MD Anderson Symptom Inventory Research Articles

The Mediating Effect of Resilience on the Relationship Between Symptom Burden and Anxiety/Depression Among Chinese Patients with Primary Liver Cancer After Liver Resection.

Primary liver cancer (PLC) is a common cancer of the digestive system. Patients with PLC often experience a heavy symptom burden and along with a significant levels of anxiety and depression after liver resection. High levels of symptom burden can lead to increased anxiety and depression, whereas high levels of resilience can alleviate these conditions. Therefore, we aimed to explore the relationships among symptom burden, resilience, and anxiety/depression in Chinese patients with PLC after liver resection and to determine whether resilience mediates the relationship between symptom burden and anxiety/depression. A total of 223 postoperative PLC patients were recruited from two public hospitals in Anhui Province, China. All participants completed the MD Anderson Symptom Inventory (MDASI), Hospital Anxiety and Depression Scale (HADS), and Connor-Davidson Resilience Scale (CD-RISC). The mediating effect of resilience was estimated using the bootstrap method via IBM SPSS AMOS 26.0. The mean HADS score was 12.37 ± 6.03 points in postoperative PLC patients. Among these patients, 78 (34.98%) had anxiety, and 64 (28.70%) had depression, as indicated by a subscale score ≥ 8. Pearson correlation analysis revealed that anxiety/depression was positively associated with symptom burden (p < 0.05) and negatively associated with resilience (p < 0.05). Furthermore, resilience partially mediated the relationship between symptom burden and anxiety/depression (β = 0.04; 95% confidence interval: 0.01-0.08). The levels of anxiety and depression in postoperative PLC patients should be decreased. Resilience partially mediated the relationship between symptom burden and anxiety/depression, but the indirect effect was much weaker than the direct effect of symptom burden on anxiety/depression. Consequently, rather than focusing primarily on resilience interventions, joint symptom-psychological interventions focusing on symptoms should be considered for patients with PLC after hepatectomy to reduce the levels of anxiety/depression.

Identification of Core Symptom Cluster in Patients With Digestive Cancer: A Network Analysis.

A lack of identified core symptom clusters in digestive cancer patients hinders achieving precision symptom intervention. There are few studies on identifying digestive cancer symptom clusters based on network analysis. The aims of this study were to construct the symptom network of digestive cancer patients and identify the core symptom cluster. A cross-sectional study was conducted among 202 digestive cancer patients. The Chinese version of the MD Anderson Symptom Inventory for gastrointestinal cancer scale was used to assess the symptoms by convenience sampling. R software was used to construct a symptom network and identify core symptom clusters. Edge weight and centrality difference tests were used to test the accuracy of core symptom cluster identification. The most common symptoms were distress, poor appetite, and sadness. The most serious symptoms were poor appetite, disturbed sleep, and fatigue. The core symptom cluster of the psychoemotional symptom group was distress, sadness, and numbness. The centrality index showed that the top 3 in strength were distress (Rs = 1.11), fatigue (Rs = 1.09), and sadness (Rs = 1.04). The edge weight difference test showed that the psychoemotional symptom group had high stability. The psychoemotional symptoms of digestive cancer patients should be given priority for intervention. Network analysis must be extended to the symptom research of cancer patients as soon as possible to provide a scientific basis for symptom management. Nurses must perform comprehensive psychological and emotional assessments, initiate referrals for psychoemotional symptom management and psychological services, and administer pharmacologic and nonpharmacologic interventions to improve appetite loss in digestive cancer patients.

Longitudinal perioperative patient-reported outcomes in open compared with minimally invasive hysterectomy

There are few prospective studies in the gynecologic surgical literature that compared patient-reported outcomes between open and minimally invasive hysterectomies within enhanced recovery after surgery pathways. This study aimed to compare prospectively collected perioperative patient-reported symptom burden and interference measures in open compared with minimally invasive hysterectomy cohorts within enhanced recovery after surgery pathways. We compared patient-reported symptom burden and functional interference in 646 patients who underwent a hysterectomy (254 underwent open surgery and 392 underwent minimally invasive surgery) for benign and malignant indications under enhanced recovery after surgery protocols. Outcomes were prospectively measured using the validated MD Anderson Symptom Inventory, which was administered perioperatively up to 8 weeks after surgery. Cohorts were compared using Fisher exact and chi-squared tests, adjusted longitudinal generalized linear mixed modeling, and Kaplan Meier curves to model return to no or mild symptoms. The open cohort had significantly worse preoperative physical functional interference (P=.001). At the time of hospital discharge postoperatively, the open cohort reported significantly higher mean symptom severity scores and more moderate or severe scores for overall (P<.001) and abdominal pain (P<.001), fatigue (P=.001), lack of appetite (P<.001), bloating (P=.041), and constipation (P<.001) when compared with the minimally invasive cohort. The open cohort also had significantly higher interference in physical functioning (score 5.0 vs 2.7; P<.001) than the minimally invasive cohort at the time of discharge with no differences in affective interference between the 2 groups. In mixed modeling analysis of the first 7 postoperative days, both cohorts reported improved symptom burden and functional interference over time with generally slower recovery in the open cohort. From 1 to 8 postoperative weeks, the open cohort had worse mean scores for all evaluated symptoms and interference measures except for pain with urination, although scores indicated mild symptomatic burden and interference in both cohorts. The time to return to no or mild symptoms was significantly longer in the open cohort for overall pain (14 vs 4 days; P<.001), fatigue (8 vs 4 days; P<.001), disturbed sleep (2 vs 2 days; P<.001), and appetite (1.5 vs 1 days; P<.001) but was significantly longer in the minimally invasive cohort for abdominal pain (42 vs 28 days; P<.001) and bloating (42 vs 8 days; P<.001). The median time to return to no or mild functional interference was longer in the open than in the minimally invasive hysterectomy cohort for physical functioning (36 vs 32 days; P<.001) with no difference in compositive affective functioning (5 vs 5 days; P=.07) between the groups. Open hysterectomy was associated with increased symptom burden in the immediate postoperative period and longer time to return to no or mild symptom burden and interference with physical functioning. However, all patient-reported measures improved within days to weeks of both open and minimally invasive surgery and differences were not always clinically significant.

