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Poster display session

3000 - Retrospective Observational Study to Evaluate the Use of Halaven plus Trastuzumab for the Treatment of HER2(+) Metastatic Breast Cancer (MBC) in Spain. HALATRUST Study

Date

11 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Breast Cancer

Presenters

María José Echarri González

Citation

Annals of Oncology (2017) 28 (suppl_5): v74-v108. 10.1093/annonc/mdx365

Authors

M.J. Echarri González1, F. Ayala de la Peña2, R. Márquez Vázquez3, J.A. García-Saenz4, E. Galve Calvo5, J.J. Illarramendi Mañas6, E. Millastre Bocos7, M. Margelí Vila8, P. Sánchez Rovira9, J.I. Chacón López-Muñiz10, P. Cerezuela Fuentes11, R. Andrés Conejero12, L. Cerrato Crespan13, I. Marrodán Ciordia14, A. Ocana Fernandez15, I. Álvarez López16, J.E. Alés Martínez17, L. Palomar Abad18, L. Orcajo Rincon19, J. Rodríguez-Villanueva19

Author affiliations

  • 1 Medical Oncology, Hospital Universitario Severo Ochoa, 28911 - Leganés/ES
  • 2 Medical Oncology, Hospital Universitario Morales Meseguer, 30007 - Murcia/ES
  • 3 Medical Oncology, MD Anderson Cancer Center Madrid, 28033 - Madrid/ES
  • 4 Medical Oncology, Hospital Universitario Clínico San Carlos, 28040 - Madrid/ES
  • 5 Medical Oncology, Hospital Universitario Basurto, 48013 - Bilbao/ES
  • 6 Medical Oncology, Complejo Hospitalario de Navarra, 31008 - Pamplona/ES
  • 7 Medical Oncology, Hospital Universitario Miguel Servet, 50009 - Zaragoza/ES
  • 8 Medical Oncology, Institut Català d'Oncologia Badalona, 08916 - Badalona/ES
  • 9 Medical Oncology, H. de Jaén, 23007 - Jaén/ES
  • 10 Medical Oncology, Hospital Virgen de la Salud, 45005 - Toledo/ES
  • 11 Medical Oncology, Hospital General Universitario Santa Lucía, 30202 - Cartagena/ES
  • 12 Medical Oncology, Hospital Clínico Universitario Lozano Blesa, 50009 - Zaragoza/ES
  • 13 Medical Oncology, Hospital Central de la Defensa, 28047 - Madrid/ES
  • 14 Medical Oncology, Hospital de Cruces, 48903 - Baracaldo/ES
  • 15 Medical Oncology, Complejo Hospitalario Universitario de Albacete, 2006 - Albacete/ES
  • 16 Medical Oncology, Hospital Universitario Donostia, 20014 - Donostia/ES
  • 17 Medical Oncology, Hospital Nuestra Señora de Sonsoles, 05004 - Ávila/ES
  • 18 Medical Oncology, Hospital Universitari i Politècnic La Fe, 46026 - Valencia/ES
  • 19 Oncology Department, Eisai Pharmaceuticals, 28033 - Madrid/ES
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Resources

Abstract 3000

Background

Eribulin is a widely used drug for the management of HER2(-) MBC. Given HER2(+) MBC is routinely treated with combinations of anti-HER2 agents plus chemotherapy, frequent use of eribulin in this context has been published in small case series. As today, clinical trial data of eribulin plus trastuzumab comes from phase 2 study in which 1st line patients achieved objective response rates (ORR) of 71% and median progression free survival (PFS) of 12 months, with median overall survival (OS) not yet achieved. HALATRUST is a retrospective, multicentre study designed to evaluate the clinical benefit rate (CBR) and safety profile of this combination in daily clinical practice.

Methods

All known HER2+ MBC patients treated with eribulin plus trastuzumab for a minimum of 1 dose and whose medical records were available and initiated from April 2011 to May 2016 were included. No statistical hypothesis was pre-established.

Results

Of the 48 patients identified in 19 Spanish public and private centres, 47 fully complied with the inclusion criteria and were analysed for efficacy and safety. Relevant baseline characteristics of the population are as follows. Median age: 55 (35 – 86) year-old, women: 45 (96%), positive estrogen and progesterone receptor: 30 (64%) and 19 (40%) respectively, disease burden of ≥ 5 lesions: 35 (75%), and median number of previous treatments for MBC: 7. Efficacy and safety results of the study population (n = 47) are summarized in the Table.Table:

307P

CategoryVariable
CBR, n (%)25 (53.2)
ORR, n (%)11 (23.4)*
PFS, median (range)3.6 (3.2 – 4.9)
OS, median (range)12.1 (9.6 – 19.1)
Dose adjustments, n (%)9 (19)
TRAE withdrawals, n (%)3 (6)**

TRAE: treatment related adverse events.

*

Including 1 complete response.

**

Most TRAE were of hematologic origin.

Conclusions

HALATRUST is, to the best of our knowledge, the largest reported case series on the use of eribulin plus trastuzumab for the treatment of late-line HER2(+) MBC. Results found provide clear evidence on the efficacy and safety of the combination, and highlight the need for its inclusion within the earlier treatment options used in this patient population.

Clinical trial identification

EIS-ERI-2016-01

Legal entity responsible for the study

Eisai Pharmaceuticals Spain

Funding

Eisai Pharmaceuticals Spain

Disclosure

L. Orcajo Rincon, J. Rodríguez-Villanueva: Employee of Eisai Pharmaceuticals. All other authors have declared no conflicts of interest.

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