Publications by authors named "Clifton David Fuller"

This study addresses the prevalent issue of missing data in patient-reported outcome datasets, particularly focusing on head and neck cancer patient symptom ratings sourced from the MD Anderson Symptom Inventory. Given that many data mining and machine learning algorithms necessitate complete datasets, the accurate imputation of missing data as an initial step becomes crucial. In this study we propose, for the first time, the use of collaborative filtering for imputing missing head and neck cancer patient symptom ratings.

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Purpose: Increasing data suggest that radiation therapy, particularly ablative radiation therapy, alters the natural history of metastatic disease. For patients with metastatic disease enrolled in prospective trials testing systemic therapy, the use of off-protocol radiation therapy to improve clinical symptoms or extend the duration of study systemic therapy may influence study endpoints. We sought to evaluate how often off-protocol radiation therapy was permitted among systemic therapy phase 3 trials, how often off-protocol radiation therapy is used, and whether off-protocol radiation therapy correlated with study outcomes.

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Digital twin models are of high interest to Head and Neck Cancer (HNC) oncologists, who have to navigate a series of complex treatment decisions that weigh the efficacy of tumor control against toxicity and mortality risks. Evaluating individual risk profiles necessitates a deeper understanding of the interplay between different factors such as patient health, spatial tumor location and spread, and risk of subsequent toxicities that can not be adequately captured through simple heuristics. To support clinicians in better understanding tradeoffs when deciding on treatment courses, we developed DITTO, a digital-twin and visual computing system that allows clinicians to analyze detailed risk profiles for each patient, and decide on a treatment plan.

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Disease progression in clinical trials is commonly defined by radiologic measures. However, clinical progression may be more meaningful to patients, may occur even when radiologic criteria for progression are not met, and often requires a change in therapy in clinical practice. The objective of this study was to determine the utilization of clinical progression criteria within progression-based trial endpoints among phase III trials testing systemic therapies for metastatic solid tumors.

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Article Synopsis
  • The radiation therapy field is rapidly developing AI models, but there is a lack of adoption in clinical practice due to unclear guidelines on their development and validation.
  • A Delphi process was used to create a comprehensive guideline, involving discussions among authors to identify key topics like decision making, image analysis, and ethics related to AI in radiation therapy.
  • The resulting guideline includes 19 highly recommended statements aimed at improving the development and reporting of AI tools, ultimately facilitating their integration into clinical workflows.
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Missing visual elements (MVE) in Kaplan-Meier (KM) curves can misrepresent data, preclude curve reconstruction, and hamper transparency. This study evaluated KM plots of phase III oncology trials. MVE were defined as an incomplete y-axis range or missing number at risk table in a KM curve.

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Purpose: To provide evidence-based recommendations for prevention and management of osteoradionecrosis (ORN) of the jaw secondary to head and neck radiation therapy in patients with cancer.

Methods: The International Society of Oral Oncology-Multinational Association for Supportive Care in Cancer (ISOO-MASCC) and ASCO convened a multidisciplinary Expert Panel to evaluate the evidence and formulate recommendations. PubMed, EMBASE, and Cochrane Library databases were searched for randomized controlled trials and observational studies, published between January 1, 2009, and December 1, 2023.

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Patient-Reported Outcomes (PRO) are collected directly from the patients using symptom questionnaires. In the case of head and neck cancer patients, PRO surveys are recorded every week during treatment with each patient's visit to the clinic and at different follow-up times after the treatment has concluded. PRO surveys can be very informative regarding the patient's status and the effect of treatment on the patient's quality of life (QoL).

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Article Synopsis
  • The study aimed to enhance segmentation accuracy in head and neck cancer radiotherapy by optimizing a specific type of MRI sequence known as SPAIR for use with a 1.5T MR-Linac.
  • After testing several sequences, three viable SPAIR sequences were analyzed for various metrics, leading to the identification of a top-performing sequence for better delineation of tumors and lymph nodes.
  • Ultimately, the research provided an optimized imaging sequence for Unity MR-Linac users and established a new pathway for objectively assessing image quality in MRI, which can benefit future protocols.
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Article Synopsis
  • The 'Table 1 Fallacy' is when researchers misuse significance testing to incorrectly assess balance in baseline variables between randomized groups in clinical trials, leading to potential misinterpretations.
  • In a study of 765 phase III oncology trials with over half a million patients, the fallacy was found in 25% of trials, with only 3% of comparisons deemed statistically significant, which is close to the expected type I error rate of 5%.
  • Factors that reduced the likelihood of encountering the fallacy included industry sponsorship, larger trial sizes, and publication in European journals, indicating a need for improved practices in reporting and analyzing trial data to avoid misleading conclusions.
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 Few recent studies have examined neurocognitive functioning (NCF) in patients with sinonasal and nasopharyngeal cancers (NPCs) prior to and following multimodality therapy or the potential differences in NCF by disease variables such as disease site.  The objective of this study is to determine rates of NCF impairments prior to and following multimodality therapy, declines in NCF following radiotherapy (RT), and possible differences in NCF by the disease site.  We conducted a retrospective chart review of 39 patients with sinonasal and NPCs who underwent comprehensive neuropsychological evaluations.