Abstract PO-049: The neural landscape is associated with functional outcomes for patients with oropharyngeal squamous cell carcinoma

Abstract Despite the excellent prognosis of patients with oropharyngeal squamous cell carcinoma (OPSCC), long-term functional impairment (e.g., dysphagia) is a major burden for many patients. Recent studies have explored the role of pharyngeal constrictors and muscle fibrosis in dysphagia. However, to date, no study has examined the association between the OPSCC neural microenvironment and posttreatment functional impairment. We hypothesized that cancer-related neuronal changes in the OPSCC tumor microenvironment (TME) would affect patients’ prognoses. Therefore, in the present study, we investigated whether cancer-related changes in the tumor neuronal microenvironment influence functional outcomes in patients with OPSCC. Prospectively collected, patient-reported outcomes (i.e., from the MD Anderson Symptom Inventory [MDASI] and the MD Anderson Dysphagia Inventory [MDADI]) and functional outcomes from the Dynamic Imaging Grade of Swallowing Toxicity [DIGEST] for patients with OPSCC were collected (n=29). OPSCC tissue samples were obtained from surgically treated patients, and multiplex/high-plex immunofluorescence and machine learning techniques were used to correlate neuronal changes with prospectively collected patient data. Electromyography was performed to assess the neuronal populations involved in neuropathies after treatment. A murine animal model of dysphagia was also used to correlate the neuronal changes. The results showed that sensory nerves with adrenergic features (CGRP+TH+) were associated with perineural and lymphovascular invasion. In addition, we found that human papillomavirus associated OPSCC was associated with an enrichment of parasympathetic progenitors (VIP+DCX+). Poor MDASI scores were associated with CGRP+, adrenergic (TH+), or CGRP+TH+ innervation, and growing progenitor neurons (GAP43+DCX+) were associated with improved oral symptoms. Swallowing, measured by MDADI scale revealed that patients with tumors enriched with growing (GAP43+), parasympathetic (VIP+), and neuronal progenitor (DCX+) neurons reported poor swallowing perception; subgroup electromyography analysis confirmed our findings. Quantitative swallowing assessment with DIGEST by speech language pathologists revealed that TMEs innervated by CGRP+, TH+, and MBP+ neurons were associated with poor swallowing functions. Finally, using a murine model of dysphagia we confirmed that sensory (CGRP+), myelinated (MBP+), and cholinergic parasympathetic (CHAT+) or progenitor (CHAT+DCX+) enrichment was associated with denervation and downstream dysphagia. In conclusion, our results show that neuronal changes are correlated with clinical features in OPSCC patients. Patients’ functional outcomes after therapy completion are influenced by distinct nerve populations in the TME. These benchmark data should be further evaluated as a potential target for cancer survivors with dysphagia and as a biomarker for patients who might need escalated swallowing rehabilitation during and after treatment for OPSCC. Citation Format: Shajedul Islam, Frederico O. Gleber-Netto, Collin F. Mulcahy, Mica D. E. Glaun, Patrick J. Hunt, Michelle D. Williams, Carly E. Barbon, Weilu Zhao, Adewale Adebayo, Shamima Akhter, Tongxin Xie, Ismail Yaman, Jared K. Burks, Javier Gomez, Karin Woodman, Teresa E. Lever, Katherine A. Hutcheson, Moran Amit. The neural landscape is associated with functional outcomes for patients with oropharyngeal squamous cell carcinoma [abstract]. In: Proceedings of the AACR-AHNS Head and Neck Cancer Conference: Innovating through Basic, Clinical, and Translational Research; 2023 Jul 7-8; Montreal, QC, Canada. Philadelphia (PA): AACR; Clin Cancer Res 2023;29(18_Suppl):Abstract nr PO-049.

Differences in Symptom Severity and Quality of Life among Patients with Cancer Using Conventional Therapies with/without Herbal Medicines in Uganda: A Cross-Sectional Study.

