Efficacy of eribulin in breast cancer: a short report on the emerging new data

Figures & data

Table 1 Clinical trials leading to the licensing of eribulin for locally advanced and metastatic breast cancer

Study	Study design	Eligibility criteria	Number of patients	ORR (%)	Median PFS	Median OS
Cortes et al^Citation23	Single-arm Phase II	Prior anthracycline, taxane and capecitabine	291	9.3	2.6 months (0.03–13.1 months)	10.4 months (0.6–19.9 months)
Cortes et al^Citation2	Open-label randomized Phase III, eribulin vs treatment of physicians choice	Two to five previous chemotherapy regimens including an anthracycline and a taxane	762	12 vs 5	3.7 vs 2.2 months, HR =0.87 (95% CI: 0.71–1.05), P=0.137	13.1 vs 10.6 months, HR =0.81 (95% CI: 0.66–0.99), P=0.041
Kaufman et al^Citation21	Open-label randomized Phase III, eribulin vs capecitabine	Up to two prior chemotherapy regimens for advanced disease	1,102	11.0 vs 11.5	4.1 vs 4.2 months, HR =1.08 (95% CI: 0.93–1.25), P=0.30	15.9 vs 14.5 months, HR =0.88 (95% CI: 0.77–1.00), P=0.056

Abbreviations: CI, confidence interval; ORR, objective response rate; OS, overall survival; PFS, progression-free survival.

Table 2 Postlicensing studies of eribulin in patients with advanced breast cancer

Study	Study design	Study treatment	Eligibility criteria	Number of patients	ORR (%)	Median PFS (months)	Median OS (months)
McIntyre et al^Citation28	Single-arm Phase II	Eribulin	First-line therapy, Her2-negative	56	28.6	6.8	NR
Wilks et al^Citation29	Single-arm Phase II	Eribulin + trastuzumab	First-line therapy, Her2-positive	52	71	11.6	NR
Yardley et al^Citation30	Randomized Phase II	Eribulin ± ramucirumab	Two to four previous chemotherapy regimens including an anthracycline and a taxane	141	21 vs 28	4.4 vs 4.1	13.5 vs 11.5

Abbreviations: NR, not reported; ORR, objective response rate; OS, overall survival; PFS, progression-free survival.

Table 3 Clinical trials of neoadjuvant eribulin in early breast cancer

Study	Study design	Study treatment	Eligibility criteria	Number of patients	pCR (%)
Abraham et al^Citation31	Randomized (2:1) Phase II	Eribulin vs weekly paclitaxel, then doxorubicin + cyclophosphamide	Her2-negative	49	17 vs 26
Yardley et al^Citation32	Randomized (2:1) Phase II	Eribulin + cyclophosphamide vs docetaxel + cyclophosphamide	Her2-negative	66	14 vs 11
Kaklamani et al^Citation33	Single-arm Phase II	Eribulin + carboplatin	TNBC	30	43
Schwartzberg et al^Citation34	Phase I/II	Eribulin + carboplatin + trastuzumab	Her2-positive	12	17

Abbreviations: pCR, pathological complete response; TNBC, triple-negative breast cancer.

Table 4 Pooled incidence of common adverse events reported by patients treated with eribulin (n=1,047) in the two randomized Phase III trials of eribulin for advanced breast cancer (EMBRACE² and 301 Study²¹)

Adverse event	All grades		Grade 3		Grade 4
	Number of patients	%	Number of patients	%	Number of patients	%
Neutropenia	555	53	240	23	236	23
Leukopenia	287	27	132	13	20	2
Anemia	198	19	20	2	1	<1
Fatigue/asthenia	444	42	74	7	4	<1
Alopecia	412	39
Peripheral neuropathy	323	31	74	7	5	<1
Nausea	295	28	7	1	0	0
Diarrhea	170	16	6	1	0	0
Pyrexia	175	17	3	<1	0	0
Headache	166	16	6	1	0	0
Anorexia	166	16	5	<1	0	0
Vomiting	156	15	5	<1	2	<1
Back pain	135	13	11	1	1	<1
Dyspnea	135	13	28	3	2	<1
Bone pain	110	11	19	2	1	<1

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