A Prospective Phase II Trial of Deintensified Chemoradiation Therapy for Low Risk HPV Associated Oropharyngeal Squamous Cell Carcinoma


      We performed a prospective multi-institutional phase II study of a substantial decrease in concurrent chemoradiotherapy (CRT) intensity as primary treatment for favorable risk, HPV-associated oropharyngeal squamous cell carcinoma (OPSCC).


      The major inclusion criteria were: (1) T0–T3, N0–N2c, M0, (2) HPV or p16 positive, and (3) minimal smoking history. Treatment was limited to 60 Gy intensity modulated radiotherapy with concurrent weekly intravenous cisplatinum (30 mg/m2). The primary study endpoint was pathologic complete response rate (pCR) based on required biopsy of the primary site and dissection of pretreatment positive lymph node regions, regardless of radiographic response. Power computations were performed for the null hypothesis that the pCR rate is 87% and N = 40, resulting in a type I error of 14.2%. Secondary endpoint measures included physician reported toxicity (CTCAE), patient-reported symptoms (PRO-CTCAE), quality of life (EORTC QLQ-C30 and H&N35), and penetration aspiration scale (PAS) scores for modified barium swallow studies.


      The study population is 43 patients. The pCR rate was 86% (37/43). All 6 non-pCR cases were limited to microscopic foci of residual cancer: 1 primary site, 5 nodal. All patients are alive with no evidence of disease (median follow-up 20.7 months; range, 6–36 months). The incidence of CTCAE Grade 3/4 toxicity and PRO-CTCAE severe/very severe symptoms were: mucositis 34%/45%, pain 5%/48%, nausea 18%/52%, vomiting 5%/34%, dysphagia 39%/55%, and xerostomia 2%/75%. Grade 3/4 hematological toxicities were 11%. Mean pre and post CRT EORTC QOL scores were: Global 80/69 (lower worse), Pain 19/26 (higher worse), Swallowing 11/18, Coughing 17/22, Dry Mouth 16/64, and Sticky Saliva 6/49. Thirty-nine percent of patients required a feeding tube (none permanent) for a median of 15 weeks (range, 5 – 22 weeks). There were no significant differences in PAS scores for thin, pureed, and solid foods before and after CRT.


      Pathological CR rate with decreased intensity of therapy with 60 Gy of IMRT and weekly low-dose cisplatinum is very high in favorable risk OPSCC with evidence of decreased toxicity compared to standard therapies (, NCT01530997).


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