Functional Assessment Of Cancer Treatment Research Articles

Abstract PO3-28-04: Ganglioside-Monosialic Acid for Prevention of Peripheral Neuropathy Induced by nab-Paclitaxel in Breast Cancer Patients (HELEN-004): A Randomized, Double-Blind, Phase II Trial

Abstract Introduction Chemotherapy-induced peripheral neuropathy (CIPN) is a dose limiting adverse effect of nab-paclitaxel. Ganglioside-Monosialic Acid (GM1) is an abundant glycosphingolipid in neuronal membranes and studies have shown its potential in preventing CIPN as a neuroprotective factor. This study was conducted to evaluate the effect of GM1 in preventing CIPN induced by nab-paclitaxel in breast cancer patients. Methods This study was a randomized, double-blind, placebo-controlled phase II trial conducted at three hospitals in China (NCT04222790). Female patients 18 to 75 years with early-stage breast cancer who were scheduled to receive nab-paclitaxel containing chemotherapy were randomly assigned to receive GM1 or placebo. Nab- paclitaxel was given 125-150 mg/m2 once per week for 12 cycles or 260 mg/m2 once every 3 weeks for four cycles. GM1 or placebo started one day before chemotherapy and was given once per day for 3 days (day −1, day 1, and day 2). The primary outcome was peripheral neuropathy evaluated by the Functional Assessment of Cancer Treatment Neurotoxicity (FACT-Ntx) subscale at 2 weeks after four cycles of chemotherapy. Other endpoints included peripheral neuropathy evaluated by CTCAE version 4.0, Functional Assessment of Cancer Therapy – General (FACT-G) scores and Functional Assessment of Cancer Therapy – Taxane (FACT-Taxane) scores at 2 weeks after four cycles of chemotherapy. Adverse events were evaluated by CTCAE version 4.0. Additional long-term assessments were performed at 3 months, 6 months, and 1 year after the completion of chemotherapy. All assessments were performed by trained physicians. Results 159 patients were enrolled from April 2020 to June 2021, with 79 patients assigned to the GM1 group and 80 patients to the placebo group. Eight patients in the GM1 group and eight patients in the placebo group did not complete the endpoint assessments. In total, 71 patients in GM1 group and 72 in placebo group were evaluated. Baseline characteristics were generally well balanced between groups. After four cycles of Nab-paclitaxel containing chemotherapy, Patients in the GM1 group reported similar mean FACT-Ntx subscale 36.1 (35.1-37.0) with patients in the placebo group 36.4 (35.3-37.3). Compared with baseline, the mean FACT-Ntx score at two weeks after four cycles of chemotherapy decreased by 7.9 in the GM1 group (p< 0.001) and 7.6 in the placebo group (p< 0.001). The difference between GM1 group and placebo group was not statistically significant (P=0.703). No difference was observed in secondary outcomes except that GM1 group showed lower FACT G scores (61.0, 95% CI, 58.1-63.9) than the control group (67.0, 95% CI, 63.2-70.8) at two weeks after four cycles of chemotherapy, the difference was statistically significant (P=0.014). The main results of primary and secondary outcomes were summarized in Table 1. Random assignment was stratified by age (< 60 or >=60) and BMI ((< 24 or >=24). Subgroup analysis was performed for patients in different age and BMI groups. Overall, patients above 60 years old showed lower FACT-Ntx score at than patients under 60 (34.1 and 36.5, respectively. P=0.056). Overweight patients (BMI >=24) showed similar FACT-Ntx score with patients with BMI smaller than 24 (36.8 and 35.7, respectively. P=0.095). The FACT-Ntx score was not significantly different between the GM1 and placebo group in different age and BMI subgroups. The most common adverse events, including myalgia-arthralgia, nausea, vomit, and diarrhea, were evaluated according to CTCAE version 4.0. Incidence and severity of adverse events were not statistically significantly different between the two groups. Conclusion GM1 did not prevent peripheral neuropathy induced by nab-paclitaxel in breast cancer patients. The effect of GM1 in preventing CIPN is still inconclusive and further studies are needed. Caution in recommending GM1 to prevent CIPN is clearly warranted. Table 1. FACT-Ntx subscale, CTCAE version 4.0, FACT-Taxane and FACT G at 2 weeks after four cycles chemotherapy. a. FACT-Ntx: Functional Assessment of Cancer Treatment- Neurotoxicity; b. CTCAE4.0: Common Terminology Criteria for Adverse Events; c. FACT-Taxane: Functional Assessment of Cancer Treatment – Taxane; d. FACT G: Functional Assessment of Cancer Treatment- General. Citation Format: Zhenduo Lu, Dechuang Jiao, Jianghua Qiao, Hao Zhang, Hao Dai, Xianfu Sun, Min Yan, Yong Zhou, Lianfang Li, Chengzheng Wang, Xiuchun Chen, Zhenzhen Liu. Ganglioside-Monosialic Acid for Prevention of Peripheral Neuropathy Induced by nab-Paclitaxel in Breast Cancer Patients (HELEN-004): A Randomized, Double-Blind, Phase II Trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-28-04.

