Osumi Hiroki, Takahari Daisuke, Chin Keisho, Ogura Mariko, Ichimura Takashi, Wakatsuki Takeru, Suzuki Takeshi, Ota Yumiko, Nakayama Izuma, Ooki Akira, Suenaga Mitsukuni, Shinozaki Eiji, Yamaguchi Kensei
Department of Gastroenterology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan,
Onco Targets Ther. 2018 Nov 23;11:8301-8307. doi: 10.2147/OTT.S184665. eCollection 2018.
Oral fluoropyrimidine plus platinum is a standard first-line treatment for advanced gastric cancer (AGC). However, this treatment is problematic for AGC patients with massive ascites or inadequate oral intake. This study aimed at evaluating the efficacy and safety of modified oxaliplatin (L-OHP) with l-leucovorin (l-LV) and bolus/continuous infusion of 5-fluorouracil (5-FU) (mFOLFOX6) regimen for patients with massive ascites or inadequate oral intake.
This retrospective study was conducted at a single Japanese institute from November 2015 to May 2018. The mFOLFOX6 regimen consisted of 85 mg/m L-OHP, 400 mg/m bolus of 5-FU, and 400 mg/m 1-LV on the first day, followed by 2,400 mg/m of 5-FU as a continuous infusion in 46 hours for first-line treatment. The definition of inadequate oral intake was the need for total parenteral nutrition (TPN). Massive ascites was defined as continuous ascites from the pelvic cavity to the upper abdomen. Improvement in oral intake was defined as no TPN for more than 7 days, and improvement in ascites was defined as a decrease in ascites of more than one grade defined by the Japan Clinical Oncology Study Group trial (JCOG0106).
Among the 364 patients with AGC who received first-line chemotherapy, 17 patients (13 [76.5%] had inadequate oral intake, and four [23.5%] had massive ascites) were enrolled in this study. Median time to treatment failure and overall survival were 4.8 (95% CI=1.5-7.5) and 8.8 months (95% CI=2.3-not available), respectively. Objective improvements in oral intake and ascites were seen in 11 of 13 patients (84.6%) and 6 of 12 patients (50%), respectively. The major grade 3 or 4 adverse events were neutropenia (35.3%), febrile neutropenia (5.9%), fatigue (5.9%), anorexia (5.9%), and infection (5.9%). No treatment-related deaths occurred.
We found that mFOLFOX6 can be a novel treatment option as the first-line treatment for AGC patients with massive ascites or inadequate oral intake.
口服氟嘧啶联合铂类是晚期胃癌（AGC）的标准一线治疗方案。然而，对于有大量腹水或口服摄入不足的AGC患者，这种治疗存在问题。本研究旨在评估改良奥沙利铂（L-OHP）联合左亚叶酸钙（l-LV）以及推注/持续输注5-氟尿嘧啶（5-FU）（mFOLFOX6）方案对有大量腹水或口服摄入不足患者的疗效和安全性。
本回顾性研究于2015年11月至2018年5月在日本一家机构进行。mFOLFOX6方案包括第1天静脉滴注85mg/m²的L-OHP、推注400mg/m²的5-FU和400mg/m²的l-LV，随后在46小时内持续静脉滴注2400mg/m²的5-FU用于一线治疗。口服摄入不足的定义为需要全胃肠外营养（TPN）。大量腹水的定义为从盆腔至中上腹的持续性腹水。口服摄入改善的定义为连续7天以上无需TPN，腹水改善的定义为腹水减少超过日本临床肿瘤学研究组试验（JCOG0106）定义的一个等级。
在364例接受一线化疗的AGC患者中，17例（13例[76.5%]口服摄入不足，4例[23.5%]有大量腹水）纳入本研究。治疗失败的中位时间和总生存期分别为4.8个月（95%CI = 1.5 - 7.5）和8.8个月（95%CI = 2.3 - 未获得）。13例患者中有11例（84.6%）口服摄入得到客观改善，12例患者中有6例（50%）腹水得到客观改善。主要的3级或4级不良事件为中性粒细胞减少（35.3%）、发热性中性粒细胞减少（5.9%）、疲劳（5.9%）、厌食（5.9%）和感染（5.9%）。未发生与治疗相关的死亡。
我们发现mFOLFOX6可作为有大量腹水或口服摄入不足的AGC患者一线治疗的一种新选择。
