Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, staging and treatment of patients with metastatic breast cancer

doi:10.1016/j.esmoop.2023.101541

Practice Guideline

. 2023 Jun;8(3):101541.

doi: 10.1016/j.esmoop.2023.101541. Epub 2023 May 11.

Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, staging and treatment of patients with metastatic breast cancer

S-A Im¹, A Gennari², Y H Park³, J H Kim⁴, Z-F Jiang⁵, S Gupta⁶, T H Fadjari⁷, K Tamura⁸, M Y Mastura⁹, M L T Abesamis-Tiambeng¹⁰, E H Lim¹¹, C-H Lin¹², A Sookprasert¹³, N Parinyanitikul¹⁴, L-M Tseng¹⁵, S-C Lee¹⁶, P Caguioa¹⁷, M Singh¹⁸, Y Naito¹⁹, R A Hukom²⁰, B K Smruti²¹, S-S Wang²², S B Kim²³, K-H Lee²⁴, H K Ahn²⁵, S Peters²⁶, T W Kim²⁷, T Yoshino²⁸, G Pentheroudakis²⁹, G Curigliano³⁰, N Harbeck³¹

Affiliations

¹ Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University, Seoul, Republic of Korea. Electronic address: moisa@snu.ac.kr.
² Department of Translational Medicine, University Piemonte Orientale, Novara, Italy.
³ Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
⁴ Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seoul National University, Seoul, Republic of Korea.
⁵ Department of Oncology, The Fifth Medical Center of PLA General Hospital, Beijing, China.
⁶ Tata Memorial Centre and Homi Bhabha National Institute, Mumbai, India.
⁷ Department of Internal Medicine, Hasan Sadikin General Hospital, Bandung, Indonesia.
⁸ Department of Medical Oncology, Shimane University Hospital, Shimane, Japan.
⁹ Cancer Centre, Pantai Hospital Kuala Lumpur, Kuala Lumpur, Malaysia.
¹⁰ Section of Medical Oncology, Department of Internal Medicine, Cardinal Santos Cancer Center, San Juan, The Philippines.
¹¹ Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore.
¹² Department of Medical Oncology, National Taiwan University Hospital, Cancer Center Branch, Taipei, Taiwan.
¹³ Department of Internal Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
¹⁴ Medical Oncology Unit, Department of Medicine, Faculty of Medicine, King Chulalongkorn Memorial Hospital and Chulalongkorn University, Bangkok, Thailand.
¹⁵ Taipei-Veterans General Hospital, Taipei, Taiwan; School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.
¹⁶ Department of Haematology-Oncology, National University Cancer Institute, Singapore (NCIS), Singapore, Singapore.
¹⁷ The Cancer Institute of St Luke's Medical Center, National Capital Region, The Philippines; The Cancer Institute of the University of Santo Tomas Hospital, National Capital Region, The Philippines.
¹⁸ Department of Radiotherapy, Pantai Cancer Institute, Pantai Hospital Kuala Lumpur, Kuala Lumpur, Malaysia; Department of Oncology, Pantai Cancer Institute, Pantai Hospital Kuala Lumpur, Kuala Lumpur, Malaysia.
¹⁹ Department of General Internal Medicine, National Cancer Center Hospital East, Kashiwa, Japan.
²⁰ Department of Hematology and Medical Oncology, Dharmais Hospital (National Cancer Center), Jakarta, Indonesia.
²¹ Medical Oncology, Lilavati Hospital and Research Centre and Bombay Hospital Institute of Medical Sciences, Mumbai, India.
²² Cancer Center, Sun Yat-sen University, Guangzhou, China.
²³ Department of Oncology, Asan Medical Centre, Seoul, Republic of Korea.
²⁴ Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University, Seoul, Republic of Korea.
²⁵ Division of Medical Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea.
²⁶ Oncology Department, Lausanne University Hospital (CHUV), Lausanne, Switzerland.
²⁷ Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
²⁸ Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
²⁹ ESMO, Lugano, Switzerland.
³⁰ Istituto Europeo di Oncologia, IRCCS, Milan, Italy; Department of Oncology and Haematology, University of Milano, Milan, Italy.
³¹ Breast Center, Department of Obstetrics and Gynaecology and Comprehensive Cancer Center Munich, LMU University Hospital, Munich, Germany.

