Eribulin mesylate use as third-line therapy in patients with metastatic breast cancer (VESPRY): a prospective, multicentre, observational study.

eribulin metastatic breast cancer multicentre prospective real world third line

Journal

Therapeutic advances in medical oncology
ISSN: 1758-8340
Titre abrégé: Ther Adv Med Oncol
Pays: England
ID NLM: 101510808

Informations de publication

Date de publication:
2019
Historique:
received: 29 03 2019
accepted: 15 11 2019
entrez: 7 1 2020
pubmed: 7 1 2020
medline: 7 1 2020
Statut: epublish

Résumé

In real-world practice, eribulin mesylate provides significant survival benefit, with a manageable safety profile in heavily pretreated patients with metastatic breast cancer (MBC). In this prospective, open-label, multicentre, observational study we evaluated the effectiveness and tolerability of eribulin as third-line treatment in a homogeneous population. The primary endpoints were the safety profile and response in metastatic sites; secondary endpoints included the response in different subtypes, overall response rate (ORR), progression-free survival (PFS) and overall survival (OS). From 2013 to 2016, 118 women were treated in 21 Sicilian institutions; the median age was 58 years (range 29-79), with 69% of patients under 65. The median cycles of eribulin were 5.5 (range 1-26). The most common adverse event was neutropenia (9.3%, 3 cases of grade 3, 4 of grade 4); only 1 case of QT prolongation was reported. Eribulin was effective in controlling metastatic disease in all sites, and it achieved the highest ORR in brain (16%) and liver (14.9%). Median OS was 31.8 months (95% CI 27.9-34.4) and median PFS 5.5 months (95% CI 4.2-6.6). PFS was 5.2 months (95% CI 2.8-8.4) in patients with triple-negative subtype. Median PFS was longer in patients over 65 years (6.1 months, 95% CI 4.4-8.3). In patients who had visceral metastases PFS was 5.5 months (95% CI 95% 3.5-6.6) and OS 33.9 months (95% CI 29.8-40.8). Eribulin as third-line treatment shows an acceptable safety profile and a substantial antitumour activity in the treatment of MBC, even in elderly patients and in those with visceral disease.

Sections du résumé

BACKGROUND BACKGROUND
In real-world practice, eribulin mesylate provides significant survival benefit, with a manageable safety profile in heavily pretreated patients with metastatic breast cancer (MBC).
METHODS METHODS
In this prospective, open-label, multicentre, observational study we evaluated the effectiveness and tolerability of eribulin as third-line treatment in a homogeneous population. The primary endpoints were the safety profile and response in metastatic sites; secondary endpoints included the response in different subtypes, overall response rate (ORR), progression-free survival (PFS) and overall survival (OS).
RESULTS RESULTS
From 2013 to 2016, 118 women were treated in 21 Sicilian institutions; the median age was 58 years (range 29-79), with 69% of patients under 65. The median cycles of eribulin were 5.5 (range 1-26). The most common adverse event was neutropenia (9.3%, 3 cases of grade 3, 4 of grade 4); only 1 case of QT prolongation was reported. Eribulin was effective in controlling metastatic disease in all sites, and it achieved the highest ORR in brain (16%) and liver (14.9%). Median OS was 31.8 months (95% CI 27.9-34.4) and median PFS 5.5 months (95% CI 4.2-6.6). PFS was 5.2 months (95% CI 2.8-8.4) in patients with triple-negative subtype. Median PFS was longer in patients over 65 years (6.1 months, 95% CI 4.4-8.3). In patients who had visceral metastases PFS was 5.5 months (95% CI 95% 3.5-6.6) and OS 33.9 months (95% CI 29.8-40.8).
CONCLUSIONS CONCLUSIONS
Eribulin as third-line treatment shows an acceptable safety profile and a substantial antitumour activity in the treatment of MBC, even in elderly patients and in those with visceral disease.

Identifiants

pubmed: 31903098
doi: 10.1177/1758835919895755
pii: 10.1177_1758835919895755
pmc: PMC6923689
doi:

Types de publication

Journal Article

Langues

eng

Pagination

1758835919895755

Informations de copyright

© The Author(s), 2019.

Déclaration de conflit d'intérêts

Conflict of interest statement: The author(s) declare that there are no conflicts of interest.

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Auteurs

Vincenzo Adamo (V)

Medical Oncology Unit A.O. Papardo and Department of Human Pathology University of Messina, Contrada Papardo, Messina, Italy.

Giuseppina Rosaria Rita Ricciardi (GRR)

Medical Oncology Unit A.O. Papardo & Department of Human Pathology University of Messina, Contrada Papardo, Messina, Italy.

Dario Giuffrida (D)

Department of Medical Oncology, Mediterranean Institute of Oncology, Viagrande, CT, Italy.

Giuseppa Scandurra (G)

Oncologia Medica, Ospedale per le Emergenze Cannizzaro, Catania, Italy.

Antonio Russo (A)

Department of Surgical, Oncological and Oral Sciences, Section of Medical Oncology, University of Palermo, Palermo, Italy.

Livio Blasi (L)

UOC Oncologia Medica, ARNAS Civico, Palermo, Piazza Nicola Leotta, Italy.

Pietro Spadaro (P)

U.O. di Oncologia ed Ematologia, Casa di Cura Villa Salus, Messina, Italy.

Carmelo Iacono (C)

Medical Oncology Department, Ospedale Maria Paterno Arezzo, Ragusa, Italy.

Hector J Soto Parra (HJ)

Medical Oncology Department, University Hospital Policlinico Vittorio Emanuele, Catania, Italy.

Antonino Savarino (A)

Unità Operativa di Oncologia, Ospedale "Barone Lombardo" di Canicattì, Contrada Giarre, Canicattì, AG, Italy.

Francesco Ferraú (F)

Medical Oncology Department, Ospedale S Vincenzo, Taormina, ME, Italy.

Filippo Zerilli (F)

Medical Oncology San Antonio Abate Hospital, Trapani, Italy.

Francesco Verderame (F)

A.O. Ospedali Riuniti Villa Sofia - Cervello, Palermo, Italy.

Alfredo Butera (A)

Medical Oncology Hospital Agrigento, Agrigento, Italy.

Carlo Santangelo (C)

P.O. Umberto I, Contrada Ferrante, Enna, Italy.

Veronica Franchina (V)

Medical Oncology Unit A.O. Papardo & Department of Human Pathology University of Messina, Contrada Papardo, Messina, Italy.

Michele Caruso (M)

Humanitas Centro Catanese di Oncologia, Catania, Italy.

Classifications MeSH