Patients with cancer experience numerous symptoms related to cancer and treatment side effects that reduce their quality of life (QOL). Although herbal medicine (HM) is used to manage such symptoms by patients in sub-Saharan Africa, data on patients' perceived clinical outcomes are limited. We compared differences in QOL and symptom severity between patients with cancer using HM plus conventional therapies (i.e., chemotherapy, hormonal therapy, radiotherapy, surgery) and those using conventional therapies alone. This cross-sectional study included patients with cancer aged >18 years who were consecutively sampled and completed a researcher-administered questionnaire between December 2022 and January 2023. Specifically, data was collected using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the MD Anderson Symptom Inventory for Traditional Chinese Medicine (MDASI-TCM). Data were analyzed using descriptive statistics and chi-square and logistic regression analyses. Of 400 participants (67.5% female), 49% (n=195) used HM plus conventional therapies and 51% (n=205) used conventional therapies alone. Most participants were aged >38 years (73.3%; median age 47 years). A univariate analysis showed the HM plus conventional therapies group had better mean scores for most QOL and symptom severity measures than the conventional therapies alone group. However, only role functioning significantly differed (p=0.046) in the bivariate analysis. There were no statistically significant differences between the two groups after confounder adjustment for all others measures of symptom severity and QOL. HM plus conventional therapies may offer minimal benefits or differences for clinical outcomes among patients with cancer. However, our findings have clinical, research, and public health implications for Uganda and other sub-Saharan African settings.

The Impact of Symptom Burden, Social Support, Self-Efficacy, and eHealth Literacy on the Quality of Life of Patients Undergoing Breast Cancer Treatment: A Cross-Sectional Study

Purpose: The number of breast cancer patients in Korea has steadily increased. However, there are few studies addressing quality of life of patients undergoing breast cancer treatment in Korea. This study aimed to identify predictors of quality of life among patients undergoing breast cancer treatment.Methods: This descriptive, cross-sectional study included 142 patients with breast cancer undergoing treatment in a cancer hospital. Data were collected using the MD Anderson Symptom Inventory, Multidimensional Scale of Perceived Social Support, Breast Cancer Survivors Scale, eHealth Literacy Scale, and the Functional Assessment of Cancer Therapy-Breast Cancer through self-administered questionnaires from January 12 to December 6, 2022. Differences in the level of quality of life according to demographic and clinical variables and correlations among continuous variables were identified using univariate statistics, and hierarchical multiple regression was used to identify predictors of quality of life.Results: Employment status, comorbidities, disease duration, and cancer stage were demographic and clinical variables that showed significant associations with quality of life. Symptom burden, social support, self-efficacy, and eHealth literacy were also significantly associated with quality of life. The predictors of quality of life were employment status (β=.13, p=.009), cancer stage (β=.12, p=.033), symptom severity (β=-.14, p=.044), symptom interference (β=-.30, p&lt;.001), social support (β=.13, p=.025), and self-efficacy (β=.46, p&lt;.001). The explanatory power was approximately 69% (F=26.90, p&lt;.001).Conclusion: Nursing interventions should be implemented for patients undergoing breast cancer treatment to improve their quality of life while reducing the symptom burden and enhancing self-efficacy and social support.

205. LONGITUDINAL PATIENT-REPORTED OUTCOMES AFTER MINIMALLY INVASIVE MCKEOWN ESOPHAGECTOMY IN PATIENTS WITH ESOPHAGEAL SQUAMOUS CELL CARCINOMA

Abstract Background Surgery for esophageal squamous cell carcinoma (ESCC) is characterized by a poor prognosis and high complication rate, resulting in a heavy symptom burden and poor quality of life (QOL). Neoadjuvant therapy followed by surgery improved the postoperative survival of ESCC patients. This study was a longitudinal patient-reported outcomes (PROs) evaluation to compare the effects of neoadjuvant therapy followed by minimally invasive Mckeown esophagectomy and surgery without neoadjuvant therapy from the patient’s perspective. Methods We investigated ESCC patients who underwent minimally invasive Mckeown esophagectomy in a single centre. Longitudinal data on clinical characteristics and PROs were collected. The MD Anderson Symptom Inventory and the European Organization for Research and Treatment of Cancer (EORTC)‘s quality of life questionnaires were used to assess symptoms and QOL before and after surgery. Compared the PROs’ trajectories during the investigation. Results Overall, 244 eligible ESCC patients were enrolled, of which 78 (group A) underwent neoadjuvant therapy followed by surgery, and 166 (group B) underwent surgery without neoadjuvant therapy. On postoperative day 5, dry mouth (p = 0.035) was more evident in group A. In postoperative month 1, patients in group A reported more disturbed sleep (p = 0.012) and drowsy (p = 0.050). In the sixth month, patients in group A had more symptom burden of disturbed sleep (p = 0.038), distress (p = 0.005) and lack of appetite (p = 0.049), and had worse physical (p = 0.050), role (p = 0.003) and emotional (p = 0.020) functions. Twelve months after surgery, group A had a worse social function (p = 0.019). Conclusion The longitudinal changes in postoperative symptoms and QOL were about the same in both groups. But at some point, especially in the sixth month after surgery, patients who underwent neoadjuvant therapy followed by surgery had a heavier symptom burden and a poorer QOL.