EFFECTS OF A PRESCRIBED, SUPERVISED EXERCISE PROGRAMME ON HEALTH-RELATED QUALITY OF LIFE IN ONCOLOGY PATIENTS: A RETROSPECTIVE OBSERVATIONAL COHORT STUDY

INTRODUCTION & AIMS Individuals diagnosed with cancer experience significant physical and psychosocial consequences from oncological treatment. Based on current research, exercise therapy may be a valuable non-pharmacological approach to improve health-related quality of life (HRQoL). However, the effectiveness of individually tailored exercise programs to improve quality of life in real-world settings is understudied. The current study aims to analyse preliminary clinical data regarding the impact of tailored exercise supervised within an Australian private day hospital (LIFT) on HRQoL in individuals diagnosed with cancer. METHODS A retrospective longitudinal cohort study was conducted on adults diagnosed with cancer who attended the LIFT clinical service for at least 12 months between 2020 and 2023. QoL and symptoms were assessed using the Functional Assessment of Cancer Treatment – General Questionnaire (FACT-G). Data collected included diagnosis (type and stage), medical treatment, session frequency, and demographic data. RESULTS Overall, 40 patients (age=67.0±16.8 years) met the inclusion criteria. A within-group analysis demonstrated significant findings in the subscales of emotional wellbeing (p = 0.008) and functional wellbeing (p = 0.003), and significance was also found in the total FACT-G score (p = 0.0019). Interestingly, while not statistically significant, a clinically significant difference in HRQoL was found between individuals completing ≤1 or ≥ 2 supervised exercise sessions per week at LIFT cancer care centre, favouring those completing ≥ 2 sessions. CONCLUSION Preliminary analysis indicated that a “real-world” individualised supervised moderate-vigorous exercise within a day hospital has the potential to significantly improve HRQoL outcomes in individuals diagnosed with cancer.

Functions of Resiliency Traits and Processes in Differential Effects of CBSM on Quality of Life in Breast Cancer Survivors: A Moderated Mediation Model.

Although there is evidence that cognitive behavioral therapy (CBT)-based group interventions can improve quality of life (QoL) in women undergoing treatment for breast cancer (BC) little is known about factors that mediate and moderate these effects. We examined a) the mediating role of benefit finding on QoL changes after a Cognitive Behavioral Stress Management (CBSM) intervention, and b) whether this mediation effect differed based on baseline optimism in the first year following surgery for BC. We used data from a prior CBSM trial in 240 women with stage 0-3 BC who completed measures of benefit finding (Benefit Finding Scale, BFS), QoL (Functional Assessment of Cancer Treatment, FACT-G), and optimism (Life Orientation Test-Revised) at baseline (2 - 10weeks post-surgery), 6-months and 12-months after randomization. CBSM-related changes and mediation and moderation effects were assessed using latent growth curve models. We found CBSM increased benefit finding (b = 2.65, p < 0.01), emotional (b = 0.53, p < 0.01), and functional QoL (b = 0.71, p < 0.05) over time. CBSM-related changes in emotional QoL were mediated by increased benefit finding (indirect effect = 0.68, 95% bootstrapped CI: 0.17, 1.56) but only among participants with low to moderate optimism at baseline. CBSM intervention improved emotional QoL over the first year of breast cancer treatment by increasing benefit finding among women who reported low trait optimism suggesting those who will most likely benefit from improving benefit finding during this stressful period.

Integrating Touchscreen-Based Geriatric Assessment and Frailty Screening for Adults with Acute Myelogenous Leukemia to Drive Personalized Treatment Decisions

