三氧化二砷对鼻咽癌放射增敏的临床研究

Arsenic trioxide enhances radiosensitivity of nasopharyngeal carcinoma： preliminary results of phase Ⅱ clinical trial

目的探讨三氧化二砷对鼻咽癌放射增敏作用临床应用的价值。方法将61例T1-4 N0-1期鼻咽癌病人随机分入单纯放疗组和三氧化二砷放射增敏组，观察两组病人鼻咽肿瘤和颈部肿瘤消退情况及毒副作用。结果放射治疗40Gy时三氧化二砷增敏组和单纯放疗组的鼻咽肿瘤消退率分别为53．13％（17／32）和17．24％（5／29），χ^2=8．495，P=0．004，差异有统计学意义；两组的颈部肿块消退速度无差别；三氧化二砷增敏组的白细胞降低和恶心呕吐较单纯放疗组发生频率高，但多为Ⅰ～Ⅱ度反应，未见Ⅳ度反应。其他的不良反应在两组间差异无统计学意义。结论与单纯放疗相比，放疗加三氧化二砷使鼻咽肿瘤消退较快，无严重毒副作用。

Objective To evaluate the radiosensitizing effect of arsenic trioxide （ATO） on nasopharyngeal carcinoma（NPC）. Methods Sixty-one patients with NPC of T1-4 N0-1 M0 were randomized into two groups： conventional fractionation radiotherapy （CFR） group and CFR ＋ ATO group. 29 patients in CFR group were irradiated by 2.0 Gy/fraction, 5 times a week, with total dose of 70-80 Gy. 32 cases in CFR ＋ ATO group received radiotherapy （RT） the same as the CFR group, but daily 10 mg ATO was added 2 days before RT and then concurrent with RT for 4 weeks. The regressions of nasopharyngeal lesions and cervical lymph nodes and acute toxicities were compared between two groups. Results When irradiation dose reached 40 Gy, the completely regression rates of nasopharyngeal lesion were 17.24% （ 5/29 ） in CFR group and 53.13 % （ 17132 ） in CFR＋ ATO group, respectively. The difference was statistically significant （χ^2 = 8.495, P = 0.004）. The differences of side effects between two groups were not statistically significant except of nausea and vomiting and granulocytopenia, which were more frequent in CFR ＋ ATO group. Most patients experienced Grade 1 to 2 acute toxieities in both groups. No Grade 4 toxicity was observed in all patients. Conclusions ATO enhances radiosensitivity of nasopharyngeal carcinoma without severe side effects.