PMID: 37178669
PMCID: PMC10186487
DOI: 10.1016/j.esmoop.2023.101541

Practice Guideline

Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, staging and treatment of patients with metastatic breast cancer

S-A Im et al. ESMO Open. 2023 Jun.

. 2023 Jun;8(3):101541.

doi: 10.1016/j.esmoop.2023.101541. Epub 2023 May 11.

Authors

Affiliations

¹ Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University, Seoul, Republic of Korea. Electronic address: moisa@snu.ac.kr.
² Department of Translational Medicine, University Piemonte Orientale, Novara, Italy.
³ Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
⁴ Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seoul National University, Seoul, Republic of Korea.
⁵ Department of Oncology, The Fifth Medical Center of PLA General Hospital, Beijing, China.
⁶ Tata Memorial Centre and Homi Bhabha National Institute, Mumbai, India.
⁷ Department of Internal Medicine, Hasan Sadikin General Hospital, Bandung, Indonesia.
⁸ Department of Medical Oncology, Shimane University Hospital, Shimane, Japan.
⁹ Cancer Centre, Pantai Hospital Kuala Lumpur, Kuala Lumpur, Malaysia.
¹⁰ Section of Medical Oncology, Department of Internal Medicine, Cardinal Santos Cancer Center, San Juan, The Philippines.
¹¹ Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore.
¹² Department of Medical Oncology, National Taiwan University Hospital, Cancer Center Branch, Taipei, Taiwan.
¹³ Department of Internal Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
¹⁴ Medical Oncology Unit, Department of Medicine, Faculty of Medicine, King Chulalongkorn Memorial Hospital and Chulalongkorn University, Bangkok, Thailand.
¹⁵ Taipei-Veterans General Hospital, Taipei, Taiwan; School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.
¹⁶ Department of Haematology-Oncology, National University Cancer Institute, Singapore (NCIS), Singapore, Singapore.
¹⁷ The Cancer Institute of St Luke's Medical Center, National Capital Region, The Philippines; The Cancer Institute of the University of Santo Tomas Hospital, National Capital Region, The Philippines.
¹⁸ Department of Radiotherapy, Pantai Cancer Institute, Pantai Hospital Kuala Lumpur, Kuala Lumpur, Malaysia; Department of Oncology, Pantai Cancer Institute, Pantai Hospital Kuala Lumpur, Kuala Lumpur, Malaysia.
¹⁹ Department of General Internal Medicine, National Cancer Center Hospital East, Kashiwa, Japan.
²⁰ Department of Hematology and Medical Oncology, Dharmais Hospital (National Cancer Center), Jakarta, Indonesia.
²¹ Medical Oncology, Lilavati Hospital and Research Centre and Bombay Hospital Institute of Medical Sciences, Mumbai, India.
²² Cancer Center, Sun Yat-sen University, Guangzhou, China.
²³ Department of Oncology, Asan Medical Centre, Seoul, Republic of Korea.
²⁴ Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University, Seoul, Republic of Korea.
²⁵ Division of Medical Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea.
²⁶ Oncology Department, Lausanne University Hospital (CHUV), Lausanne, Switzerland.
²⁷ Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
²⁸ Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
²⁹ ESMO, Lugano, Switzerland.
³⁰ Istituto Europeo di Oncologia, IRCCS, Milan, Italy; Department of Oncology and Haematology, University of Milano, Milan, Italy.
³¹ Breast Center, Department of Obstetrics and Gynaecology and Comprehensive Cancer Center Munich, LMU University Hospital, Munich, Germany.

