Advanced Gastrointestinal Cancer Patients Research Articles

Malnutrition in advanced gastrointestinal cancer patients and nutritional support therapy

The advancement of comprehensive treatment has allowed an increasing number of patients with gastrointestinal tumor to achieve long-term survival. In current clinical practice, there is a growing population of patients with advanced gastrointestinal tumor. Due to various factors, such as tumor burden, treatments including chemotherapy and radiation therapy, as well as underlying diseases, patients with advanced gastrointestinal tumor often experience malnutrition, which negatively impacts their clinical outcomes. The mechanism of malnutrition in patients with advanced gastrointestinal tumor is complex, and conventional nutritional support therapy has shown limited effectiveness. With the continuous progress in the concept and technique of nutritional support therapy, the diversification of treatment strategies, and the strengthening of multidisciplinary collaboration, the nutritional management for patients with advanced gastrointestinal tumor tends to be standardized and rational, leading to effective improvement in patients' nutritional status and clinical outcomes. Based on the latest evidence-based medicine, combined with the author's practical experience and insights, this article aims to explore nutritional support therapy for patients with advanced gastrointestinal tumor.

Liquid biopsy-based comprehensive genomic profiling to reveal mutational landscape in real-world patients with gastrointestinal cancer.

735 Background: Molecular characteristics hold substantial clinical significance in cancer. Previous research has elucidated the molecular classification of gastrointestinal (GI) cancers, leveraging biomarkers like gene alterations, MSI, EBV status, and chromosomal instability. However, most of these studies relied on tissue biopsies. Limited investigations have been documented regarding the characterization of molecular profiles through liquid biopsy. Here we present a comprehensive genomic profiling study conducted on advanced GI cancer patients using blood samples. Methods: This prospective study is a part of a global initiative focused on molecular biomarker screening across various solid tumors. Here we report the early result of 106 unresectable GI cancer patients, encompassing those with advanced disease or experiencing relapse after prior treatments. The cohort comprises 66 colorectal cancer (CRC) patients, 34 gastric cancer (GC) patients, and 6 esophageal cancer (EC) patients. Each patient contributed a 10-mL blood sample for comprehensive circulating tumor DNA (ctDNA) analysis. The study employed PredicineCARE, a 152-gene, NGS-based liquid biopsy assay, to profile somatic gene variations within this patient population. Results: The study revealed a total of 1,597 somatic mutations, with 1,077 occurring in CRC, 448 in GC, and 72 in EC. Additionally, 722 gene copy number variants were identified, with 288 in CRC, 351 in GC, and 83 in EC patients. In CRC, the most frequently altered genes (prevalence > 20%) included TP53 (58%), APC (45%), KRAS (33%), and BRCA2 (22%). Conversely, in GC, the most altered genes were TP53 (59%), TERT (35%), FAT1 (29%), ARID1A (26%), and FGFR4 (24%). Among the 6 EC patients, 3 carried TP53 variations, with variations in APC (N=2), ERCC5 (N=2), FAT1 (N=2), and EGFR (N=1) also observed. The mutation burden in CRC (median 3.73 mut/Mb) and GC (median 3.57 mut/Mb) displayed no significant differences. However, the mutation burden in CRC was significantly higher than that in EC (2.24 mut/Mb) (p=0.04). A similar pattern was observed between GC and EC but did not reach statistical significance (p=0.10) due to limitations in cohort size. Furthermore, the assay identified patients carrying both germline and somatic mutations related to homologous recombination deficiency (HRD). In CRC patients, 5 had MLH1 germline mutations, 6 had MSH2 mutations (5 were germline), 4 had MSH6 germline mutations, 2 had PMS2 somatic mutations, and 1 had an EPCAM germline mutation. While in GC patients, 2 had MLH1 germline mutations, 1 had an MSH6 mutation, and 1 had a PMS2 somatic mutation. Conclusions: This study elucidated the comprehensive mutational landscape of advanced gastrointestinal cancer through liquid biopsy, thereby contributing novel biomarkers for clinical diagnosis and facilitating targeted therapy mechanism investigations.

