Eribulin for metastatic breast cancer (MBC) treatment: a retrospective, multicenter study based in Campania, south Italy (Eri-001 trial)

doi:10.1136/esmoopen-2017-000176

. 2017 Jun 2;2(2):e000176.

doi: 10.1136/esmoopen-2017-000176. eCollection 2017.

Eribulin for metastatic breast cancer (MBC) treatment: a retrospective, multicenter study based in Campania, south Italy (Eri-001 trial)

Michele Orditura¹, Adriano Gravina², Ferdinando Riccardi³, Anna Diana¹, Carmela Mocerino³, Luigi Leopaldi⁴, Alessio Fabozzi^{5

6}, Guido Giordano⁵, Raffaele Nettuno⁷, Pasquale Incoronato⁸, Maria Luisa Barzelloni⁹, Roberta Caputo², Agata Pisano¹⁰, Giuseppe Grimaldi¹¹, Geppino Genua¹², Vincenzo Montesarchio¹³, Enrico Barbato¹⁴, Giovanni Iodice², Eva Lieto¹⁵, Eugenio Procaccini¹⁶, Roberto Mabilia¹⁷, Antonio Febbraro⁵, Michelino De Laurentiis², Fortunato Ciardiello¹

Affiliations

¹ Dipartimento di Internistica Clinica e Sperimentale Flaviano Magrassi, Università degli Studi della Campania"Luigi Vanvitelli", Naples, Italy.
² Department of Breast Oncology, National Cancer Institute 'Fondazione Pascale', Naples, Italy.
³ Oncology Unit, Cardarelli Hospital, Naples, Italy.
⁴ U.O. Oncologia Medica ASL NA1, Ospedale San Gennaro, Naples, Italy.
⁵ U.O. Oncologia Ospedale Sacro Cuore di Gesú, Fatebenefratelli, Benevento, Italy.
⁶ SSD oncologia del melanoma e dell'esofago, ISTITUTO ONCOLOGICO VENETO IRCCS, Padova, Italy.
⁷ U.O.S. di Oncologia ASL Caserta-PO AGP, di Piedimonte Matese (CE), Italy.
⁸ Servizio di Oncologia San Giuliano ASL NA2 NORD, Giugliano (NA), Italy.
⁹ U.O. Oncologia AORN San Giuseppe Moscati, Avellino, Italy.
¹⁰ U.O.C. Oncoematologia Ospedale Santa Maria Delle Grazie, Pozzuoli (NA), Italy.
¹¹ U.O. Medicina-Oncoematologia Ospedale Umberto I, Nocera Inferiore (SA), Italy.
¹² U.O. Oncologia Ospedale Civile ASL AV/1, Ariano Irpino (AV), Italy.
¹³ U.O.C. Oncologia AORN dei Colli, Ospedale 'V Monaldi', Naples, Italy.
¹⁴ U.O.S.D. Oncologia Medica Ospedale 'Moscati', Aversa (CE), Italy.
¹⁵ IX Divisione di Chirurgia Generale Dipartimento di Scienze Cardiotoraciche e Respiratorie Seconda, Università degli Studi di Napoli, Naples, Italy.
¹⁶ Breast Unit Second University of Naples School of Medicine, Naples, Italy.
¹⁷ U.O. Oncologia Ospedale Anna Rizzoli, Ischia (NA), Italy.

PMID: 28761747
PMCID: PMC5519815
DOI: 10.1136/esmoopen-2017-000176

Eribulin for metastatic breast cancer (MBC) treatment: a retrospective, multicenter study based in Campania, south Italy (Eri-001 trial)

Michele Orditura et al. ESMO Open. 2017.

. 2017 Jun 2;2(2):e000176.

doi: 10.1136/esmoopen-2017-000176. eCollection 2017.

Authors

Affiliations

¹ Dipartimento di Internistica Clinica e Sperimentale Flaviano Magrassi, Università degli Studi della Campania"Luigi Vanvitelli", Naples, Italy.
² Department of Breast Oncology, National Cancer Institute 'Fondazione Pascale', Naples, Italy.
³ Oncology Unit, Cardarelli Hospital, Naples, Italy.
⁴ U.O. Oncologia Medica ASL NA1, Ospedale San Gennaro, Naples, Italy.
⁵ U.O. Oncologia Ospedale Sacro Cuore di Gesú, Fatebenefratelli, Benevento, Italy.
⁶ SSD oncologia del melanoma e dell'esofago, ISTITUTO ONCOLOGICO VENETO IRCCS, Padova, Italy.
⁷ U.O.S. di Oncologia ASL Caserta-PO AGP, di Piedimonte Matese (CE), Italy.
⁸ Servizio di Oncologia San Giuliano ASL NA2 NORD, Giugliano (NA), Italy.
⁹ U.O. Oncologia AORN San Giuseppe Moscati, Avellino, Italy.
¹⁰ U.O.C. Oncoematologia Ospedale Santa Maria Delle Grazie, Pozzuoli (NA), Italy.
¹¹ U.O. Medicina-Oncoematologia Ospedale Umberto I, Nocera Inferiore (SA), Italy.
¹² U.O. Oncologia Ospedale Civile ASL AV/1, Ariano Irpino (AV), Italy.
¹³ U.O.C. Oncologia AORN dei Colli, Ospedale 'V Monaldi', Naples, Italy.
¹⁴ U.O.S.D. Oncologia Medica Ospedale 'Moscati', Aversa (CE), Italy.
¹⁵ IX Divisione di Chirurgia Generale Dipartimento di Scienze Cardiotoraciche e Respiratorie Seconda, Università degli Studi di Napoli, Naples, Italy.
¹⁶ Breast Unit Second University of Naples School of Medicine, Naples, Italy.
¹⁷ U.O. Oncologia Ospedale Anna Rizzoli, Ischia (NA), Italy.

