Trastuzumab emtansine for residual invasive HER2-positive breast cancer
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 tra...
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
2019
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| In: |
The New England journal of medicine
Year: 2018, Jahrgang: 380, Heft: 7, Pages: 617-628 |
| ISSN: | 1533-4406 |
| DOI: | 10.1056/NEJMoa1814017 |
| Online-Zugang: | Verlag, Volltext: http://dx.doi.org/10.1056/NEJMoa1814017
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| Verfasserangaben: | G. von Minckwitz, C.-S. Huang, M.S. Mano, S. Loibl, E.P. Mamounas, M. Untch, N. Wolmark, P. Rastogi, A. Schneeweiss, A. Redondo, H.H. Fischer, W. Jacot, A.K. Conlin, C. Arce‑Salinas, I.L. Wapnir, C. Jackisch, M.P. DiGiovanna, P.A. Fasching, J.P. Crown, P. Wülfing, Z. Shao, E. Rota Caremoli, H. Wu, L.H. Lam, D. Tesarowski, M. Smitt, H. Douthwaite, S.M. Singel, and C.E. Geyer, Jr., for the KATHERINE Investigators |
MARC
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| 245 | 1 | 0 | |a Trastuzumab emtansine for residual invasive HER2-positive breast cancer |c G. von Minckwitz, C.-S. Huang, M.S. Mano, S. Loibl, E.P. Mamounas, M. Untch, N. Wolmark, P. Rastogi, A. Schneeweiss, A. Redondo, H.H. Fischer, W. Jacot, A.K. Conlin, C. Arce‑Salinas, I.L. Wapnir, C. Jackisch, M.P. DiGiovanna, P.A. Fasching, J.P. Crown, P. Wülfing, Z. Shao, E. Rota Caremoli, H. Wu, L.H. Lam, D. Tesarowski, M. Smitt, H. Douthwaite, S.M. Singel, and C.E. Geyer, Jr., for the KATHERINE Investigators |
| 264 | 1 | |c 2019 | |
| 300 | |a 12 | ||
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a This article was published on December 5, 2018 | ||
| 500 | |a Gesehen am 08.04.2019 | ||
| 520 | |a 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 .). | ||
| 534 | |c 2018 | ||
| 650 | 4 | |a Adult | |
| 650 | 4 | |a Aged | |
| 650 | 4 | |a Aged, 80 and over | |
| 650 | 4 | |a Antineoplastic Agents, Immunological | |
| 650 | 4 | |a Breast Neoplasms | |
| 650 | 4 | |a Chemotherapy, Adjuvant | |
| 650 | 4 | |a Disease-Free Survival | |
| 650 | 4 | |a Female | |
| 650 | 4 | |a Humans | |
| 650 | 4 | |a Lymphatic Metastasis | |
| 650 | 4 | |a Maytansine | |
| 650 | 4 | |a Middle Aged | |
| 650 | 4 | |a Neoadjuvant Therapy | |
| 650 | 4 | |a Neoplasm Metastasis | |
| 650 | 4 | |a Neoplasm Staging | |
| 650 | 4 | |a Neoplasm, Residual | |
| 650 | 4 | |a Peripheral Nervous System Diseases | |
| 650 | 4 | |a Radiotherapy | |
| 650 | 4 | |a Receptor, ErbB-2 | |
| 650 | 4 | |a Trastuzumab | |
| 650 | 4 | |a Treatment Outcome | |
| 650 | 4 | |a Young Adult | |
| 700 | 1 | |a Huang, Chiun-Sheng |e VerfasserIn |4 aut | |
| 700 | 1 | |a Mano, Max S. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Loibl, Sibylle |e VerfasserIn |0 (DE-588)12433024X |0 (DE-627)085790508 |0 (DE-576)294122753 |4 aut | |
| 700 | 1 | |a Mamounas, Eleftherios P. |e VerfasserIn |0 (DE-588)142081140 |0 (DE-627)633529370 |0 (DE-576)327797630 |4 aut | |
| 700 | 1 | |a Untch, Michael |e VerfasserIn |0 (DE-588)134268083 |0 (DE-627)566077914 |0 (DE-576)300413572 |4 aut | |
| 700 | 1 | |a Wolmark, Norman |e VerfasserIn |4 aut | |
| 700 | 1 | |a Rastogi, Priya |e VerfasserIn |4 aut | |
| 700 | 1 | |a Schneeweiss, Andreas |d 1961- |e VerfasserIn |0 (DE-588)109972554 |0 (DE-627)632849630 |0 (DE-576)327251859 |4 aut | |
| 700 | 1 | |a Redondo, Andres |e VerfasserIn |4 aut | |
| 700 | 1 | |a Fischer, Hans H. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Jacot, William |e VerfasserIn |4 aut | |
| 700 | 1 | |a Conlin, Alison K. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Arce-Salinas, Claudia |e VerfasserIn |4 aut | |
| 700 | 1 | |a Wapnir, Irene L. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Jackisch, Christian |d 1960- |e VerfasserIn |0 (DE-588)1024193160 |0 (DE-627)71932730X |0 (DE-576)368124908 |4 aut | |
| 700 | 1 | |a DiGiovanna, Michael P. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Fasching, Peter Andreas |d 1975- |e VerfasserIn |0 (DE-588)129068780 |0 (DE-627)388703040 |0 (DE-576)297477099 |4 aut | |
| 700 | 1 | |a Crown, John P. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Wülfing, Pia |e VerfasserIn |4 aut | |
| 700 | 1 | |a Shao, Zhimin |e VerfasserIn |4 aut | |
| 700 | 1 | |a Rota Caremoli, Elena |e VerfasserIn |4 aut | |
| 700 | 1 | |a Wu, Haiyan |e VerfasserIn |4 aut | |
| 700 | 1 | |a Lam, Lisa H. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Tesarowski, David |e VerfasserIn |4 aut | |
| 700 | 1 | |a Smitt, Melanie |e VerfasserIn |4 aut | |
| 700 | 1 | |a Douthwaite, Hannah |e VerfasserIn |4 aut | |
| 700 | 1 | |a Singel, Stina M. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Geyer, Charles E. |e VerfasserIn |4 aut | |
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