PMID: 37178669
PMCID: PMC10186487
DOI: 10.1016/j.esmoop.2023.101541

Abstract

The most recent version of the European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for the diagnosis, staging and treatment of patients with metastatic breast cancer (MBC) was published in 2021. A special, hybrid guidelines meeting was convened by ESMO and the Korean Society of Medical Oncology (KSMO) in collaboration with nine other Asian national oncology societies in May 2022 in order to adapt the ESMO 2021 guidelines to take into account the differences associated with the treatment of MBC in Asia. These guidelines represent the consensus opinions reached by a panel of Asian experts in the treatment of patients with MBC representing the oncological societies of China (CSCO), India (ISMPO), Indonesia (ISHMO), Japan (JSMO), Korea (KSMO), Malaysia (MOS), the Philippines (PSMO), Singapore (SSO), Taiwan (TOS) and Thailand (TSCO). The voting was based on the best available scientific evidence and was independent of drug access or practice restrictions in the different Asian countries. The latter were discussed when appropriate. The aim of these guidelines is to provide guidance for the harmonisation of the management of patients with MBC across the different regions of Asia, drawing from data provided by global and Asian trials whilst at the same time integrating the differences in genetics, demographics and scientific evidence, together with restricted access to certain therapeutic strategies.

Keywords: ESMO; Pan-Asian; guidelines; metastatic breast cancer; treatment.