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Purpose: Osteoradionecrosis of the jaw (ORN) can manifest in varying severity. The aim of this study is to identify ORN risk factors and develop a novel classification to depict the severity of ORN.

Methods: Consecutive head-and-neck cancer (HNC) patients treated with curative-intent IMRT (≥ 45Gy) in 2011-2018 were included.

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Background: Open access (OA) publishing represents an exciting opportunity to facilitate the dissemination of scientific information to global audiences. However, OA publishing is often associated with significant article processing charges (APCs) for authors, which may thus serve as a barrier to publication.

Objective: In this observational cohort study, we aimed to characterize the landscape of OA publishing in oncology and, further, identify characteristics of oncology journals that are predictive of APCs.

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Purpose: Outside of randomized clinical trials, it is difficult to develop clinically relevant evidence-based recommendations for radiation therapy (RT) practice guidelines owing to lack of comprehensive real-world data. To address this knowledge gap, we formed the Learning from Analysis of Multicenter Big Data Aggregation consortium to cooperatively implement RT data standardization, develop software solutions for data analysis, and recommend clinical practice change based on real-world data analyzed. The first phase of this "Big Data" study aimed at characterizing variability in clinical practice patterns of dosimetric data for organs at risk (OARs) that would undermine subsequent use of large-scale, electronically aggregated data to characterize associations with outcomes.

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Background: Post-treatment symptoms are a focal point of follow-up visits for head and neck cancer patients. While symptoms such as dysphagia and shortness-of-breath early after treatment may motivate additional work up, their precise association with disease control and survival outcomes is not well established.

Methods: This prospective data cohort study of 470 oropharyngeal cancer patients analyzed patient-reported swallowing, choking and shortness-of-breath symptoms at 3-to-6 months following radiotherapy to evaluate their association with overall survival and disease control.

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Objective: Osteoradionecrosis (ORN) of the mandible is a devastating complication of external beam radiation therapy (EBRT) for head and neck squamous cell carcinoma (HNSCC). We sought to ascertain ORN risk in a Veteran HNSCC population treatment with definitive or adjuvant EBRT and followed prospectively.

Study Design: Retrospective analysis of prospective cohort.

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Background Radiomics is the extraction of predefined mathematic features from medical images for the prediction of variables of clinical interest. While some studies report superlative accuracy of radiomic machine learning (ML) models, the published methodology is often incomplete, and the results are rarely validated in external testing data sets. Purpose To characterize the type, prevalence, and statistical impact of methodologic errors present in radiomic ML studies.

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Importance: Previously published work reported independent benefit of maintenance of oral intake (eat) and swallowing exercise adherence (exercise) during radiotherapy (RT) on diet and functional outcomes. The current study seeks to validate the authors' previously published findings in a large contemporary cohort of patients with oropharynx cancer (OPC) and address limitations of the prior retrospective study using prospective, validated outcome measures.

Objective: To examine the longitudinal association of oral intake and swallowing exercise using validated, clinician-graded and patient-reported outcomes.

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Sinonasal malignancies make up <5% of all head and neck neoplasms, with an incidence of 0.5-1.0 per 100,000.

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Background: Peripheral neutrophil-lymphocyte ratio (NLR), reflecting immune-inflammation status, shows great potential for tumor progression and outcome. Pre-treatment NLR does not fully reflect the immune-inflammatory response to treatment. This study aimed to introduce the NLR trend as a new indicator and to investigate its prognostic value in patients with nasopharyngeal carcinoma receiving radiotherapy.

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Patient-Reported Outcome (PRO) surveys are used to monitor patients' symptoms during and after cancer treatment. Acute symptoms refer to those experienced during treatment and late symptoms refer to those experienced after treatment. While most patients experience severe symptoms during treatment, these usually subside in the late stage.

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Prior malignancy exclusion criteria (PMEC) are often utilized in cancer clinical trials; however, the incidence of PMEC and the association of PMEC with trial participant age disparities remain poorly understood. This study aimed to identify age disparities in oncologic randomized clinical trials as a result of PMEC. Using a comprehensive collection of modern phase III cancer clinical trials obtained via ClinicalTrials.

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Purpose: The objective was to identify clinical and epidemiological factors associated with utilization of a complex oral treatment device (COTD), which may decrease toxicity in patients undergoing radiation therapy for head and neck cancer (HNC).

Materials And Methods: We retrospectively reviewed data from 1992 to 2013 in the Surveillance, Epidemiology, and End Results (SEER)-Medicare databases to analyze COTD usage during intensity-modulated radiation therapy (IMRT) for patients diagnosed with cancer of the tongue, floor of mouth, nasopharynx, tonsil, or oropharynx. Patients with a radiation simulation and complex treatment device code within 4 weeks before the first IMRT claim were identified as meeting COTD usage criteria.

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This review aims to present and assess available and new methodologies to increase the clinical evidence of proton therapy data for patients with head and neck cancer. Despite the increasing number of scientific reports showing the feasibility and effectiveness of proton therapy in head and neck cancer, clinical evidence on the potential benefits of its use remains low for several reasons. In this article, the pros and cons of consolidated and new methodologies in this setting such as randomized clinical trials, the model-based approach, and the use of prospective multicentric registries will be detailed.

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