The incidence of squamous cell carcinoma of the anus (SCCA) is increasing, particularly in the elderly, with increased mortality in this age group. While the current standard of care for localized SCCA remains chemoradiation (CRT), completion of this treatment can be challenging with risks for severe acute and late toxicity. It remains unclear if full course CRT is required for the management of early-stage SCCA or if de-escalation of treatment is possible without compromising patient outcomes. Alternative therapies include radiation therapy alone or local excision for appropriate patients. Modifying standard CRT may also reduce toxicity including the routine use of intensity-modulated radiation therapy for treatment delivery, modification of treatment volumes, and selection and dosing of concurrent systemic therapy agents. Finally, we provide an overview of currently accruing prospective trials focused on defining the role of de-escalation of therapy in patients with early-stage SCCA.
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http://dx.doi.org/10.3390/cancers13092099 | DOI Listing |
Unlabelled: Transparent and accurate reporting in early phase dose-finding (EPDF) clinical trials is crucial for informing subsequent larger trials. The SPIRIT statement, designed for trial protocol content, does not adequately cover the distinctive features of EPDF trials. Recent findings indicate that the protocol contents in past EPDF trials frequently lacked completeness and clarity.
View Article and Find Full Text PDFUnlabelled: Early phase dose-finding (EPDF) trials are key in the development of novel therapies, with their findings directly informing subsequent clinical development phases and providing valuable insights for reverse translation. Comprehensive and transparent reporting of these studies is critical for their accurate and critical interpretation, which may improve and expedite therapeutic development. However, quality of reporting of design characteristics and results from EPDF trials is often variable and incomplete.
View Article and Find Full Text PDFOpen Heart
January 2025
Cardiology, Radboudumc, Nijmegen, The Netherlands
Background And Aims: Due to the multitude of risk factors outlined in the guidelines, personalised dual antiplatelet therapy (DAPT) guidance after percutaneous coronary intervention (PCI) is complex. A simplified method was created to facilitate the use of risk stratification. We aimed to compare the predictive and prognostic value of the 'Zuidoost Nederland Hart Registratie' (ZON-HR) classification for bleeding risk with the PREdicting bleeding Complications In patients undergoing Stent implantation and subsEquent DAPT (PRECISE-DAPT) score and to determine the effect of ticagrelor monotherapy versus DAPT in patients with or without high bleeding risk (HBR).
View Article and Find Full Text PDFEur Arch Otorhinolaryngol
January 2025
Department of Otolaryngology-Head and Neck Surgery, IRCCS Regina Elena National Cancer Institute, Istituti Fisioterapici Ospitalieri (IFO), Via Elio Chianesi 53, 00144, Rome, Italy.
Objectives: we evaluated the hypothesis that level of ctHPVDNA on the first postoperative day (POD-1); and at 15 days (POD-15) could be associated with the need for adjuvant therapy and the presence of recurrence.
Materials And Methods: this is a prospective observational study on biomarkers, focusing on the longitudinal monitoring of ctHPVDNA in a cohort of HPV-OPSCC patients undergoing TORS. Blood samples were collected according to the following schema: (1) pretreatment; (2) on first postoperative day (POD 1); and (3) at 15 days (POD 15).
Int J Radiat Oncol Biol Phys
January 2025
Montefiore Einstein Comprehensive Cancer Center, Bronx, NY.
Background: Standard radiotherapy (RT) for locally advanced NSCLC (LA-NSCLC) employs a uniform dose of approximately 60 Gy. Recent trials demonstrated that radiotherapy dose escalation may not improve outcomes and may cause added toxicity. XXX previously performed a single-arm trial testing a personalized, risk-adapted, and de-intensified RT strategy.
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