Midostaurin, Ibrutinib, Acalabrutinib, Imatinib, Nilotinib, Ponatinib, Bosutinib, Duvelisib, or Idelalisib within the past 3 months. Chart review confirmed medication initiation within the past 3 months for a diagnosis of MDS, AML, CML, ALL, CLL, HL, or NHL. Patients were recruited by phone and consented by email. Consenting patients were sent an 85-item online survey assessing sociodemographic information, treatment-related information, and validated surveys, including the Functional Assessment of Cancer Therapy (FACT-G7) and Comprehensive Score for Financial Toxicity (COST) questionnaires. Participants received a follow-up survey 3 months after completing the initial survey. Statistical analysis was performed with GraphPad Prism 9 by Spearman's rank correlation, Mann-Whitney U test, or Kruskal-Wallis H test as appropriate. Results Between November 2021 and April 2023, 528 patients were identified, of whom 152 were eligible for participation and 28 consented and completed the initial survey (18.4%). Demographics are reported in Table 1. The group was predominantly male (64.3%), white (92.9%), married (78.6%), college-educated (64.3%), and financially stable (50% with annual income over $100,000). In the six months prior to diagnosis, 57.1% of participants were working full time and 35.7% were retired. At the time of survey completion, 25% were working full time, 50% were retired, and 14.3% were disabled or unable to work due to health. All participants were insured (60.7% Medicare, 35.7% private insurance). All participants on Medicare had Part A and B coverage, and 82.4% had Part D coverage. All but 1 participant had prescription drug coverage. AML (32.1%), CLL (25%), and CML (17.9%) were the most common diagnoses. Venetoclax (46.6%) was the most common OAM. Results are summarized in Table 2. Those with a history of depression or anxiety had no difference in financial stress, experiencing cancer as a financial hardship, QoL satisfaction, or bother from side effects (SE) as those without such history. Income was inversely associated with identifying cancer as a financial hardship (rs -0.485; 95% CI, -0.732 to -0.125) and with pain (rs -0.389; 95% CI, -0.678 to -0.007). Income had no correlation with QoL satisfaction or bother from SE. Insurance coverage had no association with financial stress, seeing cancer as a financial hardship, QoL satisfaction, or bother from SE. Those disabled or unable to work felt more financial stress than those who were retired (P=0.018). They also saw cancer as more of a financial hardship than those who either worked full time or were retired (P=0.005). Those who had a family member stop working or reduce work hours had lower income (P=0.009), greater financial stress (P=0.015), worse QoL satisfaction (P=0.013), and increased bother from SE (P=0.017) than those who did not. Financial stress was negatively associated with QoL satisfaction (rs -0.552; 95% CI, -0.775 to -0.206) and positively associated with bother from SE (rs 0.469; 95% CI, 0.105 to 0.772). Experiencing cancer as a financial hardship was negatively associated with QoL satisfaction (rs -0.517; 95% CI, -0.755 to -0.159). Conclusions In this well-resourced cohort taking OAMs to treat hematologic malignancies, there were multiple indicators of FT. Patient or family loss of employment was notably associated with financial stress and hardship. Financial stress and hardship were associated with worse satisfaction with QoL and worse experience of SE. Further study should define change in these features over time and interventions to mitigate distress.

Coping in Patients with Hematologic Malignancies Undergoing Hematopoietic Cell Transplantation

