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Trastuzumab Emtansine plus Pertuzumab Versus Taxane plus Trastuzumab plus Pertuzumab after Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer: The Phase III KAITLIN Study
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Krop, Ian E. | - |
dc.contributor.author | Im, Seock-Ah | - |
dc.contributor.author | Barrios, Carlos | - |
dc.contributor.author | Bonnefoi, Hervé | - |
dc.contributor.author | Gralow, Julie | - |
dc.contributor.author | Toi, Masakazu | - |
dc.contributor.author | Ellis, Paul A. | - |
dc.contributor.author | Gianni, Luca | - |
dc.contributor.author | Swain, Sandra M. | - |
dc.contributor.author | Im, Young-Hyuck | - |
dc.contributor.author | De Laurentiis, Michelino | - |
dc.contributor.author | Nowecki, Zbigniew | - |
dc.contributor.author | Huang, Chiun-Sheng | - |
dc.contributor.author | Fehrenbacher, Louis | - |
dc.contributor.author | Ito, Yoshinori | - |
dc.contributor.author | Shah, Jigna | - |
dc.contributor.author | Boulet, Thomas | - |
dc.contributor.author | Liu, Haiying | - |
dc.contributor.author | Macharia, Harrison | - |
dc.contributor.author | Trask, Peter | - |
dc.contributor.author | Song, Chunyan | - |
dc.contributor.author | Winer, Eric P. | - |
dc.contributor.author | Harbeck, Nadia | - |
dc.date.accessioned | 2022-04-26T07:11:42Z | - |
dc.date.available | 2022-04-26T07:11:42Z | - |
dc.date.created | 2022-04-18 | - |
dc.date.created | 2022-04-18 | - |
dc.date.created | 2022-04-18 | - |
dc.date.created | 2022-04-18 | - |
dc.date.created | 2022-04-18 | - |
dc.date.issued | 2022-02 | - |
dc.identifier.citation | Journal of Clinical Oncology, Vol.40 No.5, pp.438-448 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.other | 158767 | - |
dc.identifier.uri | https://hdl.handle.net/10371/179213 | - |
dc.description.abstract | © 2021 by American Society of Clinical OncologyPURPOSE We aimed to improve efficacy and reduce toxicity of high-risk human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC) treatment by replacing taxanes and trastuzumab with trastuzumab emtansine (T-DM1). METHODS The phase III KAITLIN study (NCT01966471) included adults with excised HER2-positive EBC (node-positive or node-negative, hormone receptor-negative, and tumor. 2.0 cm). Postsurgery, patients were randomly assigned 1:1 to anthracycline-based chemotherapy (three-four cycles) and then 18 cycles of T-DM1 plus pertuzumab (AC-KP) or taxane (three-four cycles) plus trastuzumab plus pertuzumab (AC-THP). Adjuvant radiotherapy/endocrine therapy was permitted. Coprimary end points were invasive disease-free survival (IDFS) in the intention-to-treat node-positive and overall populations with hierarchical testing. RESULTS The median follow-up was 57.1 months (interquartile range, 52.1-60.1 months) for AC-THP (n 5 918) and 57.0 months (interquartile range, 52.1-59.8 months) for AC-KP (n 5 928). There was no significant IDFS difference between arms in the node-positive (n 5 1,658; stratified hazard ratio [HR], 0.97; 95% CI, 0.71 to 1.32) or overall population (n 5 1846; stratified HR, 0.98; 95% CI, 0.72 to 1.32). In the overall population, the three-year IDFS was 94.2% (95% CI, 92.7 to 95.8) for AC-THP and 93.1% (95% CI, 91.4 to 94.7) for AC-KP. Treatment completion rates (ie, 18 cycles) were 88.4% for AC-THP and 65.0% for AC-KP (difference driven by T-DM1 discontinuation because of laboratory abnormalities [12.5%]). Similar rates of grade $ 3 (55.4% v 51.8%) and serious adverse events (23.3% v 21.4%) occurred with AC-THP and AC-KP, respectively. KP decreased clinically meaningful deterioration in global health status versus THP (stratified HR, 0.71; 95% CI, 0.62 to 0.80). CONCLUSION The primary end point was not met. Both arms achieved favorable IDFS. Trastuzumab plus pertuzumab plus chemotherapy remains the standard of care for high-risk HER2-positive EBC. | - |
dc.language | 영어 | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.title | Trastuzumab Emtansine plus Pertuzumab Versus Taxane plus Trastuzumab plus Pertuzumab after Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer: The Phase III KAITLIN Study | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 임석아 | - |
dc.identifier.doi | 10.1200/JCO.21.00896 | - |
dc.citation.journaltitle | Journal of Clinical Oncology | - |
dc.identifier.wosid | 000819042300002 | - |
dc.identifier.scopusid | 2-s2.0-85124438534 | - |
dc.citation.endpage | 448 | - |
dc.citation.number | 5 | - |
dc.citation.startpage | 438 | - |
dc.citation.volume | 40 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Im, Seock-Ah | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | ADJUVANT CHEMOTHERAPY | - |
dc.subject.keywordPlus | PHYSICIANS CHOICE | - |
dc.subject.keywordPlus | PACLITAXEL | - |
dc.subject.keywordPlus | CYCLOPHOSPHAMIDE | - |
dc.subject.keywordPlus | COMBINATION | - |
dc.subject.keywordPlus | DOXORUBICIN | - |
dc.subject.keywordPlus | DOCETAXEL | - |
dc.subject.keywordPlus | TH3RESA | - |
dc.subject.keywordPlus | SAFETY | - |
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