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Phase II Study of Radiotherapy Dose De-Intensification for HPV-Associated Oropharyngeal Carcinoma

Phase II Study of Radiotherapy Dose De-Intensification for HPV-Associated Oropharyngeal Carcinoma.

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Phase II Study of Radiotherapy Dose De-Intensification for HPV-Associated Oropharyngeal Carcinoma

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  1. Phase II Study of Radiotherapy Dose De-Intensification for HPV-Associated Oropharyngeal Carcinoma Harry Quon1,3,4,*, Amanda Blackford 2, Giuseppe Sanguinetti1, Christine Chung 3, Shanthi Marur3, Heather Starmer4, Jeremy Richmon4, Nishant Agrawal4, Christine Gourin4, Kelly Szajna1, Katharine Oteiza1, Arlene Forastiere3, Wayne Koch4. 1Department of Radiation Oncology and Molecular Radiation Sciences, 2Oncology Biostatistics, 3Oncology and 3Otorhinolaryngology-Head and Neck Surgery, The Johns Hopkins University, School of Medicine. *Corresponding author.

  2. Background • HPV-associated OPSCC have a favourable prognosis with less competing comorbidities and are at risk for developing late treatment complications impacting quality of life expectations. • The objective of this phase II study is to reduce the prevalence of 2 year grade ≥3 (CTCAE 3.0) ≤15% with 2 year local-regional control rate of at least 85%.

  3. Materials • Prospective phase II • Eligibility criteria: • HPV16 DNA by in situ hybridization or p16 positive immunohistochemistry • Previously untreated T1-2 N0-2a M0 or T1-3 N2-3 M0 • ECOG PS 0-1 with adequate renal and liver function • Ineligible criteria: • T4 • ≥10 pack year tobacco exposure • Radiotherapy (RT): • Primary tumor planning target volume (PTV) that overlaps with pharyngeal constrictors, larynx, parotids mandible and masticatory muscles + circumferential 8 mm margin is dose reduced to 63 Gy in 35 fractions • Remaining primary PTV treated to 70 Gy in 35 fractions • Low-risk elective PTV is treated to 58.1 Gy in 35 fractions except for portions of the PTV overlapping with structures described above is dose reduced to 50.75 Gy from 58.1 Gy in 35 fractions. • Chemotherapy (CT): • concurrent weekly (40 mg/m2) cisplatin • T1-3 N2-3 M0 only • Penetration Aspiration Scale (PAS) was used to objectively quantify entrance of the swallow bolus material into the laryngeal vestibule and patient response to this material. Scores were considered normal if <3 and abnormal if ≥3.

  4. Results Prophylactic PEGs placed in all patients. All relapses alive without disease. Median follow-up 13 months (1-26 months)

  5. Discussion • Radiotherapy de-intensification in a favourable HPV-OPSCC cohort may be associated with low rates of toxicities and high rates of local-regional control rates. • Ongoing accrual and follow-up is warranted before any generalizable conclusions can be derived.

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