PubMed Disclaimer

Conflict of interest statement

Disclosure MLTAT declares consulting fees and honoraria from MSD, Roche, Novartis, Eli Lilly and AstraZeneca. HKA declares consulting fees from Daiichi Sankyo, Amgen, Yuhan and Novartis, and honoraria from Roche, BMS, MSD, Eli Lilly, AstraZeneca, Boehringer Ingelheim, Menarini, Eisai, Pfizer, Boryung Pharmaceutical Company, Celtrion, Pharmobio Korea Inc. and Yuhan. GC has served as consultant or advisor for Roche, Eli Lilly and BMS; served on a speaker’s bureau for Roche, Pfizer and Eli Lilly; received travel funding from Pfizer and Roche; and received honoraria from Roche, Pfizer, Eli Lilly, Novartis, AstraZeneca and SeaGen, all outside the submitted work. THF declares honoraria from AstraZeneca Oncology Indonesia, Takeda Indonesia, Eisai Indonesia, Roche Oncology Indonesia, J & J Indonesia and Zueling Pharma Indonesia and role as head of division of Area Development for West Java, Indonesia for the Indonesian Society of Hematology and Medical Oncology. AG declares honoraria for advisory boards from AstraZeneca, Daiichi Sankyo, Eisai, Eli Lilly, Novartis, Pfizer and Roche; honoraria for lectures from Eisai and Eli Lilly and honoraria for expert testimony from Gentili. SG declares honoraria from Lupin, Roche, Novartis, Eli Lilly, Eisai, Cipla, CADILA, Intas and AstraZeneca; honoraria for being on committees of the Indian Council of Medical Research (Government of India), Council of Scientific and Industrial Research (Government of India), Department of Biotechnology (Government of India), India Alliance and institutional; honoraria from Novartis and AstraZeneca for participation in steering committees; leadership roles include President of Indian Society of Medical and Paediatric Oncology and General Secretary of Women’s Cancer Initiative - Tata Memorial Hospital, both roles unpaid. NH reports honoraria for lectures, advisory boards and/or personal fees from Amgen, AstraZeneca, Daiichi Sankyo, Eli Lilly, MSD, Novartis, Pfizer, Pierre Fabre, Roche, Sandoz and SeaGen, and minority ownership interest in the West German Study Group. RAH declares honoraria from Roche, Novartis, MSD, Pfizer and Mylan, and support for attending meetings from Roche, MSD and Kalbe Pharma. SAI declares an institutional grant from AstraZeneca, Boryung Pharm, Daewoong Pharm, Eisai, Roche and Pfizer, and honoraria from AstraZeneca, Novartis, MSD, Roche, Pfizer; advisory role for AstraZeneca, Bertis, Daiichi Sankyo, Eisai, Hanmi, Lilly, MSD, Novartis, Roche and Pfizer. JHK declares an institutional grant from Ono Pharma Ltd., and honoraria from Novartis, MSD, Roche Pharma, Roche diagnostics, Pfizer, AstraZeneca, Eisai, Lilly, and Sanofi; fees for participation in data monitoring or advisory boards from Bixink, Eisai, Yuhan, Novartis, Daiichi Sankyo, Pfizer, Roche Pharma and Everest Medicines; institutional gifts from Eisai and Ono Pharma Ltd. SBK declares institutional funding from Novartis, Sanofi-Aventis and Dongkook Pharm Co.; consulting fees from Novartis, AstraZeneca, Lilly, DaeHwa Pharmaceutical Co Ltd., ISU Abxis, Beigene, OBI Pharma and Daiichi Sankyo; honoraria from Novartis, Pfizer, Lilly, OBI Pharma and Legochem Bioscience; participation on data safety monitoring or advisory boards for Novartis, AstraZeneca, MSD, Lilly and Daiichi Sankyo, and purchased stock in Genopeaks and Neogene TC. KHL declares honoraria from Pfizer, Novartis and Eli Lilly. SCL declares grants from Pfizer, Eisai, Taiho, ACT Genomics, MSD, Adagene and Epizyme; honoraria from Pfizer, Novartis, AstraZeneca, ACT Genomics, Eli Lilly, MSD and Roche and participation in data monitoring or advisory boards for Pfizer, Novartis, Eisai, Sanofi, Daiichi Sankyo, MSD and Roche. MYM declares institutional grants from MSD, Astella, Pfizer, Novartis, AstraZeneca, ARCUS, Amgen and honoraria from MSD, Amgen, Pfizer, Roche, Novartis, Zuelling Pharma, Specialised therapeutics, Eisai, GSK, Mundi Pharma, Eli Lilly and AstraZeneca. YN declares institutional grants from the Ministry