Background: Acute Myeloid Leukemia (AML) is a disease of older adults, with a median age of 68 years at diagnosis. The NCCN guidelines recommend comprehensive geriatric assessments (GA) be included in clinical practice to guide treatment decisions. Utility of GA in older AML patients in a real-world environment is not yet established. We tested the feasibility of using a modified GA (mGA), administered by patient self-report on a touchscreen computer, real-time use and utility by clinicians and the correlation of mGA results on treatment decision-making.Methods: 77 newly diagnosed patients were recruited from three sites to complete a tablet-based mGA screening at a treatment decision visit. The mGA includes four domains: age, activities of daily living (ADLs), instrumental ADLs, and comorbidities. Survey results along with history of falls was used to create the Frailty Index (FI). Providers were asked what they thought the fit/frailty status of the patient was before viewing the results on a dashboard. After viewing the survey results, the clinician discussed the treatment plan with the patient. Patients received intensive or non-intensive therapy. Additional information was captured on clinical trial enrollment. Baseline and 3 month surveys recorded presence and severity of 8 symptoms using the Edmonton Symptom Assessment Scale (ESAS) with 0=no symptom and 10=worst possible symptom and quality of life using the Functional Assessment of Cancer Treatment: Leukemia (FACT-LEU).Results: Participants had a median age of 71 years ( range:61-88y); 50% were female, and 87% white. Frailty Index results for 76 patients were 28 (36.4%) fit, 25 (32.5%) intermediate, and 23 (29.9%) frail. (One patient did not complete the mGA). 52 of 77 (69%) enrolled patients were alive at 3 months; 21(27%) died and 4 (5%) were lost to follow-up. Providers were asked the fit/frailty status prior to seeing the results of the mGA. Of 75 provider responses, results were 27 (36.0%) fit, 29 (38.7%) intermediate, and 19 (25.3%) frail. There was 63% (n=47) provider concordance with the mGA result. There was more agreement with fit (n=22, 81.5%) and frail status (n=11, 57.9%) and less with intermediate (n=14, 48.3%). Of the 25 of 75 (33.%) provider reports that indicated that the mGA result influenced the treatment decision, 6 patients (5 fit, 1 intermediate) received intensive treatment, 15 received non intensive treatment (1 fit, 6 intermediate, 8 frail) and 4 enrolled in a clinical trial (1 fit, 2 intermediate, and 1 frail). Significant symptom improvement at 3 months was seen for drowsiness, lack of appetite, shortness of breath, and anxiety. FACT Leu results did not change over 3 months. Providers reported an average of 4.45 minutes to review the dashboard. Patients were able to complete the surveys unassisted in an average time of 16.24 minutes.Discussion: There was nearly 40% discordance between the provider and mGA, with the most discordance on the intermediate fit status. However, results of the mGA influenced treatment decision making in one third of provider/patient interactions. Further analysis of the mGA domains is warranted to see if additional insights can be gained. With time, some symptoms improve and others don't. This points to the opportunity to direct resources towards symptom assessment during treatment. Feasibility was demonstrated in this study as providers received the aggregated results in real time and reviewed them in less than 5 minutes. In addition, patients were able to complete the survey unassisted without disturbing clinic operations. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Patient-Reported and End-of-Life Outcomes Among Adults With Lung Cancer Receiving Targeted Therapy in a Clinical Trial of Early Integrated Palliative Care: A Secondary Analysis

ContextTargeted therapy has revolutionized lung cancer treatment and markedly increased survival, though data are lacking on patient-reported and end-of-life (EOL) outcomes among patients receiving targeted therapy. ObjectivesThis study aimed to compare quality of life (QOL), symptoms, prognostic communication, and EOL care between patients receiving targeted therapy and patients with lung cancer without targetable mutations. MethodsIn this secondary analysis of a randomized trial of early palliative care in advanced lung cancer (n=154), we compared change in QOL and symptoms (per the Functional Assessment of Cancer Treatment [FACT]-Lung scale) over 24 weeks among patients with lung cancer receiving targeted therapy versus those without targetable mutations using linear mixed effects models, adjusted for receipt of palliative care, age and gender. We also compared prognostic communication and decedents’ EOL health care utilization using logistic regression, adjusted for palliative care. ResultsCompared to individuals without targetable mutations, patients receiving targeted therapy (n=35) reported greater improvements in QOL (FACT-General B=0.46; 95% CI=0.19, 0.73) and symptoms (FACT-Lung Cancer Subscale B=0.12; 95% CI=0.03, 0.20) over time, independent of palliative care. Patients receiving targeted therapy were also more likely to report they rarely discussed prognosis with their clinicians (OR=2.59, 95% CI=1.01, 6.63) and were more likely to receive cancer-directed therapy in their last 14 days of life (OR=14.98, 95% CI=4.08, 54.96). ConclusionsRelative to patients without targetable mutations, patients with lung cancer who receive targeted therapy experience improved QOL and symptoms, are less likely to discuss prognosis early in their illness course, and more likely to continue treatment until death and die in the hospital.

49. CORRELATES AND PREDICTORS OF HEALTH-RELATED QUALITY OF LIFE IN METASTATIC BRAIN CANCER

PURPOSENeurocognitive functioning (NCF), mood disturbances, physical functioning, and social support all share a relationship with health-related quality of life (HRQOL). However, a characterization of these relationships in persons with brain metastases (BM) has yet to be identified.METHODSNinety-three newly diagnosed persons with BM were administered a cognitive battery to assess neurocognitive functioning, mood disturbances, physical functioning, and social support. The Functional Assessment of Cancer Treatment (FACT) scale was used to measure HRQOL.RESULTSMood and physical function correlated with lower HRQOL in every measured domain. Verbal learning and memory correlated with every FACT subscale except emotional quality of life. Social support also correlated with several HRQOL domains. Stepwise linear regressions revealed that mood was the predominate predictor of HRQOL. Social support, physical functioning, verbal learning, and memory also contribute to HRQOL, but to a lesser extent.CONCLUSIONHRQOL is a complex construct affected by mood, physical functioning, and learning and memory. Mood is a domain-independent predictor of HRQOL, while non-mood variables predict HRQOL in domain-specific ways. Thus, multifactorial baseline assessments of persons with BM are encouraged to help mitigate the impact that BM has on HRQOL.

Impact of weight loss on cancer patients' quality of life at the beginning of the chemotherapy.