Background Patients undergoing hematopoietic cell transplantation (HCT) must cope with immense physical and psychological symptoms during HCT hospitalization, which contribute to a dramatic deterioration in quality of life (QOL). Yet, studies examining pre-HCT coping strategies are limited. We aimed to characterize use of pre-HCT coping strategies, to identify sociodemographic and clinical factors associated with coping strategy use, and to investigate the association of coping strategy use with pre-HCT QOL and psychological distress. Methods We conducted a secondary analysis of baseline data from a multi-site randomized controlled trial evaluating a supportive care intervention for patients with hematologic malignancies undergoing allogeneic or autologous HCT (NCT#03641378). From 10/2018 - 07/2022, the trial enrolled consecutive adults (age ≥ 18) with hematologic cancers undergoing HCT at three tertiary care academic centers. Prior to HCT, we assessed QOL (Functional Assessment of Cancer Therapy - Bone Marrow Transplant), psychological symptoms (Hospital Anxiety and Depression Scale and Post Traumatic Stress Disorder (PTSD) - Civilian Version), and coping (Brief COPE). We categorized coping as either “approach-oriented” (active coping, use of emotional support, positive reframing, acceptance) or “avoidant” (behavioral disengagement, denial, and self-blame). We used the median split method to categorize high and low use of approach-oriented and avoidant coping. Univariate logistic regression was used to identify sociodemographic and clinical factors associated with high use of coping strategies. Multivariate linear regression was used to measure associations of coping strategy use with QOL and psychological distress. Results Of pre-HCT patients (n=360), the majority were male (62.8%), identified as White (77.5%), were younger than 65 (73.6%), and had received at least some college education (78.9%). A minority were unemployed due to disability from illness (29.2%). Approximately half received autologous HCT (n=178, 49.4%). Figure 1 displays the proportion of patients scoring as high utilizers of individual coping strategies. While 31.3% were high utilizers of avoidant coping, 43.5% were high utilizers of approach-oriented coping. Notably, 43 (11.9%) patients identified as high utilizers of both approach-oriented and avoidant coping. No sociodemographic or clinical factors were associated with use of approach-oriented coping. Older age (&amp;gt;65 years, OR=0.9, p=0.01) and higher income (&amp;gt;$100K, OR=0.90, p=0.04) were associated with less frequent use of avoidant coping. Female gender (OR=1.11, p=0.03) and disabled employment status (OR=1.11, p=0.05) were associated with increased likelihood of high use of avoidant coping. Table 1 displays adjusted associations between approach-oriented and avoidant coping strategies and patient-reported outcomes. High use of approach-oriented coping was associated with better pre-HCT QOL (B=6.4, p&amp;lt;0.001) and lower depression (B=-1.1, p=0.001) and anxiety (B=-0.9, p=0.02) symptoms. High use of avoidant coping was associated with worse pre-HCT QOL (B=-11.7, p&amp;lt;0.001) and symptoms of depression (B=1.9, p&amp;lt;0.001), anxiety (B=3.1, p&amp;lt;0.001), and PTSD (B=8.1, p&amp;lt;0.001). Conclusions Prior to HCT, patients frequently employ approach-oriented and avoidant coping strategies. Key sociodemographic factors including age, gender, income level, and employment status were associated with avoidant coping. Patients with high use of approach-oriented coping reported higher baseline QOL and lower psychological distress, while those with high use of avoidant coping strategies reported worse QOL and psychological distress. These data suggest that supportive care interventions which enhance approach-oriented coping and mitigate avoidant coping in pre-HCT populations may improve QOL and reduce psychological distress

Patient-Reported Outcomes and Survival Following Pancreatic Cancer Resection—Results from a Cross-Section Study

The aims of this study were to assess patient-reported outcomes and the survival of patients following curative resection for pancreas cancer. Adult patients undergoing curative pancreatic resection between April 2014 and April 2019 across six major hospitals in Sydney were invited to complete the Short-Form 36 (SF-36v2) and the Functional Assessment Cancer Therapy—Hepatobiliary (FACT-Hep) questionnaires. Time from surgery was categorised into four different time points: 3–11, 12–23, 24–35, and 36–62 months. Survival analyses were performed using Kaplan–Meier and log-rank tests. A total of 278 patients underwent curative resection. Mean (SD) age was 65.0 (13.2), and 50.7% (n = 141) were males. Out of the 205 (74%) alive patients, 128 (62%) completed the study surveys. The physical component score and total FACT-Hep scores showed no significant changes over time. The mental component score improved from 3–11 months to 12–23 months (p = 0.009) and from 3–11 months to 36–62 months (p = 0.007). Survivorship showed a significant difference between malignancy, pre-malignancy, and benign disease groups, with 45.8 months (95%CI: 42.4–49.1), 40.3 months (95%CI: 36.4–44.2), and 41.3 months (95%CI: 37.9–44.9), respectively. For patients undergoing curative resection for pancreatic cancer, mental component scores improved over time, whereas overall survival outcomes seem to be influenced according to cancer pathology.

