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

Background: Patients that undergo a solid organ transplant have been shown to have a higher risk of developing cancer and even subsequent recurrences due to the immunosuppressants required to prevent rejection. Most established literature has been in the setting of cutaneous malignancies. In this study, we examine patients diagnosed with primary mucosal head and neck squamous cell carcinomas (HNSCC) diagnosed post-transplant to analyze their disease characteristics and clinical outcomes. Objectives: To retrospectively characterize patients with primary mucosal HNSCC with history of prior solid organ transplant to define patient and tumor factors as well as analyze their long-term outcomes. Methods: IRB approval was obtained for a retrospective evaluation utilizing our institutional head and neck cancer database. The analysis included patients who had previously undergone a solid organ transplant and subsequently were diagnosed with a primary mucosal HNSCC. These included patients diagnosed from March 2006 to March 2021. The onset of recurrence was analyzed to identify long-term health implications for this patient cohort. Kaplan-Meier analyses were performed to calculate overall and disease-free survival. Results: Out of 1,221 patients in our database, 24 patients met the inclusion criteria. Three patients were excluded due to lack of treatment or follow-up information, creating a sample of 21 patients. Of these, 13 (61.9%) received a liver, 4 (19%) received a kidney, 1 (4.8%) received a lung, and 3 (14.3%) received two transplants. After receiving the transplant, the median time to a HNSCC diagnosis was 6.4 years (range of 0.5 y to 18.5 y). The primary tumors included 8 (36.3%) oropharyngeal, 8 (36.3%) oral cavity, 5 (22.7%) laryngeal, and 1 (4.5%) hypopharyngeal lesion for a total of 22 lesions, with one patient having concurrent primaries of the oral cavity and oropharynx. The cohort included 1 (4.7%) stage 0, 7 (33.3%) stage I, 3 (14.3%) stage II, 3 (14.3%) stage III, and 7 (33.3%) stage IV; no patients had distant metastasis at time of diagnosis. Of the patients, 7 (33.3%) were treated with surgery alone, 6 (28.6%) received post-operative radiation/chemoradiation, 6 (28.6%) were treated with definitive chemoradiation, and 2 (9.5%) received definitive radiation. Median overall survival was 31 months. After treatment, 6 (28.6%) patients experienced a recurrence. Disease-free survival was 72.1% at 12 months. All patients who had a recurrence also died within the follow-up period. The median time of death after recurrence for all six patients was 11.5 months (range of 1 month to 22 mo). Conclusions: Solid organ transplant patients are at a higher risk of developing many different cancers. Treatment of primary mucosal HNSCC is frequently done with curative intent and can be associated with significant morbidity. A better understanding of how solid organ transplant history modifies the disease course can help properly guide treatment decisions. In particular, this series highlights a high rate of mortality among patients who experience a disease recurrence. Further research is needed to better understand the risks associated with recurrence in solid organ transplant patients

Landscape of Oncology-Specific, FDA-Approved, Artificial Intelligence and Machine Learning-Enabled Medical Devices

Purpose/Objective(s): Machine learning (ML), a type of artificial intelligence (AI) technology that uses a data-driven approach for pattern recognition, has been shown by numerous research studies to be beneficial for tasks across healthcare. In this study, we aim to characterize the commercial availability of oncology-specific AI/ML applications in the clinic by performing a detailed analysis of such devices that were approved/cleared by the US Food and Drug Administration (FDA). Materials/Methods: A list of 343 AI/ML-enabled medical devices that were approved or cleared by the FDA up to June 2021 was published by the agency, and this list was used to construct the initial database for our study. The publicly available FDA approval letters for these devices were independently reviewed by two research assistants, and a device was classified as oncology-specific if its primary intended use is related to assisting the diagnosis or treatment of oncologic pathologies. For oncology-specific devices, additional details on device characteristics, FDA regulatory process, and approved indications were obtained. A basic descriptive statistical analysis was performed on the aggregated data. Results: Fifty-two (15.2%) of the 343 AI/ML-enabled medical devices were classified as oncology-specific. The growth of the oncologic-specific devices sharply rose since the mid-2010s, with 49 (94.2%) approved in 2016 or after. Fifty (96.2%) devices were cleared by the 510(k) premarket notification pathway, and, except for one class III device, the remaining 51 devices were considered as class II by the FDA. All but one device was considered Software as a Medical Device (SaMD). Thirty-six (69.2%) devices were intended for diagnostic purposes, of which 24 (66.7%), 9 (14.3%), 1 (6.3%), 1 (6.3%), and 1 (6.3%) was for the detection of breast cancer, lung cancer, prostate cancer, thyroid cancer, and bone cancer, respectively. The 16 devices intended for therapeutic purposes were all related to radiotherapy: 15 are for radiation treatment planning (all included organ auto-segmentation as the main function), and 1 is a linear accelerator equipped with AI/ML algorithms. Conclusion: Our results showed a rapid increase of oncology-specific, FDA-approved, AI/ML-enabled medical devices since 2016. Further study is needed to assess the impact made by these devices on the delivery of oncology care

