Evidence map›Paper›PMID 30643455›Full record

ArticleCancer management and research2019

Switching to anastrozole plus goserelin vs continued tamoxifen for adjuvant therapy of premenopausal early-stage breast cancer: preliminary results from a randomized trial.

Jian-Wei Li, Guang-Yu Liu, Ya-Jie Ji, Xia Yan, Da Pang, Ze-Fei Jiang, De-Dian Chen, Bin Zhang, Bing-He Xu, Zhi-Ming Shao

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Cancer management and research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01352091 (A Randomized ,Open Label Study Comparing the Efficacy of Zoladex® Combined With Arimidex® for 3-2 Years After Selective Estrogen Receptor Modulators), which is not on this 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
1.1field-weighted citation impact, top 19% 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.

NCT01352091 phase3unknown statusnot on this map

A Randomized ,Open Label Study Comparing the Efficacy of Zoladex® Combined With Arimidex® for 3-2 Years After Selective Estrogen Receptor Modulators (SERMs) as an Adjuvant Therapy for 2-3 Years Versus Continuing Tamoxifen up to 5 Years for Premenopausal Early Breast Cancer Patients With Hormone Receptor Positive, Lymph Node Positive or Tumor≥ 4cm.

TypeinterventionalSponsorFudan UniversityRan2008 to 2018Enrolled670ConditionsBreast CancerArmsZoladex+AI, TAM
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Review
  6. Article
  7. 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

10 authors at 7 institutions in 1 country.

Jian-Wei LiDepartment of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China, zhimingshao@fudan.edu.cn.
Guang-Yu LiuDepartment of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China, zhimingshao@fudan.edu.cn.
Ya-Jie JiDepartment of Breast Surgery, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.
Xia YanDepartment of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China, zhimingshao@fudan.edu.cn.
Da PangDepartment of Breast Surgery, The Third Affiliated Hospital of Harbin Medical University, Harbin, People's Republic of China.
Ze-Fei JiangDepartment of Oncology, 307 Hospital of People's Liberation Army, Beijing, People's Republic of China.
De-Dian ChenDepartment of Breast Diseases, Cancer Hospital of Yunnan Province, Kunming, People's Republic of China.
Bin ZhangDepartment of Breast Surgery, Cancer Hospital of Liaoning Province, Shenyang, People's Republic of China.
Bing-He XuDepartment of Oncology, Cancer Hospital of Chinese Academy of Medical Sciences, Beijing, People's Republic of China.
Zhi-Ming ShaoDepartment of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China, zhimingshao@fudan.edu.cn.
Shanghai Medical College of Fudan University · CN307th Hospital of Chinese People’s Liberation Army · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNHarbin Medical University · CNLiaoning Cancer Hospital & Institute · CNSecond People's Hospital of Yunnan Province · CNShanghai University of Traditional Chinese Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo assess the efficacy, safety, and quality-of-life impact of switching adjuvant treatment in hormone receptor-positive primary breast cancer patients who are still premenopausal after 2-3 years of tamoxifen therapy to anastrozole plus goserelin as compared with continuing tamoxifen over a total period of 5 years. PATIENTS AND

methodsHormone receptor-positive, premenopausal, lymph node-positive, or tumor size ≥4 cm breast cancer patients who had received tamoxifen for 2-3 years were randomly assigned to continue tamoxifen treatment (TAM group) or switch to adjuvant anastrozole plus goserelin (ADD group) and continue treatment for another 2-3 years (total treatment duration 5 years). Endpoints evaluated were adverse events (AEs), changes in bone mineral density, quality of life, and disease-free survival-related events.

resultsA total of 62 patients (33 in the ADD group and 29 in the TAM group) were evaluated. Grade 3-4 drug-related AEs occurred in five patients (15.2%) in the ADD group vs none in the TAM group. In the ADD group, arthralgias were the most common AEs (5/33 patients; 15.2%), and three patients in this group were discontinued because of AEs. Treatment was temporarily suspended due to AEs in three patients (9.1%) in the ADD group and one patient (3.4%) in the TAM group. Compared with continuing TAM therapy, switching to anastrozole plus goserelin did not result in any worsening of bone mineral density or quality of life. During a median follow-up of 34 months, five patients (15.2%) in the ADD group had disease-free survival events vs four patients (13.8%) in the TAM group.

conclusionFor early-stage breast cancer patients who remain premenopausal following 2-3 years of adjuvant tamoxifen therapy, switching to anastrozole plus goserelin therapy was safe with tolerable adverse effects. However, it did not show superior efficacy compared to remaining on tamoxifen treatment.

trial registrationClinicalTrials.gov (identifier NCT01352091).

Indexed as

adjuvant therapyanastrozolearomatase inhibitorsbreast cancerGnRH analogstamoxifen

Identifiers

PMID30643455
PMCPMC6312049
OpenAlexW2905764688

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.