Abstract 164P
Background
5-Fluorouracil (5-FU) is a key drug in treatment of unresectable advanced gastric cancer (AGC). It is known that intravenous 5-FU and oral fluorouracil have different mechanism as anti-cancer drugs, however, a clinical benefit of intravenous 5-FU after using oral fluorouracil is not clear. Therefore, we planned a prospective study to assess the efficacy and safety of weekly intravenous 5-FU and l-leucovorin(l-LV) in Japanese patients with AGC which was resistant for oral fluorouracil, taxane, and platinum. This encore abstract was previously reported at the ESMO 21st World Congress on Gastrointestinal Cancer 2019; the abstract number was P-176.
Methods
This regimen consisted of l-LV 250mg/m2/2h iv and 5-FU 600mg/m2 iv once a week for 6 weeks followed by 2-week rest period, within an 8-week cycle. The primary endpoint was the progression free survival (PFS) rate at 8 weeks.
Results
Among the 29 enrolled patients, PFS rate at 8 weeks was 55.2% (95% CI 35.6% to 71.0%), which was higher than 47.5% which is the expected value of the hypothesis, and the lower limit of 95% CI is significantly higher than the threshold which is 23.1%. Grade 3 to 4 hematological adverse events (AE) were as follows; anemia 20.7%, neutropenia 3.4%, and platelet count decreased 3.4%. Grade 3 to 4 non-hematological AE were observed as follows; anorexia 20.7%, fatigue 13.8%, and diarrhea 3.4%.
Conclusions
The intravenous 5-FU and l-LV regimen is feasible and could be promising as the salvage line treatment in patients with AGC even if that is resistant for oral fluorouracil, taxane and platinum.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The Helsinki Ethical Principles (revised in Oct, 2013) and the Ethical Guidelines for Medical and Health Research involving in Human Subjects in 2014.
Funding
Hokkaido Gastrointestinal Cancer Study Group.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
107P - The efficacy of adjuvant chemotherapy according to the risk classification of recurrence based on the systemic inflammatory markers in patients with colorectal cancer liver metastases
Presenter: Masatsune Shibutani
Session: Poster display session
Resources:
Abstract
108P - Influence of liver metastasis locations on overall survival in patients with colorectal cancer
Presenter: Takayuki Sone
Session: Poster display session
Resources:
Abstract
109P - 18F-FDG PET/CT textural features as predictors of outcomes in patients with primary advanced colorectal cancer
Presenter: Jing Yang
Session: Poster display session
Resources:
Abstract
110P - D3 lymph node dissection may be necessary in clinical stage I right colon cancer
Presenter: Woong Bae Ji
Session: Poster display session
Resources:
Abstract
111P - Is preoperative chemoradiotherapy necessary for all patients with upper rectal cancer: One center retrospective study
Presenter: Jasur Madyarov
Session: Poster display session
Resources:
Abstract
112P - A retrospective analysis of the association between perioperative, post adjuvant carcinoembryonic antigen level and prognosis in stage III colorectal cancer
Presenter: Ryotaro Kozuki
Session: Poster display session
Resources:
Abstract
113P - Dicer contributes to chemoresistance in colorectal cancer via regulating a set of miRNAs and their downstream mRNAs
Presenter: Liang-Yi Hung
Session: Poster display session
Resources:
Abstract
114P - Efficacy and safety of the combination of bevacizumab with raltitrexed-based chemotherapy as second-line therapy in patients with metastatic colorectal cancer (mCRC): An interim analysis of a multicenter phase II trial
Presenter: Jun Zhu
Session: Poster display session
Resources:
Abstract
115P - Expression of Ki-67 as a prognostic factor in patients with colorectal cancer
Presenter: Kuantkan Zhabagin
Session: Poster display session
Resources:
Abstract
116P - Clinical significance and converionrate relevance of RAS genetic mutation analysis for unresectable colorectal liver metastases: A single-center retrospective study
Presenter: Meiling Ji
Session: Poster display session
Resources:
Abstract