Single Arm Phase II Trial of Elective Nodal Dose Reduction for Patients with Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck

Publication date: Available online 28 December 2017
Source:International Journal of Radiation Oncology*Biology*Physics
Author(s): Patrick D. Maguire, Charles R. Neal, Stuart M. Hardy, Andrew M. Schreiber
PurposeTo evaluate a novel chemoradiotherapy (CRT) regimen for patients with squamous cell carcinoma of the head and neck (SCCHN) incorporating a lower intensity modulated radiation therapy (IMRT) dose to electively treated neck lymph nodes than is currently standard.Methods and MaterialsEligible patients had locally advanced SCCHN of the oral cavity, oropharynx, larynx, or hypopharynx. The seven week CRT course consisted of weekly cisplatin at 35 mg/m2 concurrent with sequential boost IMRT: 36 Gy to high and low risk planning target volumes (PTV) followed by a sequential boost to high risk PTV to 70 Gy. The primary endpoint was elective nodal failure (ENF). Secondary endpoints were survival, toxicity, feeding tube duration, and QOL evaluated by FACT-HN and QOL-RTI surveys.ResultsBetween 2011 and 2014, 54 patients were enrolled, 31 (57%) of whom had HPV+ disease. Thirty-five (65%) patients had stage IVa disease. Median follow-up for survivors was 36 months (range 12 - 66 months). No patient developed ENF. Actuarial three-year survival for the entire cohort was 91 % (95% confidence interval [CI] 0.79-0.96); HPV- 85% (95% CI 0.61-0.95), and HPV+ 96% (95% CI 0.77-0.99). Common grade three toxicities were dysphagia 79%, mucositis/stomatitis 41%, nausea 20%, xerostomia 13%, vomiting 11%, and neutropenia 10%. Median feeding tube duration was 142 days. Patient FACT-HN scores were higher at three, six, and 12 months vs. end of treatment (p<0.0001). Total FACT-HN scores returned to pre-treatment baseline by six months. Overall QOL-RTI scores were lower from pre-treatment to end of treatment through 12 months (p=0.0001).ConclusionThis CRT regimen for patients with advanced SCCHN demonstrated the potential feasibility of reducing the elective dose to the neck, a topic that requires additional study in future clinical trials.



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