Omega-3 nanoemulgel in prevention of radiation-induced oral mucositis and its associated effect on microbiome: a randomized clinical trial

BackgroundOral mucositis (OM) is recognized as one of the most frequent debilitating sequelae encountered by head and neck cancer (HNC) patients treated by radiotherapy. This results in severe mucosal tissue inflammation and oral ulcerations that interfere with patient’s nutrition, quality of life (QoL) and survival. Omega-3 (ω-3) polyunsaturated fatty acids (PUFAs) have recently gained special interest in dealing with oral diseases owing to its anti-inflammatory, anti-oxidant and wound healing properties. Thus, this study aims to assess topical Omega-3 nanoemulgel efficacy in prevention of radiation-induced oral mucositis and regulation of oral microbial dysbiosis.Materials and methodsThirty-four head and neck cancer patients planned to receive radiotherapy were randomly allocated into two groups: Group I: conventional preventive treatment and Group II: topical Omega-3 nanoemulgel. Patients were evaluated at baseline, three and six weeks after treatment using the World Health Organization (WHO) grading system for oral mucositis severity, Visual Analogue Scale (VAS) for perceived pain severity, and MD-Anderson Symptom Inventory for Head and Neck cancer (MDASI-HN) for QoL. Oral swabs were collected to assess oral microbiome changes.ResultsVAS scores and WHO mucositis grades were significantly lower after six weeks of treatment with topical Omega-3 nanoemulgel when compared to the conventional treatment. The total MDASI score was significantly higher in the control group after three weeks of treatment, and the head and neck subscale differed significantly at both three and six weeks. A significant reduction in Firmicutes/Bacteroidetes ratio was observed after six weeks in the test group indicating less microbial dysbiosis.ConclusionsTopical Omega-3 nanoemulgel demonstrated a beneficial effect in prevention of radiation-induced oral mucositis with a possibility of regulating oral microbial dysbiosis.

Multi-organ spatial stratification of 3-D dose distributions improves risk prediction of long-term self-reported severe symptoms in oropharyngeal cancer patients receiving radiotherapy: development of a pre-treatment decision support tool.

Identify Oropharyngeal cancer (OPC) patients at high-risk of developing long-term severe radiation-associated symptoms using dose volume histograms for organs-at-risk, via unsupervised clustering. All patients were treated using radiation therapy for OPC. Dose-volume histograms of organs-at-risk were extracted from patients' treatment plans. Symptom ratings were collected via the MD Anderson Symptom Inventory (MDASI) given weekly during, and 6 months post-treatment. Drymouth, trouble swallowing, mucus, and vocal dysfunction were selected for analysis in this study. Patient stratifications were obtained by applying Bayesian Mixture Models with three components to patient's dose histograms for relevant organs. The clusters with the highest total mean doses were translated into dose thresholds using rule mining. Patient stratifications were compared against Tumor staging information using multivariate likelihood ratio tests. Model performance for prediction of moderate/severe symptoms at 6 months was compared against normal tissue complication probability (NTCP) models using cross-validation. A total of 349 patients were included for long-term symptom prediction. High-risk clusters were significantly correlated with outcomes for severe late drymouth (p <.0001, OR = 2.94), swallow (p = .002, OR = 5.13), mucus (p = .001, OR = 3.18), and voice (p = .009, OR = 8.99). Simplified clusters were also correlated with late severe symptoms for drymouth (p <.001, OR = 2.77), swallow (p = .01, OR = 3.63), mucus (p = .01, OR = 2.37), and voice (p <.001, OR = 19.75). Proposed cluster stratifications show better performance than NTCP models for severe drymouth (AUC.598 vs.559, MCC.143 vs.062), swallow (AUC.631 vs.561, MCC.20 vs -.030), mucus (AUC.596 vs.492, MCC.164 vs -.041), and voice (AUC.681 vs.555, MCC.181 vs -.019). Simplified dose thresholds also show better performance than baseline models for predicting late severe ratings for all symptoms. Our results show that leveraging the 3-D dose histograms from radiation therapy plan improves stratification of patients according to their risk of experiencing long-term severe radiation associated symptoms, beyond existing NTPC models. Our rule-based method can approximate our stratifications with minimal loss of accuracy and can proactively identify risk factors for radiation-associated toxicity.

