Ⅱ期和(或)Ⅲ期直肠癌术后希罗达同步放化疗的研究

目的 探讨Ⅱ期和（或）Ⅲ期直肠癌患者根治术后,采用希罗达同步放化疗的剂量限制性毒性反应（DLT）和最大耐受剂量（MTD）。方法24例直肠癌患者,年龄为18～75岁,KPS评分≥70分,根治性手术后病理证实为Ⅱ期和（或）Ⅲ期。希罗达从放射治疗第1天开始服用,间隔12h,连续服用14d,休息7d,为1个周期。共治疗2个周期。同步进行的盆腔放射治疗5周,共25次,总剂量为50Gy。≥3度的血液学或非血液学毒性反应为希罗达DLT。结果24例患者分别入希罗达每天1000mg/m^2组（3例）、1200mg／m^2组（3例）、1400mg／m^2组（3例）、1500mg／m^2组（3例）、1600mg／m^2组（6例）和1700mg／m^2组（6例）。1600mg／m^2组出现1例DLT（1例3度腹泻）,补充3例后,未出现DLT,继而进入每天1700mg／m^2组。1700mg／m^2组相继出现2例DLT（3度和4度腹泻各1例）。结论Ⅱ期和（或）Ⅲ期直肠癌根治术后希罗达同步放化疗是安全、可行的。希罗达的最大耐受剂量为每天1600mg／m^2,限制性毒性反应为腹泻。

Phase I study of postoperative concurrent chemoradiation with capecitabine as adjuvant treatment for stage II/III operable rectal cancer

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.