Phase I study of stereotactic body radiation therapy for peripheral T2N0M0 non-small cell lung cancer with PTV < 100 cc using a continual reassessment method (JCOG0702)

作者：Onimaru Rikiya^*; Shirato Hiroki; Shibata Taro; Hiraoka Masahiro; Ishikura Satoshi; Karasawa Katsuyuki; Matsuo Yukinori; Kokubo Masaki; Shioyama Yoshiyuki; Matsushita Haruo; Ito Yoshinori; Onishi Hiroshi

来源：Radiotherapy and Oncology, 2015, 116(2): 276-280.

DOI：10.1016/j.radonc.2015.07.008

• Phase I study
• Continual reassessment method
• Non-small cell lung cancer (NSCLC)
• Stereotactic body radiotherapy
• SBRT

Purpose: To estimate the maximum tolerated dose (MTD) and to determine the recommended dose (RD) of stereotactic body radiation therapy (SBRT) for peripheral T2N0M0 non-small cell carcinoma (NSCLC) with target volume (PTV) < 100 cc.
Materials and methods: The continual reassessment method (CRM) was used to determine the dose level that patients should be assigned to and to estimate the MTD. Dose limiting toxicity (DLT) was grade 3 radiation pneumonitis (RP) within 180 days after the start of SBRT, grade 2 RP was used as a surrogate DLT. The RD was equal to the MTD. The dose was prescribed at D-95 of the PTV.
Results: Fifteen patients were accrued. Only 1 experienced grade 2 RP at 60 Gy in 4 fractions. It was difficult to fulfill the dose constraints at 60 Gy in 4 fractions, and the maximum dose level assigned by CRM was changed to 55 Gy in 4 fractions. The lower limit of 95% of the credible interval exceeded the adjacent level, and the RD was determined as 55 Gy in 4 fractions.
Conclusions: The RD of SBRT for peripheral T2N0M0 NSCLC with PTV < 100 cc was determined to be 55 Gy in 4 fractions.

• 出版日期2015-8