400P - Efficacy of anti-HER2 retherapy with trastuzumab at first relapse and/or first occurrence of metastases of HER2-positive breast cancer in clinical...

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Breast Cancer, Metastatic
Personalised Medicine
Presenter Lars Hanker
Citation Annals of Oncology (2014) 25 (suppl_4): iv116-iv136. 10.1093/annonc/mdu329
Authors L. Hanker1, T. Hitschold2, A. Grafe3, F. Förster4, J. Schröder5, J. Janssen6, D. Reichert7, T. Wohlfarth8, J. Greinemann9, T. Hesse10
  • 1Department Of Gynecology & Obstetrics, University of Schleswig-Holstein, 23538 - Luebeck/DE
  • 2Brustzentrum, Klinikum Worms, Worms/DE
  • 3Gynäkologische Onkologie, MVZ Nordhausen, Nordhausen/DE
  • 4Gynäkologische Onkologie, Schwerpunktpraxis für Gynäkologische Onkologie und Palliativmedizin, Chemnitz/DE
  • 5Onkologie, Onkologische Schwerpunktpraxis, Mülheim a. R./DE
  • 6Medical Oncology Unit, Onkologische Westerstede, Westerstede/DE
  • 7Onkologie, Onkologische Praxis, DE-26655 - Westerstede/DE
  • 8Medical Affairs, Roche Pharma AG, 79639 - Grenzach/DE
  • 9Clinical Research, iOMEDICO AG, Freiburg/DE
  • 10Brustzentrum, Diakoniekrankenhaus Rotenburg, Rotenburg/DE

Abstract

Aim

Patients receiving trastuzumab (Herceptin®; H) ReTherapy seem to benefit from a repeated treatment. Aim of this NIS is the proof of efficacy of first line treatment with H after relapse-free (neo)adjuvant anti-HER2 therapy.

Methods

In total, 122 sites enrolled 239 patients with locally recurrent and/or metastatic HER2-positive breast cancer into this trial. The current interim analysis presents data from 225 patients collected between 10/2008 and 01/2014.

Results

At the time of inclusion, 19.2% (n = 43) of patients only suffered from local recurrence only, 80.8% (n = 181) had developed distant metastases ± local recurrence, of which 27.7% (n = 62) had exclusively non-visceral and 53,1% (n = 119) visceral (± non-visceral) metastases. Median duration of H ReTherapy was 10.7 months (m) (range 0-56.9). Median progression-free survival amounted to 10.1 m (95% CI: 8.3-12.0) in the total population, 11.5 m (8.3-20.1) for patients with non-visceral disease, and 8.0 m (6.3-10.2) for patients with visceral disease. H ReTherapy was given either as monotherapy (H: 13.3%) or in combination with hormono- (H + HT: 16.4%) and/or chemotherapy (total: 70.2%; H + CT: 54.7%; H + CT + HT: 15.5%). The most frequently used drugs were paclitaxel (26.6%), vinorelbin (18.4%), and docetaxel (10.8%). Progression-free survival for patients treated with H monotherapy amounted to 13.4 m, with H + HT to 11.2 m, with H + CT to 8.1 m, and with H + CT + HT to 19.5 m. The overall response rate in the total population was 44.3%, for patients with only local recurrence 65.5%, with non-visceral disease 35.8%, and with visceral disease 42.0%.

Conclusions

The results of the current interim analysis indicate that Herceptin ReTherapy is an efficacious treatment option in first line therapy for patients with locally recurrent and/or metastatic HER2-positive breast cancer. Over 70% of ReTherapies combined Herceptin with chemotherapy. The combination of Herceptin with both chemo- and hormonotherapy was most efficacious in terms of progression-free survival. The present data are in line with the results of other recent trials.

Disclosure

T. Wohlfarth: employee, stock ownership (Roche). All other authors have declared no conflicts of interest.