MO70-5 The clinical outcomes for anamorelin in advanced gastrointestinal cancer patients with cancer cachexia

MO70-5 The clinical outcomes for anamorelin in advanced gastrointestinal cancer patients with cancer cachexia

Feasibility and safety of exercise during chemotherapy in people with gastrointestinal cancers: a pilot study

PurposeSarcopenia is a poor prognostic factor in cancer patients, and exercise is one of the treatments to improve sarcopenia. However, there is currently insufficient evidence on whether exercise can improve sarcopenia in patients with advanced cancers. This study examined the feasibility of exercise in advanced gastrointestinal (GI) cancer patients treated with palliative chemotherapy.MethodsBetween 2020 and 2021, 30 patients were enrolled in a resistance and aerobic exercise program for six weeks. The exercise intervention program (EIP) consisted of low, moderate, and high intensity levels. Patients were asked to select the intensity level according to their ability. The primary endpoint was the feasibility of the EIP measured by compliance during the six weeks. A compliance of over 50% was considered acceptable. The secondary endpoints were changes in weight and muscle mass, safety, quality of life (QoL) and overall survival (OS).ResultsThe median age of the study’s participants was 60 (30–77). The total compliance to the EIP was 63.3% (19/30 patients). Sixteen (53.3%) patients had a compliance of over 80%. The attrition rate was 30.0% (9/30). The mean exercise time was 41.4 min, and the aerobic exercise was 92.3% and the resistant exercise was 73.7%, and both exercise was 66.5%. Most patients performed the moderate intensity level exercises at home or near their home. The mean skeletal muscle index (SMI) was 43.5 cm2/m2 pre-chemotherapy and 42.2 cm2/m2 after six weeks of chemotherapy, with a decrease of -1.2 ± 2.8 cm2/m2 (-3.0%) (p = 0.030). In the poor compliance group, the mean SMI decrease was -2.8 ± 3.0 cm2/m2 which was significantly different (p = 0.033); however, in the good compliance group, the mean SMI decrease was -0.5 ± 2.5 cm2/m2 which was maintained over the six weeks (p = 0.337). The good compliance group had a significantly longer median OS compared with the poor compliance group (25.3 months vs. 7.9 months, HR = 0.306, 95% CI = 0.120–0.784, p = 0.014). The QoL showed a better score for insomnia (p = 0.042). There were no serious adverse events.ConclusionsThe EIP during palliative chemotherapy in advanced GI cancer patients showed good compliance. In the good compliance group, muscle mass and physical functions were maintained for six weeks. The EIP was safe, and the QoL was maintained. Based on this study, further research in exercise intervention in advanced cancer patients is needed.Clinical trial registrationThe clinical trial registration number is KCT 0005615 (CRIS, https://cris.nih.go.kr/cris/en/); registration date, 23rd Nov 2020.

China special issue on gastrointestinal tumor-improved survival after multidisciplinary team decision for patients with advanced gastrointestinal cancer: A multicenter, noninterventional, controlled study.

Formal multidisciplinary team (MDT) discussions in clinical practice require time and space but have unclear survival benefits for advanced gastrointestinal cancer patients. Our study aimed to investigate the long-term survival of patients with advanced gastrointestinal cancer after MDT decision. From June 2017 to June 2019, continuous MDT discussions on advanced gastrointestinal cancer were conducted in 13 medical centers in China. MDT decisions and actual treatment received by patients were prospectively recorded. The primary endpoint was the difference in overall survival (OS) between patients in the MDT decision implementation and nonimplementation groups. The secondary endpoints included the implementation rate of MDT decisions and subgroup survival analysis. A total of 461 MDT decisions of 455 patients were included in our study. The implementation rate of MDT decisions was 85.7%. Previous treatment had an impact on MDT decision-making. The OS was 24.0 months and 17.0 months in the implementation and nonimplementation groups, respectively. The implementation of MDT decisions significantly reduced the risk of death in multivariate analyses (hazard ratio = 0.518; 95% confidence interval: 0.304-0.884, P = .016). Subgroup analysis showed a significant difference in survival of patients with colorectal cancer, but not in survival of patients with gastric cancer. The rate of secondary MDT discussion was only 5.6% among patients who the MDT decisions were discontinued due to changes in their condition. MDT discussion can prolong the OS of patients with advanced gastrointestinal cancer, especially those with colorectal cancer. Timely scheduling of the subsequent MDT discussion is necessary when the disease condition changes.

