| Added by | ircm doc |
|---|---|
| Group name | EquipeCTCS |
| Item Type | Journal Article |
| Title | Trastuzumab Deruxtecan after Endocrine Therapy in Metastatic Breast Cancer |
| Creator | Bardia et al. |
| Author | Aditya Bardia |
| Author | Xichun Hu |
| Author | Rebecca Dent |
| Author | Kan Yonemori |
| Author | Carlos H. Barrios |
| Author | Joyce A. O'Shaughnessy |
| Author | Hans Wildiers |
| Author | Jean-Yves Pierga |
| Author | Qingyuan Zhang |
| Author | Cristina Saura |
| Author | Laura Biganzoli |
| Author | Joohyuk Sohn |
| Author | Seock-Ah Im |
| Author | William Jacot |
| Author | Natasha Begbie |
| Author | Jun Ke |
| Author | Gargi Patel |
| Author | Giuseppe Curigliano |
| Abstract | BACKGROUND: Outcomes in patients with hormone receptor-positive metastatic breast cancer worsen after one or more lines of endocrine-based therapy. Trastuzumab deruxtecan has shown efficacy in patients with metastatic breast cancer with low expression of human epidermal growth factor receptor 2 (HER2) after previous chemotherapy. METHODS: We conducted a phase 3, multicenter, open-label trial involving patients with hormone receptor-positive metastatic breast cancer with low HER2 expression (a score of 1+ or 2+ on immunohistochemical [IHC] analysis and negative results on in situ hybridization) or ultralow HER2 expression (IHC 0 with membrane staining) who had received one or more lines of endocrine-based therapy and no previous chemotherapy for metastatic breast cancer. Patients were randomly assigned in a 1:1 ratio to receive trastuzumab deruxtecan or the physician's choice of chemotherapy. The primary end point was progression-free survival (according to blinded independent central review) among the patients with HER2-low disease. Secondary end points included progression-free survival among all the patients who had undergone randomization, overall survival, and safety. RESULTS: Of the 866 patients who underwent randomization, 713 had HER2-low disease, and 153 had HER2-ultralow disease. Among the patients with HER2-low disease, the median progression-free survival was 13.2 months (95% confidence interval [CI], 11.4 to 15.2) in the trastuzumab deruxtecan group and 8.1 months (95% CI, 7.0 to 9.0) in the chemotherapy group (hazard ratio for disease progression or death, 0.62; 95% CI, 0.52 to 0.75; P<0.001); the results were consistent in the exploratory HER2-ultralow population. Data for overall survival were immature. Adverse events of grade 3 or higher occurred in 52.8% of the patients in the trastuzumab deruxtecan group and in 44.4% of those in the chemotherapy group. Adjudicated interstitial lung disease or pneumonitis occurred in 49 patients (11.3%; three events were grade 5 in severity) and in 1 patient (0.2%; grade 2), respectively. CONCLUSIONS: Among patients with hormone receptor-positive, HER2-low or HER2-ultralow metastatic breast cancer who had received one or more lines of endocrine-based therapy, treatment with trastuzumab deruxtecan resulted in longer progression-free survival than chemotherapy. No new safety signals were identified. (Funded by AstraZeneca and Daiichi Sankyo; DESTINY-Breast06 ClinicalTrials.gov number, NCT04494425.). |
| Publication | The New England Journal of Medicine |
| Volume | 391 |
| Issue | 22 |
| Pages | 2110-2122 |
| Date | 2024-12-05 |
| Journal Abbr | N Engl J Med |
| Language | eng |
| DOI | 10.1056/NEJMoa2407086 |
| ISSN | 1533-4406 |
| Library Catalog | PubMed |
| Extra | PMID: 39282896 |
| Tags | Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Hormonal, Antineoplastic Agents, Immunological, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Camptothecin, clinic, Female, Humans, Immunoconjugates, Kaplan-Meier Estimate, Middle Aged, Progression-Free Survival, Receptor, ErbB-2, Receptors, Estrogen, Trastuzumab, Treatment Outcome |
| Date Added | 2025/01/16 - 11:45:21 |
| Date Modified | 2025/01/16 - 11:46:05 |
| Notes and Attachments | PubMed entry (Attachment) |
Institut de Recherche en Cancérologie de
