Lenvatinib ± Pembrolizumab Versus Chemotherapy for Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That Progressed after Platinum and Immunotherapy: The Phase 2 LEAP-009 Study
Pembrolizumab monotherapy and pembrolizumab plus platinum-based chemotherapy are the standard of care for first-line treatment of R/M HNSCC. However, there is a growing unmet need for safe and efficacious treatment options for patients with R/M HNSCC whose disease progressed on or after platinum-based chemotherapy and immunotherapy. The randomized, open-label, phase 2 LEAP-009 (NCT04428151) study is being conducted to evaluate the safety and efficacy of lenvatinib plus pembrolizumab or lenvatinib monotherapy versus chemotherapy in patients with R/M HNSCC whose disease progressed after treatment with platinum-based therapy ...
Source: International Journal of Radiation Oncology * Biology * Physics - March 14, 2024 Category: Radiology Authors: K. Harrington, H.R. Kim, S. Salas, M. Oliva, R. Metcalf, M. Bernsdorf, J.W. Kim, E. Cohen, L.L. Siu, D. Rischin, L. Licitra, J. Vermorken, Q.T. Le, M. Tahara, J.P. Machiels, K. O'Hara, K. Pathiraja, B. Gumuscu, B. Bidadi, B. Burtness Tags: 160 Source Type: research

Olaparib, a poly (ADP-ribose) polymerase (PARP) Inhibitor, in Combination with Pembrolizumab and Carboplatin as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma (RM-HNSCC): A Single-Arm, Phase 2 Trial
The homologous recombination deficiency (HRD) phenotype is common in HNSCC and is due to mutation and promoter hypermethylation of DNA repair genes and PTEN. In pre-clinical models of HNSCC, HRD sensitizes tumors to PARP inhibition and to additive antitumor activity of PARP inhibition in combination with platinum agents. PARP inhibitors also activate the STING pathway and upregulate PD-L1 expression, resulting in synergistic antitumor activity when given with PD-1 inhibitors. Olaparib is a highly selective PARP inhibitor that has been safely combined with pembrolizumab and carboplatin. (Source: International Journal of Rad...
Source: International Journal of Radiation Oncology * Biology * Physics - March 14, 2024 Category: Radiology Authors: P. Oppelt, J. Ley, J. Liu, D. Adkins Tags: 161 Source Type: research

High Tumor Mutational Burden May Predict Improved Response to Immunotherapy in Head and Neck Cancer Patients
This study assesses TMB score and progression of disease in HNSCC patients treated with immunotherapy. (Source: International Journal of Radiation Oncology * Biology * Physics)
Source: International Journal of Radiation Oncology * Biology * Physics - March 14, 2024 Category: Radiology Authors: M. Stewart, C.A. Reddy, N.M. Woody, T. Sussman, E. Yilmaz, J.L. Geiger Tags: 162 Source Type: research

Randomized Phase 2 Trial of Stereotactic Body Radiation Therapy (SBRT) and Concurrent and Adjuvant Cetuximab vs Cetuximab and Docetaxel in Recurrent, Previously Irradiated Squamous Cell Carcinoma of the Head and Neck
The treatment of recurrent head and neck cancer presents a significant challenge in previously irradiated patients. Therapeutic options in this patient population tend to be limited and are often associated with severe toxicity and decreased efficacy compared with front line therapies. Stereotactic body radiation therapy (SBRT) is a salvage technique that provides highly conformal, ablative doses to tumor while minimizing exposure of the surrounding organs at risk. The precise role of concurrent systemic therapy with SBRT, though, remains unclear and is a topic of active investigation. (Source: International Journal of Rad...
Source: International Journal of Radiation Oncology * Biology * Physics - March 14, 2024 Category: Radiology Authors: C.T. Wilke, R.L. Ferris, J. Ohr, D.P. Zandberg, Z. Rahman, S. Kim, C. Snyderman, J.T. Johnson, S.A. Burton, A.C. Olson, D. Petro, S. Marks, L. Francis, D. Friedland, V. Gorantla, J. Mountz, H. Wang, D.E. Heron, D.A. Clump, H.D. Skinner Tags: 163 Source Type: research

A Pilot Clinical Trial of Sodium Thiosulfate (STS) for Prevention of Ototoxicity in Patients with Locally Advanced Squamous Cell Carcinoma of Head and Neck (SCCHN) Undergoing Concurrent Chemoradiation with Cisplatin
Ototoxicity is a well described side effect of cisplatin and up to 88% of SCCHN patients undergoing chemoradiation develop some degree of hearing loss. Clinical trials in pediatric cancer patients receiving high cumulative doses of cisplatin have demonstrated that use of STS infusion 4-8 hours after cisplatin administration led to a significantly lower likelihood of hearing loss. We therefore conducted a prospective pilot clinical trial to assess the feasibility and safety of intravenous STS after cisplatin in locally advanced SCCHN patients undergoing concurrent chemoradiation with cisplatin. (Source: International Journa...
Source: International Journal of Radiation Oncology * Biology * Physics - March 14, 2024 Category: Radiology Authors: S. Dhar, J.P. Arios, C. Kim, B. Dingler, A. Algazi, J. Chan, S.S. Yom, H. Kang Tags: 164 Source Type: research

