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Abstract

Purpose Human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC) is treatment-responsive. Definitive chemoradiation results in high cure rates but causes long-term toxicity and may represent overtreatment of some patients. This phase II trial evaluated whether complete clinical response (cCR) to induction chemotherapy (IC) could select patients with HPV-associated OPSCC for reduced radiation dose as a means of sparing late sequelae. Methods Patients with HPV16 and/or p16-positive, stage III-IV OPSCC received three cycles of IC with cisplatin, paclitaxel, and cetuximab. Patients with primary-site cCR to IC received intensity-modulated radiation therapy (IMRT) 54 Gy with weekly cetuximab; those with less than cCR to IC at the primary site or nodes received 69.3 Gy and cetuximab to those regions. The primary end point was 2-year progression-free survival. Results Of the 90 patients enrolled, 80 were evaluable. Their median age was 57 years (range, 35 to 73 years), with the majority having stage T1-3N0-N2b OPSCC and a history of ≤ 10 pack-years of cigarette smoking. Three cycles of IC were delivered to 77 of the 80 patients. Fifty-six patients (70%) achieved a primary-site cCR to IC and 51 patients continued to cetuximab with IMRT 54 Gy. After median follow-up of 35.4 months, 2-year progression-free survival and overall survival rates were 80% and 94%, respectively, for patients with primary-site cCR treated with 54 Gy of radiation (n = 51); 96% and 96%, respectively, for patients with < T4, < N2c, and ≤ 10 pack-year smoking history who were treated with ≤ 54 Gy of radiation (n = 27). At 12 months, significantly fewer patients treated with a radiation dose ≤ 54 Gy had difficulty swallowing solids (40% v 89%; P = .011) or had impaired nutrition (10% v 44%; P = .025). Conclusion For IC responders, reduced-dose IMRT with concurrent cetuximab is worthy of further study in favorable-risk patients with HPV-associated OPSCC. Radiation dose reduction resulted in significantly improved swallowing and nutritional status. 

Author information

Marur S1, Li S1, Cmelak AJ1, Gillison ML1, Zhao WJ1, Ferris RL1, Westra WH1, Gilbert J1, Bauman JE1, Wagner LI1, Trevarthen DR1, Balkrishna J1, Murphy BA1, Agrawal N1, Colevas AD1, Chung CH1, Burtness B1.

1 Shanthi Marur and William H. Westra, Johns Hopkins University, Baltimore, MD; Shuli Li, Dana Farber Cancer Institute, Boston,MA; Anthony J. Cmelak, Jill Gilbert, and Barbara A. Murphy, Vanderbilt University, Nashville, TN; Maura L. Gillison and Weiqiang J. Zhao, Ohio State University, Columbus, OH; Robert L. Ferris and Julie E. Bauman, University of Pittsburgh, Pittsburgh, PA; Lynne I. Wagner, Wake Forest School of Medicine, Winston-Salem, NC; David R. Trevarthen, Colorado Cancer Research Program, Denver, CO; Jahagirdar Balkrishna, University of Minnesota, St Paul, MN; Nishant Agrawal, University of Chicago Medicine, Chicago, IL; A. Dimitrios Colevas, Stanford University, Stanford, CA; Christine H. Chung, Moffitt Cancer Center, Tampa, FL; and Barbara Burtness, Yale University, New Haven, CT.