Abstract 2259: Novel metallotherapeutic BOLD-100 induces circulating cytokine changes when administered in combination with FOLFOX in advanced gastrointestinal cancer patients

Abstract Proven metallotherapeutics, such as cisplatin and oxaliplatin, alter immune responses as part of their multimodal mechanisms-of-action. These immune responses can drive efficacy in specific patient populations and/or in combination with other oncology drugs. BOLD-100, currently in a multinational Phase 2 trial, is a first-in-class metallotherapeutic that (1) alters the unfolded protein response (UPR) through selective GRP78 inhibition, and (2) induces reactive oxygen species (ROS), leading to DNA damage and cell cycle arrest. Collectively, these pathways result in cell death in both sensitive and resistant cancers, giving BOLD-100 the potential to significantly improve outcomes in a wide range of both solid and liquid tumors in combination with other anticancer therapies. BOLD-100 can also alter immune responses, including through induction of immunogenic cell death, but these responses have not been investigated in a clinical population. A recently completed Phase 1b trial investigating BOLD-100 in combination with FOLFOX demonstrated a 3X improvement in progression-free survival (PFS) in 3rd line or later metastatic colorectal cancer patients compared to existing therapies, with a favorable safety profile. In this Phase 1b study, BOLD-100 was administered via IV infusion for 60-90 minutes immediately prior to FOLFOX on a 2-week cycle. To investigate the pharmacodynamics of immune markers, plasma samples were collected at baseline and 1, 6, 24, and 48 hours after initiation of BOLD-100 plus FOLFOX treatment for each of the first 4 cycles, and then at baseline for all subsequent cycles. In 326 samples collected from 15 patients, 48 cytokines were measured via multiplex. Multiple cytokines showed short-term (1 to 48 hours) transient increases in plasma concentration levels, including IL-10, IL-27, G-CSF, MIP-1β, IP-10, IL-2, IL-18 and TNFα. IL-10, a cytokine previously investigated as an anticancer therapeutic, increased significantly by 1 hour (6.7X increase) and by 6 hours (84.5X increase) after treatment, before reverting to baseline levels by 48 hours. Despite large acute increases in specific cytokines, no changes to baseline levels over multiple treatment cycles were observed. Correlation analysis showed that baseline MCP-1 and MIP-1α levels were negatively correlated with overall survival; and the maximum change in concentration over the first dosage cycle of RANTES, IL-17F, Eotaxin, TGFα and MDC were positively correlated with overall survival. These results show that BOLD-100 in combination with FOLFOX can induce immune responses, and that these immune responses may predict clinical outcome. Analysis of additional patient samples from the Phase 2 trial is ongoing. Citation Format: Mark Bazett, Brian Park, E Russell McAllister, Jim Pankovich. Novel metallotherapeutic BOLD-100 induces circulating cytokine changes when administered in combination with FOLFOX in advanced gastrointestinal cancer patients [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 2259.

Predictors of response to anamorelin in gastrointestinal cancer patients with cachexia: a retrospective study.

