Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer.
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Modi Shanu, Jacot William, Yamashita Toshinari, Sohn Joohyuk, Vidal Maria, Tokunaga Eriko, Tsurutani Junji, Ueno Naoto T, Prat Aleix, Chae Yee Soo, Lee Keun Seok, Niikura Naoki, Park Yeon Hee, Xu Binghe, Wang Xiaojia, Gil-Gil Miguel, Li Wei, Pierga Jean-Yves, Im Seock-Ah, Moore Halle C F, Rugo Hope S, Yerushalmi Rinat, Zagouri Flora, Gombos Andrea, Kim Sung-Bae, Liu Qiang, Luo Ting, Saura Cristina, Schmid Peter, Sun Tao, Gambhire Dhiraj, Yung Lotus, Wang Yibin, Singh Jasmeet, Vitazka Patrik, Meinhardt Gerold, Harbeck Nadia, Cameron David A, DESTINY-Breast04 Trial Investigators
Аннотация
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.).