of Health, Labour and Welfare, Abbvie, Ono, Daiichi Sankyo, Taiho, Pfizer, Boehringer Ingelheim, Eli Lilly, Eisai, AstraZeneca, Chugai, Bayer and honoraria from AstraZeneca, Eisai, Ono, Gardant, Takeda, Eli Lilly, Novartis, Pfizer, Chugai, Fuji Film Toyama Chemistry, Taiho, Mundi, Bristol, Shionogi. NP declares honoraria from AstraZeneca, Eisai, Roche, Eli Lilly, Novartis, Pfizer and MSD. YHP declares grants from AstraZeneca, Pfizer, Novartis, Roche and Gencurix, consulting fees from AstraZeneca, Pfizer, Novartis, Roche, Eisai, Daiichi Sankyo, MSD and Lilly, honoraria from Pfizer, MSD, Novartis and Roche, and participation on data monitoring boards and advisory boards for Roche, Eisai, Daiichi Sankyo, AstraZeneca, MSD and Novartis. SP declares fees for consultancy/advisory roles from Abbvie, Amgen, Arcus, AstraZeneca, Bayer, Beigene, Bio Invent, Biocartis, Blueprint Medicines, Boehringer Ingelheim, BMS, Daiichi Sankyo, Debiopharm, ecancer, Eli Lilly, Elsevier, F-star, Foundation Medicine, Genzyme, Gilhead, GSK, Illumina, Incyte, IQIVIA, iTHeos, Janssen, Medscape, MSD, Merck Serono, Mirati, Novartis, Novocure, Pharma Mar, Phosplatin Therapeutics, Pfizer, Regeneron, Roche/Genentech, Sanofi, SeaGen, Takeda, Vaccibody, speaker roles for AstraZeneca, Boehringer Ingelheim, BMS, ecancer, Eli Lilly, Fishawack, Illumina, Imedex, Medscape, Mirati MSD, Novartis, OncologyEducation, PER, Pfizer, PRIME, RMEI, Roche/Genentech, RTP, Sanofi, Takeda and steering committee and trial chair roles as follows: AstraZeneca, coordinating PI, institutional, no financial interest, MERMAID-1; AstraZeneca, steering committee member, institutional, no financial interest, MERMAID-2, POSEIDON, MYSTIC; Beigene, steering committee member, institutional, no financial interest, BGB-A317-A1217-301/AdvanTIG-301; BMS, steering committee member, institutional, no financial interest, clinical trial steering committee CheckMate 743, CheckMate 73L, CheckMate 331 and 451; BMS, steering committee member, institutional, no financial interest, RELATIVITY 095; GSK, trial chair, institutional, no financial interest, clinical trial chair ZEAL-1; iTeos, steering committee member, institutional, no financial interest, Phase 2 Inupadenant with chemo; Mirati, steering committee member, institutional, no financial interest, clinical trial steering committee SAPPHIRE; MSD, steering committee member, institutional, no financial interest, clinical trial steering committee PEARLS, MK-7684A; Pharma Mar, steering committee member, institutional, no financial interest, LAGOON; Phosplatin Therapeutics, steering committee member, institutional, no financial interest, phase 1/2 trials; Roche/Genentech, trial chair, institutional, no financial interest, clinical trial chair Skyscraper-01; chair ALEX; steering committee BFAST; steering committee BEAT-Meso; steering committee ImPower-030, IMforte. Also role as ESMO president, ETOP/EORTC/SAKK PI, involved in academic trials, ETOP/IBCSG partners officer. Council member and scientific chair, SAKK, vice-President Lung Group, SAMO, Vice President. BKS declares honoraria from Novartis and Eli Lilly. MS declares honoraria from AstraZeneca, MSD, Accord Health and Novartis, support for attending meetings from the Malaysia Urology Association and roles as an ex-committee member of the Malaysian Oncological Society and chairman of the Annual Scientific congress of the Malaysian Oncological Society. KT declares grants from Pfizer, Daiichi Sankyo, Eli Lilly, AstraZeneca, Eisai; honoraria from Daiichi Sankyo, Eli Lilly, Chugai, MSD; and data monitoring or advisory board fees from Daiichi Sankyo. SSW declares a grant from Pfizer and honoraria from Pfizer, Roche, AstraZeneca, Novartis, Daiichi Sankyo, Eli Lilly, MSD and Henrui. TY declares institutional grants from Amgen, Boehringer Ingelheim, Chugai, Daiichi Sankyo, Genomedia, MSD, Ono, Pfizer, Sanofi, Sysmex and Taiho, and honoraria Bayer, Chugai, Merck biopharma, MSD and Ono. All other authors have declared no conflicts of interest.

