Toukeibu Gan
Online ISSN : 1881-8382
Print ISSN : 1349-5747
ISSN-L : 1349-5747
A prospective observation study of Japanese patients with locally advanced squamous cell carcinoma of the head and neck treated by radiotherapy with cetuximab (JROSG12-2): interim appraisal of the safety and treatment compliance
Yosuke OtaTakeshi KodairaHirofumi FujiiMototsugu ShimokawaTorahiko NakashimaNobuya MondenTomoya YokotaAkihiro HommaShinya UedaTetsuo Akimoto
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2019 Volume 45 Issue 3 Pages 330-336

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Abstract

Radiotherapy combined with cetuximab(Bioradiation therapy:BRT)is one of the standard care methods for locally advanced squamous cell carcinoma of the head and neck(LA-SCCHN). Since its introduction in routine clinical practice, there have been a few reports regarding the use of BRT in Japan. To evaluate the safety and efficacy of therapy including cetuximab, a prospective observation study of Japanese patients with SCCHN treated by combination therapy with cetuximab has been launched. We report the scheduled interim appraisal of the safety and treatment compliance in BRT performed for half of the total accruals(90 patients). This study received support from Merck Serono, and was conducted by the Japanese Radiation Oncology Study Group(JROSG).
We analyzed 69 cases that were available for analysis among the 90 cases enrolled from August 2013 to May 2015. Data on baseline characteristics, treatment compliance, and the incidence and severity of adverse events were collected. Patients with cancer of the hypopharynx, oropharynx, larynx, and oral cavity were enrolled. Median age was 66(36-83), and 14 patients(20%)were 75 years old or older. 49 patients(71%)had stage ⅣA disease.
The rate of treatment completion, defined as receiving weekly cetuximab of 6 or more courses and radiotherapy dose of 60Gy or more, was 75%, which was lower than expected. Treatment compliance was especially low in elderly patients. The most frequently reported Grade 3 or 4 adverse events were pharyngeal mucositis(58%), radiation dermatitis(42%), and oral mucositis(39%). Respiratory complications such as aspiration pneumonia(5%)and pneumonitis(3%)were higher than previously reported. Therefore, careful respiratory monitoring is necessary for safe treatment.
BRT was adopted widely for patients with LA-SCCHN in Japan. However, treatment compliance was slightly lower than expected, and careful observation during treatment is needed. Safety and efficacy after 1 year will be followed up and described in a final report.

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© 2019 Japan Society for Head and Neck Cancer
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