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Poster display

3861 - Single arm, multicentre, non-randomized open-label trial to evaluate the safety of eribulin in third line chemotherapy in patients with HER2-negative metastatic or locally advanced breast cancer previously treated with anthracyclines and taxanes: Onsite study (ONCOSUR 2012-02)

Date

10 Oct 2016

Session

Poster display

Presenters

Luis Manso Sánchez

Citation

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

Authors

L.M. Manso Sánchez1, F. Moreno Antón2, Y. Izarzugaza Perón3, J..I. Delgado Mingorance4, P. Borrega5, M.J. Echarri González6, N. Martínez7, A. López González8, C. Olier9, A. Ballesteros García10, I. Chacón11, E. Ciruelos1, J.A. García-Sáenz2, L. Paz-Ares1

Author affiliations

  • 1 Oncology, University Hospital 12 De Octubre, 28041 - Madrid/ES
  • 2 Medical Oncology, Hospital Clinico Universitario San Carlos, Madrid/ES
  • 3 Medical Oncology, University Hospital "Fundacion Jimenez Diaz", Madrid/ES
  • 4 Medical Oncology, Hospital Infanta Cristina, Badajoz/ES
  • 5 Medical Oncology, Hospital San Pedro de Alcántara, Cáceres/ES
  • 6 Medical Oncology, Hospital Severo Ochoa, Leganes/ES
  • 7 Medical Oncology, Hospital Universitario Ramon y Cajal, Madrid/ES
  • 8 Medical Oncology, University Hospital of León, Leon/ES
  • 9 Medical Oncology, HUFA Hospital Universitario Fundacion Alcorcon, Alcorcon/ES
  • 10 Medical Oncology, Hospital Universitario de La Princesa, Madrid/ES
  • 11 Medical Oncology, Hospital Virgen de la Salud, Toledo/ES
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Resources

Abstract 3861

Background

Eribulin monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapy regimen for advanced disease. In an updated analysis of the EMBRACE study, survival improved in patients with 2-3 previous regimens (13.3 months vs 10.7 months HR 0.77, P = .039).

Methods

Patients received eribulin (1.23 mg/m2 on days 1 and 8 of every 21-day cycle) as third-line therapy until progression, unacceptable toxicity or withdrawal. The primary endpoint was safety, and secondary endpoints included objective response rate, clinical benefit, 1-year overall survival and progression free survival (PFS) rates, and circulating tumour cell levels (EudraCT number 2013-001416-30).

Results

Out of 59 eligible women (mean age 57.7), 58 (98.3%) had received previous taxanes and/or anthracyclines. Nearly all (98.3%) had HER2-negative tumors, 72% were positive for estrogens, 21% were triple negative; 64.4% had liver metastasis and 57.6% bone metastasis. Grade 3 or 4 hematologic adverse events were febrile neutropenia (N = 3; 5%) and neutropenia (n = 2; 3%). The most common non-hematologic adverse events were grade 1-2 asthenia (n = 2; 3%), grade 1-2 constipation (n = 2; 3%) and grade 1-2 skin rash (n = 1; 1%). Mean number of administered cycles was 6.9 ± 5.4. Follow-up was performed in 52 patients, with 19.2% (n = 10) partial response, 42.3% (n = 22) stable disease, and 38% (n = 20) progressive disease. Clinical benefit was achieved in 32 patients (61.5%). Median PFS was 5.13 months (95% CI 3.23, 8.90). After one year, 47 patients were still alive (81.03%).

Conclusions

Treatment with eribulin in third line chemotherapy for locally advanced or metastatic breast cancer is effective and minimally toxic, presenting a high clinical benefit rate.

Clinical trial identification

EudraCT number 2013-001416-30

Legal entity responsible for the study

Fundación Oncosur

Funding

Experior

Disclosure

All authors have declared no conflicts of interest.

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