SPCR-05 ENVIRONMENTAL ENRICHMENT AMONG BRAINTUMOR SURVIVORS

Abstract Individuals from underserved communities who received photon radiation are at a disproportionately increased risk of accelerated aging and symptom burden that significantly impacts independence and overall functioning. There is limited knowledge of environmental factors that mitigate these long-term sequelae. The aim of the study is to explore if higher levels of environmental enrichment (EE) are neuroprotective against accelerated brain aging experienced by brain tumor (BT) survivors who received radiation. METHODS: The study employed a retrospective cohort design among persons with low-grade glioma treated with radiation approximately 5 years from the original diagnosis (N=39). EE consists of social network/engagement, physical activity, and employment status/financial stability measured by the Berkman-Syme Social Network Index, International Physical Activity Questionnaire, Vocational Index Scale, and Socioeconomic Questionnaires, respectively. EE at enrollment is classified into high, moderate, or low levels. Montreal Cognitive Assessment and Symbol Digit Modality Test at enrollment measure cognitive function. Karnofsky Performance Status Scale and the MD Anderson Symptom Inventory – BT module at enrollment are used to measure functional status. Cortical volume is measured using temporal brain MRI images from the time of diagnosis, 3 and 5 years after diagnosis. Images are processed using FreeSurfer segmentation software. Linear mixed models will estimate mean cerebral atrophy and explore the association to cognitive and functional data across time adjusted for covariates. RESULTS: Research analysis in progress. Thirty-nine participants have been enrolled in the study. The median age is 44, 22 are male, and 27 are female. There are 18 Individuals diagnosed with Astrocytoma and 19 with Oligodendroglioma. Thirty-three percent of individuals have low EE, 43.5% have moderate EE, and 23% have high EE. CONCLUSION: BT survivors are at an increased risk of accelerated aging and progressive neurological decline. EE may serve as a positive stimulation that improves neuroplasticity and reduces accelerated aging after brain radiation.

Developing and validating utility parameters to establish patient-reported outcome-based perioperative symptom management in patients undergoing prostatectomy: a multicentre, prospective, observational cohort study protocol

IntroductionSymptom monitoring and alerting based on patient-reported outcomes have proven valuable in a postoperative setting. However, the parameters of the implemented patient-centred symptom management system for patients with prostate cancer...

Changes in the symptom clusters of elderly patients with lung cancer over the course of postoperative rehabilitation and their correlation with frailty and quality of life: A longitudinal study

ObjectiveTo explore changes in the symptom clusters of perioperatively elderly patients with lung cancer at different time points (i.e., the day of admission [T0]), 2–4 days after surgery [T1], 1 month after discharge [T2] and 3 months after discharge [T3]) and to analyze correlations between cluster severity, frailty and quality of life (QOL). MethodsA longitudinal study was conducted from August 2020 to June 2021 among elderly lung cancer patients undergoing surgery at hospitals in Jiangsu Province. Data were collected using the Chinese Tilburg Frailty Indicator, the MD Anderson Symptom Inventory and the Quality of Life-Core scale. ResultsAccording to exploratory factor analysis, a total of 5 symptom clusters were found and three of them (the global mental function symptom cluster, the special mental function symptom cluster and the respiratory function symptom cluster) were persistent. The incidence of the top four symptoms varied at different time points. The severity of symptom clusters at different time points was positively correlated with frailty and negatively correlated with QOL. ConclusionsThe findings may serve as a reference for medical staff to implement symptom management in elderly lung cancer patients after surgery. Frailty may be an important variable affecting the severity of symptom clusters and the QOL of patients.

Impact of symptom burden and self-efficacy on functional status in advanced breast cancer patients: A path analysis.

This correlational study aims at exploring the correlations between symptom burden, functional status, and self-efficacy in advanced breast cancer patients and to analyze their paths of influence. The study was performed with 122 patients with advanced breast cancer receiving outpatient chemotherapy between April 10, 2021 and April 29, 2022. Data were collected using a sociodemographic information form, the MD Anderson Symptom Inventory, the Functional Living Index-Cancer, and the Symptom Management Self-Efficacy Scale for Breast Cancer Related to Chemotherapy. Kruskal-Wallis, Mann-Whitney U, and Spearman correlation tests and path analysis were used for data evaluation. Less-educated individuals had a higher symptom burden and poorer self-efficacy. Low-income level was related to poor self-efficacy. Symptom severity did not directly influence functional status but affected it indirectly through self-efficacy, while symptom interference and self-efficacy had a direct impact on functional status. This study mainly concludes that symptom burden and self-efficacy affect functional status in advanced breast cancer patients receiving chemotherapy. Self-efficacy-enhancing interventions may be helpful strategies for symptom relief and improvement in functional status in this population.

Profunda Artery Perforator Flap Tongue Reconstruction: An Effective and Safe Alternative to the Anterolateral Thigh Flap.