Among the prognostic factors relevant to the condition of oncological patients, nutritional status (NS) has the greatest single impact on quality of life (QL). The goals of our study were to evaluate the influence of NS, weight loss (WL), and the presence of cachexia, prior to the initiation of chemotherapy, on the patient's QL. Adult patients (aged ≥ 18years) diagnosed with solid tumours for whom chemotherapy was started between April 2016 and June 2017 were eligible for inclusion in the study. They were asked to complete a QL questionnaire (Functional Assessment of Cancer Treatment (FACT-G)) at the beginning. The presence or absence of cachexia was evaluated at the outset, following the definition proposed by Fearon and nutritional assessment by the Patient-Generated Subjective Global Assessment (PG-SGA) scale. A total of 177 patients completed the FACT-G, the 60% receiving curative therapy. At the start of the treatment, 58.2% of patients had experienced WL, with an average of 4.4 ± 7.4%, and 19% were at risk of malnutrition. Patient who presented cachexia at diagnosis, were treated with palliative intention, had a Nutriscore ≥ 5 points or presented malnutrition in accordance with PG-SGA had a poorer QL (p < 0.05). Greater WL was associated with a worsened QL (p = 0.001). Breast cancer patients presented an inverse correlation between the %WL and the initial score in the FACT-G (r = - 0.304, p = 0.023), whereas no such correlation was observed for the other types of tumour (r = - 0.012, p = 0.892). These results underline the relation of NS before starting chemotherapy and QL. Greater WL was associated with a worsened QL, especially in women with breast cancer.

Relationship between cognitive functioning, mood, and other patient factors on quality of life in metastatic brain cancer.

Neurocognitive functioning (NCF), mood disturbances, physical functioning, and social support all share a relationship with health-related quality of life (HRQOL). However, investigations into these relationships have not been conducted in persons with brain metastases (BM). Ninety-three newly diagnosed persons with BM were administered various cognitive batteries. Data were collected across a wide range of categories (ie, cognitive, demographic, disease/treatment, mood, social support, physical functioning). The Functional Assessment of Cancer Treatment (FACT) scale was used to measure HRQOL. Mood and physical function correlated with lower HRQOL in every measured domain. Verbal learning and memory correlated with every FACT subscale except emotional quality of life. Social support also correlated with several HRQOL domains. Stepwise linear regression revealed that mood predicted general well-being and several FACT subscales, including physical, emotional and cognitive well-being. Social support and physical health were predictive of general well-being. Verbal learning and memory predicted cognitive well-being. HRQOL is a complex construct affected by numerous variables. In particular, mood, physical functioning, and learning and memory were important predictors of HRQOL, and clinicians are encouraged to obtain information in these areas during baseline assessments in persons with BM.

CPX-351 As First Intensive Therapy for Elderly Patients with AML

CPX-351 As First Intensive Therapy for Elderly Patients with AML

Quality-of-life assessment in French patients with metastatic melanoma in real life.

Significant progress was recently observed in the treatment of metastatic melanoma (MM). With >50% of patients now reaching a second line of treatment and a significant improvement in the survival rate, an assessment of quality of life (QoL) during the whole course of the disease becomes necessary. The objective of this study was to describe the QoL of patients with MM in France, from their diagnosis of advanced disease to their death, in real life. QoL data were collected through MelBase, a prospective, French, multicentric cohort dedicated to the follow-up of adults with MM. QoL was assessed using the EuroQoL-5D questionnaire and the Functional Assessment of Cancer Treatment (FACT)-Melanoma questionnaire at the time of study inclusion, every 3months, and at the time of each treatment change until death. To assess longitudinal changes from baseline to death, mixed-effect models for repeated-measures analyses were used to control for baseline covariates. QoL was assessed in 1435 patients who were included in the study between 2013 and 2018. The median follow-up was 9.4months, and 47% of patients died during follow-up. During first-line treatment, the model-based, mean utility score was 0.830 (95% CI, 0.818-0.843), the mean FACT-General score was 77.22 (95% CI, 76.23-78.22), and the mean FACT-Melanoma score was 129.46 (95% CI, 128.02-130.90). At the time of a change in treatment line, there was a decrease of -0.027 (95% CI, -0.03, -0.02) in the utility score, -1.82 (95% CI, -1.88, -1.76) in the FACT-General score, and -2.98 (95% CI, -3.05, -2.91) in the FACT-Melanoma score compared with first-line treatment. In the MelBase cohort, the QoL among patients with MM seems to be fairly stable over the whole disease course, although a small but significant decrease at time therapy is changed is observed.

