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PURPOSE: Nonclinical factors and cognitive biases have been shown to significantly affect clinical decision making. In this study, we aimed to identify clinical and environmental factors that might influence the decision to approve or reject image-guided radiation therapy (IGRT) images in a large multisite institution. METHODS: We identified all IGRT image approval and rejection decisions recorded within an electronic imaging system from July 1, 2016, to June 30, 2018. For each decision, we tabulated the following parameters: the attending physician of the patient, the physician reviewing the image, total images reviewed by the physician that day, time of day, day of week, treatment site, and imaging modality (kilovoltage or cone beam computed tomography [CBCT]). We created a binary multivariable logistic regression model to identify factors associated with IGRT image rejection. RESULTS: Overall, of 51,797 total image records evaluated, 881 (1.70%) were rejected and 50,916 (98.30%) were approved. Univariable analysis revealed that images reviewed by physicians with high rejection rates (odds ratio [OR], 3.16; P < .001) and by physicians reviewing fewer IGRT images (OR, 0.99; P = .024), images from various anatomic sites (particularly skin, breast, and head and neck), and CBCT imaging compared with kilovoltage imaging (OR, 1.49; P < .001) were associated with the increased rate of rejection. On multivariable analysis, images reviewed by physicians with high rejection rates (OR, 3.28; P < .001), images from specific anatomic sites including breast ( P < .001), and CBCT imaging ( P < .001) persisted as independent predictors of image rejection. CONCLUSION: These data provide important insight into the clinical, cognitive, and environmental factors that might influence the routine clinical decision of IGRT image approval. Recognition of these factors may not only improve the quality of individual decisions but also identify opportunities for systems-based quality improvement in IGRT.

Short course radiation-based total neoadjuvant therapy can improve disease-free survival for patients with high-risk locally advanced rectal cancer. Tumors that involve or threaten the circumferential resection margin have a particularly high risk of local recurrence. Intraoperative radiation therapy enables treatment escalation at the threatened or involved margin at the time of surgery.Patients with rectal adenocarcinoma treated with preoperative short course radiotherapy-based total neoadjuvant therapy and intraoperative radiation at the time of surgery were identified. All patients had a threatened or involved circumferential resection margin on magnetic resonance imaging at the time of diagnosis. Treatment details, radiation toxicities, postoperative complications and oncologic outcomes were recorded.Ten patients received intraoperative radiation after short course radiation-based total neoadjuvant therapy. All patients had an involved or threatened circumferential resection margin, 60% had extramural venous invasion, and 60% had positive lateral pelvic lymph nodes. Seven patients had negative surgical margins (≥ 2 mm), and 3 patients had an R1 resection with radial margins2 mm. The median [IQR] length of hospitalization after surgery was 11 [7-14] days. Three patients required readmission and 2 patients required reoperation due to complications including anastamotic leak and abscess. With a median follow up of 19.5 months postoperatively, no patient developed a pelvic recurrence, and 6 patients developed distant recurrences.The use of intraoperative radiation after a short course radiotherapy-based neoadjuvant therapy is safe and feasible. Further data are needed to determine whether the addition of intraoperative radiation improves local recurrence rates over preoperative radiation alone.