The anterolateral thigh (ALT) perforator flap is a workhorse flap for tongue reconstruction. The authors present an alternative option using the profunda artery perforator (PAP) flap for glossectomy reconstruction compared with the ALT flap. A retrospective review was conducted of 65 patients who underwent subtotal or total glossectomy reconstruction between 2016 and 2020 (46 ALT versus 19 PAP flaps). Flap volume was assessed using computed tomography scans at two different time points. Quality of life and functional outcomes were measured using the MD Anderson Symptom Inventory for Head and Neck Cancer. Patients receiving a PAP flap had significantly lower body mass index compared with those receiving an ALT flap (22.7 ± 5.0 versus 25.8 ± 5.1; P = 0.014). Donor-site and recipient-site complications were similar, as was the mean flap volume 7 months after surgery (30.9% for ALT versus 28.1% for PAP; P = 0.93). Radiation and chemotherapy did not appear to have a significant effect on flap volume change over time. The most frequently reported high-severity items in MD Anderson Symptom Inventory for Head and Neck Cancer were swallowing/chewing and voice/speech for both cohorts. Patients who had reconstruction with a PAP flap had significantly better swallowing function ( P = 0.034). Both the PAP and ALT flaps appear to be safe and effective choices for subtotal and total tongue reconstruction. The PAP flap can serve as an alternative donor site, especially in patients with low body mass index and thin lateral-thigh thickness undergoing reconstruction of extensive glossectomy defects. Therapeutic, III.

Utility of Patient-Reported Symptom and Functional Outcomes to Indicate Recovery after First 90 Days of Radical Cystectomy: A Longitudinal Study.

This is a longitudinal prospective study that tracked multiple symptom burden and functioning status for bladder cancer (BLC) patients for 3 months post-radical cystectomy at The University of Texas MD Anderson Cancer Center, using a validated disease-specific patient-reported outcome measure (PROM) tool, the MD Anderson Symptom Inventory (the MDASI-PeriOp-BLC). The feasibility of collecting an objective measure for physical functioning, using "Timed Up & Go test" (TUGT) and PRO scores at baseline, discharge and end of study, was tested. Patients (n = 52) received care under an ERAS pathway. The more severe scores of fatigue, sleep disturbance, distress, drowsiness, frequent urination and urinary urgency at baseline predicted poor functional recovery postoperatively (OR = 1.661, 1.039-2.655, p = 0.034); other more severe symptoms at discharge (pain, fatigue, sleep disturbance, lack of appetite, drowsiness, bloating/abdominal tightness) predicted poor functional recovery (OR = 1.697, 1.114-2.584, p = 0.014) postoperatively. Compliance rates at preoperative, discharge and end of study were 100%, 79% and 77%, while TUGT completion rates were 88%, 54% and 13%, respectively. This prospective study found that more severe symptom burden at baseline and discharge is associated with poor functional recovery post-radical cystectomy for BLC. The collection of PROs is more feasible than using performance measures (TUGT) of function following radical cystectomy.

Baseline symptom, health status, and health utilities in patients in early-phase clinical trials combining immune checkpoint blockade with other anticancer therapies.

12117 Background: The overall goal of our prospective and longitudinal study (NCI R01CA242565) is to examine the use of patient report to evaluate symptomatic adverse events associated with combination treatment including at least one immune checkpoint inhibitor in early-stage clinical trials. We present here the baseline symptom, health status and utilities in patients prior to trial start, and their association with clinical factors. Methods: Patients scheduled to start an early-phase trial of combination treatment with at least one immune checkpoint inhibitor and who had not received clinical trial-related treatment completed the validated MD Anderson Symptom Inventory - Immunotherapy (0-10, higher scores = worse severity) and the validated EuroQoL-5 dimensions questionnaire including a visual analog scale (EQ5D VAS) (0-100, higher scores = better health status) and health utility items (e.g., self-care, mobility). Clinical data were extracted from the EMR. Statistical tests included Spearman’s correlation coefficients. Results: At baseline prior to start of trial-related treatment, 38% of patients (N = 164; median age = 60 y; 52% male; 85% White; 17% ECOG PS 0, 89% ECOG PS 1, 3% ECOG PS 2) experienced at least 1 severe symptom (≥7 on 0-10 scale). The most frequent severe baseline symptoms were pain (21% of patients), fatigue (17%), disturbed sleep (15%), drowsiness (12%), lack of appetite (10%), distress (10%), and pain in the abdomen (10%). Less than 2% of pts experienced severe immunotherapy-specific symptoms of rash, fever/chills and swelling of the hands and feet at baseline. Moderate-severe symptom-related interference (≥4 on 0-10 scale) was worst for activity (40% of patients), work (38%), and enjoyment of life (30%). For the EQ5D health utility dimensions, patients reported the most problems with pain or discomfort (75%) and fewest problems with self-care (10%). Worse composite symptom severity (P = 0.013) and worse problems with activity (P = 0.001) and pain (P = 0.012) were associated with worse and higher ECOG PS. Worse symptom severity (-0.54, P &lt; 0.001), symptom interference with activity- (-0.57, P &lt; 0.001) and mood- (-0.42, P &lt; 0.001) related functioning were associated inversely with superior health status. Worse symptom interference with activity-related functioning was linked with lower concurrent lymphocyte counts (P = 0.01), hemoglobin (P = 0.01) and serum albumin (P = 0.004) levels and higher platelet (P = 0.02) counts. Conclusions: Patients in early-phase trials that combine immunotherapy with other anti-cancer therapies may experience severe symptom burden and symptom interference with functioning, even at baseline prior to treatment start. Thus, it is important to baseline symptoms to fully understand the impact of combination treatments including checkpoint inhibitors in early-stage clinical trials.

