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

BMC Cancer

Seeyoun Lee¹  Kyung Hwan Shin²  Ji Hyun Chang²  Jung Min Chang³  Woo Kyung Moon³  Yong Sik Jung⁴  Se Hyun Ahn⁵  Il Yong Chung⁵  Woosung Lim⁶  Joon Jeong⁷  Jai Min Ryu⁸  Eun-Kyu Kim⁹  Ji Gwang Jung^1,10  Wonshik Han^1,11  Seho Park^1,12 

[1] Center for Breast Cancer, National Cancer Center, Goyang, Republic of Korea;Department of Radiation Oncology, Seoul National University College of Medicine, Seoul, Republic of Korea;Department of Radiology, Seoul National University College of Medicine, Seoul, Republic of Korea;Department of Surgery, Ajou University School of Medicine, Suwon, Republic of Korea;Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea;Department of Surgery, Ewha Womans University School of Medicine, Ewha Womans University Mokdong Hospital, Seoul, Republic of Korea;Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea;Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea;Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea;Department of Surgery, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, 03080, Seoul, Republic of Korea;Department of Surgery, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, 03080, Seoul, Republic of Korea;Biomedical Research Institute, Seoul National University Hospital, Seoul, Republic of Korea;Cancer Research Institute, Seoul National University, 101 Daehak-ro, Jongno-gu, 03080, Seoul, Republic of Korea;Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea;

关键词: Breast cancer;    Sentinel node biopsy;    Ultrasound;   

DOI  :  10.1186/s12885-022-09273-1

来源: Springer

【 摘 要 】

BackgroundFollowing 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.MethodsThe 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.DiscussionThis 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 registrationClinicalTrials.gov, NCT04303715. Registered on March 11, 2020.

【 授权许可】

CC BY