scholarly journals Modified FOLFOX6 Regimen

2020 ◽  
Author(s):  
Keyword(s):  
2018 ◽  
Vol Volume 11 ◽  
pp. 8301-8307 ◽  
Author(s):  
Hiroki Osumi ◽  
Daisuke Takahari ◽  
Keisho Chin ◽  
Mariko Ogura ◽  
Takashi Ichimura ◽  
...  

2013 ◽  
Vol 74 (5) ◽  
pp. 1162-1167
Author(s):  
Tetsuya SHIMIZU ◽  
Hitoshi SEKIDO ◽  
Goro MATSUDA ◽  
Kentaroh MIYAKE ◽  
Nobuhiro TUCHIYA ◽  
...  

2020 ◽  
Vol 37 (6) ◽  
pp. 2853-2864 ◽  
Author(s):  
Seiichiro Mitani ◽  
Shigenori Kadowaki ◽  
Azusa Komori ◽  
Chihiro Kondoh ◽  
Isao Oze ◽  
...  

2015 ◽  
Vol 51 (8) ◽  
pp. 942-949 ◽  
Author(s):  
Guillem Argilés ◽  
Mark P. Saunders ◽  
Fernando Rivera ◽  
Alberto Sobrero ◽  
Al Benson ◽  
...  

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4602-4602 ◽  
Author(s):  
S. Im ◽  
S. Kim ◽  
J. Kim ◽  
H. Lee ◽  
M. Kim ◽  
...  

4602 Background: Peri-operative chemotherapy in operable advanced gastric cancer (AGC) is still in a controversial area. Results from MAGIC trial suggest that a peri-operative regimen of ECF (epirubicin, cisplatin, 5-FU) decreased tumor size and significantly improved PFS and OS in patients with operable AGC (NEJM 355: 11, 2006). The aim of this study was to evaluate the efficacy and toxicity of folinic acid (FA), infusional 5-fluorouracil (5-FU), and oxaliplatin (modified FOLFOX6), administered every 2 wks in potentially operable AGC with regional lymph node (LN) metastasis. Methods: Previously untreated gastric adenocarcinoma patients with measurable LN on CT scan (clinical stage: cT2 or cT3, N+) were eligible. Staging also included a PET-CT and endoscopic ultrasonography (EUS). Patients received 4 cycles of neoadjuvant therapy with FA 100 mg/m2 (2-hr i.v.), 5-FU 2.4 g/m2 (46-hr continuous infusion), and oxaliplatin 100 mg/m2 (2-hr i.v.), followed by curative radical surgery including D2 dissection and 4 cycles of adjuvant modified FOLFOX6. Clinical responses were assessed by RECIST using CT scan before surgery and early metabolic responses were assessed by PET-CT after 2 cycles of chemotherapy. Results: Thirty-one patients were enrolled from Oct. 2004 to Nov. 2006 and currently, 29 of them are evaluable for response. Median age was 56 yrs (range, 35–69). Most patients had EUS T3N1or2 designation. Of 29 evaluable patients, PR were observed in 19 (66%), SD in 9 (31%), and PD in 1 (3%) patient. Early metabolic responses (SUV decrement = 35% by PET-CT) were significantly correlated with conventional radiographic response (p=0.037). The R0 resection rate was 90% and pathologic CR was 7%. Median follow-up duration was 11.8 mo. and median PFS has not been reached yet. Total 219 cycles were administered. G3/4 neutropenia occurred in 6 cycles (3.0%). Nausea G3/4 occurred in 1 cycle (0.5%) and diarrhea in 1 cycle (0.5%). There were no cases of peripheral neuropathy G3/4 or febrile neutropenia G3/4. Conclusions: Peri-operative chemotherapy with modified FOLFOX6 is very effective and feasible in patients with potentially resectable AGC with regional LN metastasis. Early response can be predicted by PET-CT. No significant financial relationships to disclose.


2011 ◽  
Vol 29 (15_suppl) ◽  
pp. e14512-e14512
Author(s):  
M. Dong ◽  
X. B. Wan ◽  
X. Li ◽  
X. Wu ◽  
Q. Lin ◽  
...  

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 563-563 ◽  
Author(s):  
S. J. Salamone ◽  
C. N. Benfield ◽  
J. B. Courtney ◽  
R. L. Harney ◽  
D. R. Kozo ◽  
...  

