摘要
目的:探讨程序性死亡蛋白-1(programmed cell protein-1,PD-1)抑制剂联合奥沙利铂+替吉奥(SOX)化疗方案新辅助治疗局部进展期胃腺癌的近期疗效及安全性。方法:回顾性分析2020年1月—7月河南省人民医院胃肠外科收治的72例局部进展期(Ⅲ期)胃腺癌患者的临床资料,根据不同治疗方案将患者分为对照组(n=36)和观察组(n=36)。对照组给予SOX化疗方案,观察组给予PD-1抑制剂联合SOX方案,2组患者均化疗3个周期,休息3~4周后重新评估,疾病无进展且可耐受手术的患者行胃癌D2根治术。比较2组患者的总生存期(overall survival,OS)、病理完全缓解(Pathologic complete response,pCR)率、无进展生存期(progression-free survival,PFS)、R0切除率、客观缓解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)及药物不良反应。结果:观察组的pCR率、ORR值和DCR值均明显高于对照组[pCR率:25%(9/36)vs 5.6%(2/36),χ^(2)=5.258,P=0.022;ORR值:58.33%(21/36)vs 25.00%(9/36),χ^(2)=8.229,P=0.004;DCR值:88.89%(32/36)vs 69.44%(25/36),χ^(2)=4.126,P=0.042]。丙氨酸转氨酶(alanine transaminase,ALT)升高、天冬氨酸转氨酶(aspartate transaminase,AST)升高和手足综合征,这3种不良反应在观察组新辅助化疗期间的发生率显著高于对照组(P<0.05),其他不良反应的发生率在2组患者之间均无明显差异(P>0.05),且2组患者均无新辅助化疗相关的死亡事件。观察组与对照组的R0切除率分别为97.22%(35/36)和91.67%(33/36)(χ^(2)=1.059,P=0.303)。72例患者总体的中位OS与中位PFS分别为36个月和13个月。观察组与对照组的2年OS率分别为82.2%和71.5%,通过Kaplan-Meier生存曲线分析发现观察组的OS率明显高于对照组(χ^(2)=4.240,P=0.039);观察组的中位PFS高于对照组,分别为14个月和11个月(χ^(2)=4.173,P=0.041);单因素COX回归分析未发现影响患者生存期的因素。结论:PD-1抑制剂联合SOX化疗方案新辅助治疗局部进展期胃腺癌是安全有效的,且不良反应可控。
Objective:To explore the short-term efficacy and safety for the new adjuvant therapy of programmed cell protein-1(PD-1)inhibitor combined with Oxaliplatin+Tegafur(SOX)in locally advanced gastric adenocarcinoma.Methods:Retrospective collection of clinical data from 72 locally advanced(stage Ⅲ)gastric adenocarcinoma patients admitted to our gastrointestinal surgery department from January 2020 to July 2020,according to different treatment plans,patients were divided into a control group(n=36)and an observation group(n=36).The control group received SOX chemotherapy regimen,while the observation group received PD-1 inhibitor combined with SOX regimen.Both groups of patients underwent chemotherapy for 3 cycles,and were reevaluated after resting for 3-4 weeks.Patients with no disease progression and tolerable surgery underwent D2 gastric cancer radical surgery.The overall survival(OS),pathological complete response(pCR)rate,progression free survival period(PFS),R0 resection rate,objective response rate(ORR),disease control rate(DCR)and adverse drug reaction were compared between the two groups.Results:The pCR rate,ORR and DCR of the observation group were significantly higher than those of the control group[pCR rate:25%(9/36)vs 5.6%(2/36),χ^(2)=5.258,P=0.022;ORR:58.33%(21/36)vs 25.00%(9/36),χ^(2)=8.229,P=0.004;DCR:88.89%(32/36)vs 69.44%(25/36),χ^(2)=4.126,P=0.042].The incidence of adverse reactions such as elevated ALT,elevated AST,and hand foot syndrome during neoadjuvant chemotherapy in the observation group was significantly higher than those in the control group(P<0.05).The incidence of other adverse reactions was not significantly difference between the two groups of patients(P>0.05),and there were no neoadjuvant chemotherapy related death events in both groups.The R0 resection rates of the two groups were 97.22%and 91.67%,respectively(χ^(2)=1.059,P=0.303).The median OS and median PFS of 72 patients were 36 and 13 months,respectively.The 2-year OS rate of the two groups were 82.2%and 71.5%,respectively.Kaplan Meier survival curve analysis showed that the OS rate of the observation group was significantly higher than that of the control group(χ^(2)=4.240,P=0.039);the median PFS of the observation group was higher than that of the control group at 14 and 11 months,respectively(χ^(2)=4.173,P=0.041);COX univariate regression analysis did not identify any factors affecting survival of locally advanced gastric adenocarcinoma.Conclusion:The neoadjuvant treatment of locally advanced gastric adenocarcinoma with PD-1 inhibitor combined with SOX regimen is safe and effective,and the adverse reactions are controllable.
作者
王涛
张璐璐
马龙飞
张涵
杜书祥
吴刚
孙培春
WANG Tao;ZHANG Lulu;MA Longfei;ZHANG Han;DU Shuxiang;WU Gang;SUN Peichun(Department of Gastroenterological Surgery,Henan Provincial People’s Hospital,Zhengzhou University People’s Hospital,Zhengzhou 450003,Henan Province,China)
出处
《肿瘤》
CAS
北大核心
2023年第8期635-645,共11页
Tumor
基金
河南省医学科技攻关计划省部共建重点项目(SBGJ202102028)
作者简介
Correspondence to:孙培春,E-mail:sunpeichun@126.com
