肌层浸润性膀胱癌的2种新辅助方案疗效对比:一项回顾性倾向性评分匹配研究

Comparison of the efficacy between two neoadjuvant regimens for muscle-invasive bladder cancer:a retrospective propensity score matched study

目的:通过一项倾向性评分匹配(propensity score matching,PSM)对比研究评价新辅助化疗和化疗免疫联合治疗对肌层浸润性膀胱癌(muscle-invasive bladder cancer,MIBC)患者的无进展生存时间和病理反应,以求为MIBC患者的新辅助方案选择提供参考。方法:纳入2018年1月—2023年9月于2个医疗中心(中山大学孙逸仙纪念医院、中山大学肿瘤防治中心)接受GC(吉西他滨+顺铂)方案新辅助化疗,联合或不联合免疫治疗的MIBC患者的资料。根据新辅助治疗方案将其分为化疗组和联合组。采用PSM控制混杂因素,使用Pearsonχ^(2)检验和Fisher精确概率检验比较化疗组和联合组的基线差异,采用logistic回归评估变量与病理反应之间的关系,采用Kaplan-Meier生存曲线分析评估总生存时间和无进展生存时间。结果:在整体队列和匹配队列中联合组的病理完全缓解(pathological complete response,pCR)率和病理降期率显著优于化疗组(P<0.001、P<0.001和P=0.012、P=0.032)。2组在治疗前后主要的血液学指标变化方面差异无统计学意义。PSM前后的化疗组和联合组的无进展生存时间和总生存时间均差异无统计学意义。获得了pCR或病理降期的患者在生存情况上显著优于未获得pCR或病理降期的患者。结论:与单独的新辅助化疗相比,新辅助化疗联合免疫治疗获得了更高的pCR率和病理降期率,但无进展生存时间和总生存时间未显示出显著差异。

Objective To evaluate progression-free survival time and pathological response to neoadjuvant chemotherapy and chemoimmunotherapy combinations in patients with muscle-invasive bladder cancer by a propensity score matched comparative study in an attempt to inform the choice of neoadjuvant regimen for these patients.Methods Data from patients with muscle-invasive bladder cancer who received neoadjuvant chemotherapy with GC(gemcitabine,cisplatin)regimen with or without immunotherapy from January 2018 to September 2023 at two medical centers(Sun Yat-sen Memorial Hospital of Sun Yat-sen University and Sun Yat-sen University Cancer Centre)were included.They were divided into chemotherapy and combination groups according to the neoadjuvant regimen.Propensity score matching(PSM)was used to control for confounders,and Pearson chi-square test and Fisher exact probability test were used to compare baseline differences between chemotherapy and combination groups.Logistic regression was used to assess the relationship between variables and pathological response,and Kaplan-Meier analyses were used for survival analysis.Results Pathological complete response(pCR)rate and pathological downstaging rate were significantly better in the combination group than in the chemotherapy group in the overall cohort and in the matched cohort(P<0.001,P<0.001 and P=0.012,P=0.032).There were no significant differences between the two groups in terms of changes in major haematological parameters before and after treatment.Progression-free survival time and overall survival time were not significantly different between the chemotherapy and combination groups before and after PSM.Patients who achieved pCR or pathological downstaging were significantly better in terms of survival than those who did not.Conclusion Neoadjuvant chemotherapy combined with immunotherapy achieved higher pCR and pathological downstaging rates compared with neoadjuvant chemotherapy alone.In terms of progression-free survival time and overall survival time,the two groups did not show significant differences.