Neoadjuvant Therapy for Resectable and Borderline Resectable Pancreatic Cancer: A Meta-Analysis of Randomized Controlled Trials
Neoadjuvant Therapy for Resectable and Borderline Resectable Pancreatic Cancer: A Meta-Analysis of Randomized Controlled Trials
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DOI：
10.3390/jcm9041129
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发表时间：
2020-04-01
影响因子：
3.9
通讯作者：
Santry, Heena
中科院分区：
文献类型：
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作者：
Cloyd, Jordan M.;Heh, Victor;Santry, Heena
胰腺导管腺癌（PDAC）的新辅助治疗（NT）与先手术治疗（SF）的疗效仍存在争议。仅对比较NT与SF治疗潜在可切除（PR）或边缘可切除（BR）PDAC的前瞻性随机对照试验（RCT）进行了随机效应荟萃分析。6项随机对照试验共纳入850例患者，其中NT组411例（48.3%），SF组439例（51.6%）。在所有纳入的试验中，NT均以吉西他滨为基础：4例使用放化疗，2例仅使用化疗。基于意向治疗分析，与SF相比，NT导致总生存期（OS）改善（HR 0.73，95% CI 0.61-0.86）。该效应与解剖学分类（PR：风险比（HR）0.73，95% CI 0.59-0.91; BR：HR 0.51，95% CI 0.28-0.93）或NT类型（放化疗：HR 0.77，95% CI 0.61-0.98;单纯化疗：HR 0.68，95% CI 0.54-0.87）无关。总体切除率相似（风险比（RR）0.93，95% CI 0.82-1.04，I-2 = 39.0%），但NT增加了边缘阴性（R 0）切除的可能性（RR 1.51，95%CI 1.18-1.93，I-2 = 0%）和阴性淋巴结（RR 2.07，95%CI 1.47-2.91，I-2 = 12.3%）。在这项前瞻性随机对照试验的荟萃分析中，与SF相比，NT以意向治疗的方式显著改善了局限性PDAC的OS。使用当代多药化疗的随机对照试验将需要证实这些发现，并确定最佳的NT方案。
The efficacy of neoadjuvant therapy (NT) versus surgery first (SF) for pancreatic ductal adenocarcinoma (PDAC) remains controversial. A random-effects meta-analysis of only prospective randomized controlled trials (RCTs) comparing NT versus SF for potentially resectable (PR) or borderline resectable (BR) PDAC was performed. Among six RCTs including 850 patients, 411 (48.3%) received NT and 439 (51.6%) SF. In all included trials, NT was gemcitabine-based: four using chemoradiation and two chemotherapy alone. Based on an intention-to-treat analysis, NT resulted in improved overall survival (OS) compared to SF (HR 0.73, 95% CI 0.61-0.86). This effect was independent of anatomic classification (PR: hazard ratio (HR) 0.73, 95% CI 0.59-0.91; BR: HR 0.51 95% CI 0.28-0.93) or NT type (chemoradiation: HR 0.77, 95% CI 0.61-0.98; chemotherapy alone: HR 0.68, 95% CI 0.54-0.87). Overall resection rate was similar (risk ratio (RR) 0.93, 95% CI 0.82-1.04, I-2 = 39.0%) but NT increased the likelihood of a margin-negative (R0) resection (RR 1.51, 95% CI 1.18-1.93, I-2 = 0%) and having negative lymph nodes (RR 2.07, 95% CI 1.47-2.91, I-2 = 12.3%). In this meta-analysis of prospective RCTs, NT significantly improved OS in an intention-to-treat fashion, compared with SF for localized PDAC. Randomized controlled trials using contemporary multi-agent chemotherapy will be needed to confirm these findings and to define the optimal NT regimen.