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Item Age and comorbidity association with survival outcomes in metastatic colorectal cancer: CALGB 80405 analysis(Elsevier, 2022) McCleary, Nadine J.; Zhang, Sui; Ma, Chao; Ou, Fang-Shu; Bainter, Tiffany M.; Venook, Alan P.; Niedzwiecki, Donna; Lenz, Heinz-Josef; Innocenti, Federico; O'Neil, Bert H.; Polite, Blase N.; Hochster, Howard S.; Atkins, James N.; Goldberg, Richard M.; Ng, Kimmie; Mayer, Robert J.; Blanke, Charles D.; O'Reilly, Eileen M.; Fuchs, Charles S.; Meyerhardt, Jeffrey A.; Medicine, School of MedicineBackground: Little is known about the interaction of comorbidities and age on survival outcomes in colorectal cancer (mCRC), nor how comorbidities impact treatment tolerance. Methods: We utilized a cohort of 1345 mCRC patients enrolled in CALGB/SWOG 80405, a multicenter phase III trial of fluorouracil/leucovorin + oxaliplatin (FOLFOX) or irinotecan (FOLFIRI) plus bevacizumab, cetuximab or both. Endpoints were overall survival (OS), progression-free survival (PFS), and grade ≥ 3 toxicities assessed using NCI CTCAE v.3.0. Participants completed a questionnaire, including a modified Charlson Comorbidity Index. Adjusted Cox and logistic regression models tested associations of comorbidities and age on the endpoints. Results: In CALGB/SWOG 80405, 1095 (81%) subjects were < 70 years and >70 250 (19%). Presence of ≥1 comorbidity was not significantly associated with either OS (HR 1.10, 95% CI 0.96-1.25) or PFS (HR 1.03, 95% CI 0.91-1.16). Compared to subjects <70 with no comorbidities, OS was non-significantly inferior for ≥70 with no comorbidities (HR 1.21, 95% CI 0.98-1.49) and significantly inferior for ≥70 with at least one comorbidity (HR 1.51, 95% CI 1.22-1.86). There were no significant associations or interactions between age or comorbidity with PFS. Comorbidities were not associated with treatment-related toxicities. Age ≥ 70 was associated with greater risk of grade ≥ 3 toxicities (OR 2.15, 95% CI 1.50-3.09, p < 0.001). Conclusions: Among participants in a clinical trial of combination chemotherapy for mCRC, presence of older age with comorbidities was associated with worse OS but not PFS. The association of age with toxicity suggests additional factors of care should be measured in clinical trials.Item ColoType: a forty gene signature for consensus molecular subtyping of colorectal cancer tumors using whole-genome assay or targeted RNA-sequencing(Nature Publishing group, 2020-07-21) Buechler, Steven A.; Stephens, Melissa T.; Hummon, Amanda B.; Ludwig, Katelyn; Cannon, Emily; Carter, Tonia C.; Resnick, Jeffrey; Gökmen-Polar, Yesim; Badve, Sunil S.; Pathology and Laboratory Medicine, School of MedicineColorectal cancer (CRC) tumors can be partitioned into four biologically distinct consensus molecular subtypes (CMS1-4) using gene expression. Evidence is accumulating that tumors in different subtypes are likely to respond differently to treatments. However, to date, there is no clinical diagnostic test for CMS subtyping. In this study, we used novel methodology in a multi-cohort training domain (n = 1,214) to develop the ColoType scores and classifier to predict CMS1-4 based on expression of 40 genes. In three validation cohorts (n = 1,744, in total) representing three distinct gene-expression measurement technologies, ColoType predicted gold-standard CMS subtypes with accuracies 0.90, 0.91, 0.88, respectively. To accommodate for potential intratumoral heterogeneity and tumors of mixed subtypes, ColoType was designed to report continuous scores measuring the prevalence of each of CMS1–4 in a tumor, in addition to specifying the most prevalent subtype. For analysis of clinical specimens, ColoType was also implemented with targeted RNA-sequencing (Illumina AmpliSeq). In a series of formalin-fixed, paraffin-embedded CRC samples (n = 49), ColoType by targeted RNA-sequencing agreed with subtypes predicted by two independent methods with accuracies 0.92, 0.82, respectively. With further validation, ColoType by targeted RNA-sequencing, may enable clinical application of CMS subtyping with widely-available and cost-effective technology.Item Examining the effect of peer helping in a coping skills intervention: a randomized controlled trial for advanced gastrointestinal cancer patients and their family caregivers(Springer Nature, 2018-02) Kohli, Marc; Morrison, James J.; Wawira, Judy; Morgan, Matthew B.; Hostetter, Jason; Genereaux, Brad; Hussain, Mohannad; Langer, Steve G.; Psychology, School of SciencePURPOSE: At the end of life, spiritual well-being is a central aspect of quality of life for many patients and their family caregivers. A prevalent spiritual value in advanced cancer patients is the need to actively give. To address this need, the current randomized trial examined whether adding a peer helping component to a coping skills intervention leads to improved meaning in life and peace for advanced gastrointestinal cancer patients and their caregivers. Feasibility and acceptability outcomes were also assessed. METHODS: Advanced gastrointestinal cancer patients and caregivers (n = 50 dyads) were randomly assigned to a 5-session, telephone-based coping skills intervention or a peer helping + coping skills intervention. One or both dyad members had moderate-severe distress. Peer helping involved contributing to handouts on coping skills for other families coping with cancer. Patients and caregivers completed measures of meaning in life/peace, fatigue, psychological symptoms, coping self-efficacy, and emotional support. Patient pain and caregiver burden were also assessed. RESULTS: Small effects in favor of the coping skills group were found regarding meaning in life/peace at 1 and 5 weeks post-intervention. Other outcomes did not vary as a function of group assignment, with both groups showing small decreases in patient and caregiver fatigue and caregiver distress and burden. High recruitment and retention rates supported feasibility, and high participant satisfaction ratings supported acceptability. CONCLUSIONS: Although a telephone-based intervention is feasible and acceptable for this population, peer helping in the context of a coping skills intervention does not enhance spiritual well-being relative to coping skills alone.Item Experience with a simplified feeding jejunostomy technique for enteral nutrition following major visceral operations(AME Publishing Company, 2018-07-19) Minarich, Michael J.; Schwarz, Roderich E.; Surgery, School of MedicineBackground: Background: Perioperative nutrition support has been shown to impact on outcomes for patients with gastrointestinal cancer. Postoperative benefits of feeding tubes must be weighed against morbidity related to placement and use. A simplified jejunostomy tube technique was evaluated for outcomes. Methods: A 16-Fr rubber tube is secured at the jejunal entry site without Witzel tunnel, followed by a continuous, circumferential and alternating suture between jejunal wall and parietal peritoneum. Prospectively collected data were analyzed. Results: The technique was performed in 343 of 803 major hepatopancreatobiliary and upper gastrointestinal (GI) resections (43%). Of these patients (male =57%, median age: 65.8 years, range, 24.0-98.0 years), 89% had a cancer diagnosis. The procedures included pancreatectomy (n=189, 55%), gastrectomy (n=109, 32%), esophagectomy (n=19, 6%) and others (n=26, 7%). The operative intent was curative in 78%, palliative in 10%, or combined in 12% of patients. Postoperative morbidity rate was 40%, with 19 lethal events (5.5%), and a median length of stay of 10 days (range, 4-111 days). Tube feeds were administered in 139 patients (41%), and in 17% continued beyond discharge. Use of the feeding tube was linked to treatment interval, length of stay, major complication grade (all at P<0.0001), metastatic stage (P=0.0007) and noncurative intent (P=0.001). Tube feeds beyond discharge were associated with time interval (P<0.0001), length of stay (P=0.0006) and noncurative intent (P=0.014). Tube-specific events in 38 patients (11%) were all minor, without any intraabdominal leak, infection or obstruction. Conclusions: The technique described is safe and expedient, and the overall tube-related morbidity is low. This procedure can be recommended in cases at risk for major morbidity and nutrition support needs.Item The Clinical Significance of Incidental GIT Uptake on PET/CT: Radiologic, Endoscopic, and Pathologic Correlation(MDPI, 2023-03-30) Hosni, Mohammad N.; Kassas, Mutaz; Itani, Mohamad I.; Rahal, Mahmoud A.; Al-Zakleet, Safaa; El-Jebai, Malak; Abi-Ghanem, Alain S.; Moukaddam, Hicham; Haidar, Mohamad; Vinjamuri, Sobhan; Shaib, Yasser H.; Medicine, School of MedicineIncidental gastrointestinal tract (GIT) [18F]-Fluorodeoxyglucose (FDG) uptake in positron emission technology/computed tomography (PET/CT) is an unexpected and often complicated finding for clinicians. This retrospective study reviewed 8991 charts of patients who underwent PET/CT: 440 patients had incidental GIT uptake, of which 80 underwent endoscopy. Patient characteristics, imaging parameters, and endoscopic findings were studied. Of the 80 patients, 31 had cancer/pre-cancer lesions (16 carcinomas; 15 pre-malignant polyps). Compared to patients with benign/absent lesions, patients with cancer/pre-cancer lesions were significantly older (p = 0.01), underwent PET/CT for primary evaluation/staging of cancer (p = 0.03), had focal GIT uptake (p = 0.04), and had lower GIT uptake (p = 0.004). Among patients with focal uptake, an SUVmax of 9.2 had the highest sensitivity (0.76) and specificity (0.885) in detecting cancer/pre-cancerous lesions. Lower GIT uptake was most common in the sigmoid colon, and upper GIT uptake was most frequent in the stomach. In a bivariate analysis, predictors of cancer/pre-cancer were older age, PET/CT indicated for primary evaluation, focal uptake, uptake in the lower GIT, and higher SUVmax. Further endoscopic investigation is warranted for patients with incidental GIT uptake, especially in the elderly or those presenting for primary evaluation with PET/CT, with the following findings on imaging: lower GIT uptake, focal uptake, or high SUVmax.