Objectives: To determine the risk and risk factors for mental illness among colorectal cancer (CRC) survivors across short-term and long-term follow-up periods. Methods: We used the Utah Cancer Registry to identify CRC survivors diagnosed between 1997 and 2013. Mental health diagnoses were available in electronic medical records and statewide facilities data that were linked by the Utah Population Database. CRC survivors were matched to individuals from a general population cohort. The risk of developing a mental illness was compared between cohorts. The association between mental illness and mortality was also analyzed. Results: In total, 8961 CRC survivors and 35,897 individuals in a general population cohort were identified. CRC survivors were at increased risk for any mental health diagnosis at 0 to 2 years (hazard ratio [HR], 3.70; 95% confidence interval [CI], 3.47-3.95), >2 to 5 years (HR, 1.23; 95% CI, 1.09-1.38), and >5 years (HR, 1.20; 95% CI, 1.07-1.36) after cancer diagnosis. CRC survivors were also at increased risk of depressive disorders specifically during the same time periods. At >5 years, CRC survivors still had an increased risk of developing many mental health diagnoses. Factors associated with increased risk of any mental health disorder among CRC survivors included colostomy and Charlson Comorbidity Index of 1+. There was an increased risk of death for CRC survivors diagnosed with any mental health disorder (HR, 2.18; 95% CI, 2.02-2.35) and depression (HR, 2.10; 95% CI, 1.92-2.28). Conclusions: CRC survivors are at increased risk for mental health disorders in the short-term and long-term. Survivors who develop mental health disorders also experience decreased survival.
612 Background: Definitive chemoradiation (CRT) is the preferred bladder preservation treatment for non-metastatic urothelial cancer (nmUC). The NEXT trial (NCT03171025) evaluated the efficacy of adjuvant nivolumab to definitive CRT in pts with nmUC. Methods: This multicenter study enrolled nmUC pts who received standard-of-care CRT. Nivolumab 480 mg was administered every 4 weeks for up to 12 doses. Primary endpoint: failure-free survival (FFS) at 2 years (yrs). Secondary endpoint: safety. This is the first efficacy and safety analysis after completion of enrollment, and correlation of disease risk features, and changes in plasma cell-free DNA (cfDNA) with outcomes. Shallow whole genome sequenced data from plasma cfDNA was mapped to the human reference genome (HG19), and copy number instability (CNI) Score (Oncocyte) was derived from statistically significant altered regions. Results: From 8/03/2017 to 1/25/2023, 28 pts were enrolled. The median age was 72 yrs (range 54-86 yrs). Ten patients (36%) had ≥ T3 and/or N+ disease. At time of data cut-off (9/14/23), median nivolumab cycles were 8.5 (range 1-12), and median follow-up was 11 months (range 6 - 45). FFS at 2 yrs (n=24) was 38.7 % (95% CI 23%-65.2%). Disease relapse occurred in 16 pts, of which 9 had local recurrences. Grade ≥3 treatment-related adverse events (AEs) occurred at a frequency of 10.7%. These were elevated transaminases, diarrhea, and polymyalgia rheumatica. Grade 3 radiation therapy oncology group (RTOG) AEs occurred in 2 pts. One or more high-risk disease features (ie. plasmacytoid differentiation, T4, N+, multiple tumors, tumors > 5 cm, residual disease before CRT, CIS, and hydronephrosis) were present in 22 pts (79%). In a Cox proportional hazards model, the number of high-risk features was a significant predictor of progression (p = 0.006). Each additional high-risk feature was associated with a hazard ratio for progression of 1.77 (95% CI 1.17-2.67). Median CNI (mCNI) on C1D1 of nivolumab in relapsed pts was 31 (range 3-232) vs. 24 (range 3-109) in pts with ongoing response. The mCNI on C4D1 for pts who progressed was 15.5 (range 6-371) vs. 9 (range 3-65) in pts with ongoing response. Oncogenic gene copy number changes and the associated pathways associated with progression are listed in the table. Conclusions: Adjuvant nivolumab to CRT for nmUC has promising efficacy with tolerable AEs, even in pts with high-risk disease. Disease relapse correlates with high-risk clinical features and CNI in plasma cfDNA. Oncogenic copy number changes in genes involved in DNA repair, RTK-RAS-PI3K, WNT, and cell cycle pathways are present in cfDNA of those who progressed (Table). Clinical trial information: NCT03171025 . [Table: see text]
Introduction Ultrasound (US) guidance of the prostate has long been conducted using a transabdominal (TA) approach. More recently, a transperineal (TP) approach has been made available for image guidance. Our aim was to determine if both methods produced similar alignments within the same patients. Materials and methods We utilized two clinical US image guidance (IG) systems (Elekta Clarity and Best B AT). The B‐mode Acquisition and Targeting USIG system is a bi‐planar, so‐called 2.5D USIG system, that is acquired TA. Clarity is a 3D US system that generates a volumetric 3D US data set and US‐derived IG contours that are coregistered to the planning CT images. The probe is oriented in the sagittal plane against the perineum (TP). After positioning the patient for treatment using the TP USIG, we maintained the position defined by Clarity tracking and then acquired a TA‐based USIG. The two US‐based methods of localizing the prostate (TA vs TP) were compared via Bland–Altman (BA) statistical analysis to determine if there was alignment agreement between methods. Results The BA test for all 101 patients, 2093 fractions resulted in 95% confidence intervals (upper and lower limits of the BA test) of 0.6 mm in LR, 0.9 mm in AP and 1.0 mm in SI. The bias between the two systems was calculated as 0.03, 0.02, and 0.03 mm in LR, AP, and SI. Conclusions Both systems resulted in statistically equivalent targeting positions for the prostate. Because of the unique intrafraction, real‐time motion tracking capability of the TP system, this solution represents a unique extension to the previously reported clinical benefits of a TA approach by providing assurance of the prostate remaining in the treatment field during beam‐on.
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