Eribulin in breast cancer: Current insights and therapeutic perspectives

Table 1 Summary of studies investigating the role of eribulin in metastatic breast cancer

Clinical study	Type of study	Number of patients analysed	Number of previous chemotherapy lines	Treatment groups (number of patients)	OS		PFS		ORR (%), P value
					Median (months)	HR (95%CI), P value	Median (months)	HR (95%CI), P value
Metastatic breast cancer – all subtypes combined
Cortes et al[24], 2011	Phase III, randomised, open-label, multicentre	762	2-5 (≥ 2 for locally recurrent or MBC)	E (508) vs TPC (254)	13.1 vs 10.6	0.81 (0.66-0.99), P = 0.041	3.7 vs 2.2	0.87 (0.71-1.05), P = 0.137	12 vs 5, P = 0.002
Yuan et al[27], 2019	Phase III, randomised, open-label, multicentre	530	2-5	E (264) vs vinorelbine (266)	13.4 vs 12.5	1.03 (0.80-1.31), P = 0.838	2.8 vs 2.8	0.80 (0.65-0.98), P = 0.036	30.7 vs 16.9, P < 0.001
Kaufman et al[26], 2015	Phase III, randomised, open-label, multicentre	1102	1-3 (1-2 for advanced and/or metastatic disease)	E (554) vs capecitabine (548)	15.9 vs 14.5	0.88 (0.77-1.00), P = 0.056	4.1 vs 4.2	1.08 (0.93-1.25), P = 0.30	11.0 vs 11.5, P = 0.85
Pernas et al[28], 2018	Phase I, single-arm, multicentre	54	1-3	E + balixafortide (CXCR4 antagonist)	16.8	NA	4.6 (95%CI: 3.1, 5.7)	NA	29.6
Metastatic breast cancer – eribulin as an earlier agent
Ortega et al[48], 2019	Phase II, single-arm, multicentre	53	0	E	NA (not reached)	NA	4.1 (95%CI: 3.2, 6.6)	NA	20.8 (95%CI: 9.8, 31.7)
Hayashida et al[63], 2018	Phase II, open-label, single-arm, multicentre	32	0-1	E	NA	NA	8.3 (95%CI: 7.1, 9.4)	NA	43.8 (95%CI: 26.5, 61.0)
Takashima et al[64], 2016	Phase II, open-label single-arm, multicentre	35	0	E	35.9	NA	5.8 (95%CI: 4.8, 8.1)	NA	54.3 (95%CI: 37.8, 70.8)
McIntyre et al[65], 2014	Phase II, open-label, single-arm, multicentre	56	0	E	NA	NA	6.8 (95%CI: 4.4, 7.6)	NA	28.6 (95%CI 17.3, 42.2)
Triple Negative Breast Cancer (TNBC)
Twelves et al[38], 2016	Phase III, randomised, open-label, multicentre	284	1-3 (1-2 for advanced and/or metastatic disease)	E (150) vs capecitabine (134)	14.4 vs 9.4	0.70 (0.54-0.91), P = 0.006	2.9 vs 2.3	0.80 (0.61-1.05), P = 0.112	NA
Pivot et al[39], 2016	Phase III, randomised, open-label, multicentre	352	305 study (vs TPC): 2-5 (≥ 2 for locally recurrent or MBC); 301 study (vs capecitabine): 1-3 (1-2 for advanced and/or metastatic disease)	E (199) vs TPC/capecitabine (153)	12.4 vs 8.1	0.72 (0.57-0.90), P = 0.005	2.8 vs 2.5	0.77 (0.60-0.97), P = 0.028	NA
Tolaney et al[37], 2021	Phase Ib/ II, open-label, single-arm, multicentre	167	≤ 2; 0 (n = 66); 1-2 (n = 101)	E + pembrolizumab	16.1	NA	4.1	NA	23.4 (17.2-30.5)
Yonemori et al[36], 2019	Phase I/II, open-label, single-arm, multicentre	48 (Phase I: 24; Phase II: 24)	≥ 2	E + olaparib	14.5	NA	4.2	NA	37.5 (18.8-59.4)
Lee et al[42], 2019	Phase I, single-arm, single-centre	25	0-3	E + everolimus	8.3 (95%CI: 5.5, undefined)	NA	2.6 (95%CI: 2.1, 4.0)	NA	NA
ER-positive
Twelves et al[38], 2016	Phase III, randomised, open-label, multicentre	537	1-3 (1-2 for advanced and/or metastatic disease)	E (259) vs capecitabine (278)	18.2 vs 16.8	0.90 (0.74-1.09), P = 0.283	4.3 vs 5.3	1.11 (0.89-1.38), P = 0.367	NA
Pivot et al[39], 2016	Phase III, randomised, open-label, multicentre	945	305 study (vs TPC): 2-5 (≥ 2 for locally recurrent or MBC); 301 study (vs capecitabine): 1-3 (1-2 for advanced and/or metastatic disease)	E (544) vs TPC/capecitabine (401)	15.7 vs 13.5	0.87 (0.75-1.00), P = 0.058	4.1 vs 3.4	0.84 (0.72-0.98), P = 0.031	NA
HER2-positive
Twelves et al[38], 2016	Phase III, randomised, open-label, multicentre	169	1-3 (1-2 for advanced and/or metastatic disease)	E (86) vs capecitabine (83)	14.3 vs 17.1	0.97 (0.69-1.35), P = 0.837	4.0 vs 5.1	1.36 (0.93-1.98), P = 0.115	NA
Pivot et al[39], 2016	Phase III, randomised, open-label, multicentre	254	305 study (vs TPC): 2-5 (≥ 2 for locally recurrent or MBC); 301 study (vs capecitabine): 1-3 (1-2 for advanced and/or metastatic disease)	E (150) vs TPC/capecitabine (104)	13.5 vs 11.7	0.75 (0.57-1.00). P = 0.051	3.7 vs 4.2	1.00 (0.75-1.35), P = 0.970	NA
Sakaguchi et al[55], 2018	Phase II, single-arm, multicentre	28	0	E + trastuzumab	NA (not reached)	NA	11.3 (344 d)	NA	53.6 (95%CI: 36.62, 69.93)
Lutrino et al[54], 2016	Phase II, single-arm, single-centre	24	2-9	E + trastuzumab	8 (range 1.3-14.8)	NA	5.4 (range 1-10.5)	NA	41.7%
Inoue et al[56], 2019	Phase II, open-label, single-arm, multicentre	25	0	E + trastuzumab + pertuzumab	NA	NA	23.1 (95%CI: 14.4, 31.8)	NA	80 (95%CI: 59.3, 93.2)

CI: Confidence interval; E: Eribulin; HR: Hazard ratio/hormone receptor; NA: Not available; ORR: Objective response rate; OS: Overall survival; PFS: Progression-free survival; TNBC: Triple-negative breast cancer.