Figures

**Figure 1**
**Diagnostic work-up and staging of MBC.** Purple box: general categories or stratification; white boxes: other aspects of management. AI, aromatase inhibitor; CNS, central nervous system; CT, computed tomography; ER, estrogen receptor; ESCAT, ESMO Scale for Clinical Actionability of Molecular Targets; ESR1, estrogen receptor 1; gBRCAm, germline BRCA1/2 mutation; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; ISH, *in situ* hybridisation; MBC, metastatic breast cancer; MSI, microsatellite instability; NTRK, neurotrophic tyrosine receptor kinase; PALB2, partner and localiser of BRCA2; PD-L1, programmed death-ligand 1; PET, positron emission tomography; PgR, progesterone receptor; *PIK3CA,* phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha; TMB, tumour mutation burden; TNBC, triple-negative breast cancer. ^aIf there are important differences in ER/PgR and HER2 status between the primary tumour and recurrence, patients should be managed according to receptor status of the recurrent disease biopsy. ^bESCAT scores apply to genomic alterations only. These scores have been defined by the guideline authors and validated by the ESMO Translational Research and Precision Medicine Working Group. ^cAssess HER2-low status.

**Figure 2**
**Treatment of ER-positive/HER2-negative MBC.** Purple box: general categories or stratification; turquoise/green boxes: combination of treatments or other systemic treatments; white boxes: other aspects of management; blue boxes: systemic anticancer therapy; dark blue boxes: trastuzumab deruxtecan in HER2-low. AI, aromatase inhibitor; CDK4/6, cyclin-dependent kinase 4 and 6; ChT, chemotherapy; ctDNA, circulating tumour DNA: EMA, European Medicines Agency; ER, estrogen receptor; ESCAT, ESMO Scale for Clinical Actionability of Molecular Targets; ESR1, estrogen receptor 1; ET, endocrine therapy; FDA, Food and Drug Administration; HER2, human epidermal growth factor receptor 2; m, mutation; MBC, metastatic breast cancer; MCBS, ESMO-Magnitude of Clinical Benefit Scale; OFS, ovarian function suppression; PALB2, partner and localiser of BRCA2; PARP, poly (ADP-ribose) polymerase; PD, progressive disease; PIK3CA, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha. ^aOFS if the patient is premenopausal. ^bPreferred if the patient is ESR1 mutation positive [ESCAT score: II-A].^d ^cESMO-MCBS v1.1 was used to calculate scores for new therapies/indications approved by the EMA or FDA. The scores have been calculated by the ESMO-MCBS Working Group and validated by the ESMO Guidelines Committee (https://www.esmo.org/guidelines/esmo-mcbs/scale-evaluation-forms-v1.0-v1.1/scale-evaluationforms-v1.1). ^dESCAT scores apply to genomic alterations only. These scores have been defined by the guideline authors and validated by the ESMO Translational Research and Precision Medicine Working Group. ^eIf relapse <12 months after end of adjuvant AI: fulvestrant-CDK4/6 inhibitor;^a if relapse >12 months after end of adjuvant AI: AI-CDK4/6 inhibitor.^a

**Figure 3**
**First- and second-line treatment of HER2-positive MBC.** Purple box: general categories or stratification; orange box: surgery; green boxes: RT; white boxes: other aspects of management; blue boxes: systemic anticancer therapy. BMs, brain metastases; ChT, chemotherapy; CNS, central nervous system; EMA, European Medicines Agency; ESCAT, ESMO Scale for Clinical Actionability of Molecular Targets; ET, endocrine therapy; FDA, Food and Drug Administration; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; MBC, metastatic breast cancer; MCBS, ESMO-Magnitude of Clinical Benefit Scale; PD, progressive disease; RT, radiotherapy; SRT, stereotactic radiotherapy; T-DM1, ado-trastuzumab emtansine; WBRT, whole brain radiotherapy. ^aESMO-MCBS v1.1 was used to calculate scores for new therapies/indications approved by the EMA or FDA. The scores have been calculated by the ESMO-MCBS Working Group and validated by the ESMO Guidelines Committee (https://www.esmo.org/guidelines/esmo-mcbs/scale-evaluation-forms-v1.0-v1.1/scale-evaluationforms-v1.1). ^bESCAT scores apply to genomic alterations only. These scores have been defined by the guideline authors and validated by the ESMO Translational Research and Precision Medicine Working Group. ^cNot FDA approved for use in second line. ^dKeep on current systemic therapy unless PD outside CNS.

**Figure 4**
**Third-line and beyond treatment of HER2-positive MBC.** Purple box: general categories or stratification; orange box: surgery; green boxes: RT; white boxes: other aspects of management; blue boxes: systemic anticancer therapy. BMs, brain metastases; ChT, chemotherapy; CNS, central nervous system; EMA, European Medicines Agency; ESCAT, ESMO Scale for Clinical Actionability of Molecular Targets; FDA, Food and Drug Administration; HER2, human epidermal growth factor receptor 2; MBC, metastatic breast cancer; MCBS, ESMO-Magnitude of Clinical Benefit Scale; PD, progressive disease; RT, radiotherapy; SRT, stereotactic radiotherapy; T-DM1, ado-trastuzumab emtansine; WBRT, whole brain radiotherapy. ^aThere are no data for any of these combinations after tucatinib- and/or trastuzumab deruxtecan-based therapy. ^bESMO-MCBS v1.1 was used to calculate scores for new therapies/indications approved by the EMA or FDA. The scores have been calculated by the ESMO-MCBS Working Group and validated by the ESMO Guidelines Committee (https://www.esmo.org/guidelines/esmo-mcbs/scale-evaluation-forms-v1.0-v1.1/scale-evaluationforms-v1.1). ^cESCAT scores apply to genomic alterations only. These scores have been defined by the guideline authors and validated by the ESMO Translational Research and Precision Medicine Working Group. ^dFDA approved, not EMA approved. ^eIf not received as second-line therapy. ^fKeep on current systemic therapy unless PD outside CNS. ^gIf not previously used, including all other drugs that are also a second-line treatment option.

