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PD-1/PD-L1抑制剂用于膀胱癌新辅助治疗疗效和安全性的单组率Meta分析
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| 篇名： | PD-1/PD-L1抑制剂用于膀胱癌新辅助治疗疗效和安全性的单组率Meta分析 |
| TITLE： | Efficacy and safety of PD-1/PD-L1 inhibitors for neoadjuvant treatment of bladder cancer：meta-analysis of single-group rates |
| 摘要： | 目的 评价程序性死亡受体1（PD-1）/程序性死亡配体1（PD-L1）抑制剂用于膀胱癌新辅助治疗的疗效和安全性，为临床治疗提供循证依据。方法计算机检索PubMed、theCochraneLibrary、Embase、AmericanSocietyofClinicalOncologyMeetingLi‐brary、中国知网、维普网及万方数据等，收集PD-1/PD-L1抑制剂用于膀胱癌新辅助治疗的随机对照试验（RCT）、非RCT、病例对照研究、队列研究等，检索时限为建库起至2023年1月31日。筛选文献，提取资料及质量评价后，采用RevMan5.3软件进行单组率Meta分析，采用Stata12软件进行敏感性分析和发表偏倚分析。结果共纳入25项研究，共计940例患者。Meta分析结果显示，患者的病理完全缓解（pCR）率为32%[OR＝0.32，95%CI（0.22，0.45），P＝0.006]，降期率为52%[OR＝0.52，95%CI（0.45，0.60），P＝0.55]，3级及以上免疫相关不良反应（Grade≥3irAEs）发生率为16%[OR＝0.16，95%CI（0.11，0.22），P＜0.00001]。亚组分析结果显示，pCR率和Grade≥3irAEs发生率在单用PD-1/PD-L1抑制剂患者中分别为25%、9%，在联合免疫治疗患者中分别为29%、28%，在PD-1/PD-L1抑制剂联合化疗患者中分别为43%、12%；PD-L1阳性患者的pCR率为44%，PD-L1阴性患者为25%。敏感性分析结果显示，本研究所得结果稳健。发表偏倚分析结果显示，本研究存在发表偏倚可能性较小。结论PD-1/PD-L1抑制剂用于膀胱癌新辅助治疗的疗效和安全性均较好。 |
| ABSTRACT： | OBJECTIVE To evaluate the efficacy and safety of PD-1/PD-L1 inhibitors for neoadjuvant treatment of bladder cancer， and to provide evidence-based reference for clinical treatment. METHODS Retrieved from PubMed， Cochrane Library， Embase， American Society of Clinical Oncology Meeting Library， CNKI， VIP and Wanfang database， etc.， the randomized controlled trials （RCTs）， non-RCT， case-control studies， cohort studies， etc. about PD-1/PD-L1 inhibitors for neoadjuvant treatment of bladder cancer were collected from the inception to Jan 31st， 2023. After literature screening， data extraction and quality evaluation， RevMan 5.3 software was used to perform meta-analysis of single-group rates； sensitivity analysis and publication bias analysis were conducted using Stata12 software. RESULTS A total of 25 studies were included in this discussion， involving 940 patients. The results of meta-analysis showed that the pathologic complete response （pCR） rate was 32% [OR＝0.32， 95%CI （0.22， 0.45）， P＝0.006]， downstaging rate was 52% [OR＝0.52， 95%CI （0.45， 0.60）， P＝0.55]， and the incidence of ≥grade 3 immune-related adverse events （irAEs） was 16% [OR＝0.16， 95%CI （0.11， 0.22）， P＜0.000 01]. Subgroup analysis showed that the patients receiving PD-1/PD-L1 inhibitors alone had a pCR rate of 25% and a incidence of Grade≥3 irAEs of 9%； the patients receiving combined immunotherapy had a pCR rate of 29% and a incidence of Grade≥3 irAEs of 28%； the patients receiving PD-1/PD-L1 inhibitors combined with chemotherapy had a pCR rate of 43% and a incidence of Grade≥3 irAEs of 12%； PD-L1 positive patients had a pCR rate of 44%， and PD-L1 negative patients had a pCR rate of 25%. The results of the sensitivity analysis showed that the study was robust. The results of the publication bias analysis showed that there was no significant publication bias. CONCLUSIONS PD-1/PD-L1 inhibitors are effective and safe for adjuvant treatment of bladder cancer. |
| 期刊： | 2023年第34卷第18期 |
| 作者： | 易小琦；邓红彬；李龙浩；张渝聆；李文聪 |
| AUTHORS： | YI Xiaoqi，DENG Hongbin，LI Longhao，ZHANG Yuling，LI Wencong |
| 关键字： | 膀胱癌；程序性死亡受体1；程序性死亡配体1；新辅助治疗；单组率Meta分析；疗效；安全性 |
| KEYWORDS： | bladder cancer； programmed death receptor-1； |
| 阅读数： | 59 次 |
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