Neoadjuvant eribulin mesylate following anthracycline and taxane in triple negative breast cancer: Results from the HOPE study

Claudio Tripodo, Alessandro Gulino, Nicla La Verde, Gianfranco Scaperrotta, Massimo Di Nicola, Luigi Mariani, Maria Carmen De Santis, Biagio Paolini, Alessandro Gulino, Marina Elena Cazzaniga, Daniele Generali, Serena Di Cosimo, Massimo Di Nicola, Nicla La Verde, Anna Moretti, Daniele Generali, Luigi Mariani, Nicla La Verde, Daniele Generali, Nicla La VerdeDaniele Generali, Giulia Valeria Bianchi, Daniele Generali, Claudio Tripodo, Secondo Folli, Flavio Crippa, Filippo De Braud, Giovanni Apolone, Valter Torri, Mario Paolo Colombo, Giulia Valeria Bianchi

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6 Citazioni (Scopus)


Background Eribulin mesylate (E) is indicated for metastatic breast cancer patients previously treated with anthracycline and taxane. We argued that E could also benefit patients eligible for neoadjuvant chemotherapy. Methods Patients with primary triple negative breast cancer 2 cm received doxorubicin 60 mg/m2 and paclitaxel 200 mg/m2 x 4 cycles (AT) followed by E 1.4 mg/m2 x 4 cycles. Primary endpoint was pathological complete response (pCR) rate; secondary and explorative endpoints included clinical/metabolic response rates and safety, and biomarker analysis, respectively. Using a two-stage Simon design, 43 patients were to be included provided that 4 of 13 patients had achieved pCR in the first stage of the study. Results In stage I of the study 13 women were enrolled, median age 43 years, tumor size 2–5 cm in 9/13 (69%), positive nodal status in 8/13 (61%). Main grade 3 adverse event was neutropenia (related to AT and E in 4 and 2 cases, respectively). AT followed by E induced clinical complete + partial responses in 11/13 patients (85%), pCR in 3/13 (23%). Median measurements of maximum standardized uptake value (SUVmax) resulted 13, 3, and 1.9 at baseline, after AT and E, respectively. Complete metabolic response (CMR) occurred after AT and after E in 2 and 3 cases, respectively. Notably, 2 of the 5 (40%) patients with CMR achieved pCR at surgery. Immunostaining of paired pre-/post-treatment tumor specimens showed a reduction of β-catenin, CyclinD1, Zeb-1, and c-myc expression, in the absence of N-cadherin modulation. The study was interrupted at stage I due to the lack of the required patients with pCR. Conclusions Despite the early study closure, preoperative E following AT showed clinical and biological activity in triple negative breast cancer patients. Furthermore, the modulation of β-catenin pathway core proteins, supposedly outside the domain of epithelial–mesenchymal transition, claims for further investigation. Trial registration EU Clinical Trial Register, EudraCT number 2012-004956-12.
Lingua originaleEnglish
Numero di pagine14
RivistaPLoS One
Stato di pubblicazionePublished - 2019

All Science Journal Classification (ASJC) codes

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