Preoperative concomitant boost intensity-modulated radiotherapy with oral capecitabine in locally advanced mid-low rectal cancer: A phase II trial |
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Authors: | Jin-luan Li Jia-fu Ji Yong Cai Xiao-fan LiYong-heng Li Hao WuBo Xu Fang-yuan DouZi-yu Li Zhao-de BuAi-wen Wu Ivan WK Tham |
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Institution: | a Department of Radiation Oncology, Beijing Cancer Hospital and Institute, People’s Republic of China b Department of Gastrointestinal Surgery, Beijing Cancer Hospital and Institute, People’s Republic of China c Department of Pathology, Beijing Cancer Hospital and Institute, People’s Republic of China d Department of Radiation Oncology, National University Cancer Institute, Singapore |
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Abstract: | PurposeWe aimed to assess the safety and efficacy of preoperative intensity-modulated radiotherapy (IMRT) with oral capecitabine in patients with locally advanced mid-low rectal cancer using a concomitant boost technique.Materials and methodsPatients with resectable locally advanced mid-low rectal cancer (node-negative ?T3 or any node-positive tumor) were eligible. The eligible patients received IMRT to 2 dose levels simultaneously (50.6 and 41.8 Gy in 22 fractions) with concurrent capecitabine 825 mg/m2 twice daily 5 days/week. The primary end point included toxicity, postoperative complication, and pathological complete response rate (ypCR). The secondary endpoints included local recurrence rate, progression-free survival (PFS), and overall survival (OS).ResultsSixty-three eligible patients were enrolled; five patients did not undergo surgery. Of the 58 patients evaluable for pathologic response, the ypCR rate was 31.0% (95% CI 19.1-42.9). Grade 3 toxicities included diarrhea (9.5%), radiation dermatitis (3.2%), and neutropenia (1.6%). There was no Grade 4 toxicity reported. Four (6.9%) patients developed postoperative complications. Two-year local recurrence rate, PFS, and OS were 5.7%, 90.5%, and 96.0%, respectively.ConclusionsThe design of preoperative concurrent boost IMRT with oral capecitabine could achieve high rate of ypCR with an acceptable toxicity profile. |
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Keywords: | Intensity-modulated radiotherapy Capecitabine Rectal cancer |
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