PMID: 28761747
PMCID: PMC5519815
DOI: 10.1136/esmoopen-2017-000176

Abstract

Background: On the basis of the results of two pivotal phase III clinical trials, eribulin mesylate is currently approved in EU for the treatment of advanced breast cancer (aBC) in patients who have previously received an anthracycline and a taxane in either the adjuvant or the metastatic setting, and at least one chemotherapeutic regimen for metastatic disease.

Methods: In our study, we investigated the efficacy and tolerability of eribulin as second or further line chemotherapy in 137 women affected by aBC.

Results: Eribulin as monotherapy provided benefit in terms of progression-free survival (PFS), response rate (RR) and disease control rate (DCR) independently of its use as second or late-line therapy. The overall RR and DCR were 17.5% and 64%, respectively. In particular, DCR and overall RR were 50% and 13.6%, 65.4% and 21.1%, 70.4% and 14.8% and 66.7% and 16.7% in second, third, fourth and further lines of treatment, respectively. Median PFS (mPFS) according to the line of therapy was 5.7, 6.3, 4.5 and 4.0 months in patients treated with eribulin in second, third, fourth and over the fourth line, respectively. No significant difference in terms of mPFS was found between the various BC subtypes. Overall, eribulin resulted safe and most adverse events were of grade 1 or 2 and easily manageable. Grades 3-4 toxicities were neutropaenia and neurotoxicity.

Conclusions: With the limitations due to the observational nature of our findings, eribulin was shown to be an effective and safe therapeutic option in heavily pretreated patients with aBC.

Keywords: advanced breast cancer; chemotherapy; eribulin; real-world population.

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Conflict of interest statement

Competing interests: None declared.

Figures

**Figure 1**
Median progression-free survival in overall population.

**Figure 2**
Median progression-free survival according to the line of treatment with eribulin.

**Figure 3**
Median PFS according to the molecular subtypes of 137 MBC treated with eribulin. MBC, metastatic breast cancer; PFS, progression-free survival.

See this image and copyright information in PMC

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[1] I numeri del cancro in Italia. 2016. http://www.registri-tumori.it.

[2] I numeri del cancro in Italia. 2016. http://www.registri-tumori.it.

[3] Cardoso F, Costa A, Senkus E, et al. . 3rd ESO-ESMO International consensus guidelines for advanced breast cancer (ABC 3). Ann Oncol 2017;28:16–33.10.1093/annonc/mdw544 - DOI - PMC - PubMed

[4] Cardoso F, Costa A, Senkus E, et al. . 3rd ESO-ESMO International consensus guidelines for advanced breast cancer (ABC 3). Ann Oncol 2017;28:16–33.10.1093/annonc/mdw544 - DOI - PMC - PubMed

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[8] Geyer CE, Forster J, Lindquist D, et al. . Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006;355:2733–43.10.1056/NEJMoa064320 - DOI - PubMed

[9] Hortobagyi GN, Gomez HL, Li RK, et al. . Analysis of overall survival from a phase III study of ixabepilone plus capecitabine versus capecitabine in patients with MBC resistant to anthracyclines and taxanes. Breast Cancer Res Treat 2010;122:409–18.10.1007/s10549-010-0901-4 - DOI - PubMed

[10] Hortobagyi GN, Gomez HL, Li RK, et al. . Analysis of overall survival from a phase III study of ixabepilone plus capecitabine versus capecitabine in patients with MBC resistant to anthracyclines and taxanes. Breast Cancer Res Treat 2010;122:409–18.10.1007/s10549-010-0901-4 - DOI - PubMed

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Eribulin for metastatic breast cancer (MBC) treatment: a retrospective, multicenter study based in Campania, south Italy (Eri-001 trial)

Affiliations

Eribulin for metastatic breast cancer (MBC) treatment: a retrospective, multicenter study based in Campania, south Italy (Eri-001 trial)

Authors

Affiliations

Abstract

Conflict of interest statement

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