Anamorelin, a ghrelin receptor agonist, has recently been approved for gastric, pancreatic, and colorectal cancer patients with cachexia in Japan. However, only few studies have investigated the predictors of response to anamorelin in clinical settings. Thus, our study aimed to investigate the predictors of the response, in addition to its efficacy and safety. The clinical outcomes of 20 patients were evaluated during administration. They were divided into two groups based on lean body mass, responders and non-responders, and their clinical characteristics were compared. The mean ± standard error (SE) variations at 12weeks in lean body mass and handgrip strength were 2.63 ± 0.79kg and - 1.53 ± 1.20kg, respectively. The mean ± SE variations at 8weeks in fasting blood glucose and hemoglobin A1c were 32.88 ± 13.77mg/dL and 0.90 ± 0.18%, respectively. Total protein, albumin, transferrin, and prognostic nutritional index at baseline were significantly higher in responders (n = 8) than in non-responders (n = 12), whereas the neutrophil/lymphocyte and C-reactive protein/albumin ratios at baseline were significantly higher in non-responders than in responders. The study confirmed the efficacy and safety of anamorelin and identified nutritional or systemic inflammatory markers as predictors of anamorelin response in advanced gastrointestinal cancer patients.

Impact of acceptance and commitment therapy on physical and psychological symptoms in advanced gastrointestinal cancer patients and caregivers: Secondary results of a pilot randomized trial

Patients with advanced gastrointestinal cancer often experience high symptom burden, which is associated with heightened distress in both patients and their family caregivers. Few interventions have been tested to jointly address patient and caregiver symptoms in advanced gastrointestinal cancer. In a randomized pilot trial, telephone-based, dyadic acceptance and commitment therapy (ACT) was found to be feasible in this population. The present secondary analyses examined the impact of this intervention on patient and caregiver physical and psychological symptoms. Patients and caregivers (N = 40 dyads) were recruited from clinics in Indianapolis, Indiana and randomized to either six weeks of telephone-based ACT or education/support, an attention control condition. Outcomes were assessed at baseline and at 2 weeks and 3 months post-intervention. Study group differences in outcomes were not statistically significant. However, when examining within-group change, only ACT patients experienced moderate reductions in pain severity and interference at 2 weeks post-intervention (effect size [ES]=-0.47; -0.51) as well as moderate reductions in depressive symptoms at 2 weeks (ES=-0.42) and 3 months (ES=-0.41) post-intervention. ACT caregivers experienced moderate reductions in sleep disturbance (ES=-0.56; -0.49) and cognitive concerns (ES=-0.61; -0.85) across follow-ups. Additionally, caregivers in both conditions experienced moderate reductions in fatigue (ES=-0.38 to -0.70) and anxiety (ES=-0.40 to -0.49) across follow-ups. Findings suggest that ACT may improve certain symptoms in dyads coping with advanced gastrointestinal cancer and warrant replication in a larger trial.

Serological biomarkers predict immune-related adverse events and clinical benefit in patients with advanced gastrointestinal cancers.

BackgroundImmune checkpoint inhibitors (ICIs) have dramatically improved survival in advanced gastrointestinal (GI) cancer patients, but also resulted in immune-related adverse events (irAEs). This study aimed to evaluate serological biomarkers of irAEs and treatment response in GI cancer patients.Patients and methodsMetastatic GI cancer patients were enrolled between August 1, 2015, and July 31, 2017. Serum samples were collected at baseline, and a panel of 59 serum biomarkers was tested. The occurrence of irAEs was analyzed, and serological biomarker expression was correlated with irAE incidence and prognosis.ResultsFifty-one patients were enrolled, of whom 47.1% (24/51) were diagnosed with irAEs, including 4 patients (7.8%) with grade 3-5 irAEs. The most common irAE was thyroiditis (9/51, 17.6%), followed by colitis (7/51, 13.7%). The expression of CD28 (P = 0.042), IL-4 (P = 0.033), IL-15 (P = 0.024) and PD-L1 (P = 0.018) was significantly elevated in patients with grade 3-5 irAEs. For organ-specific irAEs, IL-6 levels were higher in patients with thyroiditis and colitis, while IL-22 and SCF levels were higher in patients with colitis. Increased IL-1α, IL-21, LIF, and PIGF-1 levels were significantly associated with myositis incidence, while the serum levels of six cytokines (BTLA, GM-CSF, IL-4, PD-1, PD-L1 and TIM-3) were higher in patients with rash. Prognostic analysis showed that patients with irAEs had better tumor response (P = 0.029), improved PFS (median survival: undefined vs. 2.1 months, P = 0.002), and extended OS (median survival: undefined vs. 4.3 months, P = 0.003). The prognostic value of irAEs was only significant in patients who received anti-PD-1 inhibitors, but not in those who received anti-PD-L1 inhibitors. Besides, elevated BTLA (median OS: not reached vs. 7 months; P = 0.0168) and PD-1 (median OS: not reached vs. 7 months; P = 0.0223) concentrations were associated with longer OS.ConclusionsSerological proteins are promising markers for predicting immune-related toxicity and prognosis in GI cancer patients. Organ-specific irAEs have various cytokine profiles. Although further validation is needed before clinical application, this study provided a direction for identifying patients at risk for irAEs, and guiding patient selection for ICI therapy.