Association between nutritional status (NS) and health-related quality of life (HRQoL) in men with early metastatic castrate-resistant prostate cancer (mCRPC).

e16539 Background: HRQoL is of paramount importance in men with mCRPC. It is not known how NS affects HRQoL in this population of patients. We hypothesized that NS is associated with HRQoL in men with early mCRPC and that NS outperforms body mass index (BMI) in this association. Methods: We prospectively enrolled men with early mCRPC into this study. Patients were assessed, and on the basis of established criteria, four NS categories were defined: normal NS (nNS), nutritional risk without cachexia/sarcopenia (NR), sarcopenia (S) (handgrip strength &lt; 30 kg) and cachexia (C) (Evans`s criteria). HRQoL was assessed by the validated questionnaire Functional Assessment of Cancer Treatment (FACT-P); higher score reflects better HRQoL. After checking for normal distribution, we performed a linear regression model for HRQoL with NS as a dummy variable (with nNS as the reference group). Age, duration of previous androgen deprivation therapy (ADT), hemoglobin level (Hb), prostate-specific antigen (PSA) and BMI were included as covariates into the multivariate model. Results: One hundred forty-one patients were enrolled in our study. At presentation, their mean age was 74.2 years (SD 7.1), and 18 (12.4 %) had visceral metastases. Fifty-eight (41.3%) had nNS, 43 (30.8 %) had sarcopenia, 24 (16.8 %) NR and 16 (11.2 %) C. Mean FACT-P score [SD] in nNS was 115.3 points [22.2], following by 97 [24.6], 98.3 [22.4] and 78.8 [25] points in NR, S and C groups, respectively. We found a significant and consistent association between better NS and worse HRQoL (β [NR:nNS] = -18.2 points; β [S:nNS] = -17 points; β [C:nNS] = -36.5 points; p &lt; 0.001; R² = 0.2). The association remained significant after adjustments (R² = 0.27). Conclusions: Suboptimal NS but not BMI is significantly associated with worse HRQoL in men with early mCRPC. Interventional trials focused on the optimization of NS in men with mCRPC are warranted.[Table: see text]

Effect of physical activity trackers and daily text messages on quality-of-life in colorectal survivors (Smart Pace): A pilot randomized controlled trial.

168 Background: There are over 1.3 million colorectal cancer (CRC) survivors in the United States, and many of whom suffer from lower health-related quality-of-life (HRQoL) years after diagnosis and treatment. Physical activity may improve survival outcomes and HRQoL for CRC survivors. Feasible interventions to support physical activity after CRC diagnosis are needed. Methods: We conducted a two-arm randomized controlled trial of 41 men and women who had completed treatment for CRC. Participants in the intervention arm were given a Fitbit Flex™ and received daily text messages for 12 weeks. HRQoL was assessed in both arms at baseline and 12 weeks using the RAND Short Form Survey (SF-36) and the Functional Assessment of Cancer Treatment – Colorectal (FACT-C). Survey score changes from baseline to 12 weeks were compared between the two arms using independent t-tests, and scores at baseline and 12 weeks were compared using paired t-tests. SAS was used for analysis, and statistical significance was declared at p &lt; 0.05. Results: We observed a statistically significant increase in the FACT-C functional well-being sub-scale in individuals in the intervention arm pre- and post- intervention (mean ∆ 1.81 ± 2.76; p: 0.02). There was no change in functional well-being in the control arm (mean ∆ -0.35 ± 4.12; p: 0.71). The between-arm comparison of change from baseline to 12 weeks was not statistically significantly ( p: 0.08). There was a statistically significant increase in the FACT-C emotional well-being sub-scale in the control arm (mean ∆ 1.20 ± 2.48; p: 0.04) and in the SF-36 role physical sub-scale in the control arm (mean ∆ 22.5 ± 38.8; p: 0.02). No other measures of HRQoL were statistically significantly different within groups, across time points, or between groups. Conclusions: A 12-week physical activity intervention using a Fitbit Flex and daily text messages may improve functional well-being among CRC survivors. Larger randomized studies are needed to definitively determine if a digital physical activity intervention improves functional well-being among CRC survivors, and if the improvement can be sustained over time. Clinical trial information: NCT02966054.

Short and long term impact of financial toxicity on quality of life in the Carolina Breast Cancer study.

e18299 Background: High cancer treatment costs are associated with considerable distress and worse outcomes in cancer patients, a phenomenon known as “financial toxicity”. We examined changes in health-related quality of life (HRQoL) among women experiencing financial toxicity after cancer diagnosis compared to cancer patients without financial toxicity in a racially diverse cohort of breast cancer patients. Methods: HRQoL was self-reported at approximately 5 and 25 months post-diagnosis using the Functional Assessment of Cancer Treatment (FACT-G) in a prospective, population-based, cohort study with oversampling of Black and young (&lt;50 years old) women. Women reported on the financial burden of their breast cancer, including whether they had declined or delayed care due to cost or transportation barriers and whether they lost a job, experienced a reduction in household income, or lost insurance coverage after their cancer diagnosis. We assessed changes in HRQoL from 5 to 25 months according to financial toxicity experience. Results: 2,432 women completed 5- and 25-month HRQoL surveys and were included in analyses. Forty-nine percent were non-Hispanic Black and 51% were non-Hispanic White; other minorities were excluded due to small numbers. Overall, 49% of women reported at least one indicator of financial toxicity (59% Black vs. 39% White). Women who reported any financial toxicity had significantly lower scores on the FACT-G at baseline (75.5 vs 87.2, p&lt;0.001) and reported significantly less improvement in HRQoL from 5- to 25-months than women who did not report financial toxicity (incremental difference: +1.4 vs +3.8, p=.01). Black women reported lower overall HRQoL than White women (p=0.03), but impact of financial toxicity on HRQOL was similar among black and white women in stratified analyses. Conclusions: Financial toxicity is associated with lower HRQoL and with less improvement in HRQoL in the two years following breast cancer diagnosis. [Table: see text]

