| 王 哲,孙玉秀,李皓静.西妥昔单抗联合化疗与单纯化疗治疗k-ras野生型晚期结直肠癌临床观察[J].肿瘤学杂志,2017,23(1):45-48. |
| 西妥昔单抗联合化疗与单纯化疗治疗k-ras野生型晚期结直肠癌临床观察 |
| Comparison Between Cetuximab Combined Chemotherapy and Chemotherapy Alone in Treatment of Advanced Colorectal Cancer Patients with Wild Type K-ras |
| 投稿时间：2016-09-04 |
| DOI：10.11735/j.issn.1671-170X.2017.01.B009 |
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| 中文关键词: 西妥昔单抗 结直肠肿瘤 药物疗法 靶向治疗 k-ras |
| 英文关键词:cetuximab colorectal neoplasms drug therapy target therapy k-ras |
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| 中文摘要: |
| 摘 要：［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/m2 d1 ivgtt，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。 |
| 英文摘要: |
| Abstract：［Objective］ To compare the efficacy and toxicity between cetuximab(erbitux) combined with chemotherapy and chemotherapy alone in treatment of advanced colorectal cancer (CRC) with wild type k-ras. ［Methods］ Thirty four advanced CRC patients with wild type k-ras were divided into CCT and CT groups with 17 cases in each. Patients in CCT group were treated with cetuximab 400mg/m2 d1，then 250mg/m2 1/wk，combined with chemotherapy (FOLFOX regimen in 4 cases，FOLFIRI 5 cases，XELIRI 2 cases，XELODA 5 cases and XELOX 1 case)；all chemotherapy regimens were administrated for 21d as a cycle，except XELIRI regimen with 14d as a cycle. Patients in CT group were treated with FOLFIRI regimen in 4 cases，FOLFOX 6 in 9 cases and XELOX in 4 cases. The efficacy and toxicity were evaluated according to RECIST criteria 1.0 version and NCI-CTC4.0 criterion，respectively. ［Results］ There were 16 cases in CCT group and 17 cases in CT group eligible for evaluation of efficacy. The overall response rate (ORR) and the disease control rate (DCR) of CCT group were 37.5% and 93.7%，17.6% and 76.5% in CT group (P=0.201；P=0.166) . The early response rate(ETS) was 37.5% in CCT group，and 29.4% in CT group （P=0.622）.The medium progression-free survival(PFS) was 6 months and 4.3 months in CCT and CT groups（P=0.024）. The main toxicities in CCT group were oral mucositis，myelosuppression，digestive tract reaction，rash，nerve system toxicity，and liver dysfunction. And the main toxicities in CT group were myelosuppression，digestive tract reaction，hand-foot syndrome and hypodynamia. There was significant difference in incidence of rash between the two groups(P=0.017). ［Conclusion］ Compared with chemotherapy alone，erbitux combined with chemotherapy can prolong PFS in advanced colorectal cancer (CRC) patients with wild type k-ras，and toxicities are tolerable. |
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