Trastuzumab deruxtecan versus treatment of physician’s choice in previously treated Asian patients with HER2-low unresectable/metastatic breast cancer: Subgroup analysis of the DESTINY-Breast04 study Journal Article
| Authors: | Yamashita, T.; Sohn, J. H.; Tokunaga, E.; Niikura, N.; Park, Y. H.; Lee, K. S.; Chae, Y. S.; Xu, B.; Wang, X.; Im, S. A.; Li, W.; Lu, Y. S.; Aguilar, C. O.; Nishijima, S.; Nishiyama, Y.; Sugihara, M.; Modi, S.; Tsurutani, J. |
| Article Title: | Trastuzumab deruxtecan versus treatment of physician’s choice in previously treated Asian patients with HER2-low unresectable/metastatic breast cancer: Subgroup analysis of the DESTINY-Breast04 study |
| Abstract: | Background: In the global phase 3 DESTINY-Breast04 study (NCT03734029), the anti-human epidermal growth factor 2 (HER2) antibody–drug conjugate trastuzumab deruxtecan (T-DXd) demonstrated a statistically significant improvement in progression-free survival (PFS) and overall survival (OS), with manageable safety compared with treatment of physician’s choice (TPC) in patients with HER2-low metastatic breast cancer (mBC) who had received 1–2 prior lines of chemotherapy. Methods: This subgroup analysis examined the efficacy and safety of T-DXd versus TPC in 213 patients from Asian countries and regions who were enrolled in the DESTINY-Breast04 trial and randomized to T-DXd (n = 147) or TPC (n = 66). Results: Median PFS with T-DXd and TPC was 10.9 and 5.3 months, respectively, in Asian patients with hormone receptor-positive mBC, and 10.9 and 4.6 months, respectively, in the overall Asian population. In both populations, median OS was not reached with T-DXd and was 19.9 months with TPC. The objective response rate was higher with T-DXd versus TPC in all Asian patients. Median treatment duration was 8.4 months with T-DXd and 3.5 months with TPC. The most common grade ≥ 3 drug-related treatment-emergent adverse events in Asian patients treated with T-DXd were neutropenia (16.3%), anemia (12.9%), and leukopenia (11.6%); the incidences of neutropenia and leukopenia were higher with TPC versus T-DXd. Adjudicated drug-related interstitial lung disease or pneumonitis with T-DXd was 14.3%; the majority of events were grade 1–2. Conclusions: T-DXd demonstrated clinically meaningful survival benefits versus TPC in Asian HER2-low mBC patients, regardless of hormone receptor status, with no new safety signals. Clinical trial registration number: ClinicalTrials.gov, NCT03734029. © The Author(s) 2024. |
| Keywords: | adult; cancer chemotherapy; cancer survival; controlled study; aged; middle aged; survival rate; major clinical study; overall survival; clinical trial; constipation; fatigue; mortality; neutropenia; drug efficacy; drug safety; side effect; treatment duration; capecitabine; gemcitabine; paclitaxel; comparative study; metabolism; progression free survival; anemia; leukopenia; nausea; randomized controlled trial; thrombocytopenia; vomiting; incidence; epidermal growth factor receptor 2; camptothecin; pathology; breast neoplasms; injection site reaction; pneumonia; disease severity; adverse outcome; total quality management; multicenter study; breast tumor; physician; receptor, erbb-2; interstitial lung disease; skin disease; asia; phase 3 clinical trial; aminotransferase; drug therapy; trastuzumab; metastatic breast cancer; alopecia; gastrointestinal disease; metabolic disorder; hematologic disease; eribulin; progression-free survival; drug choice; erbb2 protein, human; asian; lymphatic system disease; decreased appetite; geographic distribution; antibody conjugate; immunoconjugates; advanced breast cancer; nutritional disorder; humans; human; male; female; article; immunological antineoplastic agent; antineoplastic agents, immunological; trastuzumab deruxtecan; her2-low; asian people; human epidermal growth factor receptor 2 low metastatic breast cancer |
| Journal Title: | Breast Cancer |
| Volume: | 31 |
| Issue: | 5 |
| ISSN: | 1340-6868 |
| Publisher: | Springer Verlag |
| Date Published: | 2024-09-01 |
| Start Page: | 858 |
| End Page: | 868 |
| Language: | English |
| DOI: | 10.1007/s12282-024-01600-7 |
| PUBMED: | 38884900 |
| PROVIDER: | scopus |
| PMCID: | PMC11341650 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
