Jin Jing, Li Ye-Xiong, Liu Yue-Ping, Wang Wei-Hu, Li Tao, Li Ning, Song Yong-wen
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
Zhonghua Zhong Liu Za Zhi. 2006 May;28(5):393-6.
This phase I study is to determine the maximal tolerated dose and the dose-limiting toxicity of capecitabine combined with standard radiotherapy (RT) as postoperative adjuvant treatment for rectal cancer patients.
Stage II/III rectal cancer patients 18 - 75 years of age had undergone curative surgery with Karnofsky score > or = 70% were eligible to be included in this study. Total dose of RT DT 50 Gy was delivered to the pelvic area in fraction of 2.0 Gy per day for 5 weeks. Capecitabine was orally administered concurrently with radiotherapy for a total of 2 cycles in escalating doses: twice daily at 12 hour interval for consecutive 14 days as one cycle, separated by a seven day rest, then followed by another cycle. From March 2004 to May 2005, 24 patients were included and treated at the following dose levels: daily 1000 mg/m(2) (3 patients), 1200 mg/m(2) (3 patients), 1400 mg/m(2) (3 patients), 1500 mg/m(2) (3 patients), 1600 mg/m(2) (6 patients), and 1700 mg/m(2) (6 patients). Dose-limiting toxicities (DLT) including grade 3 or grade 4 hematologic and nonhematologic toxicity were observed.
Dose-limiting toxicity was observed in one patient treated at dose of 1600 mg/m(2) with grade 3 diarrhea, and in 2 patients at dose of 1700 mg/m(2) with one grade 3 and one grade 4 diarrhea.
Diarrhea is the most common dose-limiting toxicity. In our study, the maximal tolerated dose (MTD) of capecitabine given concurrently with radiotherapy was daily 1600 mg/m(2), from D1 to D14 separated by 7-day rest for 2 cycles. Capecitabine given concurrently with standard radiotherapy is safe and tolerable for operated stage II/III rectal cancer patients.
本I期研究旨在确定卡培他滨联合标准放疗（RT）作为直肠癌患者术后辅助治疗的最大耐受剂量和剂量限制性毒性。
年龄在18 - 75岁、接受根治性手术且卡氏评分≥70%的II/III期直肠癌患者符合纳入本研究的条件。盆腔区域接受放疗总剂量DT 50 Gy，每天2.0 Gy，共5周。卡培他滨与放疗同时口服，共2个周期，剂量逐步递增：连续14天，每12小时1次，每日2次为1个周期，间隔7天休息，然后进行另一个周期。2004年3月至2005年5月，24例患者纳入研究并接受以下剂量水平治疗：每日1000 mg/m²（3例）、1200 mg/m²（3例）、1400 mg/m²（3例）、1500 mg/m²（3例）、1600 mg/m²（6例）和1700 mg/m²（6例）。观察剂量限制性毒性（DLT），包括3级或4级血液学和非血液学毒性。
1例接受1600 mg/m²剂量治疗的患者出现3级腹泻，为剂量限制性毒性；2例接受1700 mg/m²剂量治疗的患者出现1例3级和1例4级腹泻。
腹泻是最常见的剂量限制性毒性。在我们的研究中，与放疗同时给予的卡培他滨最大耐受剂量（MTD）为每日1600 mg/m²，从第1天至第14天，间隔7天休息，共2个周期。卡培他滨与标准放疗同时给予对II/III期直肠癌术后患者是安全且可耐受的。
