Evidence map›Paper›PMID 19638976›Full record

Trial reportBritish journal of cancer2009

Uracil-tegafur and tamoxifen vs cyclophosphamide, methotrexate, fluorouracil, and tamoxifen in post-operative adjuvant therapy for stage I, II, or IIIA lymph node-positive breast cancer: a comparative study.

Y Park, K Okamura, S Mitsuyama, T Saito, J Koh, S Kyono, K Higaki, M Ogita, T Asaga, H Inaji and 9 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00152178 (The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 23% 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.

NCT00152178 phase3completednot on this map

The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC)

TypeinterventionalSponsorTaiho Pharmaceutical Co., Ltd.Ran1996 to 2008Enrolled680ConditionsBreast CancerArmsUFT (uracil, tegafur) and tamoxifen, CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Review
  8. Review
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  11. Review
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4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

19 authors at 16 institutions in 2 countries.

Y ParkDepartment of Surgery, Toho University School of Medicine, Sakura Hospital, 564-1 Shimoshizu, Sakura 285-8741, Japan. youngjinpark@sakura.med.toho-u.ac.jp
K Okamura
S Mitsuyama
T Saito
J Koh
S Kyono
K Higaki
M Ogita
T Asaga
H Inaji
H Komichi
N Kohno
K Yamazaki
F Tanaka
T Ito
H Nishikawa
A Osaki
H Koyama
T Suzuki
Osaka Medical Center for Cancer and Cardiovascular Diseases · JPAkashi Medical Center · JPAsahikawa Medical College Hospital · JPFukui Red Cross Hospital · JPGifu Municipal Hospital · JPHiroshima University · JPHyogo Prefectural Amagasaki General Medical Center · JPJapan Organization of Occupational Health and Safety · JPKanagawa Prefectural Hospital Organization · JPKitakyushu Municipal Medical Center · JPNara City Hospital · JPNippon Medical School · JPSaitama Red Cross Hospital · JPSapporo National Hospital · JPSocial Insurance Saitama Chuo Hospital · JPToho University Medical Center Sakura Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIt has been reported that treatment with uracil-tegafur (UFT) has shown significantly better survival and relapse-free survival (RFS) than surgery alone. Therefore, we compared UFT with a combination therapy of cyclophosphamide, methotrexate, and fluorouracil (CMF) in patients who had undergone curative surgery for axillary lymph node-positive breast cancer.

methodsA total of 377 node-positive patients with stage I, II, or IIIA disease were registered from September 1996 through July 2000 and were randomly assigned to either 6 cycles of CMF or 2 years of UFT. In both arms, tamoxifen (TAM) was concurrently administered for 2 years. The primary end point in this study was the non-inferiority of UFT to CMF.

resultsNo statistically significant difference between the two groups was observed with regard to the 5-year RFS rate (72.2% in the UFT and 76.3% in the CMF). Adverse event profiles differed between the two groups, with a significantly lower incidence of leukopenia and anaemia in the UFT group, as well as anorexia, nausea/vomiting, stomatitis, and alopecia, which have implications for quality of life.

conclusionUFT administered in combination with TAM holds promise in the treatment of lymph node-positive early breast cancer. On stratified analysis, the recurrence rate in the UFT group was found to be better in oestrogen receptor (ER)-positive patients. Tegafur-based treatment should be evaluated by a prospective randomised trial conducted in ER-positive patients.

Indexed as

Antineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantCombined Modality TherapyCyclophosphamideDisease-Free SurvivalFemaleFluorouracilHumansLymphatic MetastasisMastectomyMethotrexateMiddle AgedNeoplasm StagingSurvival RateAntineoplastic Agents, HormonalCyclophosphamideFluorouracilMethotrexateTamoxifenTegafurUracil

Identifiers

PMID19638976
PMCPMC2736822
OpenAlexW2093759693

What OpenQuestion holds

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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.