IMPROVE bleeding score predicts major bleeding in advanced gastrointestinal cancer patients with venous thromboembolism.

The incidence of venous thromboembolism has been reported as 20% in cancer patients. Anticoagulation therapy is the standard treatment for venous thromboembolism. On the other hand, bleeding should be carefully managed, because advanced cancer, particularly gastrointestinal cancer, carries a high risk of bleeding. However, the optimal management for cancer-associated thromboembolism remains to be clarified. We retrospectively examined patients with advanced gastrointestinal cancer, including gastric cancer and colorectal cancer, who were treated with chemotherapy between 2014 and 2018 for the incidence and characteristics of venous thromboembolism and bleeding. In total, 194 patients (120 men, 74 women) were enrolled in this study. The underlying pathology was gastric cancer in 74 cases and colorectal cancer in 120 cases. Of the 194 patients, 40 patients (20.6%) were diagnosed with venous thromboembolism and 10 patients (5.2%) were diagnosed with concomitant pulmonary thromboembolism. Conversely, bleeding was observed in 29 patients (15%). The location of bleeding was the primary tumor in 17 cases, metastatic tumor in 9 and hemorrhagic gastric ulcer in 3. Within the venous thromboembolism group (n=40), bleeding was observed in 10 patients (25%). Multivariate analysis showed that International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) bleeding score ≥7 correlated significantly with major bleeding (P=0.01). In patients with a low risk of bleeding, major bleeding was observed in only three patients. IMPROVE bleeding score may predict the risk for bleeding in gastrointestinal cancer patients with venous thromboembolism. Selecting patients with a low risk of bleeding using with IMPROVE bleeding score is expected to contribute to the safer management of anticoagulation therapy for cancer-associated thromboembolism.

Discriminating Epithelial to Mesenchymal Transition Phenotypes in Circulating Tumor Cells Isolated from Advanced Gastrointestinal Cancer Patients.

Gastrointestinal (GI) cancers constitute a group of highest morbidity worldwide, with colorectal cancer (CRC) and gastric cancer being among the most frequently diagnosed. The majority of gastrointestinal cancer patients already present metastasis by the time of diagnosis, which is widely associated with cancer-related death. Accumulating evidence suggests that epithelial-to-mesenchymal transition (EMT) in cancer promotes circulating tumor cell (CTCs) formation, which ultimately drives metastasis development. These cells have emerged as a fundamental tool for cancer diagnosis and monitoring, as they reflect tumor heterogeneity and the clonal evolution of cancer in real-time. In particular, EMT phenotypes are commonly associated with therapy resistance. Thus, capturing these CTCs is expected to reveal important clinical information. However, currently available CTC isolation approaches are suboptimal and are often targeted to capture epithelial CTCs, leading to the loss of EMT or mesenchymal CTCs. Here, we describe size-based CTCs isolation using the RUBYchip™, a label-free microfluidic device, aiming to detect EMT biomarkers in CTCs from whole blood samples of GI cancer patients. We found that, for most cases, the mesenchymal phenotype was predominant, and in fact a considerable fraction of isolated CTCs did not express epithelial markers. The RUBYchip™ can overcome the limitations of label-dependent technologies and improve the identification of CTC subpopulations that may be related to different clinical outcomes.

