scholarly journals Retrospective Study of L-Leucovorin and 5-FU Therapy in Gastric Cancer with Severe Ascites or Inadequate Oral Intake

2013 ◽  
Vol 24 ◽  
pp. ix66
Author(s):  
T. Matsumoto ◽  
T. Kajiwara ◽  
N. Nishide ◽  
A. Asagi ◽  
T. Nishina ◽  
...  
2019 ◽  
Author(s):  
Hiroyuki Arai ◽  
Masahiro Kawahira ◽  
Hirofumi Yasui ◽  
Toshiki Masuishi ◽  
Kei Muro ◽  
...  

Abstract Background Individuals with advanced gastric cancer (AGC) who present with severe peritoneal metastasis (SPM) have poor prognosis, and the need to improve treatment for such condition and survival time is not met. Moreover, there are only few data about the second-line treatment for patients with such condition. Methods This retrospective study included patients receiving taxane-based second-line chemotherapy at three institutions in Japan between 2010 and 2016. Patients with AGC who present with SPM were included if they had massive ascites and/or inadequate oral intake requiring intravenous nutritional support. The efficacy and safety of the treatment were evaluated. Results In the present study, 43 (40%) of 108 patients had an Eastern Cooperative Oncology Group Performance Status score > 2, and the median serum albumin level of the patients was 3.3 g/mL. Ramucirumab was used in combination with paclitaxel in 21 patients. The median overall survival (OS) and progression-free survival (PFS) were 5.1 and 2.8 months, respectively. Inadequate oral intake was considered a negative prognostic factor of both OS and PFS in the multivariate analysis. Three treatment-related deaths were observed, which include those attributed to febrile neutropenia, gastrointestinal perforation, and pneumonitis. Common grade > 3 adverse events were neutropenia (35%), leukopenia (30%), anemia (24%), and anorexia (16%). We observed febrile neutropenia in 8% and gastrointestinal perforation in 4% of patients, and such conditions were primarily observed in patients with inadequate oral intake. Conclusions Taxane-based second-line chemotherapy was effective and safe for patients with AGC who present with SPM. Attention must be provided when treating patients with inadequate oral intake as they are likely to have short prognosis and serious toxicities.


2010 ◽  
Vol 16 (1) ◽  
pp. 57-62 ◽  
Author(s):  
Satoru Iwasa ◽  
Takako Eguchi Nakajima ◽  
Kenichi Nakamura ◽  
Atsuo Takashima ◽  
Ken Kato ◽  
...  

2018 ◽  
Vol Volume 11 ◽  
pp. 8301-8307 ◽  
Author(s):  
Hiroki Osumi ◽  
Daisuke Takahari ◽  
Keisho Chin ◽  
Mariko Ogura ◽  
Takashi Ichimura ◽  
...  

2018 ◽  
Vol 29 ◽  
pp. v23
Author(s):  
H. Osumi ◽  
D. Takahari ◽  
K. Chin ◽  
M. Ogura ◽  
T. Ichimura ◽  
...  

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 119-119 ◽  
Author(s):  
H. Takiuchi ◽  
H. Yasui ◽  
T. Nishina ◽  
D. Takahari ◽  
N. Nakayama ◽  
...  

119 Background: Oral fluoropyrimidine plus cisplatin is widely used as a standard treatment for advanced gastric cancer, but patients (pts) with severe peritoneal metastasis often cannot tolerate this regimen. The aim of this study was to assess the feasibility of fluorouracil (5-FU), leucovorin (LV), plus paclitaxel (PTX) for peritoneal disseminated gastric cancer with massive ascites or inadequate oral intake. Methods: Peritoneal disseminated gastric cancer with massive ascites or inadequate oral intake were enrolled in Part I (Level 1 (n=6): 5-FU bolus/l- LV div 2hr/PTX div 1hr = 500/250/60, Level 2 (n=6): 600/250/80 mg/m2 (day1, 8, 15, q4w) to determine dose-limiting toxicity (DLT) and recommended dose (RD). In Part II (n=19), primary endpoint was completion rate of 2 cycles to evaluate the feasibility of this regimen at RD level. Results: One of Level 1 pts had DLT with grade 4 gastrointestinal perforation. Two of Level 2 pts had DLT (grade 3 febrile neutropenia and grade 3 infection with normal neutrophils) and treatment-related death (TRD) was observed in one patient due to pneumonia with grade 4 neutropenia. The RD was determined to be Level 1. Twenty-five patients were enrolled at RD level: first-line/second-line=18/7, performance status 0/1/2=1/19/5. The completion rate of 2 cycles was 92% and objective response rate of ascites was 45%. Grade 3 or 4 neutropenia was observed in 12% (febrile neutropenia in 8%). Five patients out of 7 second-line patients died within 30 days after last administration of FLTAX (TRD: 1 and disease progression: 4). Conclusions: RD of FLTAX regimen was 5-FU/l-LV/PTX=500/250/60 mg/m2. This regimen was feasible as the first-line treatment against peritoneal disseminated gastric cancer patients with massive ascites or inadequate oral intake. [Table: see text]


2017 ◽  
Vol 23 (2) ◽  
pp. 275-280 ◽  
Author(s):  
Hiroki Hara ◽  
Shigenori Kadowaki ◽  
Masako Asayama ◽  
Akira Ooki ◽  
Toko Yamada ◽  
...  

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. TPS222-TPS222
Author(s):  
Shuntaro Yoshida ◽  
Hironori Ishigami ◽  
Kei Muro ◽  
Shigenori Kadowaki ◽  
Yasushi Tsuji ◽  
...  

TPS222 Background: Systemic chemotherapy with oral fluoropyrimidine and platinum is recommended for the first-line treatment for unresectable or recurrent gastric cancer in Japan. However, some patients with severe peritoneal metastasis cannot take oral medications because of obstruction or dysfunction of the gastrointestinal tract. FOLFOX is regarded as one of the candidates for the standard of care for gastric cancer, and is now being evaluated in clinical trials. Intraperitoneal (IP) paclitaxel (PTX) provides sustained high local concentrations, and its efficacy has been shown in ovarian and gastric cancer. We developed a regimen combining IP PTX with S-1/PTX, and the phase III trial comparing with S-1/cisplatin suggested efficacy of this regimen. Therefore, we designed a regimen combining IP PTX with mFOLFOX6, and started an exploratory study in gastric cancer patients with peritoneal metastasis and inadequate oral intake. Methods: This is a prospective, multicenter, single-arm phase I/II study. Eligibility criteria include: pathologically proven unresectable or recurrent gastric adenocarcinoma; peritoneal metastasis; inadequate oral intake; adequate bone marrow function; acceptable liver and renal function; ECOG performance status of 0-2 and age between 20-80 years. Patients undergo diagnostic laparoscopy and are implanted with an IP port in the subcutaneous space of the lower abdomen, with a catheter placed in the pelvic cavity. mFOLFOX6 is administered bi-weekly, and IP PTX 20 mg/m2 is administered through an IP port on days 1, 8 and 15. The treatment course is repeated every 4 weeks until disease progression or unacceptable toxicity. The primary endpoint is the 1-year overall survival rate. Secondary endpoints are progression free survival, time to treatment failure, response rate, negative conversion rate on peritoneal cytology and safety. Twenty medical institutions from all over Japan participate in this study, and 34 patients are to be enrolled in two years. Toxicity will be evaluated in the early stage, and the protocol will be reconsidered and revised if all of the first 3 or more than 2 of the first 6 patients develop dose-limiting toxicities. Clinical trial information: UMIN000019206.


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