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Shanu Modi, William Jacot, Toshinari Yamashita, Joohyuk Sohn, Maria Jesus Vidal, Eriko Tokunaga, Junji Tsurutani, Naoto Tada Ueno, Aleix Prat, Yee Soo Chae and 28 more
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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Modi, S., Jacot, W., Yamashita, T., Sohn, J., Vidal, M. J., Tokunaga, E., Tsurutani, J., Ueno, N. T., Prat, A., Chae, Y. S., Lee, K. S., Niikura, N., Park, Y. H., Xu, B., Wang, X., Gil‐Gil, M., Li, W., Pierga, J., Im, S., … Cameron, D. (2022). Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. New England Journal of Medicine, 387(1), 9–20. https://doi.org/10.1056/nejmoa2203690
Modi, Shanu, et al. "Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer." New England Journal of Medicine, vol. 387, no. 1, 2022, pp. 9–20, https://doi.org/10.1056/nejmoa2203690.
Modi, Shanu, William Jacot, Toshinari Yamashita, Joohyuk Sohn, Maria Jesus Vidal, Eriko Tokunaga, Junji Tsurutani, et al. "Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer." New England Journal of Medicine 387, no. 1 (2022): 9–20. https://doi.org/10.1056/nejmoa2203690.
Modi S., Jacot W., Yamashita T. [и др.] Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer // New England Journal of Medicine. — 2022. — Vol. 387, № 1. — P. 9–20. — URL: https://doi.org/10.1056/nejmoa2203690
@article{modi2022trastuzumab,
title = {{Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer}},
author = {Shanu Modi and William Jacot and Toshinari Yamashita and Joohyuk Sohn and Maria Jesus Vidal and Eriko Tokunaga and Junji Tsurutani and Naoto Tada Ueno and Aleix Prat and Yee Soo Chae and Keun Seok Lee and Naoki Niikura and Yeon Hee Park and Binghe Xu and Xiaojia Wang and Miguel Gil‐Gil and Wěi Li and Jean‐Yves Pierga and Seock‐Ah Im and Halle C. F. Moore and Hope S. Rugo and Rinat Yerushalmi and Flora Zagouri and Andrea Gombos and Sung‐Bae Kim and Qiang Liu and Ting L. Luo and Cristina Saura and Peter Schmid and Tao Sun and Dhiraj Gambhire and Lotus Yung and Yibin Wang and Jasmeet Chadha Singh and Patrik Vitazka and Gerold Meinhardt and Nadia Harbeck and David Cameron},
journal = {New England Journal of Medicine},
year = {2022},
volume = {387},
number = {1},
pages = {9--20},
doi = {10.1056/nejmoa2203690},
url = {https://doi.org/10.1056/nejmoa2203690}
}TY - JOUR AU - Modi, Shanu AU - Jacot, William AU - Yamashita, Toshinari AU - Sohn, Joohyuk AU - Vidal, Maria Jesus AU - Tokunaga, Eriko AU - Tsurutani, Junji AU - Ueno, Naoto Tada AU - Prat, Aleix AU - Chae, Yee Soo AU - Lee, Keun Seok AU - Niikura, Naoki AU - Park, Yeon Hee AU - Xu, Binghe AU - Wang, Xiaojia AU - Gil‐Gil, Miguel AU - Li, Wěi AU - Pierga, Jean‐Yves AU - Im, Seock‐Ah AU - Moore, Halle C. F. AU - Rugo, Hope S. AU - Yerushalmi, Rinat AU - Zagouri, Flora AU - Gombos, Andrea AU - Kim, Sung‐Bae AU - Liu, Qiang AU - Luo, Ting L. AU - Saura, Cristina AU - Schmid, Peter AU - Sun, Tao AU - Gambhire, Dhiraj AU - Yung, Lotus AU - Wang, Yibin AU - Singh, Jasmeet Chadha AU - Vitazka, Patrik AU - Meinhardt, Gerold AU - Harbeck, Nadia AU - Cameron, David TI - Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer JO - New England Journal of Medicine VL - 387 IS - 1 SP - 9 EP - 20 PY - 2022 DA - 2022/06/05 DO - 10.1056/nejmoa2203690 UR - https://doi.org/10.1056/nejmoa2203690 ER -
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