Single-Fraction Radiation Therapy for Localized Cutaneous T-Cell Lymphoma.

PURPOSE: Mycosis fungoides is the most common type of cutaneous T-cell lymphoma (CTCL). Single-fraction radiation therapy has been used as a skin-targeted therapy to treat localized CTCL lesions. The objective of this study was to investigate the treatment outcomes associated with single-fraction radiation therapy for CTCL. METHODS AND MATERIALS: We retrospectively studied the outcomes among patients with CTCL treated with single-fraction radiation therapy at our institution between October 2013 and August 2022. Clinical response (complete response [CR], partial response [PR], or no response [NR]) and retreatment response were evaluated. RESULTS: A total of 242 lesions from 46 patients were analyzed, for an average of 5.3 lesions treated per patient. The majority of lesions presented with a plaque morphology (n = 145, 60.0%). All lesions were treated to a dose of 8 Gy in 1 fraction. Median follow-up was 24.6 months (range, 1-88 months). Of the 242 lesions, 36 (14.8%) had an initial PR or NR; all were retreated with the same regimen to the same site at a median interval of 8 weeks. Eighteen of the retreated lesions (50.0%) went on to have a CR. Thus, the overall CR rate for CTCL lesions was 92.6%. No recurrences were noted in the treated areas after achieving CR. CONCLUSIONS: Single-fraction radiation therapy to a dose of 8 Gy in 1 fraction to localized areas provided a high rate of complete and durable responses in the affected sites.

The 2021 landscape of FDA-approved artificial intelligence/machine learning-enabled medical devices: An analysis of the characteristics and intended use.

BACKGROUND: Machine learning (ML), a type of artificial intelligence (AI) technology that uses a data-driven approach for pattern recognition, has been shown to be beneficial for many tasks across healthcare. To characterize the commercial availability of AI/ML applications in the clinic, we performed a detailed analysis of AI/ML-enabled medical devices approved/cleared by the US Food and Drug Administration (FDA) by June 2021. METHODS/MATERIALS: The publicly available approval letters by the FDA on 343 AI/ML-enabled medical devices compiled by the agency were reviewed. The characteristics of the devices and the patterns of their intended use were analyzed, and basic descriptive statistical analysis was performed on the aggregated data. RESULTS: Most devices were reviewed by radiology (70.3%) and cardiovascular (12.0%) medical specialty panels. The growth of these devices sharply rose since the mid-2010s. Most (95.0%) devices were cleared under the 510(k) premarket notification pathway, and 69.4% were software as a medical device (SaMD). Of the 241 radiology-related devices, the most common applications were for diagnostic assistance (48.5%) and image reconstruction (14.1%). Of the 117 radiology-related devices for diagnostic assistance, 20.5% were developed for breast lesion assessment and 14.5% for cardiac function assessment on echocardiogram. Of the 41 cardiology-related devices, the most common applications were electrocardiography-based arrhythmia detection (46.3%) and hemodynamics & vital signs monitoring (26.8%). CONCLUSION: In this study, we characterized the patterns and trends of AI/ML-enabled medical devices approved or cleared by the FDA. To our knowledge, this is the most up-to-date and comprehensive analysis of the landscape as of 2021.

Nasogastric Feeding Tube/Dobhoff Placement: A Multidisciplinary Approach to the Management of Malnutrition During Radiation Therapy in Patients With Head and Neck Cancer.

