No clinical evidence on the efficacy and safety of
eribulin monotherapy has been obtained by a prospective clinical study in patients with metastatic
breast cancer (MBC) who had well-defined
taxane resistance. The present Phase II, multicenter, single-arm, open-label study aimed to obtain the evidence. Japanese female patients, aged 33-74 years who had the
metastasis of
taxane-resistant and histopathologically confirmed
breast cancer, received
eribulin mesylate 1.4 mg/m(2) (equivalent to
eribulin 1.23 mg/m(2) [expressed as free base])
as a 2- to 5-min
intravenous infusion on days 1 and 8 of each 21-day cycle. The primary endpoint was the clinical benefit rate (CBR) [complete response (CR), partial response (PR), and long-term stable disease (
LSD) ≥24 weeks]. A total of 51 patients underwent
chemotherapy cycles (median 4; range 1-42 cycles). The CBR was 39.2 % (CR 2.0 %; PR 23.5 %; and
LSD 13.7 %), and the rate of progressive disease was 49.0 %. The median progression-free survival and the median overall survival were 3.6 months [95 % confidence interval (CI) 2.6-4.6 months] and 11.7 months (95 % CI 9.2-14.2 months), respectively. Grade 3 or greater adverse events were
leukopenia (23.5 %),
neutropenia (35.3 %),
anemia (5.9 %), and
febrile neutropenia (7.8 %). The incidences of grade 3 and 4 peripheral sensory neuropathy were 2.0 and 0 %, respectively.
Eribulin showed a clinically manageable tolerability profile by dose adjustments or symptomatic treatment.
Eribulin was effective and well tolerated in heavily pretreated patients with MBC who had well-defined
taxane resistance, thus providing a potential therapeutic option in the clinical settings.