Eribulin mesylate in the treatment of metastatic breast cancer

Figures & data

Table 1 Review of Phase I clinical trials of eribulin in advanced solid tumors

Author	n	Treatment	RR, n (%)	SD, n (%)	Dose-limiting toxicities
Synold et al^Citation17	40	Eribulin 0.125–2 mg/m^2 over 2 minutes on days 1, 8, 15 every 28 days	2 (5)	12 (32)	Febrile neutropenia, neutropenia
Goel et al^Citation18	32	Eribulin 0.25–1.4 mg/m^2 over 1 hour on days 1, 8, 15 every 28 days	1 (3)	10 (31)	Neutropenia
Tan et al^Citation19	21	Eribulin 0.25–4 mg/m^2 over 1 hour every 21 days	1 (5)	12 (57)	Febrile neutropenia, neutropenia
Minami et al^Citation26	15	Eribulin 0.7–2 mg/m^2 over 5 minutes on days 1 and 8 every 21 days	3 (20)	3 (20)	Febrile neutropenia, neutropenia
Goel et al^Citation27	21	Eribulin 0.7–1.4 mg/m^2 with gemcitabine 800–1000 mg/m^2 on days 1, 8, 15 every 28 days. Due to DLT, changed to days 1 and 8 every 21 days	1 (5)	8 (38)	Grade 3 diarrhea, dizziness, fatigue
Swami et al^Citation28	52	Eribulin 0.7–1.4 mg/m^2 over 2–5 minutes on days 1 and 8 with carboplatin AUC 5–6 on day 1 every 21 days.	3 (6)	NR	Febrile neutropenia, neutropenia

Abbreviation: NR, not reported.

Table 2 Summary of Phase II trials of eribulin in metastatic breast cancer

Study	Protocol population	ORR (%)	SD (%)	Median PFS (months)	Median OS (months)	Grade 3/4 adverse events
Vahdat et al^Citation29	87	11.5	42.5	2.6	9	Neutropenia (64%), febrile neutropenia (4%), fatigue (5%)*, peripheral neuropathy (5%)*
Cortes et al^Citation30	269	9.3	46.5	2.6	10.4	Neutropenia (54%), febrile neutropenia (6%), fatigue (10%)*, peripheral neuropathy (7%)*
Iwata et al^Citation31	81	21.3	37.5	3.7	10.9	Neutropenia (95%), febrile neutropenia (14%), peripheral neuropathy (4%)*

* Note: No grade 4 events.

Abbreviations: ORR, overall objective response rate (CR + PR); SD, stable disease; PFS, progression-free survival; OS, overall survival; CR, complete response; PR, partial response.

Table 3 Results of Phase II EMBRACE trial

	Eribulin	TPC	P value
Intent-to-treat population, n	508	254
Median OS (months)	13.1	10.6	0.04
95% CI	11.8–14.3	9.3–12.5
Median PFS (months)	3.7	2.2	0.137
95% CI	3.3–3.9	2.1–3.4
Response evaluable population, n	468	214
Objective response rate (CR + PR), %	12.2 (9.4–15.5)	4.7 (2.3–8.4)	0.002
Clinical benefit rate (CR + PR + SD ≥ 6 months), %	23 (18.9–26.7)	17 (12.1–22.5)
Common grade 3/4 toxicities (%)
Neutropenia (febrile neutropenia)	45 (5)	21 (2)
Asthenia/fatigue	9	10*
Peripheral neuropathy	8	2*

* Note: No grade 4.

Abbreviations: SD, stable disease; PFS, progression-free survival; OS, overall survival; CR, complete response; PR, partial response.

Table 4 Ongoing/pending clinical trials evaluating eribulin in metastatic breast cancer

ClinicalTrials.gov identifier (study name)	Phase	Eligibility	Intervention	Primary endpoint(s)	Status
Second-line and beyond
NCT00337103 (E 301)	II	Prior treatment with anthracycline and taxane	Eribulin vs capecitabine	OS, PFS	Completed accrual
NCT01427933	II	Prior treatment with anthracycline and taxane	Ramucirumab with eribulin vs eribulin monotherapy	PFS	Not yet recruiting
NCT00879086 (E 209)	II	Prior treatment with a taxane	Eribulin vs ixabepilone	Percent of subjects with neuropathy adverse events	Completed accrual
First-line therapy
NCT01268150 (E 206)	II	HER2-negative disease	Eribulin	ORR	Recruiting
NCT01269346 (E 208)	II	HER2-positive disease	Eribulin with trastuzumab	ORR	Recruiting

Abbreviations: ORR, overall objective response rate (CR + PR); PFS, progression-free survival; OS, overall survival.

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