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Modified FOLFOX6 as a first-line treatment for patients with advanced gastric cancer with massive ascites or inadequate oral intake

Authors Osumi H, Takahari D, Chin K, Ogura M, Ichimura T, Wakatsuki T, Suzuki T, Ota Y, Nakayama I, Ooki A, Suenaga M, Shinozaki E, Yamaguchi K

Received 21 August 2018

Accepted for publication 30 October 2018

Published 23 November 2018 Volume 2018:11 Pages 8301—8307


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr XuYu Yang

Hiroki Osumi, Daisuke Takahari, Keisho Chin, Mariko Ogura, Takashi Ichimura, Takeru Wakatsuki, Takeshi Suzuki, Yumiko Ota, Izuma Nakayama, Akira Ooki, Mitsukuni Suenaga, Eiji Shinozaki, Kensei Yamaguchi

Department of Gastroenterology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan

Background: 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.
Methods: This retrospective study was conducted at a single Japanese institute from November 2015 to May 2018. The mFOLFOX6 regimen consisted of 85 mg/m2 L-OHP, 400 mg/m2 bolus of 5-FU, and 400 mg/m2 1-LV on the first day, followed by 2,400 mg/m2 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).
Results: 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.
Conclusion: 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.

Keywords: advanced gastric cancer, FOLFOX, massive ascites, inadequate oral intake

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