J Breast Cancer.
2024 Feb;27(1):61-71. 10.4048/jbc.2023.0265.
Omission of Breast Surgery in Predicted Pathologic Complete Response after Neoadjuvant Systemic Therapy: A Multicenter, Single-Arm, Non-inferiority Trial
- Jung JJ
1 - Cheun JH2
- Kim SY3
- Koh J4,5
- Ryu JM6
- Yoo TK7
- Shin HC1,8
- Ahn SG9
- Park S10
- Lim W11
- Nam SE12
- Park MH13
- Kim KS14
- Kang T15,16
- Lee J17
- Youn HJ18
- Kim YS19
- Yoon CI20
- Kim HK1,21
- Moon HG1,5,21
- Han W1,5,21
- Cho N3
- Kim MK22
- Lee HB1,5,21
- Affiliations
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- 1Department of Surgery, Seoul National University College of Medicine, Seoul, Korea
- 2Department of Surgery, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea
- 3Department of Radiology, Seoul National University College of Medicine, Seoul, Korea
- 4Department of Pathology, Seoul National University College of Medicine, Seoul, Korea
- 5Cancer Research Institute, Seoul National University, Seoul, Korea
- 6Division of Breast Surgery, Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
- 7Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
- 8Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Korea
- 9Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
- 10Department of Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
- 11Department of Surgery, College of Medicine, Ewha Womans University, Seoul, Korea
- 12Department of Surgery, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea
- 13Department of Surgery, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun, Korea
- 14Department of Breast Surgery, Gospel Hospital, Kosin University College of Medicine, Busan, Korea
- 15Department of Surgery, Pusan National University, School of Medicine, Busan, Korea
- 16Busan Cancer Center and Biomedical Research Institute, Pusan National University Hospital, Busan, Korea
- 17Department of Surgery, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, Daegu, Korea
- 18Department of Surgery, Jeonbuk National University Medical School, Jeonju, Korea
- 19Department of Surgery, Chosun University College of Medicine, Gwangju, Korea
- 20Division of Breast Surgery, Department of Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
- 21Biomedical Research Institute, Seoul National University Hospital, Seoul, Korea
- 22Department of Surgery, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea
- KMID: 2553578
- DOI: http://doi.org/10.4048/jbc.2023.0265
Abstract
- Purpose
Advances in chemotherapeutic and targeted agents have increased pathologic complete response (pCR) rates after neoadjuvant systemic therapy (NST). Vacuum-assisted biopsy (VAB) has been suggested to accurately evaluate pCR. This study aims to confirm the non-inferiority of the 5-year disease-free survival of patients who omitted breast surgery when predicted to have a pCR based on breast magnetic resonance imaging (MRI) and VAB after NST, compared with patients with a pCR who had undergone breast surgery in previous studies.
Methods
The Omission of breast surgery for PredicTed pCR patients wIth MRI and vacuumassisted bIopsy in breaST cancer after neoadjuvant systemic therapy (OPTIMIST) trial is a prospective, multicenter, single-arm, non-inferiority study enrolling in 17 tertiary care hospitals in the Republic of Korea. Eligible patients must have a clip marker placed in the tumor and meet the MRI criteria suggesting complete clinical response (post-NST MRI size ≤ 1 cm and lesion-to-background signal enhancement ratio ≤ 1.6) after NST. Patients will undergo VAB, and breast surgery will be omitted for those with no residual tumor. Axillary surgery can also be omitted if the patient was clinically node-negative before and after NST and met the stringent criteria of MRI size ≤ 0.5 cm. Survival and efficacy outcomes are evaluated over five years. Discussion: This study seeks to establish evidence for the safe omission of breast surgery in exceptional responders to NST while minimizing patient burden. The trial will address concerns about potential undertreatment due to false-negative results and recurrence as well as improved patient-reported quality of life issues from the omission of surgery. Successful completion of this trial may reshape clinical practice for certain breast cancer subtypes and lead to a safe and less invasive approach for selected patients.
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