Department of Surgery, Kindai University Faculty of Medicine, Osaka, Japan.
Department of Surgery, Kindai University Faculty of Medicine, Osaka, Japan.
Pancreatology. 2019 Mar;19(2):296-301. doi: 10.1016/j.pan.2019.01.001. Epub 2019 Jan 4.
FOLFIRINOX (oxaliplatin, irinotecan, 5-fluorouracil, leucovorin) treatment significantly improved overall survival in the recent phase III study and became a standard therapy for metastatic pancreatic cancer. However, treatment for locally advanced pancreatic cancer is still controversial. We conducted subset analyses from a nation-wide multicenter observational study in Japan to evaluate the tolerability and efficacy of FOLFIRINOX in patients with locally advanced pancreatic cancer and to investigate independent prognostic factors with pre-treatment variables.
The study included 66 patients with unresectable locally advanced pancreatic cancer from 27 institutions in Japan who received FOLFIRINOX as first-line treatment between December 20, 2013 and December 19, 2014 and surveyed until December 2015.
The median age was 63 with the Eastern Cooperative Oncology Group performance status of 0 or 1. Major Grade 3 or 4 adverse events included neutropenia (64%), leukopenia (33%), febrile neutropenia (15%), and diarrhea (15%). Severe adverse event occurred in 14 patients (11%) without fatal event. The median overall survival and progression-free survival times were 18.5 and 7.6 months, respectively. The objective response rate 15.2% and the disease control rate was 81.9%. A high modified Glasgow prognostic score (mGPS, ≥1) (95%CI 1.96-12.5) and female (95%CI 0.20-0.97) were identified as independent poor prognostic factors.
First-line FOLFIRINOX treatment for locally advanced pancreatic cancer seems to be effective with acceptable toxicities. A high mGPS may be associated with poor survival in patients with locally advanced pancreatic cancer who receive FOLFIRINOX. This study was registered at the UMIN Clinical Trials Registry (UMIN000014658).
在最近的 III 期研究中，FOLFIRINOX（奥沙利铂、伊立替康、5-氟尿嘧啶、亚叶酸钙）治疗显著改善了总生存期，成为转移性胰腺癌的标准治疗方法。然而，局部晚期胰腺癌的治疗仍存在争议。我们对日本一项全国多中心观察性研究进行了亚组分析，以评估 FOLFIRINOX 治疗局部晚期胰腺癌患者的耐受性和疗效，并研究与治疗前变量相关的独立预后因素。
该研究纳入了 2013 年 12 月 20 日至 2014 年 12 月 19 日期间来自日本 27 家机构的 66 例无法切除的局部晚期胰腺癌患者，他们接受了 FOLFIRINOX 作为一线治疗，并在 2015 年 12 月前进行了随访。
中位年龄为 63 岁，东部肿瘤协作组体能状态为 0 或 1。主要的 3 或 4 级不良事件包括中性粒细胞减少症（64%）、白细胞减少症（33%）、发热性中性粒细胞减少症（15%）和腹泻（15%）。14 例（11%）患者发生严重不良事件，但无致命事件。中位总生存期和无进展生存期分别为 18.5 个月和 7.6 个月。客观缓解率为 15.2%，疾病控制率为 81.9%。高改良格拉斯哥预后评分（mGPS，≥1）（95%CI 1.96-12.5）和女性（95%CI 0.20-0.97）被确定为独立的不良预后因素。
局部晚期胰腺癌患者一线使用 FOLFIRINOX 治疗似乎有效，且毒性可接受。mGPS 较高可能与接受 FOLFIRINOX 治疗的局部晚期胰腺癌患者的生存不良相关。本研究在 UMIN 临床试验注册中心（UMIN000014658）注册。
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