Definitive radiation therapy with concurrent chemotherapy is curative for nonmetastatic squamous cell carcinoma of the anus (SCCA). However, the true effect of chemoradiation on long-term functional outcomes is poorly understood owing to limited follow-up and patient-reported outcomes (PROs).We conducted a cross-sectional survey of 248 patients with SCCA treated with definitive intensity modulated radiation and concurrent chemotherapy from 2010 to 2018 who were alive and without recurrence. PRO measures were collected, including Functional Assessment of Cancer Therapy-General (FACT-G7), Fecal Incontinence Quality of Life (FIQoL), Low Anterior Resection Syndrome (LARS), and International Consultation on Incontinence Questionnaires (ICIQ). Models were used to determine the association between demographic, tumor, treatment, and dosimetric data with PROs.One hundred twelve (45%) patients completed PROs. Median [interquartile range (IQR)] time from radiation completion to survey was 51 [37-85] months. The median scores [IQR] for FACT-G7, FIQoL, and LARS were 21 [15-24], 14 [11-16], and 32 [25-37], respectively. For men, median subscores [IQR] for ICIQ voiding and incontinence subscores were 5 [2-6] and 1 [1-3], respectively. For women, median subscores [IQR] for ICIQ voiding, incontinence, and filling were 1 [1-3], 5 [3-8], and 4 [2-5], respectively. Higher (better) FIQoL scores were associated with higher (better) FACT-G7 scores (β = 0.83; 95% confidence interval, 0.58-1.09; P.001), and higher (worse) LARS scores were associated with lower (worse) FACT-G7 scores (β = -0.22; 95% confidence interval, -0.31 to -0.13; P.001). A separate multivariable analysis revealed higher bowel bag D1% was associated with lower (worse) FIQoL (P = .001) and higher (worse) LARS (P = .003) scores. Higher bladder V40 Gy was associated with increased (worse) ICIQ voiding subscore (P = .001).Patients treated with modern chemoradiation for SCCA experience significant long-term bowel toxic effects with considerable effect on quality of life. Minimizing bowel hotspots and bladder V40 Gy may improve bowel and urinary function. Other interventions to reduce long-term toxic effects and improve quality of life are needed.

In this review, we present the context of older adult (OA) cancer patients within the broader cancer population, including cancer burdens and trial representation. We first describe the proportion of older adults in clinical trials, with studies showing strong evidence that the proportion of OA in cancer trials is much less than the proportion of OA in the overall cancer population. We highlight the lack of generalizability that can lead to challenges in treatment decisions for OA as well as concerns regarding health inequity. We then discuss barriers to OA enrollment related to trial structure and design, physician perspective, and patient and/or caregiver perspective. We expand on this further by outlining these barriers throughout the process of trial design, patient enrollment/trial implementation, and data analysis in post-market settings. We summarize guidelines from national societies, regulatory agencies, and other institutional bodies, then present a compilation of on-the-ground actionable recommendations to address the challenges of clinical trial design, focusing on geriatric assessments and OA-specific trials. We conclude by providing an outline for future directions, noting specifically the potential impact that radiotherapy and radiation oncology may have on clinical trials related to OA patients.

Gamma Knife (GK) stereotactic radiosurgery (SRS) is increasingly used as an initial treatment for patients with 10 or more brain metastases. However, the clinical and dosimetric consequences of this practice are not well established.We performed a single-institution, retrospective analysis of 30 patients who received Gamma Knife SRS for 10 or more brain metastases in 1 session. We utilized MIM Software to contour the whole brain and accumulated the doses from all treated lesions to determine the mean dose delivered to the whole brain. Patient outcomes were determined from chart review.Our cohort had a median number of 13 treated lesions (range 10-26 lesions) for a total of 427 treated lesions. The mean dose to the whole brain was determined to be 1.8 ± 0.91 Gy (range 0.70-3.8 Gy). The mean dose to the whole brain did not correlate with the number of treated lesions (Pearson r = 0.23, P = 0.21), but was closely associated with tumor volume (Pearson r = 0.95, P0.0001). There were no significant correlations between overall survival and number of lesions or aggregate tumor volume. Fourteen patients (47%) underwent additional SRS sessions and 6 patients (20%) underwent whole-brain radiotherapy with a median of 6.6 months (range 3.0-50 months) after SRS. Two patients (6.6%) developed grade 2 radionecrosis following SRS beyond earlier whole-brain radiotherapy.The mean dose to the whole brain in patients treated with Gamma Knife SRS for 10 or more brain metastases remained low with an acceptable rate of radionecrosis. This strategy allowed the majority of patients to avoid subsequent whole-brain radiotherapy.