晚期胃癌的免疫治疗或靶向治疗与最佳支持治疗：随机试验的系统评价和荟萃分析

IF 1.6 Q4 ONCOLOGY

Journal of Gastrointestinal Cancer Pub Date : 2025-03-04 DOI:10.1007/s12029-024-01155-y

Adriana Meade, Marilina Santero, Olga Savall-Esteve, Javier Bracchiglione, Leire Leache, Anna Selva, Ismael Macias, Paula Cerdà, Xavier Bonfill Cosp

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引用次数: 0

摘要

目的：评价非化疗抗癌药物（免疫治疗或靶向治疗）与最佳支持治疗（BSC）或安慰剂治疗晚期胃癌（GC）的疗效和安全性。方法：检索MEDLINE、EMBASE、CENTRAL、Epistemonikos、ClinicalTrials.gov和PROSPERO，对随机对照试验（rct）进行系统评价。根据GRADE评估证据的确定性。结果：纳入6项随机对照试验。靶向治疗可能导致总生存期（OS）略有增加(HR 0.84, 95% CI 0.75, 0.93；中度确定性)和无进展生存期（PFS） (HR 0.52, 95% CI 0.43, 0.62；温和的确定性)。毒性风险略有增加(RR 1.19, 95% CI 0.95, 1.48；低确定性)。免疫治疗也可能改善PFS (HR 0.60, 95% CI 0.49, 0.73；中度确定性)，而毒性可能显示更高的风险(RR 2.72, 95% CI 1.24, 5.94；温和的确定性)。然而，生存的好处转化为时间的增加，OS的时间增加了一个多月，PFS的时间增加了不到一个月。没有关于表现状态（PS）、住院率或生活质量（QoL）的数据报告。结论：我们的研究表明，这些治疗有一些低毒性的生存获益，但获益是边际的。对于不良PS患者，其对生活质量和预后的影响仍存在不确定性。建议对晚期GC患者谨慎选择治疗方案，患者应积极参与决策。未来的研究应包括不同的患者群体，并评估以患者为中心的BSC比较组的结果。试验注册：研究方案已于2022年4月1日在OSF （https://doi.org/10.17605/OSF.IO/7CHX6）注册。

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Immunotherapy or Targeted Therapy Versus Best Supportive Care for Advanced Gastric Cancer: A Systematic Review and Meta-analysis of Randomized Trials.

Purpose: To assess the efficacy and safety of non-chemotherapy anticancer drugs (immunotherapy or targeted therapy) compared to best supportive care (BSC) or placebo for the treatment of advanced gastric cancer (GC).

Methods: Systematic review of randomized controlled trials (RCTs) searching (May 2022) MEDLINE, EMBASE, CENTRAL, Epistemonikos, ClinicalTrials.gov, and PROSPERO. Certainty of evidence was evaluated following GRADE.

Results: Six RCTs included. Targeted therapies likely result in a slight increase in overall survival (OS) (HR 0.84, 95% CI 0.75, 0.93; moderate certainty) and progression-free survival (PFS) (HR 0.52, 95% CI 0.43, 0.62; moderate certainty). Toxicity had a slightly increased risk (RR 1.19, 95% CI 0.95, 1.48; low certainty). Immunotherapy also showed a likely improvement in PFS (HR 0.60, 95% CI 0.49, 0.73; moderate certainty), while toxicity showed a likely higher risk (RR 2.72, 95% CI 1.24, 5.94; moderate certainty). However, benefits in survival translated to time gains of slightly over a month for OS and less than a month for PFS. No data were reported on performance status (PS), hospital admissions, or quality of life (QoL).

Conclusions: Our study suggests some survival benefits with low toxicity from these treatments, but gains are marginal. Uncertainties persist regarding their impact on QoL and outcomes for patients with poor PS. Caution is advised in treatment selection for advanced GC patients, who should actively participate in decision-making. Future research should include diverse patient populations and assess patient-centered outcomes with consistent comparator groups for BSC.

Trial registration: The study protocol was registered in OSF ( https://doi.org/10.17605/OSF.IO/7CHX6 ) on 2022-04-01.

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来源期刊

Journal of Gastrointestinal Cancer ONCOLOGY-

CiteScore

3.80

自引率

0.00%

发文量

121

期刊介绍： The Journal of Gastrointestinal Cancer is a multidisciplinary medium for the publication of novel research pertaining to cancers arising from the gastrointestinal tract.The journal is dedicated to the most rapid publication possible.The journal publishes papers in all relevant fields, emphasizing those studies that are helpful in understanding and treating cancers affecting the esophagus, stomach, liver, gallbladder and biliary tree, pancreas, small bowel, large bowel, rectum, and anus. In addition, the Journal of Gastrointestinal Cancer publishes basic and translational scientific information from studies providing insight into the etiology and progression of cancers affecting these organs. New insights are provided from diverse areas of research such as studies exploring pre-neoplastic states, risk factors, epidemiology, genetics, preclinical therapeutics, surgery, radiation therapy, novel medical therapeutics, clinical trials, and outcome studies.In addition to reports of original clinical and experimental studies, the journal also publishes: case reports, state-of-the-art reviews on topics of immediate interest or importance; invited articles analyzing particular areas of pancreatic research and knowledge; perspectives in which critical evaluation and conflicting opinions about current topics may be expressed; meeting highlights that summarize important points presented at recent meetings; abstracts of symposia and conferences; book reviews; hypotheses; Letters to the Editors; and other items of special interest, including:Complex Cases in GI Oncology: This is a new initiative to provide a forum to review and discuss the history and management of complex and involved gastrointestinal oncology cases. The format will be similar to a teaching case conference where a case vignette is presented and is followed by a series of questions and discussion points. A brief reference list supporting the points made in discussion would be expected.