Acute Toxicity Profile and Early Efficacy Results of De-Escalated, Risk-Directed Post-Operative Adjuvant Therapy for Human Papillomavirus-Positive Oropharynx Squamous-Cell Carcinoma: A Phase 2 Trial

Jose, Z.; Thorstad, Wade L.; Jackson, Ryan; Oppelt, Peter; Ley, Jessica; Daly, Mackenzie; Paniello, Randal C.; Pipkorn, Patrick; Rich, Jason T.; Puram, Sidarth V; Liu, J.; Gay, Hiram A.; Jacobs, Michael E.; Adkins, Douglas R.

doi:10.1016/j.ijrobp.2021.12.045

Cited by 1 publication

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“…MINT was a prospective clinical trial conducted among adults with HPV-related OPSCC treated with surgery followed by risk-adjusted deintensified adjuvant therapy. 16 Our retrospective cohort study showed that treated with the deintensification regimens utilized in MINT experienced substantially lower rates of ototoxicity compared to those within a historical cohort treated with standard adjuvant therapy. We further demonstrate that adjuvant treatment deintensification leads to a decrease in posttreatment threshold shifts compared to standard adjuvant therapy, especially at higher frequencies.…”

Section: Discussionmentioning

confidence: 76%

“…MINT was a prospective clinical trial conducted among adults with HPV‐related OPSCC treated with surgery followed by risk‐adjusted deintensified adjuvant therapy 16 . Our retrospective cohort study showed that patients treated with the deintensification regimens utilized in MINT experienced substantially lower rates of ototoxicity compared to those within a historical cohort treated with standard adjuvant therapy.…”

Section: Discussionmentioning

confidence: 90%

“…Patients were enrolled from November 16, 2018, to December 16, 2020. 16 Standard demographic and clinical data for the MINT and historical cohorts were obtained from the prospectively gathered MINT database and Washington University Oncology Data Services Cancer Registry, 17 respectively. The mean cochlear dose (MCD) of radiation was determined using the radiation oncology treatment planning software, Varian.…”

Section: Methodsmentioning

confidence: 99%

“…The high‐risk subset received adjuvant 60 Gy intensity‐modulated radiation therapy (IMRT) with up to 3 doses of cisplatin (100 mg/m 2 /dose), the intermediate‐risk subset received 42 Gy IMRT with a single dose of cisplatin, and the low‐risk subset received 42 Gy IMRT (no cisplatin). Patients were enrolled from November 16, 2018, to December 16, 2020 16 …”

Section: Methodsmentioning

confidence: 99%

“…Herein, we present a retrospective cohort study comparing hearing outcomes among patients in the Minimalist Trial (MINT), a prospective phase 2 trial conducted among patients with HPV‐related OPSCC that determined acute toxicities and efficacy outcomes with surgery followed by risk‐directed deintensified adjuvant therapy (42 Gy radiation given alone or with a single 100 mg/m 2 dose of cisplatin), to a historical cohort treated with surgery and standard adjuvant therapy (60‐66 Gy radiation with up to three 100 mg/m 2 doses of cisplatin) 16 …”

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Hearing Outcomes in a Deintensification Trial of Adjuvant Therapy for HPV‐Related Oropharyngeal Squamous Cell Carcinoma

Lee

Mahal

Tharakan

et al. 2023

Otolaryngol.--head neck surg.

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Objective. To explore whether deintensification of adjuvant therapy reduces ototoxicity among patients with human papillomavirus (HPV)-related oropharyngeal squamous cell carcinoma (OPSCC).Study Design. Retrospective cohort study. Setting. Single academic center.Methods. The ototoxicity rate among adult patients with HPVrelated OPSCC enrolled in the Minimalist Trial (MINT), a prospective phase 2 trial of surgery followed by risk-adjusted deintensified adjuvant therapy (42 Gy radiation given alone or with a single 100 mg/m 2 dose of cisplatin), was compared to that among a historical cohort treated with standard adjuvant therapy (60-66 Gy radiation with up to three 100 mg/m 2 doses of cisplatin). Ototoxicity was defined as Common Terminology Criteria for Adverse Events v5.0 ≥ Grade 2. Mixed model analysis was performed to investigate the association between deintensified adjuvant therapy and treatment-related hearing loss.Results. A total of 29 patients (58 ears) were analyzed in the MINT cohort, and 27 patients (54 ears) in the historical cohort. The ototoxicity rate was 5% (n = 3/58 ears) in the MINT cohort and 46% (n = 25/54 ears) in the historical cohort (difference, 41%; 95% confidence interval [CI] = 27%-56%). Patients in the MINT cohort demonstrated a 95% decrease in risk of ototoxicity compared to those in the historical cohort (adjusted odds ratio: 0.05, 95% CI = 0.01-0.31). Differences in estimated marginal mean threshold shifts were statistically and clinically significant at frequencies ≥ 3 kHz. Conclusion.The deintensified adjuvant therapy given in MINT led to less ototoxicity than standard adjuvant therapy among patients with HPV-related OPSCC.

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Section: Discussionmentioning

confidence: 76%

Section: Discussionmentioning

confidence: 90%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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confidence: 99%

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