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@ARTICLE{vonMinckwitz:142997,
author = {G. von Minckwitz and C.-S. Huang and M. S. Mano and S.
Loibl and E. P. Mamounas and M. Untch and N. Wolmark and P.
Rastogi and A. Schneeweiss and A. Redondo and H. H. Fischer
and W. Jacot and A. K. Conlin and C. Arce-Salinas and I. L.
Wapnir and C. Jackisch and M. P. DiGiovanna and P. A.
Fasching and J. P. Crown and P. Wülfing and Z. Shao and E.
Rota Caremoli and H. Wu and L. H. Lam and D. Tesarowski and
M. Smitt and H. Douthwaite and S. M. Singel and C. E. Geyer
and L. Fein and L. Kaen and G. Lerzo and D. Egle and R.
Greil and M. Hubalek and C. Singer and G. Steger and L.
Dirix and F. Duhoux and G. Jerusalem and V. Renard and R.
Araujo and A. Boukai and R. Hegg and J. P. Lima and M. Mano
and A. Morelle and A. P. Muller and C. E. Paiva and J. L.
Pedrini and H. Pinczowski and L. Santos and N. L. Teich and
L. Testa and E. Wiermann and M. Basik and J. A. Davidson and
R. Goel and D. Logan and C. Lohrisch and J. Mackey and L. A.
Martin and A. Paterson and C. Prady and L. Provencher and A.
Robidoux and S. Sridhar and M. Thirlwell and K. Tonkin and
D. Warr and W. Li and N. Liao and D. Pang and Z. Shao and K.
Shen and S. Wang and Y. Wang and S. Franco and M. Gonzalez
and A. Quiroga Echeverri and A. Yepes and E. Kubala and B.
Melichar and A. Paulik and M. Zimovjanova and H. Bonnefoi
and H. Bourgeois and E. Brain and E. Curtit and V. D'Hondt
and V. Dieras and M. Espie and J. M. Extra and J. Gligorov
and J. Grenier and C. Levy and M. A. Mouret-Reynier and J.
M. Nabholtz and H. Orfeuvre and T. Petit and J. Y. Pierga
and X. Pivot and G. Romieu and M. Saghatchian-D'Assignies
and L. Teixeira and J. C. Thery and C. Veyret and B. Aktas
and S. Bauer and A. Belau and J.-U. Blohmer and H. Eidtmann
and P. Fasching and T. Fehm and G. Feisel-Schwickardi and H.
H. Fischer and A. Gerteis and A. Grafe and G. Graffunder and
E. M. Grischke and J. Hackmann and N. Harbeck and B.
Heinrich and C. Hielscher and O. Hoffmann and C. Jackisch
and W. Janni and M. Just and P. Klare and U. Kronawitter and
T. Kühn$^*$ and S. Kümmel and G. Kunz and T. Lantzsch and
K. Lübbe and W. Meinerz and C. Mundhenke and M. Negwer and
T. Neunhöffer and F. Overkamp and T. W. Park-Simon and B.
Rack and B. Rautenberg and T. Reimer and M. Rezai and C.
Salat and C. Schem and R. Schlag and S. Schmatloch and B.
Schnappauf and A. Schneeweiss and M. Schrauder and C.
Schumacher and I. Schwaner and C. Solbach and E. Stickeler
and H. Tesch and I. Thalmann and C. Thomssen and M. Untch
and G. T. Wachsmann and M. Warm and H. Wiebringhaus and P.
Wulfing and D. Mavroudis and K. Papazisis and H.
Castro-Salguero and C. E. Hernandez-Monroy and F. Y. Cheung
and A. Kwong and T. Y. Ng and S. I. Soong and L. Coate and
J. Crown and B. Hennessy and M. Higgins and M. Keane and C.
Kelly and E. Moylan and S. Nasim and S. O'Reilly and N. Ben
Baruch and D. Geffen and B. Kaufman and O. Rosengarten and
B. Uziely and R. Yerushalmi and G. Allegrini and G. Bianchi
and A. Brandes and M. Cazzaniga and S. Cinieri and M. A.
Colleoni and P. F. Conte and M. De Laurentiis and S. De
Placido and L. Del Mastro and E. Fiorio and A. Fontana and
D. Generali and L. Gianni and P. Marchetti and A. M. Molino
and F. Montemurro and E. Rota Caremoli and G. Tonini and C.