563 Background: 5-fluorouracil (5-FU) is one of the most widely used chemotherapy agents in the treatment of colorectal cancer. Studies over the last 30 years have demonstrated wide pharmacokinetic variability of 5-FU which can lead to undue toxicity and suboptimal treatment. Recent clinical studies have demonstrated that managing plasma 5-FU levels and adjusting doses to target steady state concentrations effectively minimizes toxicity and improves outcome. Methods: An existing immunoassay using a novel antibody to 5-FU was modified to directly quantify 5-FU in patient plasma samples without any sample pretreatment. The assay was adapted to Beckman Coulter AU analyzers and to Roche COBAS c 111 analyzer. Method comparison to LC-MS/MS, limit of detection (LoD), lower limit of quantitation (LLoQ), precision, and linearity of the assay were evaluated. The assay was also validated by testing samples of patients being treated by modified FOLFOX6 from an on-going clinical trial ( NCT00943137 ). Results: The modified immunoassay was confirmed to have a linear reportable range from 85 to 18,000ng/mL and a LoD of 52ng/mL. The immunoassay was established to have good precision (CV<6%) around the medical decision points for FOLFOX and FOLFIRI regimens. Method comparison of the immunoassay obtained by testing 58 clinical samples from patients under 5-FU treatment provides excellent correlation to LC- MS/MS: Deming slope 1 ± 0.05, R > 0.98. Another 82 samples of patients on modified FOLFOX6 regimen from clinical trial (( NCT00943137 ) were tested using the immunoassay and range of these sample were reported to be from 95 to 2,970 ng/mL. Conclusions: The assay provided the performance required to rapidly quantify 5-FU plasma concentrations. It was fast (time to 1st result < 10 minutes), precise, correlated well to a physical method, required only 100uL sample on the analyzer and 7ul for actual testing per assay, and was easily adapted to a variety of clinical analyzers. Clinical and pharmacokinetic laboratories could use this assay to introduce an evidence-based approach to optimize 5-FU dosing that would have higher throughput, simpler methodology, and require less labor, space or expense than the physical methods. [Table: see text]


2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 530-530 ◽  
Author(s):  
Katsunori Shinozaki ◽  
Masahito Kotaka ◽  
Tetsuo Touyama ◽  
Dai Manaka ◽  
Takanori Matsui ◽  
...  

530 Background: Adjuvant FOLFOX is a widely accepted standard regimen for resected colon cancer. The incidence of grade ≥ 3 peripheral sensory neuropathy (PSN) was 12.4% and 5.7% in Western MOSAIC and Eastern MASCOT (outside Japan) trials, while that of grade ≥ 3 allergic reactions (AR) was 2.9% and 3.1%, respectively. JOIN Trial investigated the tolerability of modified FOLFOX6 (mFOLFOX6) in Japanese patients (UMIN ID: 000004443). Methods: Twelve cycles of mFOLFOX6 were given to patients fitting the following criteria, which were the same as those of MOSAIC: stage II/III resected colon cancer, PS of 0-1, 20 years or older, starting FOLFOX within 7 weeks of surgery, and adequate organ function. The primary endpoint was the incidence of PSN persisting for at least 8 days that interfered with daily activities and that of grade ≥ 3 AR. Target sample size was 800, assuming the expected incidence of grade ≥ 3 PSN and grade ≥ 3 AR would be 12.0% and 3.0%, and the two-sided 95% confidence interval (CI) would not include the corresponding threshold levels (16.5% for PSN and 6.5% for AR) with a 95% probability. Results: From Nov 2010 to Mar 2012, 882 patients were enrolled at 198 institutions. The safety data was analyzed in 828 patients whose data were finalized out of 848 patients received mFOLFOX6, and patient characteristics included: median age of 64 years (21-83); Male/ Female: 444/384; PS 0/1: 776/52; colon/rectosigmoid: 633/195; and stage IIA/IIB/IIC/IIIA/IIIB/IIIC: 96/33/23/61/437/178. The incidence of persistent PSN was 3.3% (95% CI: 2.2%-4.7%), while that of grade ≥ 3 AR was 1.7% (95% CI: 1.0%-2.8%), and the primary endpoint was met. Only grade ≥ 3 neutropenia showed a ≥ 10% incidence (28.7%). The incidence of grade ≥ 3 PSN was 5.8% and interstitial pneumonitis was observed in one case. There was no treatment-related death. The median number of cycles of chemotherapy was 12, and the completion treatment rate was 67.0%. The median total dosage of oxaliplatin (L-OHP) was 811.1 mg/m2. The median relative dose intensity of L-OHP, fluorouracil (FU) bolus and FU infusion were 90.0%, 76.9% and 81.7%, respectively. Conclusions: Adjuvant mFOLFOX6 is tolerable in Japanese patients with colon cancer. Clinical trial information: UMIN000004443.


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