Phase II trial of de-intensified chemoradiotherapy for human papillomavirus–associated oropharyngeal squamous cell carcinoma

Bhishamjit S. Chera, Robert J. Amdur, Rebecca Green, Colette Shen, Gaorav Gupta, Xianming Tan, Mary Knowles, David Fried, Neil Hayes, Jared Weiss, Juneko Grilley-Olson, Shetal Patel, Adam Zanation, Trevor Hackman, Jose Zevallos, Jeffrey Blumberg, Samip Patel, Mohit Kasibhatla, Nathan Sheets, Mark WeisslerWendell Yarbrough, William Mendenhall

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Abstract

PURPOSE To report the results of a phase II clinical trial of de-intensified chemoradiotherapy for patients with human papillomavirus–associated oropharyngeal squamous cell carcinoma. MATERIALS AND METHODS Major inclusion criteria were (1) having American Joint Committee on Cancer (AJCC) 7th edition T0-T3, N0-N2c, M0 (AJCC 8th edition T0-T3, N0-N2, M0), (2) being p16 positive, and (3) reporting minimal or remote smoking history. Treatment was limited to 60 Gy intensity-modulated radiotherapy with concurrent intravenous cisplatin 30 mg/m2 once per week. Patients with T0-T2 N0-1 (AJCC 7th edition) did not receive chemotherapy. All patients had a 10- to 12-week post-treatment positron emission tomography/ computed tomography to assess for neck dissection. The primary end point was 2-year progression-free survival. Secondary end points included 2-year local-regional control, distant metastasis-free survival and overall survival, and patient-reported outcomes (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire and the patient-reported outcomes version of the Common Terminology Criteria for Adverse Events). RESULTS One hundred fourteen patients were enrolled (median follow-up of 31.8 months), with 81% having a minimum follow-up of 2 years. Eighty percent of patients had 10 or fewer tobacco pack-years. Two-year local-regional control, distant metastasis-free survival, progression-free survival, and overall survival were as follows: 95%, 91%, 86%, and 95%, respectively. Mean pre- and 2-year post-treatment European Organisation for Research and Treatment of Cancer quality of life scores were as follows: global, 79/84 (lower worse); swallowing, 8/9 (higher worse); and dry mouth, 14/45 (higher worse). Mean pre- and 2-year post-treatment patient-reported outcomes version of the Common Terminology Criteria for Adverse Events scores (0 to 4 scale, higher worse) were as follows: swallowing, 0.5/0.7, and dry mouth, 0.4/1.3. Thirty-four percent of patients required a feeding tube (median, 10.5 weeks; none permanent). There were no grade 3 or higher late adverse events. CONCLUSION Clinical outcomes with a de-intensified 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.

Original languageEnglish
Pages (from-to)2661-2669
Number of pages9
JournalJournal of Clinical Oncology
Volume37
Issue number29
DOIs
StatePublished - Oct 10 2019

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    Chera, B. S., Amdur, R. J., Green, R., Shen, C., Gupta, G., Tan, X., Knowles, M., Fried, D., Hayes, N., Weiss, J., Grilley-Olson, J., Patel, S., Zanation, A., Hackman, T., Zevallos, J., Blumberg, J., Patel, S., Kasibhatla, M., Sheets, N., ... Mendenhall, W. (2019). Phase II trial of de-intensified chemoradiotherapy for human papillomavirus–associated oropharyngeal squamous cell carcinoma. Journal of Clinical Oncology, 37(29), 2661-2669. https://doi.org/10.1200/JCO.19.01007