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Mini Oral - Breast cancer, early stage

LBA14 - De-escalated neoadjuvant T-DM1 with or without endocrine therapy (ET) vs trastuzumab+ET in early HR+/HER2+ breast cancer (BC): ADAPT-TP survival results

Date

18 Sep 2020

Session

Mini Oral - Breast cancer, early stage

Presenters

Nadia Harbeck

Citation

Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325

Authors

N. Harbeck1, U. Nitz2, M. Christgen3, S. Kuemmel4, M. Braun5, C. Schumacher6, J. Potenberg7, J. Tio8, B. Aktas9, W. Malter10, H. Forstbauer11, R. von Schumann12, M. Just13, K. Jóźwiak14, M. Hauptmann14, R. Kates15, M. Gräser16, R. Wuerstlein17, H. Kreipe3

Author affiliations

  • 1 Breast Center, Dept. Ob&gyn And Cclmu, Ludwig Maximilians University Hospital- Grosshadern, 81377 - Munich/DE
  • 2 Breast Center Niederrhein, Evangelical Hospital Johanniter Bethesda, Moenchengladbach/DE
  • 3 Institute Of Pathology, Hannover Medical School, 30625 - Hannover/DE
  • 4 Breast Unit, Klinikum Essen-Mitte, 45136 - Essen/DE
  • 5 Abteilung Für Senologie, Klinikum Rotkreuz München, Munich/DE
  • 6 Brustzentrum Köln-hohenlind, St. Elisabeth-Krankenhaus, Cologne/DE
  • 7 Oncology, Ev. Waldkrankenhaus, 13589 - Berlin/DE
  • 8 Breast Unit, University Clinics of Münster, 48149 - Albert-Schweitzer-Campus ,/DE
  • 9 Gynecology And Obstetrics And University Clinics Leipzig, University of Essen, Essen/DE
  • 10 Breast Center Department, University Hospital Cologne, 50924 - Köln/DE
  • 11 Oncology, Praxisnetzwerk Onkologie, 53840 - Troisdorf/DE
  • 12 Breast Center, Evang. Krankenhaus "Bethesda" Klinik, 41061 - Mönchengladbach/DE
  • 13 Haematology And Oncology, Onkologische Schwerpunktpraxis Bielefeld, Bielefeld/DE
  • 14 Institute Of Biostatistics And Registry Research, Brandenburg Medical School Theodor Fontane, Neuruppin/DE
  • 15 West German Study Group, West German Study Group, Moenchengladbach/DE
  • 16 Wsg, West German Study Group and Breast Center Niederrhein, Moenchengladbach/DE
  • 17 Gynecology, LMU Klinikum der Universität München, 80336 - Munich/DE
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Abstract LBA14

Background

HR+/HER2+ BC is a distinct entity associated with different molecular and therapeutic features compared to HR-/HER2+ BC. The HER2 antibody drug conjugate T-DM1 is highly effective in metastatic and early HER2+ BC. So far, no survival data for de-escalated T-DM1-based (neo)adjuvant regimens without systemic chemotherapy (CT) are available. Here, we present first survival data from ADAPT-TP.

Methods

The prospective WSG-ADAPT-TP phase II-trial is part of the ADAPT-umbrella protocol (NCT NCT01779206): 375 patients (pts) with HR+/HER2+ BC were randomized to 12 weeks of T-DM1 +/- standard ET and trastuzumab+ET q3w (ratio 1:1:1). Primary endpoint was pCR (ypT0/is/ypN0) (previously published: T-DM1/T-DM1+ET/T+ET: 41%/42%/15%). Secondary endpoints: safety, 5-y DFS, OS, translational research. Omission of further CT was allowed in all pts with pCR after 12-weeks study therapy.

Results

After median follow-up of 5 years, no significant differences between study arms were observed regarding DFS (T-DM1/T-DM1+ET/T+ET 5-y rate: 88.9%, 85.3%, and 84.6%) and OS (97.2%, 96.4% and 96.3%). pCR (vs. non-pCR) after the 12-week study treatment was strongly associated with improved DFS (5y DFS 92.7% vs. 82.7, HR=0.40, 95% CI 0.18-0.85). Among 117 pts with pCR, no further CT was given in 41 pts (35%). Significant differences between CT-treated vs. non-treated pCR pts regarding baseline characteristics were only observed for age (median 50y vs. 56y, p=0.005); similar 5y DFS was observed in both groups (92.1% (95%-CI: 78-97%) vs. 93% (84-97%)). Only 3 deaths occurred in pts with pCR.

Conclusions

Early pCR after 12 weeks of therapy was strongly associated with improved outcome in ADAPT TP and may serve as a predictive marker for CT treatment (de)-escalation. Despite substantially higher pCR rates, T-DM1 +/- ET was not associated with different DFS or OS vs. T+ET, most likely due to standard CT, given to all non-pCR pts and most pCR pts or small sample size of study. Excellent 93% 5y DFS in pts with pCR after only 12 weeks of T-DM1 +/- ET (even w/o further CT) is promising and may serve as a basis for further prospective trials addressing omission of CT overtreatment in carefully selected patients with HER2+ early BC.

Clinical trial identification

NCT01779206.

Editorial acknowledgement

Legal entity responsible for the study

West German Study Group.

Funding

Roche.

Disclosure

N. Harbeck: Advisory/Consultancy: Daiichi Sankyo; Advisory/Consultancy: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Seattle Genetics. U. Nitz: Honoraria (self), Advisory/Consultancy: Amgen; AstraZeneca; Genomic Health; Novartis; Pfizer; Pierre Fabre; Roche; Zodiac Pharma. S. Kuemmel: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche, Genomic Health, Novartis, AstraZeneca, Amgen, Celgene, Somatex Medical Technologies, Daiichi Sankyo, pfm medical, Pfizer, MSD, Lilly, SonoscapeRoche, Genomic Health, Novartis, AstraZeneca, Amgen, Celgene, Somatex Medical Technologies, Daiichi Sanky. M. Braun: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca, Celgene, Eisai, Genomic Health, GalaxoSmithKline, Medac, Novatis, Pfizer, Roche, RTI Surgical, Teva. J. Tio: Travel/Accommodation/Expenses: Roche. B. Aktas: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer, Roche Pharma, Novartis Pharma, AstraZeneca, Amgen, Tesaro Bio Germany, PharmaMar, Eisai. W. Malter: Honoraria (self), Advisory/Consultancy: Nanostring, Celgene, Roche. R. Wuerstlein: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Agendia, Amgen, Aristo, AstraZeneca, Boeringer Ingelheim, Carl Zeiss, Celgene, Clinsol, Daiichi-Sankyo, Eisai, Genomic Health, GlaxoSmithKline, Hexal, Lilly, Medstrom Medical, MSD, Mundipharma, NanoString, Novartis, Odonate, Paxman, Palleos, Pfizer, Pi. H. Kreipe: Honoraria (self), Advisory/Consultancy: Roche, Novartis, AstraZeneca, Genomic Health. All other authors have declared no conflicts of interest.

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