PMID- 23877339
OWN - NLM
STAT- MEDLINE
DCOM- 20140317
LR  - 20220311
IS  - 1573-7217 (Electronic)
IS  - 0167-6806 (Print)
IS  - 0167-6806 (Linking)
VI  - 140
IP  - 2
DP  - 2013 Jul
TI  - Eribulin mesylate versus ixabepilone in patients with metastatic breast cancer: a 
      randomized Phase II study comparing the incidence of peripheral neuropathy.
PG  - 341-51
LID - 10.1007/s10549-013-2574-2 [doi]
AB  - Peripheral neuropathy is a common toxicity associated with tubulin-targeted 
      chemotherapeutic agents. This Phase II study compares the incidence and severity 
      of neuropathy associated with eribulin mesylate or ixabepilone in metastatic 
      breast cancer (MBC). The primary objective was to assess the incidence of 
      neuropathy; the study was designed to detect a difference in neuropathy rate of 
      35 % for eribulin versus 63 % for ixabepilone (odds ratio 0.316, 80 % power, 0.05 
      two-sided significance level). Eligibility criteria included: MBC; prior taxane 
      therapy; at least one chemotherapy for advanced disease; no or minimal 
      pre-existing neuropathy (Grade 0 or 1). The intent-to-treat population comprised 
      104 patients randomized (1:1) to eribulin mesylate (1.4 mg/m(2), 2-5 min 
      intravenous on days 1 and 8) or ixabepilone (40 mg/m(2), 3 h intravenous on day 
      1) on a 21-day cycle. 101 patients in the safety population received a median of 
      5.0 eribulin and 3.5 ixabepilone cycles. Incidence of neuropathy (any grade) was 
      33.3 and 48.0 %, and peripheral neuropathy was 31.4 and 44.0 % for eribulin and 
      ixabepilone, respectively. After controlling for pre-existing neuropathy and 
      number of prior chemotherapies, these differences were not significant. Compared 
      with ixabepilone, fewer patients receiving eribulin discontinued treatment due to 
      neuropathy (3.9 vs. 18.0 %) or adverse events (AEs) in general (11.8 vs. 32.0 %). 
      Time to onset of neuropathy was 35.9 weeks for eribulin and 11.6 weeks for 
      ixabepilone, and time to resolution was 48 versus 10 weeks, respectively; other 
      AEs were comparable. Objective responses were 15.4 versus 5.8 % and clinical 
      benefit rates were 26.9 versus 19.2 %. In conclusion, after controlling for 
      pre-existing neuropathy and number of prior chemotherapies, the differences in 
      the incidence of neuropathy with eribulin and ixabepilone were not statistically 
      significant. Onset of neuropathy tended to occur later with eribulin and resolve 
      later.
FAU - Vahdat, Linda T
AU  - Vahdat LT
AD  - Weill Cornell Medical College, 425 East 61st Street, 8th Floor, New York, NY 
      10065, USA. ltv2001@med.cornell.edu
FAU - Garcia, Agustin A
AU  - Garcia AA
FAU - Vogel, Charles
AU  - Vogel C
FAU - Pellegrino, Christine
AU  - Pellegrino C
FAU - Lindquist, Deborah L
AU  - Lindquist DL
FAU - Iannotti, Nicholas
AU  - Iannotti N
FAU - Gopalakrishna, Prashanth
AU  - Gopalakrishna P
FAU - Sparano, Joseph A
AU  - Sparano JA
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130723
PL  - Netherlands
TA  - Breast Cancer Res Treat
JT  - Breast cancer research and treatment
JID - 8111104
RN  - 0 (Epothilones)
RN  - 0 (Furans)
RN  - 0 (Ketones)
RN  - K27005NP0A (ixabepilone)
RN  - LR24G6354G (eribulin)
SB  - IM
MH  - Adult
MH  - Breast Neoplasms/*drug therapy/pathology
MH  - Epothilones/*administration & dosage/adverse effects
MH  - Female
MH  - Furans/*administration & dosage/adverse effects
MH  - Humans
MH  - Ketones/*administration & dosage/adverse effects
MH  - Middle Aged
MH  - Neoplasm Metastasis/*drug therapy/pathology
MH  - Peripheral Nervous System Diseases/chemically induced/pathology
MH  - Survival Rate
PMC - PMC3732762
EDAT- 2013/07/24 06:00
MHDA- 2014/03/19 06:00
PMCR- 2013/07/23
CRDT- 2013/07/24 06:00
PHST- 2013/04/04 00:00 [received]
PHST- 2013/05/17 00:00 [accepted]
PHST- 2013/07/24 06:00 [entrez]
PHST- 2013/07/24 06:00 [pubmed]
PHST- 2014/03/19 06:00 [medline]
PHST- 2013/07/23 00:00 [pmc-release]
AID - 2574 [pii]
AID - 10.1007/s10549-013-2574-2 [doi]
PST - ppublish
SO  - Breast Cancer Res Treat. 2013 Jul;140(2):341-51. doi: 10.1007/s10549-013-2574-2. 
      Epub 2013 Jul 23.