Cited by 2,006HER2/EGFR in Cancer ResearchLung Cancer Treatments and MutationsAdvanced Breast Cancer Therapies

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Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer

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Modi, Shanu, Saura, Cristina, Yamashita, Toshinari, Park, Yeon Hee, Kim, Sung-Bae, Tamura, Kenji, Andre, Fabrice, Iwata, Hiroji, Ito, Yoshinori, Tsurutani, Junji, Sohn, Joohyuk, Denduluri, Neelima, Perrin, Christophe, Aogi, Kenjiro, Tokunaga, Eriko, Im, Seock-Ah, Lee, Keun Seok, Hurvitz, Sara A., Cortes, Javier, Lee, Caleb, Chen, Shuquan, Zhang, Lin, Shahidi, Javad, Yver, Antoine, Krop, Ian·2020·New England Journal of Medicine

DOI 10.1056/nejmoa1914510PMC PMC7458671

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Abstract

BACKGROUND: Trastuzumab deruxtecan (DS-8201) is an antibody-drug conjugate composed of an anti-HER2 (human epidermal growth factor receptor 2) antibody, a cleavable tetrapeptide-based linker, and a cytotoxic topoisomerase I inhibitor. In a phase 1 dose-finding study, a majority of the patients with advanced HER2-positive breast cancer had a response to trastuzumab deruxtecan (median response duration, 20.7 months). The efficacy of trastuzumab deruxtecan in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab emtansine requires confirmation. METHODS: In this two-part, open-label, single-group, multicenter, phase 2 study, we evaluated trastuzumab deruxtecan in adults with pathologically documented HER2-positive metastatic breast cancer who had received previous treatment with trastuzumab emtansine. In the first part of the study, we evaluated three different doses of trastuzumab deruxtecan to establish a recommended dose; in the second part, we evaluated the efficacy and safety of the recommended dose. The primary end point was the objective response, according to independent central review. Key secondary end points were the disease-control rate, clinical-benefit rate, duration of response and progression-free survival, and safety. RESULTS: Overall, 184 patients who had undergone a median of six previous treatments received the recommended dose of trastuzumab deruxtecan (5.4 mg per kilogram of body weight). In the intention-to-treat analysis, a response to therapy was reported in 112 patients (60.9%; 95% confidence interval [CI], 53.4 to 68.0). The median duration of follow-up was 11.1 months (range, 0.7 to 19.9). The median response duration was 14.8 months (95% CI, 13.8 to 16.9), and the median duration of progression-free survival was 16.4 months (95% CI, 12.7 to not reached). During the study, the most common adverse events of grade 3 or higher were a decreased neutrophil count (in 20.7% of the patients), anemia (in 8.7%), and nausea (in 7.6%). On independent adjudication, the trial drug was associated with interstitial lung disease in 13.6% of the patients (grade 1 or 2, 10.9%; grade 3 or 4, 0.5%; and grade 5, 2.2%). CONCLUSIONS: Trastuzumab deruxtecan showed durable antitumor activity in a pretreated patient population with HER2-positive metastatic breast cancer. In addition to nausea and myelosuppression, interstitial lung disease was observed in a subgroup of patients and requires attention to pulmonary symptoms and careful monitoring. (Funded by Daiichi Sankyo and AstraZeneca; DESTINY-Breast01 ClinicalTrials.gov number, NCT03248492.).

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10.3121/cmr.2008.825 · DOI
Modi S Tsurutani J Takahashi S et al. Safety and efficacy results from a phase 1 study of trastuzumab deruxtecan (DS-8201a) in subjects with HER2 expressing metastatic breast cancers. Presented at the 2017 San Antonio Breast Cancer Symposium San Antonio TX December 5–9 2017.

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Authors: Modi, S., Saura, C., Yamashita, T., Park, Y. H., Kim, S.-B., Tamura, K., Andre, F., Iwata, H., Ito, Y., Tsurutani, J., Sohn, J., Denduluri, N., Perrin, C., Aogi, K., Tokunaga, E., Im, S.-A., Lee, K. S., Hurvitz, S. A., Cortes, J., Lee, C., Chen, S., Zhang, L., Shahidi, J., Yver, A., & Krop, I.
Affiliations: SHOWA Medical University (JP)
From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer...
ORCID: Modi, Shanu
Saura, Cristina
Yamashita, Toshinari
Park, Yeon Hee
Kim, Sung-Bae
Tamura, Kenji
Iwata, Hiroji
Tsurutani, Junji
Sohn, Joohyuk
Denduluri, Neelima
Perrin, Christophe
Aogi, Kenjiro
Tokunaga, Eriko
Im, Seock-Ah
Lee, Keun Seok
Hurvitz, Sara A.
Lee, Caleb
Chen, Shuquan
Zhang, Lin
Krop, Ian
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2020-02-13
Volume: 382
Issue: 7
Pages: 610-621
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1914510
PMC: PMC7458671
OpenAlex: W2996630100
Cited by: 2,006
References: 40
Citations by year: 2026: 234 · 2025: 266 · 2024: 317 · 2023: 355 · 2022: 345 · 2021: 312 · 2020: 174
FWCI: 86.91
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
eScholarship (California Digital Library) (submittedVersion)
YUHSpace (Yonsei University Medical Library) (submittedVersion, cc-by-nc-nd)
Seoul National University Open Repository (Seoul National University) (submittedVersion)
Funders: Daiichi-Sankyo
Topics: Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Oncology › Advanced Breast Cancer Therapies
Keywords: trastuzumab deruxtecan, HER2-positive breast cancer, metastatic breast cancer, trastuzumab emtansine, antibody-drug conjugates, previously treated patients, objective response rate, progression-free survival, neutropenia, dose escalation, topoisomerase I inhibitor, HER2-targeted therapy, treatment efficacy and safety
MeSH terms: Trastuzumab, Progression-Free Survival, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Camptothecin, Female, Humans, Middle Aged, Lung Diseases, Interstitial, Erb-b2 Receptor Tyrosine Kinases, Immunoconjugates, Kaplan-Meier Estimate, Intention to Treat Analysis, Consolidation Chemotherapy, Antibodies, Monoclonal, Humanized

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Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer

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