Assessment of HER2 status in extramammary Paget disease and its implication for disitamab vedotin, a novel humanized anti-HER2 antibody-drug conjugate therapy

References

[1] Jeong SH, Hyeong JH, Park EJ, Kim KJ, Kim KH. Human epidermal growth factor receptor 2 expression in extramammary Paget’s disease and mammary Paget’s disease. Australas J Dermatol 2022; 63(1): 115–118

[2] Angelico G, Santoro A, Inzani F, Straccia P, Arciuolo D, Mulè A, Valente M, Spadola S, D’Alessandris N, Garganese G, Cianfrini F, Piermattei A, Scambia G, Zannoni GF. Hormonal environment and HER2 status in extra-mammary Paget’s disease (eMPD): a systematic literature review and meta-analysis with clinical considerations. Diagnostics (Basel) 2020; 10(12): 1040

[3] Sekiguchi N, Kubota S, Noguchi T, Fukushima T, Kobayashi T, Kanda S, Koizumi T, Miyake T, Shirai T, Okuyama R. Experiences of trastuzumab plus paclitaxel combination therapy in metastatic human epidermal growth factor receptor 2-positive extramammary Paget’s disease: four cases and a review. J Dermatol 2020; 47(11): 1276–1279

[4] National Medical Products Administration. Disitamab vedotin: NMPA Approval notice. 2021, available from the website of NMPA

[5] RemeGen. Disitamab vedotin: Chinese prescribing information. Yantai. 2021

[6] Wang J, Liu Y, Zhang Q, Feng J, Fang J, Chen X, Han Y, Li Q, Zhang P, Yuan P, Ma F, Luo Y, Fan Y, Cai R, Chen S, Li Q, Li Y, Xu B. RC48-ADC, a HER2-targeting antibody-drug conjugate, in patients with HER2-positive and HER2-low expressing advanced or metastatic breast cancer: a pooled analysis of two studies. J Clin Oncol 2021; 39(15 Suppl): 1022 (abstract no. 1022)

[7] Xu Y, Wang Y, Gong J, Zhang X, Peng Z, Sheng X, Mao C, Fan Q, Bai Y, Ba Y, Jiang D, Yang F, Qi C, Li J, Wang X, Zhou J, Lu M, Cao Y, Yuan J, Liu D, Wang Z, Fang J, Shen L. Phase I study of the recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugate RC48-ADC in patients with HER2-positive advanced solid tumors. Gastric Cancer 2021; 24(4): 913–925

[8] Zattarin E, Nichetti F, Ligorio F, Mazzeo L, Lobefaro R, Fucà G, Peverelli G, Vingiani A, Bianchi GV, Capri G, de Braud F, Vernieri C. Case Report: prolonged clinical benefit with sequential trastuzumab-containing treatments in a patient with advanced extramammary Paget disease of the groin. Front Oncol 2022; 12: 925551

[9] Shin DS, Sherry T, Kallen ME, Wong S, Drakaki A. Human epidermal growth factor receptor 2 (HER-2/neu)-directed therapy for rare metastatic epithelial tumors with HER-2 amplification. Case Rep Oncol 2016; 9(2): 298–304

[10] Tokuchi K, Maeda T, Kitamura S, Yanagi T, Ujiie H. HER2-targeted antibody-drug conjugates display potent antitumor activities in preclinical extramammary Paget’s disease models: in vivo and immunohistochemical analyses. Cancers (Basel) 2022; 14(14): 3519

Acknowledgements

This study was supported by Beijing Medical Award Foundation (No. YXJL-2020-0889-0106), Beijing Municipal Administration of Hospitals’ Ascent Plan (No. DFL20220901), Beijing Xisike Clinical Oncology Research Foundation (Nos. Y-Roche2019/2-0076 and Y-SY201901-0270).

Electronic Supplementary Material

Supplementary material is available in the online version of this article at https://doi.org/10.1007/s11684-023-1046-2 and is accessible for authorized users.

Compliance with ethics guidelines

Conflicts of Interest Lu Si has received speakers’ honoraria from Merck, Sharp&Dohme, Roche, Novartis, Shanghai Junshi Biosciences, and Oriengene. Jia Jia, Lili Mao, Jing Lin, Wenyu Li, Pei Yuan, Lei Guo, Jie Dai, Caili Li, Xue Bai, Zhongwu Li, Yu Chen, Jun Guo, and Jianming Ying declared no conflicts of interest.

This study has been conducted in compliance with local Institutional Review Board policies (IRB approval number: 2021YJZ50), and all patients signed informed consent forms prior to sample collection and consented to the publication of related clinical information and data. In addition, the two patients were treated with DV, which was approved by the Pharmacy Administration and Therapeutics Committee of Peking University Hospital for off-label use, and with the informed consent of the patients, the treatment process was in line with clinical diagnosis and treatment norms.

RIGHTS & PERMISSIONS

2024 Higher Education Press