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De-intensified chemoradiotherapy confers favorable outcomes in HPV-associated oropharyngeal cancer
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A de-intensified chemoradiotherapy regimen conferred favorable clinical outcomes among patients with HPV-associated oropharyngeal squamous cell carcinoma, according to results of a single-arm phase 2 study published in Journal of Clinical Oncology.
Patients achieved the favorable results without the need for neoadjuvant chemotherapy or routine surgery, researchers noted.
“In general, these patients have excellent outcomes with the standard-intensity treatment,” Bhishamjit S. Chera, MD, associate professor, associate chair of clinical operations and improvement, and director of patient safety and quality in the department of radiology at UNC Lineberger Comprehensive Cancer Center, told HemOnc Today. “However, standard-intensity treatments are associated with significant long-term toxicity, namely dysphagia and xerostomia.”
Over the past 10 years, there has been avid interest in evaluating less intensive treatment regimens with the goals of maintaining excellent cancer control and decreasing toxicity, according to researchers.
Chera and colleagues reported 2-year cancer control and survival rates and patient-reported outcomes of 114 patients (median age, 62 years; range, 37-87; 84% men; 91% white) with HPV-associated oropharyngeal squamous cell carcinoma enrolled in a phase 2 trial of de-intensified chemoradiotherapy.
Patients had American Joint Committee on Cancer (AJCC) 7th edition T0 to T3, N0 to N2c and M0 disease (8th edition T0-T3, N0-N2 and M0), were p16-positive, and reported minimal or remote smoking history.
Chemoradiotherapy was limited to 60 Gy intensity-modulated radiotherapy with concurrent 30 mg/m2 IV cisplatin once per week. All patients received the intended radiation dose, and 89 patients (78%) received chemotherapy.
Two-year PFS served as the primary endpoint. Two-year locoregional control, distant metastasis-free survival, OS and patient-reported outcomes served as secondary endpoints.
Median follow-up was 31.8 months (range, 1.1-51.4).
Results showed 2-year PFS of 86% (95% CI, 77.5-91.3), 2-year locoregional control of 95% (95% CI, 88.6-97.9), 2-year OS of 95% (95% CI, 89.3-98.1) and 2-year distant metastasis-free survival of 91% (95% CI, 83.9-95.4).
Patients reported improvements in physical, emotional, cognitive and social functioning from baseline to 2 years after treatment with the regimen. However, swallowing and speech problems persisted for some patients, with 34% requiring a feeding tube for a median 10.5 weeks.
The greatest symptom burden was dry mouth, which was most symptomatic at 6 to 8 weeks after treatment. Patients reported improvement after 1 year, but it never returned to baseline.
A randomized phase 3 trial comparing 60 Gy vs. 70 Gy radiotherapy is set to accrue patients, according to researchers.
“The incidence of HPV-associated oropharynx cancer is rapidly rising, and it is now the most prevalent HPV-associated malignancy in the United States,” Chera said. “The phase 3 trial will need to be completed [before this regimen becomes the standard of care].” – by John DeRosier
For more information:
Bhishamjit S. Chera , MD, can be reached at bchera@med.unc.edu.
Disclosures: Chera reports stock ownership in Naveris and a consultant/advisory role with American Society for Radiation Oncology. Please see the study for all other authors’ relevant financial disclosures.
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