Lingual Raynaud\u27s Phenomenon after Surgical and Radiotherapeutic Intervention for Oral Squamous Cell Carcinoma

Raynaud\u27s phenomenon of the tongue after radiation therapy with or without chemotherapy is an exceedingly rare complication. Symptoms are similar to Raynaud\u27s disease of other sites and involve pallor and discomfort on exposure to cold temperatures that resolve with rewarming. Presentation occurs approximately 18-24 months after radiotherapy on average and can usually be managed effectively with lifestyle modification and pharmacotherapy. Here, we present a case of lingual Raynaud\u27s following surgery and adjuvant radiation therapy in a patient with squamous cell carcinoma of the oral cavity

Treating cutaneous T-cell lymphoma with highly irregular surfaces with photon irradiation using rice as tissue compensator.

PurposeCutaneous T-cell lymphoma (CTCL) is known to have an excellent response to radiotherapy, an important treatment modality for this disease. In patients with extremity and digit involvement, the irregular surface and depth variations create difficulty in delivering a homogenous dose using electrons. We sought to evaluate photon irradiation with rice packing as tissue equivalence and determine clinical tolerance and response.Materials and methodsThree consecutive CTCL patients with extensive lower extremity involvement including the digits were treated using external beam photon therapy with rice packing for tissue compensation. The entire foot was treated to 30-40 Gy in 2-3 Gy per fraction using 6 MV photons prescribed to the mid-plane of an indexed box filled with rice in which the foot was placed. Treatment tolerance and response were monitored with clinical evaluation.ResultsAll patients tolerated the treatment without treatment breaks. Toxicities included grade 3 erythema and desquamation with resolution within 4 weeks. No late toxicities were observed. All patients had a partial response by 4 weeks after therapy with two patients achieving a complete response. Patients reported improved functionality after treatment. No local recurrence has been observed.ConclusionTissue compensation with rice packing offers a convenient, inexpensive, and reproducible method for the treatment of CTCL with highly irregular surfaces

Expanding Our Understanding of Adherence: The Role of Health Literacy and Cognitive Function in Adherence and Outcomes in Head and Neck Cancer

Background: Health literacy is the degree to which a person has the capacity to obtain, process, and understand basic information and services needed to make decisions about their health care. Poor health literacy has been associated with difficulties managing medications, assessing and evaluating health information, completing medical and financial forms, and comparing nutritional information of foods. As such, health literacy is closely related to adherence to medical treatment. Cognitive function contributes to one\u27s health literacy, though also independently contributes to adherence. Patients with head and neck cancers require complex, often multimodal care, and both health literacy and cognitive function have been found to be lower than the general population. However no study has examined the interaction between cognitive function and health literacy within treatment for head and neck cancer and outcomes. Objectives: To examine the role of cognitive function and health literacy in adherence to definitive and adjuvant radiotherapy and chemoradiotherapy and disease-free and overall survival in patients with head and neck cancer. Methods: 149 patients who received either definitive or adjuvant radiotherapy or chemoradiotherapy for squamous cell carcinoma of the head and neck and were assessed by psycho-oncology provider before initiating treatment were included. Patients between August 2017 through March 2020 were included. Patients were administered the Montreal Cognitive Assessment (MoCA) and the Rapid Estimate of Adult Literacy in Medicine (REALM-SF) by the psych-oncologist before starting treatment. Cancer and treatment related variables, including adherence, were obtained via chart review. Adherence was defined as having completed the treatment recommended by the Multi-disciplinary Tumor Board. Results: Patients were predominantly male (78%), white (73%), with an average age of 62 years (SD=9.1). The average years of education was 13.6 years (SD=2.6). The mean health literacy score was 6.3 out of 7 (SD=1.3, range 0-7), indicating reading at 7-8th grade level. The mean cognitive function score was 23.8 out of 30 (SD=3.6, range 10-30, scores less than 26 are indicative of cognitive impairment). Sixteen percent of patients were non-adherent to treatment recommendations and this was not associated with either health literacy or cognitive function (P=0.5 & 0.36, respectively). Lower health literacy was associated with later stage at presentation (P\u3c0.05). Health literacy was not associated with disease-free or overall survival (P=0.66 & 0.11, respectively). However, cognitive function was associated with overall survival (P\u3c0.0001) but not disease-free survival (P=0.22). Conclusions: Psychosocial variables such as health literacy and cognitive function are infrequently considered or studied in head and neck cancer. However, there exists significant evidence that patients with head and neck cancer tend to have higher rates of cognitive impairment and lower health literacy than the general population. Further, literacy and cognitive function are known to contribute to health outcomes in other populations. The current study found that cognitive impairment, but not health literacy, is associated with overall survival, while not being associated with treatment adherence. Further research is needed into the pathways that cognitive function interacts with cancer care and survival. This study highlights the need for assessment of cognitive function in patients with head and neck cancer, as identification and intervention with these patients can aid in survival outcomes and quality of life

