Evidence map›Paper›PMID 27980221›Full record

Trial reportOncotarget2017

Maintenance treatment of Uracil and Tegafur (UFT) in responders following first-line fluorouracil-based chemotherapy in metastatic gastric cancer: a randomized phase II study.

Wenhua Li, Xiaoying Zhao, Huijie Wang, Xin Liu, Xinmin Zhao, Mingzhu Huang, Lixin Qiu, Wen Zhang, Zhiyu Chen, Weijian Guo and 2 more

Registry-linked trialOpen access · diamondAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Oncotarget, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03701373 (Maintenance Treatment With S-1 Versus Observation After First-line Chemotherapy in Patients With Advanced Gastric Cancer), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 15% of its field
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.

NCT03701373 phase2unknown statusnot on this map

Maintenance Treatment With S-1 Versus Observation After First-line Chemotherapy in Patients With Advanced Gastric Cancer: a Randomized Phase II Study

TypeinterventionalSponsorSun Yat-sen UniversityRan2016 to 2018Enrolled200ConditionsGastric Cancer Stage IV, Cancer of StomachArmsS-1 maintenance, Observation
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Relevance ofBMJ open · 2018
    Pooled it
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
  7. Optimal duration of first-line chemotherapy for advanced gastric cancer: data from the AGAMENON registry.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2020
    Article
  8. Article
  9. Article
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

12 authors at 2 institutions in 1 country.

Wenhua LiDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Xiaoying ZhaoDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Huijie WangDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Xin LiuDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Xinmin ZhaoDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Mingzhu HuangDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Lixin QiuDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Wen ZhangDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Zhiyu ChenDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Weijian GuoDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Jin LiDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Xiaodong ZhuDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Fudan University Shanghai Cancer Center · CNShanghai Medical College of Fudan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMaintenance therapy proves to be effective in advanced lung and breast cancer after initial chemotherapy. The purpose of this phase II study was to evaluate the efficacy and safety of Uracil and Tegafur (UFT) maintenance in metastatic gastric cancer patients following the first-line fluorouracil-based chemotherapy.

methodsMetastatic gastric cancer patients with stable disease or a better response after the completion of first-line chemotherapy were randomized to oral UFT (360mg/m2 × 2 weeks) every 3 weeks until disease progression/intolerable toxicity or to observation (OBS). The primary endpoint was progression-free survival (PFS); the secondary endpoints were overall survival (OS) and safety.

resultsThe trial was closed after the interim analysis of the 58 enrolled (120 planned) patients. Median PFS was not improved in the UFT group compared with the OBS group (3.2 months versus 3.6 months, P = 0.752), as well as the median OS (14.2 months for both, P = 0.983). However, subgroup analysis showed that low baseline hemoglobin (< 120 g/L) was associated with poorer PFS with maintenance therapy (P = 0.032), while the normal hemoglobin patients benefit from the UFT treatment (P = 0.008). Grade 3 to 4 toxicities in the UFT group were anemia (3.4%), thrombocytopenia (3.4%) and diarrhea (6.9%).

conclusionsThis trial did not show superiority of UFT maintenance in non-selected patients responding to fluorouracil-based first-line chemotherapy. The normal hemoglobin level at baseline is a predictive biomarker for favorable patient subsets from the maintenance treatment.

Indexed as

AdultAgedDisease-Free SurvivalFemaleFluorouracilHumansMaleMiddle AgedNeoplasm MetastasisStomach NeoplasmsTegafurUracilYoung AdultFluorouracilTegafurUracilchemotherapygastric carcinomamaintenance treatmentUFT

Identifiers

PMID27980221
PMCPMC5514953
OpenAlexW2563490717

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.