PMID- 24472478
OWN - NLM
STAT- MEDLINE
DCOM- 20140922
LR  - 20210527
IS  - 1879-4076 (Electronic)
IS  - 1879-4068 (Linking)
VI  - 4
IP  - 4
DP  - 2013 Oct
TI  - Efficacy and safety of ixabepilone plus capecitabine in elderly patients with 
      anthracycline- and taxane-pretreated metastatic breast cancer.
PG  - 346-52
LID - S1879-4068(13)00078-7 [pii]
LID - 10.1016/j.jgo.2013.07.006 [doi]
AB  - OBJECTIVES: Data on chemotherapy regimens in elderly patients with metastatic 
      breast cancer (MBC) are limited. The aim of this retrospective pooled analysis 
      was to determine efficacy and safety of ixabepilone plus capecitabine versus 
      capecitabine alone in patients with MBC aged >/= 65 years. MATERIALS AND METHODS: A 
      total of 1973 patients with MBC previously treated with or resistant to 
      anthracyclines and taxanes were randomized in two open-label, multinational, 
      phase 3 studies (study 046 and study 048). Patients received ixabepilone (40 
      mg/m(2) as a 3-hour intravenous infusion every 3 weeks) plus oral capecitabine 
      (1000 mg/m(2) administered twice each day), or capecitabine alone (1250 mg/m(2) 
      twice each day). RESULTS: In total, 251 randomized patients were aged >/= 65 years 
      (ixabepilone plus capecitabine, n=116; capecitabine monotherapy, n=135). Efficacy 
      results were consistent in patients aged <65 and >/= 65 years with respect to the 
      observed improvement in progression-free survival and objective response rate 
      with ixabepilone plus capecitabine compared with capecitabine alone. No 
      significant differences in overall survival between arms were observed for either 
      subgroup. In the ixabepilone plus capecitabine arm, grade 3/4 hematologic adverse 
      events (AEs) were similar in both subgroups except leukopenia and febrile 
      neutropenia, which had a higher incidence in patients aged >/= 65 years. The 
      majority of grade 3/4 nonhematologic AEs were similar in the two subgroups, 
      including fatigue, peripheral sensory neuropathy, and hand-foot syndrome. 
      CONCLUSION: The combination of ixabepilone plus capecitabine maintains its 
      efficacy in elderly patients with anthracycline and taxane pretreated MBC, with a 
      similar safety profile to patients aged < 65 years.
CI  - (c) 2013.
FAU - Vahdat, Linda T
AU  - Vahdat LT
AD  - Weill Cornell Medical College, New York, NY, USA. Electronic address: 
      ltv2001@med.cornell.edu.
FAU - Vrdoljak, Eduard
AU  - Vrdoljak E
AD  - Klinicka Bolnica Split, Split, Croatia.
FAU - Gomez, Henry
AU  - Gomez H
AD  - Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru.
FAU - Li, Rubi Khaw
AU  - Li RK
AD  - St. Luke's Medical Center, Quezon City, Philippines.
FAU - Bosserman, Linda
AU  - Bosserman L
AD  - Wilshire Oncology, Pomona, CA, USA.
FAU - Sparano, Joseph A
AU  - Sparano JA
AD  - Montefiore Medical Center, Bronx, NY, USA.
FAU - Baselga, Jose
AU  - Baselga J
AD  - MGH Cancer Center, Massachusetts General Hospital, Boston, MA, USA.
FAU - Mukhopadhyay, Pralay
AU  - Mukhopadhyay P
AD  - Bristol-Myers Squibb, Wallingford, CT, USA.
FAU - Valero, Vicente
AU  - Valero V
AD  - The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT00080301
SI  - ClinicalTrials.gov/NCT00082433
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130823
PL  - Netherlands
TA  - J Geriatr Oncol
JT  - Journal of geriatric oncology
JID - 101534770
RN  - 0 (Anthracyclines)
RN  - 0 (Antibiotics, Antineoplastic)
RN  - 0 (Epothilones)
RN  - 0 (Taxoids)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - K27005NP0A (ixabepilone)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Anthracyclines/administration & dosage
MH  - Antibiotics, Antineoplastic/administration & dosage/*therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/administration & 
      dosage/*therapeutic use
MH  - Breast Neoplasms/*drug therapy
MH  - Capecitabine
MH  - Deoxycytidine/administration & dosage/*analogs & derivatives/therapeutic use
MH  - Disease-Free Survival
MH  - Drug Resistance, Neoplasm
MH  - Epothilones/administration & dosage/*therapeutic use
MH  - Female
MH  - Fluorouracil/administration & dosage/*analogs & derivatives/therapeutic use
MH  - Humans
MH  - Retrospective Studies
MH  - Taxoids/administration & dosage
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Capecitabine
OT  - Elderly patients
OT  - Ixabepilone
OT  - Metastatic breast cancer
EDAT- 2014/01/30 06:00
MHDA- 2014/09/23 06:00
CRDT- 2014/01/30 06:00
PHST- 2012/12/13 00:00 [received]
PHST- 2013/05/14 00:00 [revised]
PHST- 2013/07/23 00:00 [accepted]
PHST- 2014/01/30 06:00 [entrez]
PHST- 2014/01/30 06:00 [pubmed]
PHST- 2014/09/23 06:00 [medline]
AID - S1879-4068(13)00078-7 [pii]
AID - 10.1016/j.jgo.2013.07.006 [doi]
PST - ppublish
SO  - J Geriatr Oncol. 2013 Oct;4(4):346-52. doi: 10.1016/j.jgo.2013.07.006. Epub 2013 
      Aug 23.