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Poster Discussion session - Breast cancer, early stage

3890 - Prognostic impact of anthracyclines and immune/proliferation markers in TNBC according to pCR after de-escalated neoadjuvant chemotherapy with 12 weeks of nab-paclitaxel/carboplatin or gemcitabine: Survival results of WSG-ADAPT-TN phase II trial

Date

20 Oct 2018

Session

Poster Discussion session - Breast cancer, early stage

Topics

Cytotoxic Therapy;  Tumour Immunology

Tumour Site

Breast Cancer

Presenters

Oleg Gluz

Authors

O. Gluz1, U. Nitz2, C. Liedtke3, M. Christgen4, E. Grischke5, H. Forstbauer6, M. BRAUN7, M. Warm8, J. Hackmann9, C. Uleer10, B. Aktas11, C. Schumacher12, C. Lindner13, S. Kümmel14, R.E. Kates15, J. Potenberg16, P. Staib17, R. Wuerstlein18, H.H. Kreipe4, N. Harbeck19

Author affiliations

  • 1 Breast Center Niederrhein, West German Study Group and Ev. Clinics Johanniter Bethesda, 41061 - Moenchengladbach/DE
  • 2 Breast Center Niederrhein, Ev. Hospital Bethesda, 41061 - Mönchengladbach/DE
  • 3 Women´s Clinic, University Clinics Charité, Berlin/DE
  • 4 Institute Of Pathology, Medical School Hannover, Hannover/DE
  • 5 Women’s Clinic, University Clinics Tuebingen, Tuebingen/DE
  • 6 Hämatologisch-onkologische Schwerpunktpraxis, Praxisnetzwerk Onkologie, 53840 - Troisdorf/DE
  • 7 Gynecology, RED CROSS HOSPITAL MUNICH, 81541 - Munich/DE
  • 8 Breast Center, City Hospital Holweide, Cologne/DE
  • 9 Breast Center, Marien Hospital, Witten/DE
  • 10 Gynecology, Practice of Gynecology and Oncology, Hildesheim/DE
  • 11 Women’s Clinic, University Clinics, Leipzig/DE
  • 12 Breast Center, St. Elisabeth Krankenhaus Hohenlind, 50935 - Köln/DE
  • 13 Clinic Of Gynecology, Charité University Clinics, Berlin/DE
  • 14 Breast Unit, Kliniken Essen Mitte Evang. Huyssens-Stiftung, 45136 - Essen/DE
  • 15 Statistics, West German Study Group, Moenchengladbach/DE
  • 16 Onkologisches Zentrum, Ev. Waldkrankenhaus, 13589 - Berlin/DE
  • 17 Klinik Für Hämatologie/onkologie, St. Antonius Hospital, 52249 - Eschweiler/DE
  • 18 Breast Center, Dept. Ob&gyn, University of Munich and CCCLMU, München/DE
  • 19 Breast Center, Ludwig Maximilians University - Grosshadern, 81377 - Munich/DE

Resources

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Abstract 3890

Background

Optimal chemotherapy in early TNBC is unclear. ADAPT TN demonstrated higher pCR (ypT0/is/ypN0/(primary endpoint): 46% vs. 29%) and better safety for nab-paclitaxel/carboplatin(nab-pac/carbo) vs nab-paclitaxel/gemcitabine (nab-pac/gem). Planned translational analysis (e.g. expression of 119 genes (nCounter®)) revealed a strong positive predictive impact of basal-like subtype, Ki‑67, HER2-score and immune markers (PDL1, PD1) on pCR.

Methods

Patients with centrally confirmed TNBC (ER/PR<1%, HER2-, cT1c-cT4c, cN0/+) were randomized to neoadjuvant 4x nab-pac/gem 125 mg/m2/1000 mg/m2 d1,8 q3w (A) vs. 4x nab-pac/carbo 125 mg/m2/ AUC2 day 1/8 3-weekly (q3w) (B). Adjuvant anthracycline-based chemotherapy CHT/4xEC was optional in patients with pCR at investigator decison. Per-protocol (interim) survival analysis was performed after 3y median follow-up (FU).

Results

336 patients (median age 50y) were enrolled (48 centers, arms A/B: n=182/154). At baseline, 63% had cT2-4c tumors; 26.2% were cN+. Attainment of pCR was highly favorable for EFS (3y EFS: 92% vs. 71%, p<0.001) and OS (3y OS: 99.1% vs. 81.6%, p<0.001); 3y EFS was similar in Arm A vs. B (77.6% vs 80.8%, p=0.48); 3y OS was numerically higher in Arm B (84.7% vs. 92.2%, p=0.08).

Further (adjuvant) CHT was omitted in n=48 pCR patients (41%, n=26/22 A/B). Differences in EFS and OS by CHT were not significant (3y EFS: 97.0% with CHT vs. 85.5% without CHT, p=.16; 3y OS: 100% with CHT vs. 97.8 without CHT, p=.08).

Among immune/proliferation markers and clinical factors with significant (or borderline significant) association with pCR overall, only PD1 and clinical factors cN and cT were significantly associated with EFS in univariable analysis.

Conclusions

ADAPT TN confirms the strong prognostic impact of pCR in TNBC. However, the higher pCR rate favoring carbo was not reflected in a significant EFS or OS advantage for carbo-containing CHT in our collective after 36 months FU. Nonetheless, a more detailed evaluation of carbo-based de-escalated chemotherapy in selected patients could be a viable approach in TNBC.

Clinical trial identification

NCT01815242

Editorial Acknowledgement

Resources from the same session

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