The Prognostic Value for Survival of Patient-Reported Outcomes in Hematological Malignancies: A Systematic Review

Introduction: Patient-reported outcomes (PROs) are now critical to more comprehensively evaluate treatment outcomes in oncology. There is convincing evidence indicating that, similarly to traditional biomarkers, PROs may also predict survival outcomes. This systematic review examined state of the art literature on the prognostic value of PROs for survival in hematological malignancies.Methods: We searched PubMed and Google Scholar from 2000-2016 for studies assessing the predictive relationship between PROs and overall survival (OS) in Acute Myelogenous Leukemia (AML), Chronic Lymphocytic Lymphoma (CLL), Diffuse Large B-Cell Lymphoma (DLBCL), indolent Non-Hodgkin's Lymphoma (iNHL), Follicular Lymphoma (FL), marginal Zone Lymphoma (mZL), Myelodysplastic Syndrome (MDS), and Multiple Myeloma (MM). Search terms included but were not limited to: quality of life, physical functioning, predictive/prognostic, survival, patient-reported outcomes, and fatigue. Studies were excluded if they did not use multivariate analyses, did not examine OS as an endpoint, were case reports, did not report results for PROs, were reported in an abstract only, or used only clinician-reported outcomes as a predictor. A pre-defined data extraction form (DEF) was used to assess the following data from each article: disease, sample size, demographics, type of PRO measures included, clinical parameters included as predictors, type of analysis, and outcomes assessed.Results: 223 articles were reviewed of which 13 met the inclusion criteria (6 AML/MDS, 3 MM, 2 aggressive lymphomas, 1 mixed heme diagnoses, and 1 DLBCL). PROs in these studies were captured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core30 (EORTC QLQ-C30) or the EORTC myeloma module 24 item (MY24), a health-related quality of life questionnaire for patients with myelodysplastic syndromes (QOL-E), Functional Assessment of Cancer Treatment (FACT) or Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and the MD Anderson Symptom Inventory (MDASI). PROs that were independently associated with OS in multivariate analyses from the different studies were: physical function, fatigue, pain, difficulty with strenuous activity, and impaired physical performance in AML patients; physical function and fatigue in MM; fatigue in MDS; global/total QOL and functional well-being in aggressive lymphomas; drowsiness in a mixed group of heme diagnoses; and global QOL, function, and symptoms/signs in DLBCL (see Table). Baseline PROs were obtained following diagnosis of de novo or relapsed disease in 3 studies, within 6 months of registration in 1 study, and prior to any treatment in 6 studies.Conclusions: PROs related to physical functioning, fatigue, and performance were the most common predictors of OS in hematological malignancies and remained significant indicators even after accounting for clinical variables. This review highlights the prognostic value of PROs in both newly diagnosed and relapsed patients, and argues for their use in clinical decision-making and risk assessment at the time of diagnosis and pre-treatment. It also raises the question of how baseline PROs should be used in assessing new treatments within clinical trials in order to identify patients who may respond better to treatments or be in need of pre-treatment adjuvant therapy. [Display omitted] DisclosuresCampinha-Bacote:Genentech, Inc.: Employment. Trask:Genentech, Inc.: Employment, Equity Ownership. Efficace:Lundbeck: Research Funding; Seattle Genetics: Consultancy; Bristol Myers Squibb: Consultancy; TEVA: Consultancy, Research Funding.

A survey of fertility and sexual health following allogeneic haematopoietic stem cell transplantation in New South Wales, Australia.

Four hundred and twenty-one adult allogeneic haematopoietic stem cell transplant (HSCT) survivors participated in a cross-sectional study to assess sexual dysfunction and infertility post-transplant. Survey instruments included the Sydney Post-Blood and Marrow Transplant (BMT) Survey, Functional Assessment of Cancer Treatment (FACT) - BMT, the Depression, Anxiety, Stress Scales (DASS 21), the Chronic Graft-versus-Host Disease (cGVHD) Activity Assessment- Patient Self Report (Form B), the Lee cGVHD Symptom Scale and The Post-Traumatic Growth Inventory. Most HSCT survivors reported sexual difficulties (51% of males; 66% of females). Men reported erectile dysfunction (79%) and decreased libido (61·6%) and women reported loss of libido (83%), painful intercourse (73%) and less enjoyment of sex (68%). Women also commonly reported vaginal dryness (73%), vaginal narrowing (34%) and vaginal irritation (26%). Woman had much higher rates of genital cGvHD than men (22% vs. 5%). Age and cGVHD were significantly associated with sexual dysfunction. Few survivors had children following transplant (3·3%). However, for those of reproductive age at HSCT, 22% reported trying to conceive, with 10·3% reporting success. This study is the largest to date exploring sexual function in survivors of allo-HSCT. This data provides the basis for health service reform to better meet the needs of HSCT survivors, including evidence to support counselling and education both pre- and post-transplant.