Evaluation of Practice Patterns and Outcomes after Implementing SMART for Pancreatic Cancer

Purpose/Objective(s): Stereotactic MRI-guided adaptive radiation therapy (SMART) enables safe dose escalation for locally advanced, borderline resectable, and medically inoperable pancreatic cancer and has shown favorable toxicity and survival outcomes. In late 2018, our institution commissioned SMART for these patients, making it available to all patient referrals. We wanted to review changes in our patient population and differences in clinical outcomes for patients before and after the implementation of SMART. Materials/Methods: In this IRB approved analysis, we retrospectively reviewed 167 consecutive patients from 2015-2021 with locally advanced, borderline resectable, or medically unresectable pancreatic cancer who were treated with radiation therapy. Chemoradiation (chemoRT) was defined as any 28-30 fraction radiation regimen that included concurrent chemotherapy. SMART was defined as 50 Gy over 5 consecutive daily fractions without concurrent chemotherapy. Baseline patient characteristics were compared between groups. Overall survival (OS) was evaluated by Kaplan-Meier (KM) and log-rank test. Univariate (UVA) and multivariate analysis (MVA) were also performed on multiple treatment variables. Results: Of the patients included, 58 received chemoRT (2015-2018) and 109 received SMART (2018-2021). Median follow up from time of diagnosis for the chemoRT and SMART cohorts were 53.7 months and 29.2 months respectively. Cohorts did not have significant differences in age, gender, race, T or N staging, rates of surgery or surgical margin status. Patients receiving SMART had overall worse performance (p = 0.011) including a lower percentage of PS 0 patients (22.9% vs 44.8%) and a higher percentage of PS 2+ patients (34% vs 15.5%). Similarly, the SMART patients did numerically more often have locally advanced (50% vs 43%) and medically inoperable (26% vs 21%) disease (p = 0.294). The SMART cohort did have longer neoadjuvant chemotherapy with mean of 3.5 months vs 2.3 months in the chemoRT cohort (p = 0.002). There was no OS difference between each group when measured from diagnosis (p=0.79) or from first day of radiation (p=0.2). Median survival in the chemoRT and SMART groups was 18.7 vs 17.4 months from diagnosis. When including only PS 0-1 patients, the median survival in the chemoRT and SMART groups was 18.8 vs 22.3 months (p=0.37). There was also no difference in locoregional control, distant control, or progression free survival using KM. On MVA positive prognostic factors for OS from diagnosis included ECOG \u3c2 (HR 0.54, p=0.015), increasing months of neoadjuvant chemo (HR 0.88, p=0.004) and pancreatectomy (HR 0.14, p \u3c0.001). Conclusion: Despite the fact that the patient cohort receiving radiation therapy per the SMART approach had poorer performance status compared with chemoRT, OS was not significantly different. The multidisciplinary team was highly supportive of SMART with increased patients being treated

