曲妥珠单抗联合多西他赛/S-1二线治疗进展期胃癌的初步研究

Clinical effect of trastuzumab plus docetaxel/S-1 in the second-line treatment of HER2 positive gastric cancer.

目的评价曲妥珠单抗联合多西他赛/S-1二线治疗人类表皮生长因子受体2（HER2）阳性胃癌的临床疗效。方法选取17例既往治疗失败且具有HER-2过表达的晚期胃癌患者。多西他赛40 mg/m2,d1;每3周重复。S-1剂量按照体表面积（BSA）计算给予,BSA〈1.25 m2为80 mg/d;1.25≤BSA〈1.5 m2为100 mg/d;BSA≥1.5 m2为120 mg/d;d1~14;每3周重复。曲妥珠单抗每3周给药,首日给予负荷剂量8 mg/kg,然后6 mg/kg,每三周重复。两个周期后评价疗效及对生存质量的影响。结果 17例患者中CR 1例,PR 7例,SD 6例,PD 3例,总有效率为47.06%。常见不良反应为食欲下降11例、乏力10例和粒细胞减少9例,没有严重不良反应发生。治疗后生存质量评分得到明显提升。结论曲妥珠单抗联合多西他赛/S-1作为二线治疗HER2阳性的进展期胃癌疗效令人满意,不良反应少,值得进一步研究。

Objective To evaluate the effect and toxicity of trastuzumab plus docetaxel/s-1 in the treatment of pretreated Her-2 positive gastric cancer. Methods Seventeen pretreated patients of advanced gastric cancers were enrolled in this study. Trastuzumab was administrated at 8 mg/kg as a loading dose followed by 6 mg/kg every 21 days. Docetaxel 40 mg/m2 was given on day 1 and oral S-1 on days 1~14 of a 21 day cycle. The daily dose of S-1 was as-signed according to body surface area as follows：BSA〈1.25 m2, 80 mg/d;1.25≤BSA〈1.5 m2, 100 mg/d;BSA≥1.5 m2, 120 mg/d. All enrolled patients received at least two cycles of treatment. Results Among the 17 cases, there were one case of complete response （CR）, seven cases of partial response （PR）, 6 cases of stable disease （SD）, and 3 cases of progression disease （PD）, with an overall response rate of 47.06%. Most common adverse reactions were decreased appetite （11 cases）, fatigue （10 cases）, leucopenia （9 cases）. No serious adverse reactions occurred. The quality of life was improved significantly after treatment. Conclusion Trastuzumab plus docetaxel/s-1 is effective for pretreated Her-2 positive advanced gastric cancer, with few adverse reactions, and toxicities are well tolerated.