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目的 :本研究旨在比较贝伐珠单抗联合FOLFOX方案与西妥昔单抗联合FOLFOX方案一线治疗野生型KRAS晚期结直肠癌的疗效、不良反应和生存情况。方法 :研究对象为2008年1月—2014年2月在中国人民解放军总医院肿瘤内科住院的72例野生型KRAS晚期结直肠癌患者,分别接受FOLFOX方案(28例)、贝伐珠单抗联合FOLFOX方案(17例)和西妥昔单抗联合FOLFOX方案(27例)的一线化疗。化疗3个周期后,评价近期疗效;观察化疗不良反应。对所有患者进行随访,计算无进展生存期(progression-free survival,PFS)。结果 :FOLFOX组客观有效率(objective response rate,ORR)为14.3%,疾病控制率(disease control rate,DCR)为75.0%,中位PFS为8.0个月;贝伐珠单抗联合FOLFOX组ORR为64.7%,DCR为94.1%,中位PFS为10.0个月;西妥昔单抗联合FOLFOX组ORR为59.3%,DCR为92.6%,中位PFS为9.2个月。FOLFOX组ORR与贝伐珠单抗联合FOLFOX组和西妥昔单抗联合FOLFOX组比较,差异均有统计学意义(χ2=12.101,P=0.000 5;χ2=12.014,P=0.000 5)。3组DCR和中位PFS的差异均无统计学意义(P>0.05)。结论 :贝伐珠单抗或西妥昔单抗联合FOLFOX方案可提高野生型KRAS晚期结直肠癌患者的ORR和DCR,延长PFS;并且,这2种方案的疗效相当,不良反应均较小,耐受性也较好。
Objectives: This study was designed to compare the efficacy, side effects and survival of first-line treatment of wild type KRAS with advanced colorectal cancer treated with bevacizumab in combination with FOLFOX and cetuximab in combination with FOLFOX. Methods: The study was performed in 72 patients with wild-type KRAS advanced colorectal cancer hospitalized in Department of Oncology, Chinese PLA General Hospital from January 2008 to February 2014 and received FOLFOX regimen (n = 28), bevacizumab combined First-line chemotherapy with FOLFOX regimen (n = 17) and cetuximab plus FOLFOX regimen (n = 27). After 3 cycles of chemotherapy, evaluate the recent curative effect; observe the adverse reaction of chemotherapy. All patients were followed up to calculate progression-free survival (PFS). Results: The objective response rate (ORR) of FOLFOX group was 14.3%, the disease control rate (DCR) was 75.0% and the median PFS was 8.0 months. The ORR of bevacizumab plus FOLFOX group was 64.7%, DCR 94.1% and median PFS 10.0 months. The ORR of cetuximab plus FOLFOX group was 59.3%, the DCR was 92.6% and the median PFS was 9.2 months. There was significant difference between ORF and FOLFOX group (P = 0.0005; χ2 = 12.014, P = 0.0005). There was no significant difference between the 3 groups of DCR and the median PFS (P> 0.05). Conclusions: Bevacizumab or cetuximab in combination with FOLFOX regimen increases ORR and DCR and prolongs PFS in patients with wild-type KRAS with advanced colorectal cancer. Moreover, these two regimens have similar efficacy and minimal adverse reactions, Tolerance is also better.