NCOG-36. IMPACT OF COLLAGEN TILE BRACHYTHERAPY AS TREATMENT FOR RECURRENT GLIOBLASTOMAS ON FUNCTIONAL STATUS AND QUALITY OF LIFE

Abstract BACKGROUND Recurrent glioblastoma is an aggressive disease with dismal prognosis despite advances in standard therapy, making the maintenance of functional status and quality of life (QOL) in patients an important endpoint during treatment. Here, we report functional status (KPS) and QOL metrics (LASA and FACT-Br) at 6-months post-treatment for recurrent glioblastoma patients treated with maximal safe resection followed by intraoperative placement of collagen tile brachytherapy with Cesium-131 (Surgically Targeted Radiation Therapy or STaRT), a novel brachytherapy carrier. OBJECTIVE To assess the impact of STaRT on KPS and QOL among patients with recurrent glioblastoma (rGBM) at 6-months post-treatment. METHODS Patients were treated between 10/2020 and 05/2023 as part of a multi-institutional registry study (NCT#04427384). KPS was used to measure functional status. Linear Analog Self-Assessment (LASA) and Functional Assessment of Cancer Therapy – Brain (FACT-Br) were used to measure QOL. All assessments were collected at pre-surgery, and 1,3, and 6-months post-treatment. RESULTS 57 rGBM patients were treated on the Registry between 10/2020 and 05/2023. Of the 57 participants, 47 participants remain in the study, with 21 participants reaching the 6-month time point (5 exits, 5 deaths). Median age was 60 years (range 28-81). Methylguanine methyltransferase (MGMT) promoter was methylated in 17.5%, unmethylated in 38.5%, and unknown in 44%. Gross total resection was achieved in 72% of participants. Median KPS was 80% (range 40%-100%) at screening versus 70% (range 40%-90%) at 6 months post-treatment. Median LASA was 37 (range 8-50) at pre-surgery versus 34 (range 5-48) at 6-months post-treatment. Minimally important differences (MID) were noted between pre-surgery (136.9 ± 29.5) and 6-months post-treatment (112.5 ± 35.7) for the FACT-Br Total Score. CONCLUSION This interim data analysis supports further investigation of STaRT as a treatment for recurrent glioblastomas as a means of providing stable functional status and quality of life.

Prevalence of active cytomegalovirus infection at diagnosis of ovarian cancer and during chemotherapy and subsequent changes in cognitive functioning

PurposeOne of the most frequently reported effects of cancer and its treatments is cancer-related cognitive impairment (CRCI). Viral infections may affect inflammation and immune function and therefore may influence patient symptoms, including CRCI. The goal of this study was to describe the prevalence of cytomegalovirus (CMV) infections at diagnosis, during, and after chemotherapy in individuals with ovarian cancer and explore CMV infection at diagnosis with cancer-related cognitive impairment (CRCI) following chemotherapy.MethodsWe recruited adults newly diagnosed with ovarian, primary peritoneal or fallopian tube cancer at a single academic cancer center into two prospective studies. In Study 1 (N = 71), participants provided blood samples at diagnosis. In Study 2 (N = 18), participants provided blood samples and completed symptom surveys before, during and after front-line adjuvant chemotherapy. Serum CMV DNA levels were assessed using digital PCR; >100 copies/mL of serum was considered positive for active CMV infection (CMV+). CRCI was measured using the Functional Assessment of Cancer Therapy – Cognitive Function (FACT-Cog) questionnaire. Changes in FACT-Cog scores were compared by CMV status at diagnosis using t-tests at each time point.ResultsAt diagnosis, 29.2% were CMV+ (28.2% in Study 1, 33.3% in Study 2). Following three cycles of chemotherapy (Study 2), CMV positivity rose to 60.0% and then back down to 31.3% after chemotherapy. We observed significant differences in CRCI following chemotherapy by CMV status at diagnosis.ConclusionOur data suggest that active CMV infection is common among patients undergoing treatment for ovarian cancer and may contribute to symptoms of CRCI.