Effect of fecal transplantation on patients’ reported outcome after immune checkpoint inhibitor colitis.

2645 Background: The use of fecal microbiota transplantation (FMT) has traditionally been reserved for the treatment of recurrent Clostridioides difficile infections (CDI). As the gut microbiome has been increasingly acknowledged to play a role in a variety of bodily processes, FMT has seen its application extended to other gastrointestinal disorders. Immune-mediated colitis (IMC) is a similar entity to inflammatory bowel disease and arises as a side effect of immune checkpoint inhibitor therapy to stimulate the immune response. Treatment of IMC is mostly limited to immunosuppressants e.g. corticosteroids, infliximab, and vedolizumab. Cases refractory to such medications pose a significant challenge. FMT has been shown to be a successful treatment in refractory IMC in small case series, further large studies are needed to determine its efficacy. Methods: We measured the efficacy of FMT for refractory IMC among 47 patients via chart review and clinical assessment and patients’ reported outcome (PRO) via established MD Anderson Symptom Inventory (MDASI). Among them, 9 patients had concurrent CDI as well at the time of diagnosis. Results: Forty-seven patients were included in our study. Most patients had a peak diarrhea grade ≥ 3 (93.6%) and colitis grade ≥ 2 (91.5%). Ulcerous (23, 49.0%) and non-ulcerous (12, 25.5%) inflammation were the predominant endoscopic findings. 45 (95.7%) patients received corticosteroids, and 43 patients (91.5%) received add-on infliximab or vedolizumab. IMC symptom response was 85.1% after FMT with median time to response of 4.5 days. The transient complications rate is 34.0% at 7 days and 17.0% at 30 days. Response rate among the 38 patients without concurrent CDI was 86.8%. Forty-one (87.2%) patients demonstrated clinical remission by the end of the study period. On the PRO analysis, we observed a favorable trend of significant patient-reported symptom reduction on diarrhea during 12 weeks after FMT, along with improved daily physical functioning on working. Conclusions: FMT may serve as a potential treatment option in IMC refractory to standard treatment to avoid long-term steroid dependency and immunosuppression. It is effective to maintain IMC remission with a low complication rate. The role of the gut microbiome in cancer and the implications for FMT remain uncertain and need further elucidation. Clinical trial information: NCT03819296 . [Table: see text]

Phase II trial evaluating nivolumab in patients with recurrent IDH-mutant gliomas with and without hypermutation phenotype.

e14043 Background: Tumor mutational burden (TMB) may predict immunotherapy response in solid tumors. Response to immune checkpoint inhibitor (ICI) treatment in the rare gliomas with biallelic mismatch repair deficiencies have been attributed to their hypermutation phenotype (HMP). This has not been tested in other gliomas. We developed a phase II clinical trial using nivolumab in recurrent IDH-mutant gliomas evaluating response in tumors with HMP (approximately 10% of cases) and in tumors with non-HMP (NHMP). Here we report the results of the interim analysis of the NHMP cohort. Methods: Adults with recurrent IDH-mutant glioma, KPS ≥ 60, normal organ function, with known somatic TMB (analyzed at NIH) were enrolled to a phase II trial. Nivolumab is given at 480mg IV every 28-day cycle with a maximum of 16 cycles. The primary endpoint is PFS rate at 6 months (PFS6) in both HMP and NHMP cohorts. Responses to treatment are evaluated by MRI every 2 cycles using iRANO criteria. A Simon’s two-stage design was used for conducting the HMP/NHMP cohort independently. For NHMP cohort, the null and alternative hypotheses for PFS6 are 0.3 and 0.5, respectively. Fifteen patients were planned to accrue in stage I. If ≥10 have disease progression at 6 months, the cohort will be terminated, otherwise continue to stage II and accrue additional 31 patients, resulting a total cohort size of 46. The design controls the type I error at 0.05 and yields a power of 0.8. Tumor samples and peripheral blood were collected for correlative studies. Patient-reported outcomes (PRO) were evaluated by longitudinal symptom burden analysis using Brain Tumor Module of the MD Anderson Symptom Inventory. Results: As of May 2022, 17 patients were enrolled to NHMP cohort and 15 were treated (TMB˂5 mut/Mb). Among 15 evaluable patients, 10 were male, median age 39.5 and KPS 90. Histological diagnosis included 12 astrocytoma (grade 3, n = 4; grade 4, n = 8) and oligodendroglioma (grade 2, n = 1; grade 3, n = 2). Median number of prior recurrences is 3. At the time of interim analysis, four patients were receiving ongoing treatment, but all have received more than 6 cycles, with 100% PRO completion. Eleven patients were off study treatment, 2 completed all 16 cycles, 9 had disease progression. Six out of 15 (40%) patients were progression free at 6 months. Per design, the NHMP cohort proceeded to stage II. One treatment related grade 3 immune-related colitis was reported. Conclusions: Nivolumab is well tolerated and has demonstrated efficacy in a cohort of patients with recurrent IDH-mutant gliomas with low TMB. Accrual to this NHMP cohort continues along with continued enrollment to the HMP cohort. Clinical benefit measured by objective response, PFS, OS and longitudinal PRO measure along with longitudinal immune monitoring will help address whether TMB correlates with tumor, immunologic and clinical response, and benefit of ICI therapy in IDH-mutant gliomas. Clinical trial information: NCT03718767 .

