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Background in Asian Countries

  • For HER2 positive metastatic BC patients, the guidelines from Japan, Hong Kong, and Republic of Korea recommend T-DM1 as a second-line treatment11. The Society of Korean Medicine Obstetrics and Gynecology. The 9th Korean clinical practice guideline for breast cancer. 2021. NCKM website. https://www.kbcs.or.kr/journal/file/211104_2.pdf
  • T-DM1 has been recently approved for metastatic BC in China and Taiwan (listed in the code of reimbursement); however, limited access is still a barrier to use in Asian countries
  • The Chinese guideline recommends a combination of the pan-HER2 TKI pyrotinib plus capecitabine, as well as T-DM1 monotherapy22. Chinese Society of Clinical Oncology [CSCO]. CSCO guidelines for the diagnosis and treatment of breast cancer. 2021. http://www.csco.org.cn/cn/ncontent.aspx?oid=8990
  • Median PFS was 9.3 months with T-DM1 in the Asia subgroup analysis from EMILIA; however, some articles reported that HER2 positive metastatic BC patients who received trastuzumab and pertuzumab experienced diminished clinical benefit from T-DM13,43. Dzimitrowicz H, Berger M, Vargo C, et al. T-DM1 activity in metastatic human epidermal growth factor receptor 2-positive breast cancers that received prior therapy with trastuzumab and pertuzumab. J Clin Oncol. 2016;34(29):3511-3517.4. Im S-A, Park I, Sohn JH, et al. Trastuzumab emtansine (T-DM1) in Asian patients with previously treated HER2-positive locally advanced (LA) or metastatic breast cancer (MBC): Data from the phase III EMILIA study [poster]. Poster presented at: European Society of Medical Oncology (ESMO) 2021 Virtual Meeting; September 16-21, 2021. Ann Oncol. 2021;32(suppl 5):S488-S489.
  • In the EMILIA study, although generally similar to the global safety profile, an increased incidence of grade 3 or 4 thrombocytopenia (39.3% for Asia vs 13.9% in global) was noted with T-DM1 in the Asia subgroup analysis44. Im S-A, Park I, Sohn JH, et al. Trastuzumab emtansine (T-DM1) in Asian patients with previously treated HER2-positive locally advanced (LA) or metastatic breast cancer (MBC): Data from the phase III EMILIA study [poster]. Poster presented at: European Society of Medical Oncology (ESMO) 2021 Virtual Meeting; September 16-21, 2021. Ann Oncol. 2021;32(suppl 5):S488-S489.
  • These facts highlight the remaining unmet need for a more effective and safe new treatment option for patients with HER2 positive metastatic BC in Asian countries

Abbreviations

BC = breast cancer

;

HER2 = human epidermal growth factor receptor 2

;

PFS = progression-free survival 

;

T-DM1 = trastuzumab emtansine

;

TKI = tyrosine kinase inhibitor

References

1. The Society of Korean Medicine Obstetrics and Gynecology. The 9th Korean clinical practice guideline for breast cancer. 2021. NCKM website. https://www.kbcs.or.kr/journal/file/211104_2.pdf

2. Chinese Society of Clinical Oncology [CSCO]. CSCO guidelines for the diagnosis and treatment of breast cancer. 2021. http://www.csco.org.cn/cn/ncontent.aspx?oid=8990

3. Dzimitrowicz H, Berger M, Vargo C, et al. T-DM1 activity in metastatic human epidermal growth factor receptor 2-positive breast cancers that received prior therapy with trastuzumab and pertuzumab. J Clin Oncol. 2016;34(29):3511-3517.

4. Im S-A, Park I, Sohn JH, et al. Trastuzumab emtansine (T-DM1) in Asian patients with previously treated HER2-positive locally advanced (LA) or metastatic breast cancer (MBC): Data from the phase III EMILIA study [poster]. Poster presented at: European Society of Medical Oncology (ESMO) 2021 Virtual Meeting; September 16-21, 2021. Ann Oncol. 2021;32(suppl 5):S488-S489.

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