Dry eyes and AIs: If you don't ask you won't find out

ObjectivesOur objective was to investigate the hypothesis that women on adjuvant aromatase inhibitors (AIs) for treatment of breast cancer have a higher prevalence of dry eye syndrome (DES) compared with controls. Materials and methodsExposure and control groups were recruited. A cross sectional questionnaire-based study was performed. Demographic data and medical histories were collected. The presence of dry eye syndrome was determined by the ocular surface disease index (OSDI). The Functional Assessment of Cancer Treatment – Endocrine Subscale (FACT-ES) was performed to investigate correlations with other side effects of AIs. Results93 exposure group and 100 control group questionnaires were included. The groups were similar in all demographic variables. The prevalence of dry eye syndrome was 35% (exposure) and 18% (control) (p < 0.01, OR 2.5). AIs were the only factor associated with dry eyes. The OSDI score was negatively correlated with the total FACT-ES score and positively correlated with duration of treatment. ConclusionOur study is the first to use a validated questionnaire to assess for DES in this population. DES is significantly more prevalent in women on AIs compared with controls. This is a newly emerging, and easily treated side effect of AIs. Self-reporting of dry eye symptoms underestimates the prevalence of DES with AIs. We recommend routine screening of patients on AIs with the OSDI with the aim of improving patient quality of life and possibly adherence.

Abstract P1-09-03: Prevention of aromatase Inhibitor (AI)-induced joint symptoms with omega-3 fatty acid supplementation: A randomized placebo-controlled pilot study

Abstract Introduction: AI-induced joint symptoms negatively impact drug adherence and quality of life. Based on observations that n-3 polyunsaturated fatty acids (PUFAs) have anti-inflammatory effects and that the mechanism of AI-induced joint symptoms may be partly due to inflammation, we hypothesized that women taking more n-3 PUFAs are less likely to develop AI-induced joint symptoms. Methods: We conducted a randomized, double-blind, placebo-controlled study comparing n-3 PUFA vs placebo in postmenopausal breast cancer patients starting adjuvant AIs. Participants were randomized to n-3 supplements [2.58 g eicosapentaenoic acid + 1.74 g docosahexaenoic acid/day; Marine Nutriceuticals, Mt. Bethel, PA] vs matched placebo for 24 weeks (wks). Primary endpoints was feasibility; secondary outcomes were self-reported symptoms as assessed by the Brief Pain Inventory short form (BPI-SF), Functional Assessment of Cancer Treatment, Breast &amp; Endocrine Symptoms (FACTB-ES), and Stanford's Health Assessment and Disability Index (HAQ) at baseline prior to AI receipt, 12 and 24 wks. Compliance and toxicity were evaluated monthly. Serial peripheral blood n-3 PUFA levels and inflammatory cytokines (IL-6, TNFR2, IL-17) were drawn. MRI of hands/wrists was performed in selected patients using a 3 Tesla dedicated wrist coil at baseline and treatment end. Results: Forty-four women were enrolled and randomized to study drug; 42 received ≥1 cycle (4 wks) of treatment; 36 had ≥1 post treatment evaluation at wk 12 or 24. Median age was 59.5 (range 43-76); history of prior taxane (n=15, 34%). The two groups’ baseline characteristics were similar. Overall, 93% and 88% of patients took &amp;gt;80% of the placebo and n-3 PUFA doses, respectively. Baseline erythrocyte n-3 PUFA was similar for both groups (6.6% ± 1.6%, 7.2% ±1.9%, p=0.20), but higher in the n-3 PUFA arm by wk 24 (6.5%±1.0% vs 15.0%±3.3%, p&amp;lt;0.001). Most toxicities were grade 1; the n-3 PUFA arm had only 1 (2.5%) grade 3 toxicity (diarrhea). The n-3 PUFA arm reported lower mean BPI-SF scores after treatment [(-.0.28/ -0.25 at week 12/24); but not statistically significant compared to placebo (p=0.494 and 0.601)]. Based on BPI-SF, the n-3 PUFA arm reported less interference of pain symptoms compared to placebo at 12 weeks (-.72, p=0.08). This arm also had a decreased walking, activity and working (WAW) score on BPI-SF at 12 weeks (-.81 p=0.05), and reported significantly greater pain relief from medications at 12 (p=0.043) and 24 weeks (p=0.011). Both arms had similar baseline and wk 24 serum IL-6 levels; levels decreased from baseline to wk 24 in the n-3 PUFA arm (-0.54±0.25, p=0.048). There was a non-significant trend (p= 0.2) toward decreased wrist inflammation by MRI imaging at 24 wks in the n-3 PUFA arm. Conclusions: This is the first randomized pilot study to show that n-3 PUFA supplementation to prevent AI-induced joint symptoms is feasible and well tolerated. There is preliminary evidence that this intervention may help reduce the burden of AI-induced arthralgias. OSU Study #11022; ClinicalTrials.gov Identifier: NCT01478477. Grants from the National Cancer Institute (CA037447-26) to the Alliance for Clinical Trials in Oncology supported this pilot study. Citation Format: Maryam B Lustberg, Tonya Orchard, Xueliang Pan, Raquel Reinbolt, Amanda Logan, Joanne Lester, Rachel M Layman, Erin Macrae, Ewa Mrozek, Bhuvaneswari Ramaswamy, Robert Wesolowski, Michael Berger, Michael Knopp, Charles Loprinzi, Charles L Shapiro, Lisa Yee. Prevention of aromatase Inhibitor (AI)-induced joint symptoms with omega-3 fatty acid supplementation: A randomized placebo-controlled pilot study [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P1-09-03.

