No axillary surgical treatment for lymph node-negative patients after ultra-sonography [NAUTILUS]: protocol of a prospective randomized clinical trial

Ji Gwang Jung; Se Hyun Ahn; Seeyoun Lee; Eun Kyu Kim; Jai Min Ryu; Seho Park; Woosung Lim; Yong Sik Jung; Il Yong Chung; Joon Jeong; Ji Hyun Chang; Kyung Hwan Shin; Jung Min Chang; Woo Kyung Moon; Wonshik Han

doi:10.1186/s12885-022-09273-1

No axillary surgical treatment for lymph node-negative patients after ultra-sonography [NAUTILUS]: protocol of a prospective randomized clinical trial

Ji Gwang Jung, Se Hyun Ahn, Seeyoun Lee, Eun Kyu Kim, Jai Min Ryu, Seho Park, Woosung Lim, Yong Sik Jung, Il Yong Chung, Joon Jeong, Ji Hyun Chang, Kyung Hwan Shin, Jung Min Chang, Woo Kyung Moon, Wonshik Han

Department of Surgery

Research output: Contribution to journal › Article › peer-review

9 Scopus citations

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.

Original language	English
Article number	189
Journal	BMC Cancer
Volume	22
Issue number	1
DOIs	https://doi.org/10.1186/s12885-022-09273-1
State	Published - Dec 2022

Bibliographical note

Funding Information:
This research is supported by a grant from the Patient-Centered Clinical Research Coordinating Center (PACEN) funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HI19C0481, HC19C0110). The funding source was not involved in the study design, and has no role in data collection, data analysis and interpretation, or decision to submit results for presentation or publication.

Publisher Copyright:
© 2022, The Author(s).

Keywords

Breast cancer
Sentinel node biopsy
Ultrasound

Access to Document

10.1186/s12885-022-09273-1

Cite this

Jung, J. G., Ahn, S. H., Lee, S., Kim, E. K., Ryu, J. M., Park, S., Lim, W., Jung, Y. S., Chung, I. Y., Jeong, J., Chang, J. H., Shin, K. H., Chang, J. M., Moon, W. K., & Han, W. (2022). No axillary surgical treatment for lymph node-negative patients after ultra-sonography [NAUTILUS]: protocol of a prospective randomized clinical trial. BMC Cancer, 22(1), Article 189. https://doi.org/10.1186/s12885-022-09273-1

@article{414153af0603410a8810b9b157db27f9,

title = "No axillary surgical treatment for lymph node-negative patients after ultra-sonography [NAUTILUS]: protocol of a prospective randomized clinical trial",

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.",

keywords = "Breast cancer, Sentinel node biopsy, Ultrasound",

author = "Jung, {Ji Gwang} and Ahn, {Se Hyun} and Seeyoun Lee and Kim, {Eun Kyu} and Ryu, {Jai Min} and Seho Park and Woosung Lim and Jung, {Yong Sik} and Chung, {Il Yong} and Joon Jeong and Chang, {Ji Hyun} and Shin, {Kyung Hwan} and Chang, {Jung Min} and Moon, {Woo Kyung} and Wonshik Han",

note = "Funding Information: This research is supported by a grant from the Patient-Centered Clinical Research Coordinating Center (PACEN) funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HI19C0481, HC19C0110). The funding source was not involved in the study design, and has no role in data collection, data analysis and interpretation, or decision to submit results for presentation or publication. Publisher Copyright: {\textcopyright} 2022, The Author(s).",

year = "2022",

month = dec,

doi = "10.1186/s12885-022-09273-1",

language = "English",

volume = "22",

journal = "BMC Cancer",

issn = "1471-2407",

publisher = "BioMed Central Ltd.",

number = "1",

}

Jung, JG, Ahn, SH, Lee, S, Kim, EK, Ryu, JM, Park, S, Lim, W, Jung, YS, Chung, IY, Jeong, J, Chang, JH, Shin, KH, Chang, JM, Moon, WK & Han, W 2022, 'No axillary surgical treatment for lymph node-negative patients after ultra-sonography [NAUTILUS]: protocol of a prospective randomized clinical trial', BMC Cancer, vol. 22, no. 1, 189. https://doi.org/10.1186/s12885-022-09273-1

TY - JOUR

T1 - No axillary surgical treatment for lymph node-negative patients after ultra-sonography [NAUTILUS]

T2 - protocol of a prospective randomized clinical trial

AU - Jung, Ji Gwang

AU - Ahn, Se Hyun

AU - Lee, Seeyoun

AU - Kim, Eun Kyu

AU - Ryu, Jai Min

AU - Park, Seho

AU - Lim, Woosung

AU - Jung, Yong Sik

AU - Chung, Il Yong

AU - Jeong, Joon

AU - Chang, Ji Hyun

AU - Shin, Kyung Hwan

AU - Chang, Jung Min

AU - Moon, Woo Kyung

AU - Han, Wonshik

N1 - Funding Information: This research is supported by a grant from the Patient-Centered Clinical Research Coordinating Center (PACEN) funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HI19C0481, HC19C0110). The funding source was not involved in the study design, and has no role in data collection, data analysis and interpretation, or decision to submit results for presentation or publication. Publisher Copyright: © 2022, The Author(s).

PY - 2022/12

Y1 - 2022/12

N2 - 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.

AB - 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.

KW - Breast cancer

KW - Sentinel node biopsy

KW - Ultrasound

UR - http://www.scopus.com/inward/record.url?scp=85125002636&partnerID=8YFLogxK

U2 - 10.1186/s12885-022-09273-1

DO - 10.1186/s12885-022-09273-1

M3 - Article

C2 - 35184724

AN - SCOPUS:85125002636

SN - 1471-2407

VL - 22

JO - BMC Cancer

JF - BMC Cancer

IS - 1

M1 - 189

ER -

No axillary surgical treatment for lymph node-negative patients after ultra-sonography [NAUTILUS]: protocol of a prospective randomized clinical trial

Abstract

Bibliographical note

Keywords

Access to Document

Fingerprint

Cite this