Omission of Breast Surgery in Predicted Pathologic Complete Response after Neoadjuvant Systemic Therapy: A Multicenter, Single-Arm, Non-inferiority Trial

정지정; 천종호; 김수연; 고지원; 유재민; Tae-Kyung Yoo; 신희철; 안성귀; 박세호; 임우성; 남상은; 박민호; 김구상; 강태우; 이지연; 윤현조; 김유석; 윤창익; 김홍규; 문형곤; 한원식; 조나리야; 김민균; 이한별

doi:10.4048/jbc.2023.0265

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저자정보: 정지정 (Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.) 천종호 (Department of Surgery, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea.) 김수연 (Department of Radiology, Seoul National University College of Medicine, Seoul, Korea.) 고지원 (Department of Pathology, Seoul National University College of Medicine, Seoul, Korea.Cancer Research Institute, Seoul National University, Seoul, Korea.) 유재민 (Division of Breast Surgery, Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.) Tae-Kyung Yoo (Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.) 신희철 (Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Korea.) 안성귀 (Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.) 박세호 (Department of Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.) 임우성 (Department of Surgery, College of Medicine, Ewha Womans University, Seoul, Korea.) 남상은 (Department of Surgery, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea.) 박민호 (Department of Surgery, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun, Korea.) 김구상 (Department of Breast Surgery, Gospel Hospital, Kosin University College of Medicine, Busan, Korea.) 강태우 (Department of Surgery, Pusan National University, School of Medicine, Busan, Korea.Busan Cancer Center and Biomedical Research Institute, Pusan National University Hospital, Busan, Korea.) 이지연 (Department of Surgery, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, Daegu, Korea.) 윤현조 (Department of Surgery, Jeonbuk National University Medical School, Jeonju, Korea.) 김유석 (Department of Surgery, Chosun University College of Medicine, Gwangju, Korea.) 윤창익 (Division of Breast Surgery, Department of Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.) 김홍규 (Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.Biomedical Research Institute, Seoul National University Hospital, Seoul, Korea.) 문형곤 (Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.Cancer Research Institute, Seoul National University, Seoul, Korea.Biomedical Research Institute, Seoul Nat) 한원식 (Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.Cancer Research Institute, Seoul National University, Seoul, Korea.Biomedical Research Institute, Seoul Nat) 조나리야 (Department of Radiology, Seoul National University College of Medicine, Seoul, Korea.) 김민균 (Department of Surgery, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea.) 이한별 (Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.Cancer Research Institute, Seoul National University, Seoul, Korea.Biomedical Research Institute, Seoul Nat)

저널정보: 한국유방암학회 Journal of Breast Cancer Journal of Breast Cancer Vol.27 No.1

발행연도: 2024.2

수록면: 61 - 71 (11page)

DOI: 10.4048/jbc.2023.0265

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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 vacuum-assisted 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. Trial Registration ClinicalTrials.gov Identifier: NCT05505357. Registered on August 17, 2022. Clinical Research Information Service Identifier: KCT0007638. Registered on July 25, 2022.

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 vacuum-assisted 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. Trial Registration ClinicalTrials.gov Identifier: NCT05505357. Registered on August 17, 2022. Clinical Research Information Service Identifier: KCT0007638. Registered on July 25, 2022.

#Biopsy #Breast Neoplasms #Clinical Trial #Multicenter Study #Neoadjuvant Therapy

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