Quality of Life Assessment in Women with Breast Cancer: A Prospective Study Including Hormonal Therapy

PurposeEvaluating the effect of hormonal treatment on quality of life (QoL) in breast cancer patients by using the Functional Assessment of Cancer Treatment (FACT) questionnaire is the main purpose of this trial.MethodsBreast cancer patients treated with adjuvant between January 2007 and December 2009 were evaluated. The first survey was done after patients completed their whole adjuvant treatment except for the hormonal therapy and this was as 'basal assessment.' The second survey was done 6 to 12 months after the basal surveys during their routine policlinic controls. The last survey was done within the last 18 to 24 months of the follow-up period.ResultsThe effect of marital status, number of pregnancies, residence in the village or city, hemoglobin levels, chemotherapy and hormonal therapy for any other reason except for breast cancer on the QoL could not be seen. Endocrine subscale scores were detected to be higher in patients aged >60 years than in younger ones. The other dimension scores were low in the elderly patient group. There was a statistically significant relationship between being >30 years old and improvement in the social well-being score (p=0.028). The functional well-being scores were found to be significantly higher in the patient group that had no comorbid disease (p=0.018). Endocrine subscale scores were statistically worse in patients who had psychiatric disease (p=0.057) but the general QoL data were similar with others. It was shown that all QoL scores for all dimensions had statistically significant changes (p<0.001) in terms of hormonal regimes.ConclusionThe diagnosis of breast cancer was found to be an independent factor that affects social well-being and social life in a negative way. We must give attention to complaints including complaints about sexual life and hormonal status in order to ensure compliance of patients with the required hormonal regimens. By the help of future research, we can improve the prognosis of this disease through increased treatment adherence and belief of patients.

Comparing three validated methods of patient self-reported fatigue in a prospective randomized clinical trial.

9108 Background: Fatigue can be measured with different validated assessment instruments in symptom management trials. Methods: Between 2004-2009, the Wake Forest CCOP Research Base protocol 97202 randomized 236 women receiving adjuvant chemotherapy for newly diagnosed breast cancer to Coenzyme Q10 supplementation vs placebo. The primary endpoint was change in self-reported fatigue. Patients (pt) were assessed at baseline, 8, 16, and 24 weeks (wk) with 3 instruments: 1) Profile of Mood States – Fatigue (POMS; 7 questions; scored 0-4); 2) Functional Assessment of Cancer Treatment – Fatigue (FACIT; 13 questions; scored 0-4); and 3) Visual Analog Scale (VAS; one scale; scored 0-10). For comparison, each instrument was rescaled from 0 to 100; higher numbers indicate worse fatigue. Results: CoQ10 did not significantly affect fatigue (Lesser G et al, ASCO Proc., 2010). All 3 measures demonstrated an increase in fatigue after chemotherapy initiation at 8 &amp; 16 wks with trend towards baseline levels at 24 wks. The fatigue measures were highly correlated: r ≥ 0.8 for all pairwise associations at all times. However, their scores varied. The Table shows mean rescaled scores for pt below/above the median fatigue level, calculated by taking mean of the three scores averaged across the four time periods. In general, POMS tended to give the lowest and VAS the highest scores, but differences between POMS and FACIT and FACIT and VAS depended on mean fatigue level. For pt experiencing lower (&lt;median) fatigue, FACIT and VAS scores were similar, while POMS scores were significantly lower. For higher (&gt;median) fatigue, POMS and FACIT scores were similar, while VAS was significantly higher. Conclusions: While POMS, FACIT, and VAS scores were highly correlated, their scale scores varied depending on the level of fatigue experienced by the pt. Fatigue assessment methods in clinical trials should be selected carefully as they do not always give equivalent results. Supported by NCI/DCP grant U10 CA81851. [Table: see text]

Up-Front Use of Aromatase Inhibitors As Adjuvant Therapy for Breast Cancer: The Emperor Has No Clothes

Up-Front Use of Aromatase Inhibitors As Adjuvant Therapy for Breast Cancer: The Emperor Has No Clothes