Evidence map›Paper›PMID 29468454›Full record

Trial reportCancer chemotherapy and pharmacology2018

Randomized phase II study of anastrozole plus tegafur-uracil as neoadjuvant therapy for ER-positive breast cancer in postmenopausal Japanese women (Neo-ACET BC).

Takahiro Nakayama, Yasuaki Sagara, Tsutomu Takashima, Nobuki Matsunami, Norikazu Masuda, Yasuo Miyoshi, Tetsuya Taguchi, Toyokazu Aono, Toshikazu Ito, Tatsuo Kagimura and 1 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
–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

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Review
  6. Article
  7. Oral Administration ofFrontiers in pharmacology · 2018
    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

11 authors.

Takahiro NakayamaDepartment of Breast and Endocrine Surgery, Osaka International Cancer Institute, 3-1-69, Otemae, Chuou, Osaka, 541-8567, Japan. taqnakayama@gmail.com.
Yasuaki SagaraDepartment of Breast Surgery, Sagara Hospital, Kagoshima, Japan.
Tsutomu TakashimaDepartment of Surgical Oncology, Osaka City University Hospital, Osaka, Japan.
Nobuki MatsunamiDepartment of Surgery, Osaka Rosai Hospital, Sakai, Japan.
Norikazu MasudaDepartment of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, Japan.
Yasuo MiyoshiDepartment of Surgery, Division of Breast and Endocrine Surgery, Hyogo College of Medicine, Nishinomiya, Japan.
Tetsuya TaguchiDepartment of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Toyokazu AonoDepartment of Breast Surgery, Osaka Breast Clinic, Osaka, Japan.
Toshikazu ItoDepartment of Surgery, Rinku General Medical Center, Izumisano, Japan.
Tatsuo KagimuraTranslational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, Japan.
Shinzaburo NoguchiDepartment of Breast and Endocrine Surgery, Graduate School of Medicine Osaka University, Suita, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis phase II study evaluated the efficacy and safety of anastrozole concurrent with tegafur/uracil (UFT) as neoadjuvant therapy for ER-positive postmenopausal breast cancer.

methodsPostmenopausal Japanese women with ER-positive, HER2-negative, T2,N0-1,M0 breast cancer seen at tertiary hospitals were eligible for this open-label, randomized, multicenter study. Patients were randomized 1:1 by minimization to orally receive either anastrozole (1 mg once daily) plus UFT (tegafur/uracil combination in 1:4 molar ratio; 270 mg/m

resultsThe study was prematurely terminated due to Grade ≥ 3 liver dysfunction reported in 3 patients receiving anastrozole/UFT. Of 57 patients randomized before termination (29 anastrozole/UFT, 28 anastrozole), all were analyzed for safety and 56 (28 each group) for tumor response. Compared with anastrozole alone, anastrozole/UFT did not achieve significantly higher RR [39.3% (90% CI 23.8-56.5%) vs 14.3% (90% CI 5.0-29.8%); p = 0.0683, Fisher's exact test], but produced significantly greater tumor shrinkage (mean tumor reduction rate 31.0 vs. 14.2%; p = 0.0181, unpaired t-test). Grade ≥ 3 adverse events were more common with anastrozole/UFT than with anastrozole (17.2 vs. 0%).

conclusionAlthough the study was terminated owing to the altered liver function, it showed that there was a trend to greater shrinkage of tumor in the combination group for ER-positive, HER2-negative postmenopausal breast cancer.

Indexed as

Neoadjuvant TherapyPostmenopauseAgedAged, 80 and overAnastrozoleAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsFemaleFollow-Up StudiesHumansJapanMiddle AgedNeoplasm InvasivenessPrognosisTegafurUracilAnastrozoleTegafurUracilAnastrozoleBreast cancerClinical studyNeoadjuvant therapyUFT

Identifiers

PMID29468454
PMCPMC5854715

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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.