**Figure 5**
**Treatment of mTNBC.** Purple box: general categories or stratification; turquoise/green box: combination of treatments or other systemic treatments; white boxes: other aspects of management; blue boxes: systemic anticancer therapy. ChT, chemotherapy; EMA, European Medicines Agency; ESCAT, ESMO Scale for Clinical Actionability of Molecular Targets; FDA, Food and Drug Administration; gBRCAm, germline BRCA1/2 mutation; ICI, immune checkpoint inhibitor; MCBS, ESMO-Magnitude of Clinical Benefit Scale; mTNBC, metastatic triple-negative breast cancer; PARP, poly (ADP-ribose) polymerase; PD-L1, programmed death-ligand 1. ^aMay be considered as monotherapy in further lines in case of high PD-L1 positivity and no previous exposure to ICI. ^bEMA approved, not FDA approved. ^cFDA approved, not EMA approved. ^dChT physician’s choice of nab-paclitaxel, paclitaxel or gemcitabine/carboplatin. ^eESMO-MCBS v1.1 was used to calculate scores for new therapies/indications approved by the EMA or FDA. The scores have been calculated by the ESMO-MCBS Working Group and validated by the ESMO Guidelines Committee (https://www.esmo.org/guidelines/esmo-mcbs/scale-evaluation-forms-v1.0-v1.1/scale-evaluationforms-v1.1). ^fESCAT scores apply to genomic alterations only. These scores have been defined by the guideline authors and validated by the ESMO Translational Research and Precision Medicine Working Group. ^gIf not used previously.

**Figure 6**
**Treatment of OMD.** Purple boxes: general categories or stratification; white boxes: other aspects of management. CNS, central nervous system; MDT, multidisciplinary team; OMD, oligometastatic disease; PET, positron emission tomography; RFA, radiofrequency ablation; RT, radiotherapy. ^aConsider elements in current definitions, i.e. limited or low-volume metastatic disease; up to five lesions in total, not necessarily in the same organ; all potentially amenable to receive local treatment. ^bThe duration of systemic treatment remains a topic of debate.

See this image and copyright information in PMC

Cited by

Preliminary results from ASCENT-J02: a phase 1/2 study of sacituzumab govitecan in Japanese patients with advanced solid tumors.
Naito Y, Nakamura S, Kawaguchi-Sakita N, Ishida T, Nakayama T, Yamamoto Y, Masuda N, Matsumoto K, Kogawa T, Sudo K, Shimomura A, Lai C, Zhang D, Iwahori Y, Gary D, Huynh D, Iwata H. Naito Y, et al. Int J Clin Oncol. 2024 Sep 20. doi: 10.1007/s10147-024-02589-x. Online ahead of print. Int J Clin Oncol. 2024. PMID: 39302614
Neutrophil-to-lymphocyte ratio at the end of treatment with CDK4/6 inhibitors is an independent prognostic factor for ER-positive HER2-negative advanced breast cancer.
Mitsuyoshi A, Nagahashi M, Kanaoka H, Oshiro A, Togashi Y, Hattori A, Tsuchida J, Higuchi T, Nishimukai A, Murase K, Takatsuka Y, Miyoshi Y. Mitsuyoshi A, et al. Int J Clin Oncol. 2024 Sep 15. doi: 10.1007/s10147-024-02625-w. Online ahead of print. Int J Clin Oncol. 2024. PMID: 39278979
Palbociclib in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer: A Systematic Scoping Review of Real-World Evidence from Countries Outside of Western Regions that Are Underrepresented in Clinical Trials.
Rauthan A, Jain A, Singh M, Sendur MAN. Rauthan A, et al. Oncol Ther. 2024 Sep;12(3):395-418. doi: 10.1007/s40487-024-00295-2. Epub 2024 Aug 2. Oncol Ther. 2024. PMID: 39095679 Free PMC article. Review.
Drug exposure and risk factors of maculopathy in tamoxifen users.
Kwon HY, Kim J, Ahn SJ. Kwon HY, et al. Sci Rep. 2024 Jul 22;14(1):16792. doi: 10.1038/s41598-024-67670-x. Sci Rep. 2024. PMID: 39039208 Free PMC article.
Trastuzumab deruxtecan versus treatment of physician's choice in previously treated Asian patients with HER2-low unresectable/metastatic breast cancer: subgroup analysis of the DESTINY-Breast04 study.
Yamashita T, Sohn JH, Tokunaga E, Niikura N, Park YH, Lee KS, Chae YS, Xu B, Wang X, Im SA, Li W, Lu YS, Aguilar CO, Nishijima S, Nishiyama Y, Sugihara M, Modi S, Tsurutani J. Yamashita T, et al. Breast Cancer. 2024 Sep;31(5):858-868. doi: 10.1007/s12282-024-01600-7. Epub 2024 Jun 17. Breast Cancer. 2024. PMID: 38884900 Free PMC article. Clinical Trial.

