Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 임우성 | * |
dc.date.accessioned | 2022-03-29T16:31:07Z | - |
dc.date.available | 2022-03-29T16:31:07Z | - |
dc.date.issued | 2022 | * |
dc.identifier.issn | 1471-2407 | * |
dc.identifier.other | OAK-31097 | * |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/260962 | - |
dc.description.abstract | Background: Following sentinel lymph node biopsy (SLNB), the axillary recurrence rate is very low although SLNB has a false-negative rate of 5–10%. In the ACOSOG Z0011 trial, non-sentinel positive-lymph nodes were found in more than 20% of the axillary dissection group; the SLNB only group did not have a higher axillary recurrence rate. These findings raised questions about the direct therapeutic effect of the SLNB. SLNB has post-surgical complications including lymphedema. Considering advances in imaging modalities and adjuvant therapies, the role of SLNB in early breast cancer needs to be re-evaluated. Methods: The NAUTILUS trial is a prospective multicenter randomized controlled trial involving clinical stage T1–2 and N0 breast cancer patients receiving breast-conserving surgery. Axillary ultrasound is mandatory before surgery with predefined imaging criteria for inclusion. Ultrasound-guided core needle biopsy or needle aspiration of a suspicious node is allowed. Patients will be randomized (1:1) into the no-SLNB (test) and SLNB (control) groups. A total of 1734 patients are needed, considering a 5% non-inferiority margin, 5% significance level, 80% statistical power, and 10% dropout rate. All patients in the two groups will receive ipsilateral whole-breast radiation according to a predefined protocol. The primary endpoint of this trial is the 5-year invasive disease-free survival. The secondary endpoints are overall survival, distant metastasis-free survival, axillary recurrence rate, and quality of life of the patients. Discussion: This trial will provide important evidence on the oncological safety of the omission of SLNB for early breast cancer patients undergoing breast-conserving surgery and receiving whole-breast radiation, especially when the axillary lymph node is not suspicious during preoperative axillary ultrasound. Trial registration: ClinicalTrials.gov, NCT04303715. Registered on March 11, 2020. © 2022, The Author(s). | * |
dc.language | English | * |
dc.publisher | BioMed Central Ltd | * |
dc.subject | Breast cancer | * |
dc.subject | Sentinel node biopsy | * |
dc.subject | Ultrasound | * |
dc.title | No axillary surgical treatment for lymph node-negative patients after ultra-sonography [NAUTILUS]: protocol of a prospective randomized clinical trial | * |
dc.type | Article | * |
dc.relation.issue | 1 | * |
dc.relation.volume | 22 | * |
dc.relation.index | SCIE | * |
dc.relation.index | SCOPUS | * |
dc.relation.journaltitle | BMC Cancer | * |
dc.identifier.doi | 10.1186/s12885-022-09273-1 | * |
dc.identifier.wosid | WOS:000758118700002 | * |
dc.identifier.scopusid | 2-s2.0-85125002636 | * |
dc.author.google | Jung J.G. | * |
dc.author.google | Ahn S.H. | * |
dc.author.google | Lee S. | * |
dc.author.google | Kim E.-K. | * |
dc.author.google | Ryu J.M. | * |
dc.author.google | Park S. | * |
dc.author.google | Lim W. | * |
dc.author.google | Jung Y.S. | * |
dc.author.google | Chung I.Y. | * |
dc.author.google | Jeong J. | * |
dc.author.google | Chang J.H. | * |
dc.author.google | Shin K.H. | * |
dc.author.google | Chang J.M. | * |
dc.author.google | Moon W.K. | * |
dc.author.google | Han W. | * |
dc.contributor.scopusid | 임우성(27167744500) | * |
dc.date.modifydate | 20240130112620 | * |