Evidence map›Paper›PMID 16767365›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2006

Phase II multicenter trial of docetaxel, epirubicin, and 5-fluorouracil (DEF) in the treatment of advanced gastric cancer: a novel, safe, and active regimen.

André M Murad, Nils G Skare, Jéferson Vinholes, Sérgio Lago, Ricardo Pecego, Brazilian Gastric Cancer Study Group, Belo Horizonte, MG, Brazil

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

André M MuradOncology Department, Hospital das Clinicas Universidade Federal de Minas Gerais, Rua Piaui 150, Belo Horizonte, MG Brazil 30150-320.
Nils G Skare
Jéferson Vinholes
Sérgio Lago
Ricardo Pecego
Brazilian Gastric Cancer Study Group, Belo Horizonte, MG, Brazil

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study evaluated the efficacy and safety of docetaxel, epirubicin, and 5-fluorouracil (5-FU) [DEF] as treatment for locally advanced unresectable or metastatic gastric cancer.

methodsThirty-seven patients participated in the study (median age, 56 years; range, 22-73 years); Eastern Cooperative Oncology Group performance status [PS], 0-2). Docetaxel 75 mg/m2 IV (day 1), 5-FU 500 mg/m2 IV (days 1-3), and epirubicin 50 mg/m2 IV (day 1) were administered every 3 weeks for six cycles.

resultsIn total, 20/37 patients (54%) completed six treatment cycles. Thirteen patients (35%; 95% confidence intervals [CI], 20% to 51%) had an objective response; 1 patient (3%) achieved a complete response and 12 patients (32%) achieved partial responses. Stable disease was observed in 7 patients (19%) and progressive disease in 5 patients (14%). Twelve patients (32%) were unevaluable. Clinical benefit (based on PS, weight gain, and analgesic consumption) was observed in 11 patients (30%). Median follow-up was 41 months (range, 26-53 months), median time to progression was 6.6 months (range, 0.5-29.2 months), median overall survival was 10.7 months (range, 7.0-14.6 months), and 1-year survival was 40%. The regimen was well tolerated. Grade 3-4 febrile neutropenia occurred in 8 patients (22%; 6% of cycles) and grade 3-4 neutropenia in 1 patient (1% of cycles). The most frequent grade 3-4 toxicities were alopecia (11% of cycles), diarrhea (4% of cycles) and vomiting (2% of cycles); grade 1-2 asthenia and fatigue occurred in 43% of cycles.

conclusionDEF is effective in the treatment of advanced gastric cancer, and has a good safety profile.

Indexed as

AdenocarcinomaAdolescentAdultAgedAntineoplastic Combined Chemotherapy ProtocolsDocetaxelDose-Response Relationship, DrugEpirubicinFemaleFluorouracilHumansMaleMiddle AgedStomach NeoplasmsSurvival RateTaxoidsDocetaxelEpirubicinFluorouracilTaxoids

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.