ADVANCED UPPER GASTROINTESTINAL CANCER PATIENTS ON HOME PARENTERAL NUTRITION: CLINICAL FEATURES AND OUTCOME

to analyze data collected by the Unit of Home Parenteral Nutrition in Oncology of a tertiary hospital for upper gastrointestinal disease cancer patients care. patients were assessed for HPN eligibility according to the guidelines. Median and range data of clinical and anthropometric features are shown. Duration of therapy and outcome are assessed. 139 patients (50 females, 89 males) were enrolled on HPN from 2015 to 2019. Age was 65 (30-90). Performance status KI was: 50 in 1%, 60 in 17%, 70 in 36%, 80 in 43%, 90 in 3% of cases. Peritoneal carcinosis was present in 44% of patients and metastatic disease in 47% of cases; 32% of patients undergoing chemioteraphy and 35% were treated with curative surgery, 7% with palliative surgery. Nutritional data at the beginning of HPN were: weight 57 (29-85) kg, BMI 20 (13-32) Kg/m2, weight loss -8 (+15-30) kg during 3 months before HPN beginning. HPN duration was 64 (5-1198) days. Outcomes were: exitus or worsening of general clinical conditions 67%, enough oral food intake or Home Enteral Nutrition 23%, shift to other care center 4%, ongoing therapy 6%. Patients with a HPN duration shorter than 60 days were 64 (46% of total patients). There was no statistically significant difference between all patients and the group with shorter HPN duration outcomes. HPN is a supportive therapy for advanced upper gastrointestinal cancer patients when oral or enteral feeding is not feasible or is contraindicated. Our experience data confirm the adequacy of the selection criteria for HPN enrollment.

Acceptance and commitment therapy for fatigue interference in advanced gastrointestinal cancer and caregiver burden: protocol of a pilot randomized controlled trial

BackgroundFatigue interference with activities, mood, and cognition is one of the most prevalent and bothersome concerns of advanced gastrointestinal (GI) cancer patients. As fatigue interferes with patient functioning, family caregivers often report feeling burdened by increasing responsibilities. Evidence-based interventions jointly addressing cancer patient fatigue interference and caregiver burden are lacking. In pilot studies, acceptance and commitment therapy (ACT) has shown promise for addressing symptom-related suffering in cancer patients. The current pilot trial seeks to test a novel, dyadic ACT intervention for both advanced GI cancer patients with moderate-to-severe fatigue interference and their family caregivers with significant caregiving burden or distress.MethodsA minimum of 40 patient-caregiver dyads will be randomly assigned to either the ACT intervention or an education/support control condition. Dyads in both conditions attend six weekly 50-min telephone sessions. Outcomes are assessed at baseline as well as 2 weeks and 3 months post-intervention. We will evaluate the feasibility, acceptability, and preliminary efficacy of ACT for improving patient fatigue interference and caregiver burden. Secondary outcomes include patient sleep interference and patient and caregiver engagement in daily activities, psychological flexibility, and quality of life. We will also explore the effects of ACT on patient and caregiver physical and mental health service use.DiscussionFindings will inform a large-scale trial of intervention efficacy. Results will also lay the groundwork for further novel applications of ACT to symptom interference with functioning and caregiver burden in advanced cancer.Trial RegistrationClinicalTrials.gov, NCT04010227. Registered 8 July 2019.

