Evidence map›Paper›PMID 34277393›Full record

ArticleFrontiers in oncology2021

Patient-Reported Outcomes From Phase III Neoadjuvant Systemic Trial Comparing Neoadjuvant Chemotherapy With Neoadjuvant Endocrine Therapy in Pre-Menopausal Patients With Estrogen Receptor-Positive and HER2-Negative, Lymph Node-Positive Breast Cancer.

Sungchan Gwark, Sei Hyun Ahn, Woo Chul Noh, Eun Sook Lee, Yongsik Jung, Lee Su Kim, Wonshik Han, Seok Jin Nam, Gyungyub Gong, Seon-Ok Kim and 1 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Frontiers in oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01622361 (A Phase III, Open-Label, Prospective, Randomized, Multicenter, Neo-adjuvant Study of Chemotherapy Versus Endocrine Therapy in Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 62% 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.

NCT01622361 phase3unknown statusnot on this map

A Phase III, Open-Label, Prospective, Randomized, Multicenter, Neo-adjuvant Study of Chemotherapy Versus Endocrine Therapy in Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer

TypeinterventionalSponsorAsan Medical CenterRan2012 to 2016Enrolled290ConditionsBreast CancerArmsAdriamycin+Cyclophosphamide>Docetaxel, GnRHa with Tamoxifen
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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 at 8 institutions in 1 country.

Sungchan GwarkDepartment of Surgery, College of Medicine, Asan Medical Center, University of Ulsan, Seoul, South Korea.
Sei Hyun AhnDepartment of Surgery, College of Medicine, Asan Medical Center, University of Ulsan, Seoul, South Korea.
Woo Chul NohDepartment of Surgery, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, South Korea.
Eun Sook LeeDepartment of Surgery, Center for Breast Cancer, Research and Institute and Hospital, National Cancer Center, Goyang, South Korea.
Yongsik JungDepartment of Surgery, School of Medicine, Ajou University, Suwon, South Korea.
Lee Su KimDivision of Breast and Endocrine Surgery, Hallym University Sacred Heart Hospital, Hallym University, Anyang, South Korea.
Wonshik HanDepartment of Surgery and Cancer Research Institute, College of Medicine, Seoul National University, Seoul, South Korea.
Seok Jin NamDepartment of Surgery, School of Medicine, Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea.
Gyungyub GongDepartment of Pathology, College of Medicine, Asan Medical Center, University of Ulsan, Seoul, South Korea.
Seon-Ok KimDepartment of Clinical Epidemiology and Biostatistics, Asan Medical Center, Seoul, South Korea.
Hee Jeong KimDepartment of Surgery, College of Medicine, Asan Medical Center, University of Ulsan, Seoul, South Korea.
Asan Medical Center · KRAjou University · KRHallym University Sacred Heart Hospital · KRKorea Institute of Radiological and Medical Sciences · KRNational Cancer Center · KRSamsung Medical Center · KRSeoul National University · KRUniversity of Ulsan · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We aimed to evaluate the patient-reported outcomes (PROs) in a prospective phase III clinical trial, comparing neoadjuvant endocrine therapy (NET) with conventional neoadjuvant chemotherapy (NCT) in patients with hormone status positive, lymph node-positive premenopausal breast cancer (NCT01622361). The patients were randomized prospectively to either 24 weeks of NCT with adriamycin plus cyclophosphamide followed by taxane or NET with gonadotropin-releasing hormone agonist and tamoxifen. The patients were examined at the surgery unit of a large tertiary care hospital with a comprehensive cancer center. PROs were assessed on the first day of the trial (day 1, baseline) and at the end of treatment, using the breast cancer module of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 23 (EORTC QLQ BR23). One hundred and eighty-seven patients were randomly assigned to chemotherapy (n=95) or endocrine therapy (n=92), and 174 patients completed 24 weeks of the neoadjuvant treatment period (n=87, in each group). Baseline scores were similar between the groups. After treatment, there were no statistically significant differences in the function scales, including body image, sexual functioning, and sexual enjoyment between the groups, although the endocrine treatment group showed a significant improvement in the future perspective (hazard ratio, 8.3; 95% confidence interval, 1.72-18.38; P = 0.021). Similarly, there were no statistically significant differences in the symptom scales between the groups, including adverse effects of systemic therapy, breast symptoms, arm symptoms, and upset about hair loss. In conclusion, overall PROs were similar in both treatment groups, except for "future perspective," which was significantly better in the NET group than in the NCT group. CLINICAL

trial registrationClinicalTrials.Gov, identifier NCT01622361.

Indexed as

HER2-negativelymph node-positive breaST cancer (NEST)neoadjuvant chemotherapyneoadjuvant endocrine therapyNeoadjuvant stusdy of chemotherapy versus Endocrine therapy in premenopausal patient with hormone responsivepatient-reported outcomesquality of life

Identifiers

PMID34277393
PMCPMC8284076
OpenAlexW3186384803

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.