Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer
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Abstract
BACKGROUND: Among breast cancers without human epidermal growth factor receptor 2 (HER2) amplification, overexpression, or both, a large proportion express low levels of HER2 that may be targetable. Currently available HER2-directed therapies have been ineffective in patients with these "HER2-low" cancers. METHODS: We conducted a phase 3 trial involving patients with HER2-low metastatic breast cancer who had received one or two previous lines of chemotherapy. (Low expression of HER2 was defined as a score of 1+ on immunohistochemical [IHC] analysis or as an IHC score of 2+ and negative results on in situ hybridization.) Patients were randomly assigned in a 2:1 ratio to receive trastuzumab deruxtecan or the physician's choice of chemotherapy. The primary end point was progression-free survival in the hormone receptor-positive cohort. The key secondary end points were progression-free survival among all patients and overall survival in the hormone receptor-positive cohort and among all patients. RESULTS: Of 557 patients who underwent randomization, 494 (88.7%) had hormone receptor-positive disease and 63 (11.3%) had hormone receptor-negative disease. In the hormone receptor-positive cohort, the median progression-free survival was 10.1 months in the trastuzumab deruxtecan group and 5.4 months in the physician's choice group (hazard ratio for disease progression or death, 0.51; P<0.001), and overall survival was 23.9 months and 17.5 months, respectively (hazard ratio for death, 0.64; P = 0.003). Among all patients, the median progression-free survival was 9.9 months in the trastuzumab deruxtecan group and 5.1 months in the physician's choice group (hazard ratio for disease progression or death, 0.50; P<0.001), and overall survival was 23.4 months and 16.8 months, respectively (hazard ratio for death, 0.64; P = 0.001). Adverse events of grade 3 or higher occurred in 52.6% of the patients who received trastuzumab deruxtecan and 67.4% of those who received the physician's choice of chemotherapy. Adjudicated, drug-related interstitial lung disease or pneumonitis occurred in 12.1% of the patients who received trastuzumab deruxtecan; 0.8% had grade 5 events. CONCLUSIONS: In this trial involving patients with HER2-low metastatic breast cancer, trastuzumab deruxtecan resulted in significantly longer progression-free and overall survival than the physician's choice of chemotherapy. (Funded by Daiichi Sankyo and AstraZeneca; DESTINY-Breast04 ClinicalTrials.gov number, NCT03734029.).
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The record
- Venue
- New England Journal of Medicine
- Topic
- HER2/EGFR in Cancer Research
- Field
- Medicine
- Canadian institutions
- —
- Funders
- Daiichi Sankyo EuropeNational Cancer InstituteFirst Hospital of Jilin UniversityWest China Hospital, Sichuan UniversityUniversity of California, San FranciscoKyungpook National UniversityFundació Institut de Recerca Hospital Universitari Vall d’HebronPeking Union Medical CollegeCleveland ClinicSamsungUniversitat de BarcelonaSeoul National University HospitalCollege of Medicine, Seoul National UniversityMemorial Sloan-Kettering Cancer CenterYonsei UniversityChinese Academy of Medical SciencesTel Aviv UniversitySeoul National UniversityJilin UniversityLiaoning Cancer Hospital and InstituteSichuan UniversitySun Yat-sen UniversityQueen Mary University of LondonCleveland Clinic FoundationUniversity of UlsanInstitute of GeneticsAstraZenecaCancer Research Institute
- Keywords
- TrastuzumabBreast cancerMedicineOncologyInternal medicineCancer
- Has abstract in OpenAlex
- yes