| Added by | standudu |
|---|---|
| Group name | EquipeCTCS |
| Item Type | Journal Article |
| Title | Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer |
| Creator | von Minckwitz et al. |
| Author | Gunter von Minckwitz |
| Author | Chiun-Sheng Huang |
| Author | Max S. Mano |
| Author | Sibylle Loibl |
| Author | Eleftherios P. Mamounas |
| Author | Michael Untch |
| Author | Norman Wolmark |
| Author | Priya Rastogi |
| Author | Andreas Schneeweiss |
| Author | Andres Redondo |
| Author | Hans H. Fischer |
| Author | William Jacot |
| Author | Alison K. Conlin |
| Author | Claudia Arce-Salinas |
| Author | Irene L. Wapnir |
| Author | Christian Jackisch |
| Author | Michael P. DiGiovanna |
| Author | Peter A. Fasching |
| Author | John P. Crown |
| Author | Pia Wülfing |
| Author | Zhimin Shao |
| Author | Elena Rota Caremoli |
| Author | Haiyan Wu |
| Author | Lisa H. Lam |
| Author | David Tesarowski |
| Author | Melanie Smitt |
| Author | Hannah Douthwaite |
| Author | Stina M. Singel |
| Author | Charles E. Geyer |
| Abstract | BACKGROUND: Patients who have residual invasive breast cancer after receiving neoadjuvant chemotherapy plus human epidermal growth factor receptor 2 (HER2)-targeted therapy have a worse prognosis than those who have no residual cancer. Trastuzumab emtansine (T-DM1), an antibody-drug conjugate of trastuzumab and the cytotoxic agent emtansine (DM1), a maytansine derivative and microtubule inhibitor, provides benefit in patients with metastatic breast cancer that was previously treated with chemotherapy plus HER2-targeted therapy. METHODS: We conducted a phase 3, open-label trial involving patients with HER2-positive early breast cancer who were found to have residual invasive disease in the breast or axilla at surgery after receiving neoadjuvant therapy containing a taxane (with or without anthracycline) and trastuzumab. Patients were randomly assigned to receive adjuvant T-DM1 or trastuzumab for 14 cycles. The primary end point was invasive disease-free survival (defined as freedom from ipsilateral invasive breast tumor recurrence, ipsilateral locoregional invasive breast cancer recurrence, contralateral invasive breast cancer, distant recurrence, or death from any cause). RESULTS: At the interim analysis, among 1486 randomly assigned patients (743 in the T-DM1 group and 743 in the trastuzumab group), invasive disease or death had occurred in 91 patients in the T-DM1 group (12.2%) and 165 patients in the trastuzumab group (22.2%). The estimated percentage of patients who were free of invasive disease at 3 years was 88.3% in the T-DM1 group and 77.0% in the trastuzumab group. Invasive disease-free survival was significantly higher in the T-DM1 group than in the trastuzumab group (hazard ratio for invasive disease or death, 0.50; 95% confidence interval, 0.39 to 0.64; P<0.001). Distant recurrence as the first invasive-disease event occurred in 10.5% of patients in the T-DM1 group and 15.9% of those in the trastuzumab group. The safety data were consistent with the known safety profile of T-DM1, with more adverse events associated with T-DM1 than with trastuzumab alone. CONCLUSIONS: Among patients with HER2-positive early breast cancer who had residual invasive disease after completion of neoadjuvant therapy, the risk of recurrence of invasive breast cancer or death was 50% lower with adjuvant T-DM1 than with trastuzumab alone. (Funded by F. Hoffmann-La Roche/Genentech; KATHERINE ClinicalTrials.gov number, NCT01772472 .). |
| Publication | The New England Journal of Medicine |
| Volume | 380 |
| Issue | 7 |
| Pages | 617-628 |
| Date | 02 14, 2019 |
| Journal Abbr | N. Engl. J. Med. |
| Language | eng |
| DOI | 10.1056/NEJMoa1814017 |
| ISSN | 1533-4406 |
| Library Catalog | PubMed |
| Extra | PMID: 30516102 |
| Tags | Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Immunological, Breast Neoplasms, Chemotherapy, Adjuvant, clinic, Disease-Free Survival, Female, Humans, Lymphatic Metastasis, Maytansine, Middle Aged, Neoadjuvant Therapy, Neoplasm Metastasis, Neoplasm Staging, Neoplasm, Residual, Peripheral Nervous System Diseases, Radiotherapy, Receptor, ErbB-2, Trastuzumab, Treatment Outcome, Young Adult |
| Date Added | 2019/05/14 - 17:46:06 |
| Date Modified | 2019/05/14 - 19:15:56 |
| Notes and Attachments | PubMed entry (Attachment) |
Institut de Recherche en Cancérologie de
