Table 1.

Review of phase I to III clinical trials of eribulin in patients with metastatic breast cancer

ReferencePhaseCancer typePatients, NDoseResponse rate, n (%)Stable disease, n (%)Median PFS, months (range)Toxicitya
Synold et al. (10)IAdvanced solid tumors380.125–2 mg/m2 over 2 minutes on days 1, 8, 15 every 28 days2 (5)12 (32)N/ADLT: febrile neutropenia at 2 mg/m2
Goel et al. (11)IAdvanced solid tumors320.25–1.4 mg/m2 over 1 hour on days 1, 8, 15 every 28 days1 (3)b10 (31)N/ADLT: neutropenia at 1.4 mg/m2. Fatigue (53%), nausea (41%), anorexia (38%), neuropathy (25%)
Tan et al. (12)IAdvanced solid tumors210.25–4 mg/m2 over 1 hour every 21 days1 (5)c12 (57)N/ADLT: neutropenia at 2 mg/m2. Neutropenia (38%), alopecia (33%), fatigue (33%), febrile neutropenia (29%), nausea (19%), anorexia (14%)
Minami et al. (17)IAdvanced solid tumors150.7–2 mg/m2 over 5 minutes on days 1 and 8 every 21 days3 (20)3 (20)N/ADLT: febrile neutropenia at 1.4 mg/m2
Vahdat et al. (18)IIMetastatic breast cancer103 (87d)Cohort 1: 1.4 mg/m2 over 2–5 minutes on days 1, 8, 15 every 28 days. Cohort 2: 1.4 mg/m2 on days 1 and 8 every 21 daysCohort 1: 6 (10.2) Cohort 2: 4 (14.3)Cohort 1: 21 (35.6) Cohort 2: 16 (57.1)2.6 (0–14.9)Neutropenia (75%), fatigue (52%), nausea (37%), anorexia (15%), neuropathy (31%), febrile neutropenia (4%)
Cortes et al. (19)IIMetastatic breast cancer291 (269e)1.4 mg/m2 over 2–5 minutes on days 1 and 8 every 21 days25 (9.3)125 (46.5)2.6 (0.03–13.1)Fatigue (65%), neutropenia (60%), nausea (44%), neuropathy (32.6%), febrile neutropenia (5.5%)
Iwata et al. (20)IIMetastatic breast cancer811.4 mg/m2 over 2–5 minutes on days 1 and 8 every 21 days17 (21.3)30 (37.5)3.6 (2–4.4)Grade 3 to 4 neutropenia (95.1%), febrile neutropenia (13.6%), grade 3 neuropathy (3.7%)
Cortes et al. (21)IIIMetastatic breast cancer762f1.4 mg/m2 over 2–5 minutes on days 1 and 8 every 21 days57 (13)g208 (44)g3.6 (3.3–3.7)gFatigue (54%), neutropenia (52%), nausea (35%), neuropathy (35%), febrile neutropenia (5%)

Abbreviations: DLT, dose-limiting toxicity; N/A, not available.

  • aToxicity is any grade unless otherwise noted.

  • bUnconfirmed partial response in cervical cancer patient.

  • cUnconfirmed partial response in non–small cell lung cancer patient.

  • dPer protocol population.

  • eEligible population.

  • f508 women randomized to eribulin, 254 to treatment of physician's choice.

  • gResponse in eribulin population.