SOX方案及XELOX方案一线治疗晚期胃癌的临床研究

A randomized trial of S-1-oxaliplatin versus capecitabine-oxaliplatin for advanced gastric cancer

目的比较SOX方案（替吉奥联合奥沙利铂）和XELOX方案（卡培他滨联合奥沙利铂）一线治疗晚期胃癌近期疗效、远期疗效及化疗不良反应。方法 62例晚期胃癌患者随机分为SOX组（n=32）和XELOX组（n=30）,两组均接受〉2周期的化疗,每2周期后评价近期疗效,观察化疗相关不良反应。结果 SOX组有效率、疾病控制率、中位疾病进展时间、中位生存时间分别为43.8%、81.3%、6.2月、11.6月;XELOX组有效率、疾病控制率、中位疾病进展时间、中位生存时间分别为33.3%、73.3%、6.0月、10.9月,两组有效率及生存期比较差异均无统计学意义（均P〉0.05）。两组Ⅲ~Ⅳ级血液学毒性方面差异无统计学意义（P〉0.05）,非血液学毒性方面外周神经毒性及手足综合征发生率XELOX组高于SOX组（均P〈0.05）。结论 SOX及XELOX方案一线治疗晚期胃癌疗效均较高,疗效相近,不良反应均可耐受,XELOX组在外周神经症状及手足综合征方面发生率较SOX组高。

Objective To compare the efficacy and toxicity of SOX（ S-1 and oxaliplatin） and XELOX（ capecitabine and oxaliplatin） regimens for advanced gastric cancer. Methods Sixty-two patients with advanced gastric cancer were randomly divided into SOX group（ n = 32） and XELOX group（ n = 30）. Both groups received 2 cycles of chemotherapy,and therapeutic efficacy and toxicity were evaluated after every two cycles. Results Response rate（ RR）,disease control rate（ DCR）,median time to progression（ m TTP）,median overall survival（ m OS） in SOX group were43. 8%,81. 3%,6. 2 months and 11. 6 months,those for XELOX group were 33. 3%,73. 3%,6. 0 months and 10. 9months. There were no significant differences between two groups（ all P〉 0. 05）. There was no significant difference in grade Ⅲ ~ Ⅳ hematological toxicity between two groups（ P〉 0. 05）. However,the incidences of non-hematological adverse events including neuropathy and hand-foot syndrome were higher in XELOX group than those in SOX group（ both P〈 0. 05）.Conclusions S-1 or capecitabine plus oxaliplatin are considered as active and tolerable first-line treatment for advanced gastric cancer patients. There is no significant difference in therapeutic efficacy between two regimens. However,the incidences of neuropathy and hand-foot syndrome are higher in patients with XELOX regimen than in those with SOX regimen.