论文部分内容阅读
[目的]探讨西妥昔单抗(爱必妥)联合化疗对比单纯化疗治疗k-ras野生型晚期结直肠癌的疗效及不良反应。[方法]17例k-ras野生型(其中2例k-ras、n-ras均野生型)的晚期结直肠癌患者,给予爱必妥联合化疗,另收集同期晚期结直肠癌行k-ras检测为野生型17例患者(其中2例k-ras、n-ras均野生型),因经济原因拒绝应用靶向治疗,单纯给予化疗患者作为对照组。爱必妥联合化疗组(CCT组):爱必妥400mg/m2d1ivgtt,以后250mg/m2每周1次,化疗方案为FOLFOX 4例,FOLFIRI 5例,XELIRI 2例,XELODA 5例,XELOX 1例,21d为1个周期(其中XELIRI为14d 1个周期),每2个周期(双周方案每3个周期)评价疗效。单纯化疗组(CT组):化疗方案为FOLFIRI 4例,FOLFOX6 9例,XELOX 4例)。根据RECIST 1.0标准评价疗效,按CTC 4.0不良反应标准评价不良反应。[结果]治疗组可评价病例(治疗2次以上)16例,对照组可评价病例17例。CCT组客观反应率(ORR)37.5%,疾病控制率(DCR)93.7%;CT组ORR 17.6%,DCR 76.5%(ORR:P=0.201;DCR:P=0.166)。CCT组的早期肿瘤反应率(ETS)37.5%,CT组为29.4%(P=0.622)。中位无疾病进展时间(PFS)CCT组及CT组分别为6个月和4.3个月(P=0.024)。CCT组主要不良反应为口腔黏膜炎、骨髓抑制、胃肠道反应、皮疹、神经毒性、肝功能异常,CT组主要为骨髓抑制、胃肠道反应、手足综合征、乏力。两组皮疹情况差异有统计学意义(P=0.017)。[结论]爱必妥联合化疗较单纯化疗可延长k-ras野生型晚期结直肠癌的PFS,疗效较好,不良反应可耐受。
[Objective] To investigate the efficacy and adverse reactions of cetuximab (Erbitux) in combination with chemotherapy in the treatment of k-ras wild-type advanced colorectal cancer. [Method] Seventeen patients with advanced colorectal cancer of k-ras wild type (including 2 wild type k-ras and n-ras wild type) were treated with Erbitux combined with chemotherapy. In addition, k-ras 17 cases of wild type (2 k-ras and n-ras wild type) were detected in the wild type. Because of the economic reasons, the targeted therapy was rejected and the chemotherapy alone was given as the control group. Erbitux combination chemotherapy group (CCT group): Erbitux 400mg / m2d1ivgtt, after 250mg / m2 once a week, the chemotherapy regimen was FOLFOX 4 cases, FOLFIRI 5 cases, XELIRI 2 cases, XELODA 5 cases, XELOX 1 case, 21d for 1 cycle (where XELIRI is 1 cycle for 14d) and the efficacy is evaluated every 2 cycles (biweekly schedule every 3 cycles). The chemotherapy alone group (CT group): FOLFIRI chemotherapy regimen in 4 cases, FOLFOX6 in 9 cases, XELOX 4 cases). According to RECIST 1.0 standard evaluation of efficacy, according to the CTC 4.0 adverse reaction standard evaluation of adverse reactions. [Results] In the treatment group, 16 cases were evaluable (more than 2 times treatment) and 17 cases were evaluable in the control group. The objective response rate (ORR) was 37.5% in the CCT group and the disease control rate (DCR) was 93.7%. The ORR in the CT group was 17.6% and the DCR was 76.5% (ORR: P = 0.201; The early tumor response rate (ETS) was 37.5% in the CCT group and 29.4% in the CT group (P = 0.622). The median progression-free time (PFS) was 6 months and 4.3 months in the CCT and CT groups, respectively (P = 0.024). The main adverse reactions in CCT group were oral mucositis, myelosuppression, gastrointestinal reaction, skin rash, neurotoxicity and abnormal liver function. The CT group was mainly bone marrow suppression, gastrointestinal reaction, hand-foot syndrome and fatigue. The difference between the two groups was statistically significant (P = 0.017). [Conclusion] Erbitux combined with chemotherapy can prolong the PFS of k-ras wild-type advanced colorectal cancer more effectively than simple chemotherapy, and the adverse reactions are tolerable.