新辅助 FOLFIRINOX 方案在边界可切除胰腺癌患者中的应用：系统评价和患者水平的荟萃分析。
Neoadjuvant FOLFIRINOX in Patients With Borderline Resectable Pancreatic Cancer: A Systematic Review and Patient-Level Meta-Analysis.
机构信息
See the Notes section for the full list of authors' affiliations.
出版信息
J Natl Cancer Inst. 2019 Aug 1;111(8):782-794. doi: 10.1093/jnci/djz073.
BACKGROUND
FOLFIRINOX is a standard treatment for metastatic pancreatic cancer patients. The effectiveness of neoadjuvant FOLFIRINOX in patients with borderline resectable pancreatic cancer (BRPC) remains debated.
METHODS
We performed a systematic review and patient-level meta-analysis on neoadjuvant FOLFIRINOX in patients with BRPC. Studies with BRPC patients who received FOLFIRINOX as first-line neoadjuvant treatment were included. The primary endpoint was overall survival (OS), and secondary endpoints were progression-free survival, resection rate, R0 resection rate, and grade III-IV adverse events. Patient-level survival outcomes were obtained from authors of the included studies and analyzed using the Kaplan-Meier method.
RESULTS
We included 24 studies (8 prospective, 16 retrospective), comprising 313 (38.1%) BRPC patients treated with FOLFIRINOX. Most studies (n = 20) presented intention-to-treat results. The median number of administered neoadjuvant FOLFIRINOX cycles ranged from 4 to 9. The resection rate was 67.8% (95% confidence interval [CI] = 60.1% to 74.6%), and the R0-resection rate was 83.9% (95% CI = 76.8% to 89.1%). The median OS varied from 11.0 to 34.2 months across studies. Patient-level survival data were obtained for 20 studies representing 283 BRPC patients. The patient-level median OS was 22.2 months (95% CI = 18.8 to 25.6 months), and patient-level median progression-free survival was 18.0 months (95% CI = 14.5 to 21.5 months). Pooled event rates for grade III-IV adverse events were highest for neutropenia (17.5 per 100 patients, 95% CI = 10.3% to 28.3%), diarrhea (11.1 per 100 patients, 95% CI = 8.6 to 14.3), and fatigue (10.8 per 100 patients, 95% CI = 8.1 to 14.2). No deaths were attributed to FOLFIRINOX.
CONCLUSIONS
This patient-level meta-analysis of BRPC patients treated with neoadjuvant FOLFIRINOX showed a favorable median OS, resection rate, and R0-resection rate. These results need to be assessed in a randomized trial.
背景
FOLFIRINOX 是转移性胰腺癌患者的标准治疗方法。新辅助 FOLFIRINOX 在边界可切除胰腺癌（BRPC）患者中的疗效仍存在争议。
方法
我们对 BRPC 患者接受新辅助 FOLFIRINOX 的研究进行了系统评价和患者水平的荟萃分析。纳入了接受 FOLFIRINOX 作为一线新辅助治疗的 BRPC 患者的研究。主要终点是总生存期（OS），次要终点是无进展生存期、切除率、R0 切除率和 3-4 级不良事件。从纳入研究的作者处获得患者水平的生存结果，并使用 Kaplan-Meier 方法进行分析。
结果
我们纳入了 24 项研究（8 项前瞻性，16 项回顾性），包括 313 例（38.1%）接受 FOLFIRINOX 治疗的 BRPC 患者。大多数研究（n=20）报告了意向治疗结果。中位数接受的新辅助 FOLFIRINOX 周期数为 4-9 个。切除率为 67.8%（95%置信区间[CI] = 60.1%至 74.6%），R0 切除率为 83.9%（95% CI = 76.8%至 89.1%）。不同研究的中位 OS 从 11.0 到 34.2 个月不等。从 20 项研究中获得了 283 例 BRPC 患者的患者水平生存数据。患者水平的中位 OS 为 22.2 个月（95% CI = 18.8 至 25.6 个月），患者水平的中位无进展生存期为 18.0 个月（95% CI = 14.5 至 21.5 个月）。3-4 级不良事件的累积发生率最高的是中性粒细胞减少症（17.5/100 例，95% CI = 10.3%至 28.3%）、腹泻（11.1/100 例，95% CI = 8.6%至 14.3%）和疲劳（10.8/100 例，95% CI = 8.1%至 14.2%）。没有死亡归因于 FOLFIRINOX。
结论
这项接受新辅助 FOLFIRINOX 治疗的 BRPC 患者的患者水平荟萃分析显示，中位 OS、切除率和 R0 切除率均较好。这些结果需要在随机试验中进行评估。
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