铂类药物与免疫治疗不可切除性食管癌的比较：系统评价和荟萃分析方案。
Platinum versus immunotherapy for unresectable esophageal cancer: A protocol for systematic review and meta analysis.
机构信息
Department of Thoracic Surgery, Fujian Medical University Union Hospital.
Department of Ophthalmology, The First Affiliated Hospital, Fujian Medical University, Fuzhou, China.
出版信息
Medicine (Baltimore). 2020 Dec 18;99(51):e23537. doi: 10.1097/MD.0000000000023537.
BACKGROUND
Esophageal cancer is one of the most common malignant tumors, with early metastasis, highly malignant characteristics. Morbidity ranks 7th among all malignant tumors, and mortality ranks 6th. Esophageal adjuvant therapy can significantly improve overall survival in unresectable esophageal cancer patients. With the breakthrough and progress of immunotherapy, the possibility of curing esophageal cancer has greatly increased. Some clinical trials have reported that compared with traditional platinum-based chemotherapy, the use of programmed death 1 (PD-1) and programmed death ligand 1 (PD-L1) inhibitors alone can benefit patients and effectively prolong their overall survival. We compare the efficacy of single immunotherapy with traditional platinum-based chemotherapy in a systematic review and meta-analysis to provide a reliable basis for clinicians.
METHODS
We will search PubMed, Medline, Embase, Web of Science, Cancerlit, Google Scholar, and the Cochrane Central Register of Controlled Trials for related studies published before December 1, 2019 without language restrictions. Two review authors will search and assess relevant studies independently. Randomized controlled trials (RCTs) or quasi-RCTs, and prospective cohort studies will be included. We will perform subgroup analysis in sex, age, ethnicity, and tumor stage of esophageal cancer patients.
RESULTS
The results of this study will be published in a peer-reviewed journal.
CONCLUSION
The results of this systematic review and meta-analysis will provide a basis for clinicians to formulate the best chemotherapy regimen for patients, as well as a research clue for clinical researchers in this field. The results of this study will expand the treatment options for esophageal patients, but due to the nature of the disease and intervention, large sample clinical trials are not abundant, so we will include some high-quality small sample trials, which may cause high heterogeneity.
INPLASY REGISTRATION NUMBER
INPLASY2020110012.
背景
食管癌是最常见的恶性肿瘤之一，具有早期转移、高度恶性的特点。其发病率在所有恶性肿瘤中排名第 7，死亡率排名第 6。食管癌辅助治疗能显著提高不可切除食管癌患者的总生存期。随着免疫治疗的突破和进展，治愈食管癌的可能性大大增加。一些临床试验报告称，与传统的铂类化疗相比，单独使用程序性死亡 1（PD-1）和程序性死亡配体 1（PD-L1）抑制剂可以使患者受益，并有效延长其总生存期。我们通过系统评价和荟萃分析比较了单免疫治疗与传统铂类化疗的疗效，为临床医生提供可靠的依据。
方法
我们将检索 PubMed、Medline、Embase、Web of Science、Cancerlit、Google Scholar 和 Cochrane 中心对照试验注册库，检索时间截至 2019 年 12 月 1 日，不限制语言。两名综述作者将独立检索和评估相关研究。纳入随机对照试验（RCT）或准 RCTs 及前瞻性队列研究。我们将根据食管癌患者的性别、年龄、种族和肿瘤分期进行亚组分析。
结果
本研究的结果将发表在同行评议期刊上。
结论
本系统评价和荟萃分析的结果将为临床医生为患者制定最佳化疗方案提供依据，也为该领域的临床研究人员提供研究线索。本研究的结果将扩大食管癌患者的治疗选择，但由于疾病和干预的性质，大样本临床试验并不丰富，因此我们将纳入一些高质量的小样本试验，这可能会导致高度异质性。
INPLASY 注册号：INPLASY2020110012。
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