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Poster display

3859 - Results of Neoteam: A randomized multicenter phase II study of liposomal doxorubicin hydrochloride + trastuzumab vs conventional doxorubicin both in combination with cyclophosphamide and followed by docetaxel + trastuzumab as neoadjuvant treatment of HER2-positive primary breast cancer

Date

10 Oct 2016

Session

Poster display

Presenters

Sonia Pernas Simon

Citation

Annals of Oncology (2016) 27 (6): 68-99. 10.1093/annonc/mdw365

Authors

S. Pernas Simon1, M. Rezai2, M. Hauschild3, J.P. Machiels4, S. Paepke5, A. Llombart Cussac6

Author affiliations

  • 1 Department Of Oncology, Institut Català d'Oncologia, 08908 - Barcelona/ES
  • 2 Department Of Gynaecology And Obstetrics, European Breast Center Luis Hospital Dusseldorf Medical Center, Düsseldorf/DE
  • 3 Department Of Gynaecology And Obstetrics, Frauenklinik, Rheinfelden/CH
  • 4 Department Of Oncology, Cliniques Universitaires Saint-Luc, Brussels/BE
  • 5 Department Of Breast Surgery, Sankt Gertrauden- Krankenhaus, Berlin/DE
  • 6 Department Of Oncology, Institut Català d'Oncologia, IDIBELL, L'Hospitalet de Llobregat, 08908 - Barcelona/ES
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Resources

Abstract 3859

Background

The addition of trastuzumab (TH) to primary chemotherapy in HER2-positive breast cancer (BC) significantly improved pathological complete response (pCR) and survival. Concurrent use of TH to an anthracycline taxane-based regimen increased pCR but raised concerns about cardiac toxicity. Given the lower cardiotoxicity of liposomal doxorubicin hydrochloride (MYOCET®), the objective of this study was to explore the benefit of liposomal doxorubicin hydrochloride plus TH in a neoadjuvant scenario.

Methods

Patients with stage II-III HER2-positive BC were randomized to liposomal doxorubicin hydrochloride (60 mg/m2) plus cyclophosphamide (600 mg/m2) and TH (MCH) or conventional doxorubicin plus cyclophosphamide alone (AC), each followed by docetaxel (100 mg/m2) and TH. The primary objective of this trial, carried out in 21 European centers, was efficacy assessed by BC-pCR; secondary objectives included pCR by hormonal status and disease stage, progression-free survival (PFS) at 5 years, and safety.

Results

From Mar 2008-Oct 2010, 126 patients were enrolled and were evaluable. No statistically significant differences were observed in demographics and baseline clinical characteristics between treatment groups. Adverse events and discontinuations during cycles 1-8 were similar in both treatment groups. pCR was 41.3% for the MCH group and 54.0% for the AC but differences were not statistically significant (p =.154, 95% CI −0.30 to 0.05). However, in patients with stage II disease, pCR was 31.0% vs 62.5% in favor of AC (p =.004; 95% CI 0.52-0.11). PFS was similar in both arms. The safety profile was similar in both groups; however, more patients in the AC group (12.7%) experienced cardiovascular events than in the MCH group (6.5%).

Conclusions

MCH was similar in efficacy to the traditional regimen of AC in terms of pCR in HER2-positive BC. However in stage II patients alone, the AC arm had a significant benefit in terms of pCR. More patients in the AC group experienced cardiovascular events than in the MCH group.

Clinical trial identification

C19562/2037/BC/EU

Legal entity responsible for the study

This is a company-sponsored study: Teva Branded Pharmaceutical Products R&D, Inc. Sponsor's Responsible Medical Officer Richard Malamut, MD

Funding

Teva Branded Pharmaceutical Products R&D, Inc.

Disclosure

S. Paepke: Honoraria from Teva. All other authors have declared no conflicts of interest.

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