Disparities in the Uptake of Telemedicine During the COVID-19 Surge in a Multidisciplinary Head and Neck Cancer Population by Patient Demographic Characteristics and Socioeconomic Status

This cohort study examines the association between patient demographic characteristics and socioeconomic status and engagement in telemedicine during the COVID-19 pandemic

Stereotactic MRI-guided Adaptive Radiation Therapy for Non-metastatic Pancreatic Cancer; Outcomes and Toxicity Analysis for Patients Treated in an Underserved Urban Center

Background: Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) is an emerging technology for treatment of pancreatic cancer patients. Initial results show favorable survival and toxicity. However, data is still sparse overall, and especially in underserved patient populations. The purpose of this study is to review SMART outcomes at our underserved urban academic cancer. Objectives: Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) is an emerging technology for treatment of pancreatic cancer patients. Initial results show favorable survival and toxicity. However, data is still sparse overall, and especially in underserved patient populations. The purpose of this study is to review SMART outcomes at our underserved urban academic cancer. Methods: In this IRB approved retrospective chart review we reviewed 98 patients with non-metastatic pancreatic cancer, who completed SMART between November 2018-January 2021. All 98 patients were treated with 50 Gy in 5 daily fractions with adaptive technique as deemed appropriate by treating radiation oncologist. The primary endpoints were overall survival (OS), progression free survival (PFS), and both acute and late grade 3+ GI toxicity. OS, PFS, locoregional control and distant control were estimated by Kaplan-Meier method and compared using log-rank test. The effect of clinical features on OS was assessed using univariate and multivariate Cox proportional hazard models. OS and PFS were calculated from completion of radiation. Grade 3+ GI toxicity probably or definitively related to radiation was recorded. All incidences of GI bleeding, regardless of attribution, were also recorded. Results: Median follow up was 20.9 months from time of diagnosis and 14 months from radiation. 21 (21%) patients were borderline resectable, 42 (43%) locally advanced, 22 (22%) medically inoperable and 13 (13%) resectable. Neoadjuvant chemotherapy was given to 86 (88%) patients with a median of 3.5 months of chemotherapy (range 1-12), leaving 11 (12%) patients who did not have systemic chemotherapy. Median overall survival from radiation for the whole group was 15.7 months, and 1-year OS was 58%. There was a statistically significant worsening of overall survival from diagnosis between ECOG 2+ and ECOG 0/1 patients (HR 1.94, 1.05-3.57). 27 (27%) patients went on to have surgical resection with 23 (82%) having R0 resection, and 3 (11%) have an R1 resection. Improved OS was seen in patients with surgical resection (HR 0.06, 0.02-0.23). Acute grade 3+ GI toxicity from radiation was seen in 4 (4%) patients and late toxicity from radiation was seen in 6 (6%) patients. GI bleeding was seen in 16(16%) patients, 10 (62%) of which were on anticoagulation at the time of GI bleed and 5 (19%) of which had surgery. Portal vein complications occurred with 7 (7%) having portal vein thrombosis and 6 (6%) portal vein stenosis. Conclusions: SMART showed durable responses in pancreatic cancer patients with an acceptable toxicity profile. Attention needs to be paid to the moderate incident of GI bleeding, however further work is necessary to determine if bleeding was due to radiation, surgery, or disease progression. Surgical resection as well as performance status of ECOG 0-1 were associated with improved overall survival. Further follow up will be necessary to determine further durability of treatment response and long-term survival in these patients

Morphometrics predicts overall survival in patients with multiple myeloma spine metastasis: A retrospective cohort study

Background: Treatment strategies for spinal metastases for myeloma range from conservative measures (radiation and chemotherapy) to invasive (surgical). Identifying better predictors of overall survival (OS) would help in surgical decision making. Analytic morphometrics has been shown to predict survival in oncologic patients, and our study evaluates whether morphometrics is predictive of survival in patients with multiple myeloma (MM) spinal metastases. Methods: For this observational retrospective cohort study, we identified 46 patients with MM spinal metastases who had undergone stereotactic body radiation therapy. OS was the primary outcome measure. Morphometric analysis of the psoas muscle was performed using computed tomography scans of the lumbar spine. Results: OS was statistically correlated with age ( Conclusions: Morphometric analysis successfully predicts long-term survival in patients with MM. More research is needed to validate these results and to see if these methodologies can be applied to other cancer histologies