Safety of Planned Dental Extractions Immediately after Radiation Therapy: First Report of a Prospective Observational Study
Non-restorable teeth are recommended to be extracted prior to radiation therapy (RT). Occasionally, patients are unable or unwilling to complete the extractions, and RT delay can compromise survival. Some have proposed a safe “window” for extractions immediately post-RT which could improve time-to-treatment, but data is non-existent. We evaluated the feasibility and safety of dental extractions post-RT (D.E.Po.R.T.). (Source: International Journal of Radiation Oncology * Biology * Physics)
Source: International Journal of Radiation Oncology * Biology * Physics - March 14, 2024 Category: Radiology Authors: M.C. Ward, C. Petersen, J. Noll, M.S. Bernard, J.G. Kuremsky, A. Patel, C.A. Baldwin, J.P. Morgan, V.V. Thakkar, J.L. Atlas, D.R. Carrizosa, R.S. Prabhu, B.J. Moeller, Z.L. Milas, D.S. Brickman, C.H. Frenkel, M. Brennan Tags: 165 Source Type: research

Subgroup Analysis of the Benefit of Avasopasem Manganese on the Incidence, Severity, Duration and Onset of Severe Oral Mucositis in ROMAN Phase 3 Trial
IMRT plus cisplatin is established treatment for LAHNC, but ∼70% of patients develop severe oral mucositis (SOM; WHO grade 3 or 4), limiting their ability to eat solids (gr 3) or liquids (gr 4), and often requiring feeding tube nutrition. Radiotherapy (RT)-induced bursts of superoxide initiate SOM (Sonis 2004). Avasopasem (AVA) is an investigational small molecule selective dismutase mimetic converting superoxide to hydrogen peroxide, which may protect normal cells from, and potentially sensitize cancer cells to, RT (Anderson 2019, Sishc 2021). (Source: International Journal of Radiation Oncology * Biology * Physics)
Source: International Journal of Radiation Oncology * Biology * Physics - March 14, 2024 Category: Radiology Authors: G.V. Walker, C.M. Lee, J.R. Kelley, N.E. Dunlap, V. Bar-Ad, D.A. Miller, V. King, A. Peddada, D. Ciuba, F. Vincent, B.C. Muzyka, A.L. Gillespie-Twardy, S. Sonis, J. Holmlund, D. Saunders, R. Beardsley, C.M. Anderson Tags: 166 Source Type: research

A Pilot Study of HNC Patients Treated Daily with an Intraoral Photobiomodulation (PBM) Device While Undergoing IMRT Demonstrates Tolerability, Safety, and Preliminary Efficacy for Reducing the Impact of Oral Mucositis
Oral mucositis (OM) is a significant AE and can impact cancer treatment (interruptions and/or early termination), increase opioid usage, impact diet (dysgeusia, dysphagia, inadequate nutritional intake), instigate depression and cause sepsis and death. Pharmacological options are limited; however supportive care treatment guidelines (MASCC, WALT) recommend intraoral photobiomodulation therapy (IOPBMT) for the prevention/treatment of OM. Photobiomodulation (PBM) is the use of non-ionizing light in the visible and near-infrared light spectra to modulate biological processes, such as promoting wound healing. (Source: Internat...
Source: International Journal of Radiation Oncology * Biology * Physics - March 14, 2024 Category: Radiology Authors: M. Marotta, C. Holtzapfel, P.H. Shah, K.S. Hu, J.L. Frustino, C.D. Willey, C.M. McCluskey, S. Valentin, D. Ludlow, J. Lazzara, V. Kothari, N. Lipko Tags: 167 Source Type: research

Developing Machine Learning Algorithms Incorporating Patient Reported Outcomes to Predict Disease Progression in Head and Neck Cancers
Patient reported outcome (PRO) is gaining traction for implementation into clinical practice within electronic medical record systems. Recent randomized controlled trials support standardized PRO-base monitoring in enhancing health-related quality of life, reducing emergency department use and improving overall survival. Here, we examined whether a validated head and neck cancer (HNC) specific PRO or general PRO can better predict disease progression using machine learning algorithms. (Source: International Journal of Radiation Oncology * Biology * Physics)
Source: International Journal of Radiation Oncology * Biology * Physics - March 14, 2024 Category: Radiology Authors: C.M. Yao, K. Hueniken, S.H. Huang, C.J. Tsai, A. McPartlin, A. Hosni, A.J. Hope, G. Liu, D. Goldstein, T. Chan, J. de Almeida Tags: 168 Source Type: research

Ideal Reconstruction of Parotidectomy Defects with Parascapular Flaps: A Volumetric Analysis
Parotidectomy defects after oncologic surgery lead to significant soft tissue volume loss, resulting in unfavorable cosmetic outcomes and impaired quality of life. Free tissue transfer has become increasingly utilized for restoration of facial contours, although the optimal donor site requires a careful evaluation of patient preference and tissue volume. The purpose of this study was to compare free flap volumes to determine the optimal donor site for parotid defects. (Source: International Journal of Radiation Oncology * Biology * Physics)
Source: International Journal of Radiation Oncology * Biology * Physics - March 14, 2024 Category: Radiology Authors: P. Kahng, M.E. Heft-Neal, K. Contrera, S. Sridharan, P. Pipkorn, M.E. Spector Tags: 169 Source Type: research

