Randomized Prospective Phase II Study to Compare the Combination Chemotherapy Regimen Epirubicin, Cisplatin, and 5-Fluorouracil With Epirubicin, Cisplatin, and Capecitabine in Patients With Advanced or Metastatic Gastric Cancer

Ocvirk, Janja; Reberšek, Martina; Škof, Erik; Hlebanja, Zvezdana; Boc, Marko

doi:10.1097/coc.0b013e31820dc0b0

Cited by 21 publications

(7 citation statements)

References 21 publications

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“…The median OS and PFS times of 11.3 and 6.2 months in patients with good risk TSER genotypes were also comparable to those reported in non-genotype selected populations (Figure 2). Although the observed response rate did not support the utility of TSER genotyping as a treatment selection guide, it should also be noted that the enrolled patients experienced a very promising disease control rate of 95.7% (9 PR and 13 SD out of 23 patients), higher than those reported in the literature [32]–[36]. The high disease control rate in the current study may provide the first prospectively obtained evidence for the utility of TSER genotyping in improving clinical outcomes in patients with gastric and GEJ cancers.…”

Section: Discussioncontrasting

confidence: 80%

Thymidylate Synthase Genotype-Directed Chemotherapy for Patients with Gastric and Gastroesophageal Junction Cancers

Goff

Thakkar

et al. 2014

PLoS ONE

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BackgroundRetrospective studies indicate associations between TSER (thymidylate synthase enhancer region) genotypes and clinical outcomes in patients receiving 5-FU based chemotherapy, but well-controlled prospective validation has been lacking.MethodsIn this phase II study (NCT00515216 registered through ClinicalTrials.gov, http://clinicaltrials.gov/show/NCT00515216), patients with “good risk” TSER genotypes (at least one TSER*2 allele) were treated with FOLFOX chemotherapy to determine whether prospective patient selection can improve overall response rates (ORR) in patients with gastric and gastroesophageal junction (GEJ) cancers, compared with historical outcomes in unselected patients (estimated 43%).ResultsThe ORR in genotype-selected patients was 39.1% (9 partial responses out of 23 evaluable patients, 95% CI, 22.2 to 59.2), not achieving the primary objective of improving ORR. An encouraging disease control rate (DCR, consisting of partial responses and stable diseases) of 95.7% was noted and patients with homozygous TSER*2 genotype showed better tumor response.ConclusionsIn this first prospective, multi-institutional study in patients with gastric or GEJ cancers, selecting patients with at least one TSER*2 allele did not improve the ORR but led to an encouraging DCR. Further studies are needed to investigate the utility of selecting patients homozygous for the TSER*2 allele and additional genomic markers in improving clinical outcomes for patients with gastric and GEJ cancers.Trial RegistrationClinicalTrials.gov NCT00515216

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Section: Discussioncontrasting

confidence: 80%

Thymidylate Synthase Genotype-Directed Chemotherapy for Patients with Gastric and Gastroesophageal Junction Cancers

Goff

Thakkar

et al. 2014

PLoS ONE

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“…1 ). In total, 15 studies containing 4,713 patients were eligible 8 – 12 , 14 , 17 – 25 . The number of patients that received capecitabine-based, 5-FU-based and S-1 based regimens was 945, 2,132 and 1,636 respectively (Fig.…”

Section: Resultsmentioning

confidence: 99%

Capecitabine, 5-fluorouracil and S-1 based regimens for previously untreated advanced oesophagogastric cancer: A network meta-analysis