See all "Cited by" articles

References

1. Sung H., Ferlay J., Siegel R.L., et al. Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–249. - PubMed
1. Anderson W.F., Jatoi I., Tse J., et al. Male breast cancer: a population-based comparison with female breast cancer. J Clin Oncol. 2010;28(2):232–239. - PMC - PubMed
1. Heer E., Harper A., Escandor N., et al. Global burden and trends in premenopausal and postmenopausal breast cancer: a population-based study. Lancet Glob Health. 2020;8(8):e1027–e1037. - PubMed
1. Xu S., Liu Y., Zhang T., et al. The global, regional, and national burden and trends of breast cancer from 1990 to 2019: results from the Global Burden of Disease Study 2019. Front Oncol. 2021;11 - PMC - PubMed
1. Youn H.J., Han W. A review of the epidemiology of breast cancer in Asia: focus on risk factors. Asian Pac J Cancer Prev. 2020;21(4):867–880. - PMC - PubMed

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

LinkOut - more resources

Full Text Sources
Medical
- MedlinePlus Health Information

[1] Sung H., Ferlay J., Siegel R.L., et al. Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–249. - PubMed

[2] Sung H., Ferlay J., Siegel R.L., et al. Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–249. - PubMed

[3] Anderson W.F., Jatoi I., Tse J., et al. Male breast cancer: a population-based comparison with female breast cancer. J Clin Oncol. 2010;28(2):232–239. - PMC - PubMed

[4] Anderson W.F., Jatoi I., Tse J., et al. Male breast cancer: a population-based comparison with female breast cancer. J Clin Oncol. 2010;28(2):232–239. - PMC - PubMed

[5] Heer E., Harper A., Escandor N., et al. Global burden and trends in premenopausal and postmenopausal breast cancer: a population-based study. Lancet Glob Health. 2020;8(8):e1027–e1037. - PubMed

[6] Heer E., Harper A., Escandor N., et al. Global burden and trends in premenopausal and postmenopausal breast cancer: a population-based study. Lancet Glob Health. 2020;8(8):e1027–e1037. - PubMed

[7] Xu S., Liu Y., Zhang T., et al. The global, regional, and national burden and trends of breast cancer from 1990 to 2019: results from the Global Burden of Disease Study 2019. Front Oncol. 2021;11 - PMC - PubMed

[8] Xu S., Liu Y., Zhang T., et al. The global, regional, and national burden and trends of breast cancer from 1990 to 2019: results from the Global Burden of Disease Study 2019. Front Oncol. 2021;11 - PMC - PubMed

[9] Youn H.J., Han W. A review of the epidemiology of breast cancer in Asia: focus on risk factors. Asian Pac J Cancer Prev. 2020;21(4):867–880. - PMC - PubMed

[10] Youn H.J., Han W. A review of the epidemiology of breast cancer in Asia: focus on risk factors. Asian Pac J Cancer Prev. 2020;21(4):867–880. - PMC - PubMed

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, staging and treatment of patients with metastatic breast cancer

Affiliations

Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, staging and treatment of patients with metastatic breast cancer

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

Similar articles

Cited by

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources

Medical

Abstract

Conflict of interest statement

Figures

Similar articles

Cited by

References

Publication types

MeSH terms

Related information

LinkOut - more resources

Full Text Sources

Medical