Non-HPV In-Field Second Primary Squamous Cell Cancers in the HPV De-Escalation Quarterback Trials
Clinical trials evaluating treatments for HPV oropharynx cancer select patients by p16 status rather than molecular identification of HPV and HPV genotype. It is unclear whether recurrences in these trials are tested for HPV either by p16 status or molecular HPV testing. Applying molecular diagnostics for HPV at diagnosis and relapse can avoid significant miss-assignment and inaccurate results. We reviewed and report results from the Quarterback Trials (QT) where we used molecular testing to assign HPV status to all patients at diagnosis and relapse. (Source: International Journal of Radiation Oncology * Biology * Physics)
Source: International Journal of Radiation Oncology * Biology * Physics - March 14, 2024 Category: Radiology Authors: M. Posner, W.H. Westra, S. Roof, R.L. Bakst, K. Sindhu, E. Genden, T. Chen, M. Dougherty, D.K. Misiukiewicz Tags: 170 Source Type: research

Aspiration Rates and Clinician-graded Dysphagia after Transoral Surgery (TOS): An Interim Analysis of Modified Barium Swallow (MBS) Studies (videofluoroscopy) from the PATHOS trial
PATHOS is an ongoing Phase II/III randomized trial examining risk-stratified de-escalated adjuvant therapy after transoral surgery (TOS) for human papillomavirus associated oropharyngeal cancer. While the goal of TOS is functional preservation, acute postsurgical dysphagia is expected with post-TOS aspiration prevalence (prior to adjuvant treatment) recently reported in 13% of patients from the E3311 trial. Our objective was to assess clinician-graded swallowing function per modified barium swallow (MBS, videofluoroscopy) in the PATHOS trial before and after TOS, prior to randomization for adjuvant therapy. (Source: Intern...
Source: International Journal of Radiation Oncology * Biology * Physics - March 14, 2024 Category: Radiology Authors: K.A. Hutcheson, J. Patterson, C. Hurt, C.E. Barbon, L.J. Watson, D. Valencia, C. Alvarez, C. Heiberg, T. Jones, M. Evans Tags: 171 Source Type: research

The Impact of De-Escalated Radiotherapy on Carotid Stenosis Rates in Head and Neck Cancer Patients
Radiotherapy (RT) to the head and neck (H&N) often includes incidental dose to the carotid arteries, contributing to long-term development of carotid stenosis. While standard definitive and adjuvant (chemo)radiotherapy generally ranges from 60-70 Gy in 30-35 fractions, recent de-escalated approaches delivering total 30-36 Gy in 20-24 fractions have been developed. This project aims to evaluate whether de-escalated radiotherapy contributes to reduced carotid toxicity. (Source: International Journal of Radiation Oncology * Biology * Physics)
Source: International Journal of Radiation Oncology * Biology * Physics - March 14, 2024 Category: Radiology Authors: C. Geno, D.K. Ebner, J. Qian, D.J. Ma Tags: 172 Source Type: research

Characterizing Voice Changes and Primary Aberrant Features in Survivors of Locally Advanced Head and Neck Cancer Treated with Radiation Therapy
Voice changes are common in head and neck cancer (HNC) survivors who undergo radiation therapy (RT). Most studies have assessed changes with validated patient reported outcomes measures (PROMS). There is a need to combine PROMS with patient voice recordings. The purpose of this study was to characterize voice changes using a standardized protocol and describe primary aberrant features using expert listeners. (Source: International Journal of Radiation Oncology * Biology * Physics)
Source: International Journal of Radiation Oncology * Biology * Physics - March 14, 2024 Category: Radiology Authors: A. Hubler, C. Cooper, K. Heinzman, E. Hapner, W. Boswell, A.M. McDonald Tags: 173 Source Type: research

Pilot Randomized Clinical Trial of Geriatric Comanagement or Geriatric Guided Supportive Care for Older Patients with Head and Neck CancerReceiving Radiation and Chemotherapy
The standard of care for locally advanced head and neck cancer (HNC) includes radiation with concurrent chemotherapy due to superior disease control. Older adults with HNC experience higher rates of morbidity, treatment breaks, hospitalizations, and death. New strategies are needed to better support older adults with HNC through radiation and chemotherapy to minimize treatment morbidity. Geriatric assessment (GA) can be used to identify patient-specific deficits and facilitate interventions to improve patient outcomes. (Source: International Journal of Radiation Oncology * Biology * Physics)
Source: International Journal of Radiation Oncology * Biology * Physics - March 14, 2024 Category: Radiology Authors: K. Zakeri, D. Gelblum, A. Shahrokni, Z. Zhang, A. Lopez, S.J. Kim, K. Alexander, F. Amirnia, S.W. Sun, B. Korc-Grodzicki, N.Y. Lee Tags: 174 Source Type: research