Veer

Ngai

Valkenhoef

et al. 2017

Sci Rep

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As evidence is inconsistent and based on either isolated Asian or Western studies, we conducted a network meta-analysis (NMA) to examine efficacy and safety of 5-FU (5-fluorouracil), capecitabine and S-1-based first-line treatment of advanced esophagogastric cancer in Asian and Western patients. Medline, EMBASE, CENTRAL and conferences ASCO and ESMO were searched up to January 2016 for randomized-controlled-trials comparing 5-FU, capecitabine or S-1-based regimens with equal chemotherapy backbones. Direct and indirect data for overall survival (OS) and progression-free-survival (PFS) were combined on the Hazard Ratio (HR)-scale using random-effects NMA and calculated as combined HRs and 95%credible intervals (95%CrI). Grade 1-2 and grade 3-4 adverse events were compared with pair-wise meta-analysis. Fifteen studies were identified including capecitabine (n = 945), 5-FU (n = 2,132) or S-1 (n = 1,636). No differences were found in respectively OS and PFS for capecitabine-based versus 5-FU-based regimens (HR = 0.89, 95%CrI = 0.76–1.04 and HR = 0.98, 95%CrI = 0.75–1.32), S-1-based versus 5-FU-based regimens (HR = 0.92, 95%CrI = 0.82–1.04 and HR = 0.88, 95%CrI = 0.70–1.11) and S-1-based versus capecitabine-based regimens (HR = 1.03, 95%CrI = 0.87–1.22 and HR = 0.89, 95%CrI = 0.65–1.20). Effects were similar in Asian and Western subgroups. Toxicity profiles were different but a lower frequency of relevant adverse events was observed with S-1 In conclusion, as efficacy was similar, choosing fluoropyrimidines should be based on their individual toxicity profiles.

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“…After reviewing the remaining 54 trials, we excluded 25 trials because of preoperative/postoperative adjuvant chemotherapy, no appropriate grouping studies, abstracts, reduplicative publications, and article including esophagus cancer. Finally, 29 relevant RCTs, comprising a total of 15 154 patients, were included . The characteristics and qualities of included trials were shown in Table and Figure .…”

Section: Resultsmentioning

confidence: 99%

Oral fluoropyrimidine versus intravenous 5‐fluorouracil for the treatment of advanced gastric and colorectal cancer: Meta‐analysis

Zhang

Xing

Fang

et al. 2017

J of Gastro and Hepatol

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Background and Aim: 5-Fluorouracil (5-Fu) is one of the most commonly prescribed antineoplastic agents against gastric and colorectal cancers. Continuous infusion would be the optimal way of its administration, however, may usually cause thrombosis, infection, and prolonged hospital stay. Oral fluoropyrimidines would be an attractive alternative, but their efficiency and toxicities for the treatment of gastric and colorectal cancer are still obscure as compared with infusion 5-Fu. Methods: Literature retrieval, trials selection and assessment, data collection, and statistic analysis were performed according to the Cochrane Handbook. The outcome measures were tumor response rate, progression-free survival, overall survival, and adverse effects. Results: Twenty-nine randomized controlled trials, comprising totally 15 154 patients, were included. Meta-analysis showed similar overall outcome in terms of response rate (1.01; 95% confidence interval [CI], 0.92-1.12), progression-free survival (hazard ratio 1.00; 95%CI, 0.94-1.06), and overall survival (hazard ratio 0.96; 95%CI, 0.92-1.01) between oral fluoropyrimidine-based and intravenous 5-Fu-based regimens in gastric and colorectal cancer patients. The risk of grade 3/4 neutropenia, thrombocytopenia, and stomatitis was more prominent in intravenous 5-Fu-based regimens; while more frequent grade 3/4 hand-foot syndrome, diarrhea, and anorexia were detected in oral fluoropyrimidine-based regimens. Conclusions: Oral-fluoropyrimidines showed equivalent response and similar survival outcomes, but different toxicity profiles, as compared with intravenous 5-Fu. Thus, it would be a more convenient and adjustable alternative in treatment of advanced gastric and colorectal cancer.

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Randomized Prospective Phase II Study to Compare the Combination Chemotherapy Regimen Epirubicin, Cisplatin, and 5-Fluorouracil With Epirubicin, Cisplatin, and Capecitabine in Patients With Advanced or Metastatic Gastric Cancer

Abstract: The ECX regimen was at least as effective as the ECF regimen with a similar tolerability profile, and could therefore replace the ECF regimen for the first-line treatment of patients with advanced gastric cancer.

Cited by 21 publications

References 21 publications

Thymidylate Synthase Genotype-Directed Chemotherapy for Patients with Gastric and Gastroesophageal Junction Cancers

Thymidylate Synthase Genotype-Directed Chemotherapy for Patients with Gastric and Gastroesophageal Junction Cancers

Capecitabine, 5-fluorouracil and S-1 based regimens for previously untreated advanced oesophagogastric cancer: A network meta-analysis

Oral fluoropyrimidine versus intravenous 5‐fluorouracil for the treatment of advanced gastric and colorectal cancer: Meta‐analysis

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