In a phase II trial reported in the Journal of Clinical Oncology, Chera et al found that deintensified chemoradiotherapy produced favorable outcomes in human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma.
In the multicenter trial, 114 patients were recruited between August 2014 and October 2017 and received treatment limited to 60 Gy intensity-modulated radiotherapy with concurrent low-dose cisplatin 30 mg/m2 once per week for six doses. Radiotherapy was given at 2 Gy per fraction in 30 fractions 5 days a week for 6 weeks. Patients had to have American Joint Committee on Cancer (AJCC) 7th edition T0–T3, N0–N2c, M0 disease (AJCC 8th edition T0–T3, N0–N2, M0 disease), HPV p16–positive disease, and minimal or remote smoking history. Patients with AJCC 7th edition T0–T2 N0–1 disease did not receive chemotherapy. Overall, 78% of patients received chemotherapy.
The primary endpoint was 2-year progression-free survival.
Median follow-up was 31.8 months. The posttreatment positron-emission tomography/computed tomography complete response rate was 93% at the primary site and 80% in the neck. Four of 11 patients who underwent neck dissection had pathologic residual disease, with all who underwent dissection remaining alive without evidence of disease at time of analysis. Two-year rates were 95% for locoregional control, 91% for distant metastasis–free survival, 86% for progression-free survival, and 95% for overall survival.
Adverse Events and Quality of Life
The most common acute grade ≥ 3 adverse events as reported by clinicians were mucositis (in 33% of patients), decreased appetite (25%), dysphagia (21%), and pain (12%). The most common reported as severe/very severe by patients were xerostomia (60%), decreased appetite (59%), dysphagia (50%), and pain (45%). A feeding tube was required by 34% of patients for a median of 10.5 weeks. One patient died during treatment due to neutropenic sepsis. There were no clinician-reported grade ≥ 3 late adverse events.
Mean pretreatment vs 2-year posttreatment European Organisation for Research and Treatment of Cancer quality of life scores were: global = 79 vs 84; swallowing = 8 vs 9; and dry mouth = 14 vs 45.
The investigators concluded, “Clinical outcomes with a deintensified chemoradiotherapy regimen of 60 Gy intensity-modulated radiotherapy with concurrent low-dose cisplatin are favorable in patients with human papillomavirus–associated oropharyngeal squamous cell carcinoma. Neither neoadjuvant chemotherapy nor routine surgery is needed to obtain favorable results with de-escalation.”
Bhishamjit S. Chera, MD, of the Department of Radiation Oncology, University of North Carolina School of Medicine, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by the University of North Carolina School of Medicine Department of Radiation Oncology, and by the University of Florida School of Medicine Department of Radiation Oncology. For full disclosures of the study authors, visit jco.ascopubs.org.
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