Weekly Adaptive Radiotherapy vs Standard Intensity-Modulated Radiotherapy for Improving Salivary Function in Patients With Head and Neck Cancer

Xerostomia is a major toxic effect associated with intensity-modulated radiotherapy (IMRT) for oropharyngeal cancers. To assess whether adaptive radiotherapy (ART) improves salivary function compared with IMRT in patients with head and neck cancer. This phase 3 randomized clinical trial was conducted in 11 French centers. Patients aged 18 to 75 years with stage III-IVB squamous cell oropharyngeal cancer treated with chemoradiotherapy were enrolled between July 5, 2013, and October 1, 2018. Data were analyzed from November 2021 to May 2022. The patients were randomly assigned (1:1) to receive standard IMRT (without replanning) or ART (systematic weekly replanning). The primary end point was the frequency of xerostomia, measured by stimulating salivary flow with paraffin. Secondary end points included salivary gland excretory function measured using technetium-99m pertechnetate scintigraphy, patient-reported outcomes (Eisbruch xerostomia-specific questionnaire and the MD Anderson Symptom Inventory for Head and Neck Cancer questionnaire), early and late toxic effects, disease control, and overall and cancer-specific survival. A total of 132 patients were randomized, and after 1 exclusion in the ART arm, 131 were analyzed: 66 in the ART arm (mean [SD] age at inclusion, 60 [8] years; 57 [86.4%] male) and 65 in the standard IMRT arm (mean [SD] age at inclusion, 60 [8] years; 57 [87.7%] male). The median follow-up was 26.4 months (IQR, 1.2-31.3 months). The mean (SD) salivary flow (paraffin) at 12 months was 630 (450) mg/min in the ART arm and 584 (464) mg/min in the standard arm (P = .64). The mean (SD) excretory function of the parotid gland at 12 months, measured by scintigraphy, improved in the ART arm (48% [17%]) compared with the standard arm (41% [17%]) (P = .02). The 2-year-overall survival was 76.9% (95% CI, 64.7%-85.4%) in both arms. This randomized clinical trial did not demonstrate a benefit of ART in decreasing xerostomia compared with standard IMRT. No significant differences were found in secondary end points except for parotid gland excretory function, as assessed by scintigraphy, or in survival rates. ClinicalTrials.gov Identifier: NCT01874587.

Measuring symptom burden in patients with cancer during a pandemic: the MD Anderson symptom inventory for COVID-19 (MDASI-COVID)

BackgroundSymptom expression in SARS-CoV-2 infection (COVID-19) may affect patients already symptomatic with cancer. Patient-reported outcomes (PROs) can describe symptom burden during the acute and postacute stages of COVID-19 and support risk stratification for levels of care. At the start of the COVID-19 pandemic, our purpose was to rapidly develop, launch through an electronic patient portal, and provide initial validation for a PRO measure of COVID-19 symptom burden in patients with cancer.MethodsWe conducted a CDC/WHO web-based scan for COVID-19 symptoms and a relevance review of symptoms by an expert panel of clinicians treating cancer patients with COVID-19 to create a provisional MD Anderson Symptom Inventory for COVID-19 (MDASI-COVID). English-speaking adults with cancer who tested positive for COVID-19 participated in the psychometric testing phase. Patients completed longitudinal assessments of the MDASI-COVID and the EuroQOL 5 Dimensions 5 Levels (EQ-5D-5L) utility index and visual analog scale, which were presented through an electronic health record patient portal. To test the validity of the MDASI-COVID to distinguish between known groups of patients, we hypothesized that patients hospitalized, including having a hospitalization extended, for COVID-19 versus those not hospitalized would experience higher symptom burden. Correlation of mean symptom severity and interference scores with relevant EQ-5D-5L scores tested concurrent validity. The reliability of the MDASI-COVID was evaluated by calculating Cronbach alpha coefficients and test-retest reliability was evaluated by calculating Pearson correlation coefficients between the initial assessment and a second assessment no more than 14 days later.ResultsThe web-based scan found 31 COVID-19-related symptoms; rankings of a 14-clinician expert panel reduced this list to 11 COVID-specific items to be added to the core MDASI. Time from literature scan start in March 2020 to instrument launch in May 2020 was 2 months. Psychometric analysis established the MDASI-COVID’s reliability, known-group validity, and concurrent validity.ConclusionsWe were able to rapidly develop and electronically launch a PRO measure of COVID-19 symptom burden in patients with cancer. Additional research is needed to confirm the content domain and predictive validity of the MDASI-COVID and define the symptom burden trajectory of COVID-19.