阿帕替尼单用或联合度伐利尤单抗治疗晚期结直肠癌的有效性和安全性研究

Efficacy and safety of apatinib monotherapy or in combination wtih duvarizumab in the treatment of advanced colorectal cancer

目的 评估度伐利尤单抗联合阿帕替尼(联合用药)三线治疗不可切除的晚期结直肠癌(colorectal cancer,CRC)的有效性和安全性。方法 纳入66例接受联合用药(联合组,n=30)或阿帕替尼单药(单药组,n=36)作为三线治疗不可切除的晚期CRC患者。两组患者均给药治疗至不可耐受或疾病进展,对比两组总体治疗应答、客观反应率、疾病控制率、不良事件发生率等。结果 联合组的总体治疗应答高于单药组(P=0.025),其中联合组的完全缓解、部分缓解、疾病稳定及疾病进展率分别为0、26.67%、50.00%和23.33%,单药组分别为0、8.33%、47.23%和44.44%。联合组的客观反应率高于单药组(26.67%vs 8.33%,P=0.047),但两组的疾病控制率差异无统计学意义(76.67%vs 55.56%,P=0.073)。联合组的无进展生存期(中位值:8.60个月vs 4.50个月,P=0.012)和总生存期(中位值:15.70个月vs 8.10个月,P=0.009)均优于对照组。联合组的不良事件发生率与单药组相似(P> 0.05)。联合组大部分不良事件均为1~2级,仅7例患者(23.33%)发生3~4级不良事件。结论 度伐利尤单抗联合阿帕替尼三线治疗不可切除的晚期CRC可提高应答率,延长生存且安全性良好。

Objective To evaluate the efficacy and safety of third-line treatment of duvarizumab combined with apatinib in the treatment of unresectable advanced colorectal cancer(CRC).Methods Sixty-six unresectable advanced CRC patients who received combination therapy(combination group,n=30)or apatinib monotherapy(monotherapy group,n=36)as third-line treatment were included.All patients were treated until intolerance or disease progression.The overall treatment response,objective response rate,disease control rate and incidence of adverse events were compared between the two groups.Results The overall response in the combination group was higher than that of the monotherapy group(P=0.025).The rates of complete response,partial response,stable disease,and disease progression in the combination group were 0,26.67%,50.00%,and 23.33%,respectively.Meanwhile,those in the monotherapy group were 0,8.33%,47.23%,and 44.44%,respectively.The objective response rate in the combination group was higher than that in the monotherapy group(26.67%vs 8.33%,P=0.047),but the difference was not statistically significant in disease control rate between the two groups(76.67%vs 55.56%,P=0.073).The progression-free survival(median:8.60 months vs 4.50 months,P=0.012)and overall survival(median:15.70 months vs 8.10 months,P=0.009)of combination group were superior to those of the monotherapy group.The incidence of adverse events in the combination group was similar to that in the monotherapy group(P>0.05).Most adverse events in the combination group were grade 1-2,and only 7 patients(23.33%)had grade 3-4 adverse events.Conclusion Third-line treatment of duvaliuzumab combined with apatinib could improve the response rate and prolong survival in patients with unresectable advanced CRC with an acceptable safety profile.