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新辅助改良 FOLFIRINOX 对比 nab-紫杉醇联合吉西他滨治疗手术可切除或局部进展期胰腺癌患者。

Neoadjuvant-modified FOLFIRINOX vs nab-paclitaxel plus gemcitabine for borderline resectable or locally advanced pancreatic cancer patients who achieved surgical resection.

机构信息

Department of Radiation Oncology, Ohio State University James Comprehensive Cancer Center, Columbus, OH, USA.

Department of Medical Oncology, Ohio State University James Comprehensive Cancer Center, Columbus, OH, USA.

出版信息

Cancer Med. 2020 Jul;9(13):4711-4723. doi: 10.1002/cam4.3075. Epub 2020 May 16.

Abstract

We conducted an institutional study to compare the clinical and pathological efficacy between the neoadjuvant therapy (NAT)-modified FOLFIRINOX (mFOLF) vs nanoparticle albumin-bound paclitaxel plus gemcitabine (nab-P/G) for borderline resectable pancreatic cancer (BRPC) and locally advanced pancreatic cancer (LAPC) patients who completed resection. The study retrospectively enrolled patients with pathologically confirmed BRPC or LAPC from 2010 to 2018 at our institution. The survival rates were determined by the Kaplan-Meier method and log-rank test was used to test differences. Cox's proportional hazard model was used to assess survival with respect to covariates. Seventy-two patients who completed at least two cycles of neoadjuvant chemotherapy and surgical resection were included, with 52 (72.2%) patients receiving mFOLF and 20 (27.8%) receiving nab-P/G. Patients treated with mFOLF had statistically higher rates of RECIST 1.1 partial or complete response (16/52 vs 1/20, P = .028). Additionally, mFOLF patients had greater pathological tumor size reduction, fewer positive lymph nodes, and higher treatment response grade compared to the nab-P/G patients (all P < .05). The median overall survival was 33.3 months vs 27.1 months (P = .105), and distant metastasis-free survival (DMFS) was 21.3 months vs 14.6 months (P = .042) in the mFOLF vs nab-P/G groups, respectively. On multivariate analysis, mFOLF (hazard ratio, 0.428; 95% confidence interval [CI], 0.186-0.987) and abnormal postoperative CA 19-9 (hazard ratio, 2.47; 95% CI, 1.06-5.76) were associated with DMFS. Among patients with BRPC and LAPC who complete surgical resection, neoadjuvant mFOLF was associated with improved pathological and clinical outcomes compared with nab-P/G.

摘要

我们进行了一项机构研究,比较了新辅助治疗(NAT)改良的 FOLFIRINOX(mFOLF)与纳米白蛋白结合紫杉醇加吉西他滨(nab-P/G)治疗边界可切除胰腺癌(BRPC)和局部进展期胰腺癌(LAPC)患者的临床和病理疗效,这些患者完成了手术切除。该研究回顾性纳入了 2010 年至 2018 年我院经病理证实为 BRPC 或 LAPC 的患者。通过 Kaplan-Meier 法确定生存率,并用对数秩检验比较差异。Cox 比例风险模型用于评估与协变量相关的生存情况。共纳入 72 例至少完成两个周期新辅助化疗并接受手术切除的患者,其中 52 例(72.2%)接受 mFOLF 治疗,20 例(27.8%)接受 nab-P/G 治疗。接受 mFOLF 治疗的患者 RECIST 1.1 部分或完全缓解率更高(16/52 比 1/20,P=.028)。此外,与 nab-P/G 患者相比,mFOLF 患者的肿瘤大小减小更多,阳性淋巴结更少,治疗反应分级更高(均 P<.05)。mFOLF 组的中位总生存期为 33.3 个月,nab-P/G 组为 27.1 个月(P=.105),mFOLF 组无远处转移生存期(DMFS)为 21.3 个月,nab-P/G 组为 14.6 个月(P=.042)。多变量分析显示,mFOLF(风险比,0.428;95%置信区间[CI],0.186-0.987)和术后 CA19-9 异常(风险比,2.47;95%CI,1.06-5.76)与 DMFS 相关。在完成手术切除的 BRPC 和 LAPC 患者中,与 nab-P/G 相比,新辅助 mFOLF 可改善病理和临床结局。

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