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Copyright ©The Author(s) 2024.
World J Exp Med. Jun 20, 2024; 14(2): 92558
Published online Jun 20, 2024. doi: 10.5493/wjem.v14.i2.92558
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], 2011Phase III, randomised, open-label, multicentre7622-5 (≥ 2 for locally recurrent or MBC)E (508) vs TPC (254)13.1 vs 10.60.81 (0.66-0.99), P = 0.0413.7 vs 2.20.87 (0.71-1.05), P = 0.13712 vs 5, P = 0.002
Yuan et al[27], 2019Phase III, randomised, open-label, multicentre5302-5E (264) vs vinorelbine (266)13.4 vs 12.5 1.03 (0.80-1.31), P = 0.8382.8 vs 2.80.80 (0.65-0.98), P = 0.03630.7 vs 16.9, P < 0.001
Kaufman et al[26], 2015Phase III, randomised, open-label, multicentre11021-3 (1-2 for advanced and/or metastatic disease)E (554) vs capecitabine (548)15.9 vs 14.50.88 (0.77-1.00), P = 0.0564.1 vs 4.21.08 (0.93-1.25), P = 0.3011.0 vs 11.5, P = 0.85
Pernas et al[28], 2018Phase I, single-arm, multicentre541-3E + balixafortide (CXCR4 antagonist)16.8NA4.6 (95%CI: 3.1, 5.7)NA29.6
Metastatic breast cancer – eribulin as an earlier agent
Ortega et al[48], 2019Phase II, single-arm, multicentre530ENA (not reached)NA4.1 (95%CI: 3.2, 6.6)NA20.8 (95%CI: 9.8, 31.7)
Hayashida et al[63], 2018Phase II, open-label, single-arm, multicentre320-1ENANA8.3 (95%CI: 7.1, 9.4)NA43.8 (95%CI: 26.5, 61.0)
Takashima et al[64], 2016Phase II, open-label single-arm, multicentre350E35.9NA5.8 (95%CI: 4.8, 8.1)NA54.3 (95%CI: 37.8, 70.8)
McIntyre et al[65], 2014Phase II, open-label, single-arm, multicentre560ENANA6.8 (95%CI: 4.4, 7.6)NA28.6 (95%CI 17.3, 42.2)
Triple Negative Breast Cancer (TNBC)
Twelves et al[38], 2016Phase III, randomised, open-label, multicentre2841-3 (1-2 for advanced and/or metastatic disease)E (150) vs capecitabine (134)14.4 vs 9.40.70 (0.54-0.91), P = 0.0062.9 vs 2.30.80 (0.61-1.05), P = 0.112NA
Pivot et al[39], 2016Phase III, randomised, open-label, multicentre352305 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 8.10.72 (0.57-0.90), P = 0.0052.8 vs 2.50.77 (0.60-0.97), P = 0.028NA
Tolaney et al[37], 2021Phase Ib/ II, open-label, single-arm, multicentre167≤ 2; 0 (n = 66); 1-2 (n = 101)E + pembrolizumab16.1NA4.1NA23.4 (17.2-30.5)
Yonemori et al[36], 2019Phase I/II, open-label, single-arm, multicentre48 (Phase I: 24; Phase II: 24)≥ 2E + olaparib14.5NA4.2NA37.5 (18.8-59.4)
Lee et al[42], 2019Phase I, single-arm, single-centre250-3E + everolimus8.3 (95%CI: 5.5, undefined)NA2.6 (95%CI: 2.1, 4.0)NANA
ER-positive
Twelves et al[38], 2016Phase III, randomised, open-label, multicentre5371-3 (1-2 for advanced and/or metastatic disease)E (259) vs capecitabine (278)18.2 vs 16.80.90 (0.74-1.09), P = 0.2834.3 vs 5.31.11 (0.89-1.38), P = 0.367NA
Pivot et al[39], 2016Phase III, randomised, open-label, multicentre945305 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 13.50.87 (0.75-1.00), P = 0.0584.1 vs 3.40.84 (0.72-0.98), P = 0.031NA
HER2-positive
Twelves et al[38], 2016Phase III, randomised, open-label, multicentre1691-3 (1-2 for advanced and/or metastatic disease)E (86) vs capecitabine (83)14.3 vs 17.10.97 (0.69-1.35), P = 0.8374.0 vs 5.11.36 (0.93-1.98), P = 0.115NA
Pivot et al[39], 2016Phase III, randomised, open-label, multicentre254305 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 11.70.75 (0.57-1.00). P = 0.0513.7 vs 4.21.00 (0.75-1.35), P = 0.970NA
Sakaguchi et al[55], 2018Phase II, single-arm, multicentre280E + trastuzumabNA (not reached)NA11.3 (344 d)NA53.6 (95%CI: 36.62, 69.93)
Lutrino et al[54], 2016Phase II, single-arm, single-centre242-9E + trastuzumab8 (range 1.3-14.8)NA5.4 (range 1-10.5)NA41.7%
Inoue et al[56], 2019Phase II, open-label, single-arm, multicentre250E + trastuzumab + pertuzumabNANA23.1 (95%CI: 14.4, 31.8)NA80 (95%CI: 59.3, 93.2)