Abstract A053: Association between socioeconomic status and access to specialized cancer consultation and treatment among advanced gastrointestinal cancers

Abstract Introduction: Gastrointestinal (GI) cancers of the pancreas, esophagus, stomach, colon and rectum often present at an incurable stage. Treatments such as chemotherapy and radiotherapy can improve quality and quantity of life for patients with these advanced gastrointestinal (GI) cancers. However, many patients fail to receive such treatments or even consult with a cancer specialist to determine if treatment is an option. Socioeconomic status (SES) is associated with cancer outcomes, but the mechanisms as to why, such as access to specialized care, are not clearly established. This study examined the association between SES and receipt of specialized cancer consult and treatment in Ontario, Canada. Methods: This was a population-based retrospective cohort study of advanced GI cancer patients diagnosed between 2007 and 2017 using linked administrative databases. The exposure of SES was defined using the deprivation item in the Ontario Marginalization Index. The outcome of oncology consult was defined as a consultation with either a radiation oncologist or a medical oncologist and the outcome of treatment was defined as receipt of chemotherapy or radiotherapy. Both were measured in the year following diagnosis. Multivariable Cox-proportional hazards regression models were used to determine association of deprivation with oncology consult and treatment. Confounders identified a priori include age, sex, comorbidities and cancer site. Results: 29,297 patients had a diagnosis of advanced GI cancer and were included in the study. 27.4% of the cohort did not have an oncology consult and 53.7% did not receive treatment in the year following diagnosis. The most deprived quintile compared to the least deprived quintile was associated with decreased consult (HR 0.89 (0.85-0.93)) and decreased treatment (HR 0.81 (0.77-0.86)) after adjusting for confounders. Conclusion: This study found that even in a single-payer universal healthcare system, SES is associated with access to specialized cancer care. Future research should examine mechanisms through which policy might help low SES patients access specialized cancer care. Citation Format: Laura E Davis, Natalie G Coburn, Julie Hallet, Craig C Earle, Sten Myrehaug, Ying Li, Alyson L Mahar. Association between socioeconomic status and access to specialized cancer consultation and treatment among advanced gastrointestinal cancers [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr A053.

Outcomes of advanced gastrointestinal (GI) cancer patients in relationship to opioid use: An individual patient data pooled analysis from eight clinical trials.

687 Background: The current study aims at assessing the patterns of opioid use, and evaluating the impact of opioid use on survival outcomes among patients with advanced GI cancers who were included in eight clinical trials. Methods: De-identified datasets of eight clinical trials evaluating first-line systemic treatment for advanced GI cancers (NCT01124786; NCT00844649; NCT00290966; NCT00678535; NCT00699374; NCT00272051; NCT00305188; NCT00384176) were accessed from the Project Data Sphere platform. These trials evaluated patients with pancreatic, gastric, hepatocellular and colorectal carcinoma. Multivariable logistic regression analysis was used to evaluate factors predicting the use of opioids. Kaplan-Meier survival estimates were used to compare survival outcomes in each disease entity among patients who did or did not receive opioid treatment. Multivariable Cox regression analysis was used to assess the impact of opioid use on survival outcomes in each disease entity. Results: A total of 3441 participants were included in the current analysis. The following factors predicted a higher probability of opioid use within logistic regression analysis: younger age (P = 0.004), non-white race (P = 0.010), higher ECOG score (P < 0.001) and pancreatic primary site (P < 0.001). Use of opioids was consistently associated with worse overall survival in Kaplan-Meier survival estimates of each disease entity (for pancreatic cancer: P = 0.008; for gastric cancer: P < 0.001; for hepatocellular carcinoma: P < 0.001 and for colorectal cancer: P < 0.001). Within multivariable Cox regression analysis, opioid use was associated with worse overall survival among patients with pancreatic cancer (HR = 1.245; 95% CI: 1.063-1.459; P = 0.007), gastric cancer (HR = 1.725; 95% CI: 1.403-2.122; P < 0.001), hepatocellular carcinoma (HR = 1.841; 95 CI: 1.480-2.290; P < 0.001) and colorectal cancer (HR = 1.651; 95% CI: 1.380-1.975; P < 0.001). Conclusions: Opioid use is consistently associated with worse overall survival among patients with different GI cancers. Further studies are needed to evaluate the underlying mechanisms of this observation.