Background Radiation therapy (RT)-associated oral mucositis, xerostomia, thick mucoid saliva, nausea/vomiting, and loss of taste may result in significantly compromised oral intake in patients undergoing treatment for head and neck cancers (HNC). Feeding tube placement allows patients to receive enteral nutrition and continue the planned course of treatment. Objectives RT-associated oral mucositis, xerostomia, and loss of taste may result in significantly compromised oral intake in patients undergoing treatment for head and neck cancers. We sought to determine if reactive nasogastric (NG) tube placement was an effective strategy for nutritional support in these patients and if invasive percutaneous endoscopic gastrostomy (PEG) tube insertion could be avoided. Methods This is an institutional review board (IRB)-approved study of patients treated for head and neck cancer using definitive or adjuvant RT with or without concurrent chemotherapy between June 2017 and December 2020. We evaluated the indications for NG tube (Dobhoff) placement, time of placement during the course of RT, patient tolerance of NG tube, and median duration of NG tube placement. In addition, we followed weight loss during treatment, treatment interruptions, and treatment-related toxicities. Complications associated with having the NG tube, if the NG tube needed to be replaced during treatment, and if the patient had any hospitalization during the course of treatment were tracked. Results Of the 441 patients treated for head and neck cancer during the time period of this study, 47 required reactive NG tube placement for nutritional support. Patients included 40 with primary oropharynx, three with oral cavity, two with larynx, one with nasopharyngeal, and one was unknown. Chemotherapy was given concurrently with radiation in 87.2% (n=41) patients. The median time of NG tube placement was during Week 5 of the six to seven-week course of RT. The median percentage of weight loss from baseline to the date of NG tube placement was 12.9% (range, -0.9% to 25.9%). The median rate of weight loss decreased by 8.7% from the date of NG tube placement to the end of treatment. The median duration of NG tube placement was 29 days (range, 5 to 151 days). There were no serious medical complications associated with having the NG tube in place during treatment. Twenty-seven point six percent (27.6%; n=13) of patients had the NG tube dislodged or displaced and needed replacement. Thirty-eight point three percent (38.3%; n=18) of patients with an NG tube had to be hospitalized during the course of RT, with the predominant symptoms being failure to thrive (22.2%; n=4) and nausea/vomiting 22.2% (n=4). Six point four percent (6.4%; n=3) of patients requested the removal of the NG tube due to local irritation. Seventy-six point six percent (76.6%; n=36) of patients did not require further nutritional support with the placement of a percutaneous endoscopic gastrostomy (PEG) tube. Conclusion This study indicates that clinic placement of an NG tube for patients receiving RT for head and neck cancer is a safe and effective way to maintain nutrition during treatment. The rate of weight loss decreased after the patient had an NG tube placed. The placement procedure is well-tolerated and there were no complications associated with having the NG tube during treatment. PEG tube insertion was avoided in approximately 80% of the patients.

Outcomes of Primary Mucosal Head and Neck Squamous Cell Carcinoma in Solid Organ Transplant Recipients.

Introduction Patients who undergo solid organ transplants have a higher risk of developing malignancies and subsequent recurrences. Clinical outcomes in transplant recipients with primary mucosal head and neck squamous cell carcinoma (HNSCC) are not well described in the published literature. Therefore, we retrospectively studied the outcomes in this group of patients.  Methods This Institutional Review Board (IRB)-approved analysis included patients who had previously undergone solid organ transplants and subsequently were diagnosed with primary mucosal HNSCC between 2006 and 2021. Our institutional database of solid organ transplant recipients was cross-referenced with our head and neck cancer database to identify the patients included in this cohort. In addition, Kaplan-Meier analyses were performed to calculate overall and disease-free survival. Results Of 1,221 patients, 20 met the inclusion criteria. The median time from organ transplant to HNSCC diagnosis was 5.9 years (range: 0.5-18.5 years). A total of 11 (55.0%) and 9 (45.0%) patients presented with localized and locally advanced disease, respectively. Two-year overall and disease-free survivals were 59.1% and 73.5%, respectively. After initial treatment, six (30.0%) patients experienced a recurrence. All patients who developed a recurrence died within the follow-up period. The median time of death after recurrence for all six patients was 11.5 months (range: 2-22 months).  Conclusion This series highlights a high mortality rate following recurrence among patients with primary mucosal HNSCC and a solid organ transplant history. A better understanding of how solid organ transplant history adversely impacts the course of HNSCC could help properly guide treatment, follow-up, and survivorship decisions.

Life satisfaction among older adult, long-term cancer survivors: A comparison of Black with White survivors.

OBJECTIVE: This paper proposes and evaluates a model of the relative importance that cancer-related health factor along with other health factors have for the self-rated health and life satisfaction of older adult, long-term cancer survivors. The data are examined in the context of important racial differences in health and life satisfaction along with other covariates including gender and education. METHOD: This research utilizes regression-based path analysis to examine data from a sample of 321 older (age 60+), long-term (5+ years since diagnosis) cancer survivors. Respondents were randomly selected from the tumor registry of a major university hospital cancer center from among those with breast, prostate, or colorectal cancer. Blacks were oversampled to provide the analytic power to make racial comparisons among cancer survivors. RESULTS: Bivariate analysis indicates that there is a consistent pattern of Black/White differences in both cancer-related and general health characteristics as well as life satisfaction among older cancer survivors. Moreover, the results suggest that race is an important predictor of older survivors' health characteristics. These, in turn, explain significant variance in both self-rated health and life satisfaction, that is, attributed to Black/White differences in these predictors. CONCLUSIONS: Clinical health and social service providers need to be aware of the importance of both general health and cancer-related health factors when working with minority long-term cancer survivors as these have implications for their overall quality of life.