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Article: Trastuzumab emtansine (T-DM1) versus trastuzumab in Chinese patients with residual invasive disease after neoadjuvant chemotherapy and HER2-targeted therapy for HER2-positive breast cancer in the phase 3 KATHERINE study

TitleTrastuzumab emtansine (T-DM1) versus trastuzumab in Chinese patients with residual invasive disease after neoadjuvant chemotherapy and HER2-targeted therapy for HER2-positive breast cancer in the phase 3 KATHERINE study
Authors
KeywordsChinese
Early breast cancer
HER2-positive
Invasive disease-free survival (IDFS)
Thrombocytopenia
Issue Date2021
PublisherSpringer New York LLC. The Journal's web site is located at http://springerlink.metapress.com/openurl.asp?genre=journal&issn=0167-6806
Citation
Breast Cancer Research and Treatment, 2021, v. 187 n. 3, p. 759-768 How to Cite?
AbstractPurpose: In the KATHERINE study (NCT01772472), patients with HER2-positive early breast cancer (EBC) and residual invasive disease after neoadjuvant chemotherapy plus HER2-targeted therapy who were treated with adjuvant trastuzumab emtansine (T-DM1) had a 50% reduction in the risk of an invasive disease-free survival (IDFS) event compared to patients treated with adjuvant trastuzumab. In metastatic disease, T-DM1 has resulted in higher rates of thrombocytopenia in Asian versus non-Asian patients. Here, we report safety and efficacy in Chinese patients from KATHERINE. Methods: Patients with HER2-positive EBC and residual invasive disease after taxane- and trastuzumab-containing neoadjuvant chemotherapy followed by surgery were randomized 1:1 to 14 cycles of adjuvant T-DM1 or trastuzumab. The primary endpoint was time to an IDFS event. Results: Among Chinese patients (T-DM1 n = 51, trastuzumab n = 50), T-DM1 treatment resulted in a 43% reduction in risk of an IDFS event compared to trastuzumab (HR = 0.57; 95% CI 0.25–1.31), with similar results for secondary endpoints. As in the global population, Chinese patients receiving T-DM1 versus trastuzumab had more grade ≥ 3 adverse events (AEs; 39.2% versus 4.1%) and AEs leading to treatment discontinuation (27.5% versus 0%). The most common grade ≥ 3 AE with T-DM1 was thrombocytopenia (21.6%), a frequency higher than the frequency in the global population (5.7%). Grade ≥ 3 hemorrhage was reported in 1 patient (T-DM1 arm). Conclusions: In the KATHERINE study, T-DM1 demonstrated increased efficacy compared to trastuzumab in Chinese patients. Consistent with previous data in Asian patients, T-DM1 was associated with more grade ≥ 3 AEs, and AEs leading to discontinuation, which was driven by an increase in thrombocytopenia.
Persistent Identifierhttp://hdl.handle.net/10722/299269
ISSN
2023 Impact Factor: 3.0
2023 SCImago Journal Rankings: 1.267
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorHuang, CS-
dc.contributor.authorYang, Y-
dc.contributor.authorKwong, A-
dc.contributor.authorChen, SC-
dc.contributor.authorTseng, LM-
dc.contributor.authorLiu, MC-
dc.contributor.authorShen, K-
dc.contributor.authorWang, S-
dc.contributor.authorNg, TY-
dc.contributor.authorFeng, Y-
dc.contributor.authorSun, G-
dc.contributor.authorYan, IR-
dc.contributor.authorShao, Z-
dc.date.accessioned2021-05-10T06:59:25Z-
dc.date.available2021-05-10T06:59:25Z-
dc.date.issued2021-
dc.identifier.citationBreast Cancer Research and Treatment, 2021, v. 187 n. 3, p. 759-768-
dc.identifier.issn0167-6806-
dc.identifier.urihttp://hdl.handle.net/10722/299269-
dc.description.abstractPurpose: In the KATHERINE study (NCT01772472), patients with HER2-positive early breast cancer (EBC) and residual invasive disease after neoadjuvant chemotherapy plus HER2-targeted therapy who were treated with adjuvant trastuzumab emtansine (T-DM1) had a 50% reduction in the risk of an invasive disease-free survival (IDFS) event compared to patients treated with adjuvant trastuzumab. In metastatic disease, T-DM1 has resulted in higher rates of thrombocytopenia in Asian versus non-Asian patients. Here, we report safety and efficacy in Chinese patients from KATHERINE. Methods: Patients with HER2-positive EBC and residual invasive disease after taxane- and trastuzumab-containing neoadjuvant chemotherapy followed by surgery were randomized 1:1 to 14 cycles of adjuvant T-DM1 or trastuzumab. The primary endpoint was time to an IDFS event. Results: Among Chinese patients (T-DM1 n = 51, trastuzumab n = 50), T-DM1 treatment resulted in a 43% reduction in risk of an IDFS event compared to trastuzumab (HR = 0.57; 95% CI 0.25–1.31), with similar results for secondary endpoints. As in the global population, Chinese patients receiving T-DM1 versus trastuzumab had more grade ≥ 3 adverse events (AEs; 39.2% versus 4.1%) and AEs leading to treatment discontinuation (27.5% versus 0%). The most common grade ≥ 3 AE with T-DM1 was thrombocytopenia (21.6%), a frequency higher than the frequency in the global population (5.7%). Grade ≥ 3 hemorrhage was reported in 1 patient (T-DM1 arm). Conclusions: In the KATHERINE study, T-DM1 demonstrated increased efficacy compared to trastuzumab in Chinese patients. Consistent with previous data in Asian patients, T-DM1 was associated with more grade ≥ 3 AEs, and AEs leading to discontinuation, which was driven by an increase in thrombocytopenia.-
dc.languageeng-
dc.publisherSpringer New York LLC. The Journal's web site is located at http://springerlink.metapress.com/openurl.asp?genre=journal&issn=0167-6806-
dc.relation.ispartofBreast Cancer Research and Treatment-
dc.rightsThis is a post-peer-review, pre-copyedit version of an article published in [insert journal title]. The final authenticated version is available online at: https://doi.org/[insert DOI]-
dc.subjectChinese-
dc.subjectEarly breast cancer-
dc.subjectHER2-positive-
dc.subjectInvasive disease-free survival (IDFS)-
dc.subjectThrombocytopenia-
dc.titleTrastuzumab emtansine (T-DM1) versus trastuzumab in Chinese patients with residual invasive disease after neoadjuvant chemotherapy and HER2-targeted therapy for HER2-positive breast cancer in the phase 3 KATHERINE study-
dc.typeArticle-
dc.identifier.emailKwong, A: avakwong@hku.hk-
dc.identifier.authorityKwong, A=rp01734-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1007/s10549-021-06166-y-
dc.identifier.pmid33860389-
dc.identifier.scopuseid_2-s2.0-85104745938-
dc.identifier.hkuros322342-
dc.identifier.volume187-
dc.identifier.issue3-
dc.identifier.spage759-
dc.identifier.epage768-
dc.identifier.isiWOS:000640477500002-
dc.publisher.placeUnited States-

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