Dispositional Mindfulness, Perceived Stress, and Mental Well-Being in the Cancer Survivorship

The present study aims to investigate how dispositional mindfulness affects the mental well-being of cancer patients through the way they perceive stress. A total of 182 moderate and advanced gastrointestinal cancer patients volunteered to complete the Mindful Attention Awareness Scale (MAAS), the Chinese Perceived Stress Scale (CPSS), and the General Health Questionnaire (GHQ). Results showed that perceived stress significantly mediated the relationship between dispositional mindfulness and all dimensions of the mental well-being as captured by the GHQ (i.e. anxiety/depression, social dysfunction, and loss of confidence), and perceived stress was positively correlated with all the dimensions of mental well-being. Results of the Structural Equation Model showed that the model fit the data very well (χ2/df = 1.72，RMSEA = 0.063 (95% CI = 0.014 ~ 0.103), CFI = 0.984, TLI = 0.970, SRMR=0.041). Further analyses showed that dispositional mindfulness predicted all the dimensions of psychological well-being. Specifically, higher levels of dispositional mindfulness predicted reduced subjective perceptions of stress, which in turn predicted lower levels of anxiety/depression, social impairment, and loss of confidence. This study indicated a possible mechanism of intervention focused on improving mindfulness capability. Future work is encouraged to investigate the long-term influence of dispositional mindfulness on perceived stress and psychological well-being in cancer patients with other types of cancer.

A multicenter, open-label, single-arm study of anamorelin (ONO-7643) in advanced gastrointestinal cancer patients with cancer cachexia.

BackgroundCancer cachexia is characterized by weight loss and is associated with increased morbidity and mortality in patients with cancer. Anamorelin (ONO‐7643; ANAM) is a novel and selective ghrelin receptor agonist that improves appetite, lean body mass (LBM), body weight, and anorexia.MethodsThis multicenter, open‐label, single‐arm study investigated the efficacy and safety of 100 mg anamorelin in 50 Japanese patients with advanced and unresectable gastrointestinal (colorectal, gastric, or pancreatic) cancer. ANAM was administered once daily over 12 weeks. The primary endpoint was the proportion of patients that maintained or gained LBM over the course of the study. Secondary endpoints included changes in LBM, body weight, quality of life (QoL), and nutritional status biomarkers.ResultsThe proportion of patients who responded to treatment was 63.3% (95% CI, 48.3%‐76.6%), with a least square mean ± SE change in LBM and body weight from baseline of 1.89 ± 0.36 kg and 1.41 ± 0.61 kg, respectively. Appetite‐related questions on the QoL questionnaire showed that ANAM improved appetite. Adverse events occurred in 79.6% of patients, and the most common treatment‐related adverse events were increased γ‐glutamyl transpeptidase (8.2%), diabetes mellitus (6.1%), hyperglycemia (6.1%), and prolonged QRS complex (6.1%).ConclusionsANAM improved anorexia and patients' nutritional status, resulting in rapid increases in LBM and body weight in patients with advanced gastrointestinal cancer who had cancer cachexia. ANAM treatment was well tolerated over 12 weeks. ANAM is a potential clinically beneficial pharmacotherapeutic option for patients with advanced gastrointestinal cancer who have cancer cachexia.

Telephone Support for Advanced Gastrointestinal Cancer Patients and Caregivers

Telephone Support for Advanced Gastrointestinal Cancer Patients and Caregivers

P-014 - Associations between primary cancer site, metastatic site, comorbidity, and details of symptoms and treatment in advanced gastrointestinal cancer patients at end-of-life

P-014 - Associations between primary cancer site, metastatic site, comorbidity, and details of symptoms and treatment in advanced gastrointestinal cancer patients at end-of-life

P-015 - Association between prognosis and discontinuation by image diagnosis for advanced gastrointestinal cancer patients who received end-of-life chemotherapy

P-015 - Association between prognosis and discontinuation by image diagnosis for advanced gastrointestinal cancer patients who received end-of-life chemotherapy