论文部分内容阅读
目的:对西妥昔单抗联合卡培他滨和顺铂一线治疗晚期胃癌的有效性和安全性以及疗效相关生物标志进行研究。方法:对符合入组标准的52例晚期胃癌患者予以西妥昔单抗联合化疗,具体用法:西妥昔单抗起始剂量400mg/m2,静滴,第1天,随后每周250mg/m2;顺铂80mg/m2,静滴,第1天;卡培他滨2 000mg/(m2.d),分早、晚口服,第1～14天,21天为1个周期。采用RECIST标准评价疗效。同时对EGFR基因拷贝数与表达、血清TGF-α与EGF表达、K-ras突变等生物标志进行检测分析,并对临床疗效和不良反应进行相关性分析。结果:52例患者中,47例可评价疗效,有效率为53.2%,疾病控制率85.1%,中位疾病进展时间(TTP)5.23个月。出现0～1级与2～3级皮疹患者有效率分别为40.0%和76.5%(P=0.016),其TTP分别为3.6个月和6.5个月(P=0.006)。4例EGFR基因扩增者中3例PR,1例SD。PR+CR组患者血清TGF-α明显高于SD+PD组(36.6ng/Lvs.26.0 ng/L,P=0.048),TGF-α高表达患者TTP较低表达长(6.1个月vs.2.7个月,P=0.044)。EGF高表达患者TTP较低表达长(5.9个月vs.2.9个月,P=0.050)。EGFR高表达与重度皮疹相关(P=0.001)。检测49例患者均未发现K-ras突变。结论:西妥昔单抗联合卡培他滨和顺铂方案一线治疗晚期胃癌疗效及耐受性良好;EGFR基因拷贝数、血清EGF及TGF-α可能是预测本方案治疗获益的生物标志。
OBJECTIVE: To study the efficacy and safety of cetuximab combined with capecitabine and cisplatin in the treatment of advanced gastric cancer and the biomarkers of therapeutic efficacy. Methods: 52 patients with advanced gastric cancer who met the inclusion criteria were given cetuximab in combination with chemotherapy. The initial dose of cetuximab 400mg / m2, intravenous infusion, on the first day, then 250mg / m2 ; Cisplatin 80mg / m2, intravenous infusion, the first day; capecitabine 2 000mg / (m2.d), points early and late oral administration, the first to 14 days, 21 days for a cycle. RECIST standard evaluation of efficacy. Meanwhile, biomarkers such as EGFR gene copy number and expression, serum TGF-α and EGF expression, K-ras mutation were detected and analyzed, and the correlation between clinical efficacy and adverse reactions was analyzed. Results: Of the 52 patients, 47 patients were evaluated for efficacy, with an effective rate of 53.2%, a disease control rate of 85.1%, and a median time to progression of disease (TTP) of 5.23 months. The patients with grade 0 to 1 and grade 2 to 3 rashes had an effective rate of 40.0% and 76.5%, respectively (P = 0.016). The TTP was 3.6 months and 6.5 months respectively (P = 0.006). In 4 cases of EGFR gene amplification in 3 cases of PR, 1 case of SD. The serum level of TGF-α in PR + CR group was significantly higher than that in SD + PD group (36.6ng / Lvs.26.0 ng / L, P = 0.048) Month, P = 0.044). Patients with EGF-overexpression had lower expression of TTP (5.9 months vs.2.9 months, P = 0.050). High EGFR expression was associated with severe rash (P = 0.001). None of the 49 patients tested for K-ras mutations. CONCLUSION: Cetuximab combined with capecitabine and cisplatin is a good first-line therapy for advanced gastric cancer. The EGFR gene copy number, serum EGF and TGF-α may be biomarkers for predicting the benefit of this regimen.