Abstract
Background
A phase II study of adaptive two-step intensity-modulated radiotherapy (IMRT) with chemotherapy for nasopharyngeal cancer (NPC) (JCOG1015) was conducted to evaluate the efficacy and safety.
Methods
Patients aged 20–75 years with stages II–IVB NPC were enrolled. As adaptive two-step IMRT, computed tomography planning was performed twice before IMRT for the initial plan of 46 Gy/23 fractions and during treatment for the boost plan of 24 Gy/12 fractions with a total dose of 70 Gy. Chemotherapy (cisplatin 80 mg/m2/3-weeks × 3 courses) was administered concurrently with IMRT, followed by adjuvant chemotherapy (cisplatin at 70 mg/m2 with 5-FU 700 at mg/m2 for 5 days/4 weeks × 3 courses).
Results
Between 2011 and 2014, 75 patients were enrolled from 12 institutions. The 3-year overall survival (OS) for the 75 patients was 88%, and the upper and lower limits of the 95% CI of 78%–94% were higher than the expected 3-year OS of 75% for the target population adjusted by the actual proportion of stage II:III:IV = 21%:44%:35%. The 3-year progression-free survival (PFS) and loco-regional PFS were 71% [59–80%] and 77% [66–85%], respectively. Although no grade 4–5 late toxicities were observed, 15 patients (20%) developed grade 3 late toxicities. Grade 2 xerostomia was noted in 26%, 12%, and 9% at 1, 2, and 3 years after starting IMRT, respectively.
Conclusions
Adaptive two-step IMRT for NPC demonstrated an excellent 3-year OS with acceptable toxicities. This method may be one treatment option for locally advanced NPC.
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Acknowledgements
We would like sincerely thank all participating patients, the 12 participating institutions from the JCOG Radiation Therapy Study Group, Data and Safety Monitoring Committee, Audit Committee of JCOG, and JCOG Data Center/Operations Office. JCOG Data Center and Operation Office: H. Fukuda (Data Center Director), R. Machida (Statistical Section), C. Aibara and M. Murai (Data Management Section), and J. Eba and Y. Takahashi (Operations Office).
Funding
This study was supported by Health Sciences Research Grants for the Grant-in-Aid for Cancer Research (H23-009) from the Ministry of Health, Labour and Welfare of Japan, the Japan Agency for Medical Research and Development under Grant number JP16ck0106093, and the National Cancer Center Research and Development Funds (26-A-4, 29-A-3).
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Nishimura, Y., Ishikura, S., Shibata, T. et al. A phase II study of adaptive two-step intensity-modulated radiation therapy (IMRT) with chemotherapy for loco-regionally advanced nasopharyngeal cancer (JCOG1015). Int J Clin Oncol 25, 1250–1259 (2020). https://doi.org/10.1007/s10147-020-01665-2
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DOI: https://doi.org/10.1007/s10147-020-01665-2