Zamagni and C. Arce Salinas and Y. Chavarri Guerra and C. A.
Hernandez and F. Lopez-Lopez and G. Martinez and C. M.
Villarreal Garza and J. C. Alcedo and R. I. Lopez and D.
Aleman and J. Becerra and C. Desposorio and A. Kobashigawa
and P. Pimentel and J. Pesic and L. Stamatovic and M.
Coccia-Portugal and S. M. Cullis and K. Maart and S. D.
Moodley and F. Pienaar and B. Rapoport and I. Alvarez Lopez
and F. Carabantes and M. J. Echarri Gonzalez and I.
Fernandez Perez and L. Garcia Estevez and J. J. Illarramendi
Mañas and R. M. Llorente Domenech and M. Mele Olive and M.
Muñoz Mateu and A. Redondo Sanchez and C. Rodriguez Sanchez
and M. Ruiz Borrego and A. Ruiz Simo and J. Bjöhle and O.
Del Val Munoz and T. Hatschek and N. Loman and A. Schreiber
and C. Tausch and S.-C. Chen and C. S. Huang and M. C. Liu
and L. M. Tseng and Y. Yang and D. C. Yeh and M. Aliustaoglu
and I. Cicin and E. T. Elkiran and T. Evrensel and M. Gumus
and B. Karabulut and R. Uslu and M. E. Yildirim and D.
Adamson and C. Bradley and J. Braybrooke and S. Chan and A.
Dhadda and J. Joffe and C. Lowdell and J. Mansi and C.
Michie and J. Mohanamurali and T. Perren and D. Rea and K.
Scatchard and J. Stebbing and A. Wardley and D. Wheatley and
M. Winter and J. Abraham and T. Avery and H. D. Bear and L.
E. Boyle and A. Brufsky and M. Chambers and J. Chang$^*$ and
A. Charles and M. Chaudhry and M. Cobleigh and A. Conlin and
S. Constantino and P. DeFusco and M. DiGiovanna and T. Doyle
and W. Farrar and L. Fehrenbacher and L. Flaherty and P. J.
Flynn and A. Gayle and S. Giordano and H. Han and A. Hantel
and J. Hargis and D. Hershman and D. Ibach and R. Jaslow and
T. Julian and M. Karwal and R. Kramer and A. Krie and E.
Krill-Jackson and S. Limentani and J. Link and E. Mamounas
and M. Maurer and E. McCarron and R. Mehta and A. Menter and
S. Murali and B. Nguyen and D. Oldham and G. Padula and E.
Pajon and K. Patel and A. Paterson and J. Phelan and J.
Polikoff and R. Resta and M. Rimawi and D. Riseberg and J.
Robertson and E. Romond and S. Seaward and J. Seeger and N.
Shah and I. Shalaby and S. Sinclair and P. Steen and K.
Sturtz and D. Tamkus and A. R. Tan and A. Thomas and A.
Tolentino and D. Toppmeyer and S. Trehan and V. Valero and
C. Vaughn and T. Wahl and J. Waisman and I. Wapnir and T. F.
Weisberg and D. L. Wickerham and K. Yost and D. Zakalik and
J. Zapas and R. Zera and W. Zhang},
collaboration = {K. Investigators},
title = {{T}rastuzumab {E}mtansine for {R}esidual {I}nvasive
{HER}2-{P}ositive {B}reast {C}ancer.},
journal = {The New England journal of medicine},
volume = {380},
number = {7},
issn = {1533-4406},
address = {Waltham, Mass.},
publisher = {MMS},
reportid = {DKFZ-2019-00622},
pages = {617 - 628},
year = {2019},
abstract = {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.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).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.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 .).},
keywords = {Antineoplastic Agents, Immunological (NLM Chemicals) /
Maytansine (NLM Chemicals) / ERBB2 protein, human (NLM
Chemicals) / Receptor, ErbB-2 (NLM Chemicals) / Trastuzumab
(NLM Chemicals) / ado-trastuzumab emtansine (NLM Chemicals)},
cin = {C020},
ddc = {610},
cid = {I:(DE-He78)C020-20160331},
pnm = {313 - Cancer risk factors and prevention (POF3-313)},
pid = {G:(DE-HGF)POF3-313},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:30516102},
doi = {10.1056/NEJMoa1814017},
url = {https://inrepo02.dkfz.de/record/142997},
}
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