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Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer.
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.
Affiliation
  • Modi S; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Jacot W; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Yamashita T; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Sohn J; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Vidal M; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Tokunaga E; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Tsurutani J; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Ueno NT; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Prat A; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Chae YS; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Lee KS; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Niikura N; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Park YH; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Xu B; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Wang X; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Gil-Gil M; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Li W; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Pierga JY; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Im SA; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Moore HCF; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Rugo HS; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Yerushalmi R; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Zagouri F; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Gombos A; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Kim SB; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Liu Q; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Luo T; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Saura C; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Schmid P; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Sun T; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Gambhire D; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Yung L; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Wang Y; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Singh J; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Vitazka P; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Meinhardt G; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Harbeck N; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
  • Cameron DA; From the Memorial Sloan Kettering Cancer Center, New York (S.M.); Institut du Cancer de Montpellier, Université Montpellier, INSERM Unité 1194, Montpellier (W.J.), and Institut Curie, Université Paris Cité, Paris (J.-Y.P.) - both in France; Kanagawa Cancer Center, Yokohama (T.Y.), Kyushu Cancer Cent
N Engl J Med ; 387(1): 9-20, 2022 07 07.
Article in En | MEDLINE | ID: mdl-35665782
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 21 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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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Breast Neoplasms / Receptor, ErbB-2 / Trastuzumab / Antineoplastic Agents, Immunological Type of study: Clinical_trials Limits: Female / Humans Language: En Journal: N Engl J Med Year: 2022 Type: Article
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Breast Neoplasms / Receptor, ErbB-2 / Trastuzumab / Antineoplastic Agents, Immunological Type of study: Clinical_trials Limits: Female / Humans Language: En Journal: N Engl J Med Year: 2022 Type: Article