PMID- 24268206
OWN - NLM
STAT- MEDLINE
DCOM- 20141022
LR  - 20181203
IS  - 1938-0666 (Electronic)
IS  - 1526-8209 (Linking)
VI  - 14
IP  - 1
DP  - 2014 Feb
TI  - Phase II trial of fulvestrant with metronomic capecitabine for postmenopausal 
      women with hormone receptor-positive, HER2-negative metastatic breast cancer.
PG  - 13-9
LID - S1526-8209(13)00216-4 [pii]
LID - 10.1016/j.clbc.2013.09.003 [doi]
AB  - BACKGROUND: In this phase II study, we explored efficacy and toxicity of combined 
      endocrine and low-dose metronomic chemotherapy therapy consisting of fulvestrant 
      and capecitabine in estrogen and/or progesterone receptor-positive, HER2-negative 
      MBC. PATIENTS AND METHODS: Patients with </= 1 previous hormonal treatment in the 
      metastatic setting received an injection fulvestrant loading dose 500 mg on day 
      1, 250 mg on days 15 and 29 followed by 250 mg every 28 days along with 
      continuous oral capecitabine in divided doses. The total fixed daily dose of 
      capecitabine was either 1500 mg or 2000 mg, depending on the patient's weight (< 
      80 kg vs. >/= 80 kg). Primary end points were PFS and TTP. Toxicity was assessed by 
      continuous evaluations of treatment-emergent adverse events (AEs) and changes 
      from baseline in laboratory values. RESULTS: Forty-one women, with a mean age of 
      64.5 years, were enrolled. Patients completed a median of 11 monthly treatment 
      cycles. Median PFS was 14.98 months (95% confidence interval [CI], 7.26-upper 
      limit [UL] not estimated) and median TTP was 26.94 months (95% CI, 7.26-UL not 
      estimated). Median overall survival was 28.65 months (95% CI, 23.95-UL not 
      estimated). Treatment was well tolerated with < 10% Grade 3 palmar-plantar 
      erythrodysesthesia. Overall, the most frequent AEs were palmar-plantar 
      erythrodysesthesia, fatigue, and nausea. CONCLUSION: Fulvestrant with metronomic 
      capecitabine demonstrates substantial activity in hormone receptor-positive MBC 
      and is well tolerated. Combined chemoendocrine approaches should be further 
      explored considering the low toxicity of the combination with meaningful TTP.
CI  - Copyright (c) 2014 Elsevier Inc. All rights reserved.
FAU - Schwartzberg, Lee S
AU  - Schwartzberg LS
AD  - The West Clinic, Memphis, TN. Electronic address: lschwartzberg@westclinic.com.
FAU - Wang, Grace
AU  - Wang G
AD  - Advanced Medical Specialties, Miami, FL.
FAU - Somer, Bradley G
AU  - Somer BG
AD  - The West Clinic, Memphis, TN.
FAU - Blakely, L Johnetta
AU  - Blakely LJ
AD  - Tennessee Oncology, Nashville, TN.
FAU - Wheeler, Benton M
AU  - Wheeler BM
AD  - The West Clinic, Memphis, TN.
FAU - Walker, Mark S
AU  - Walker MS
AD  - ACORN Research, LLC, Memphis, TN.
FAU - Stepanski, Edward J
AU  - Stepanski EJ
AD  - ACORN Research, LLC, Memphis, TN.
FAU - Houts, Arthur C
AU  - Houts AC
AD  - ACORN Research, LLC, Memphis, TN.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20130927
PL  - United States
TA  - Clin Breast Cancer
JT  - Clinical breast cancer
JID - 100898731
RN  - 0 (Receptors, Estrogen)
RN  - 0 (Receptors, Progesterone)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 22X328QOC4 (Fulvestrant)
RN  - 4TI98Z838E (Estradiol)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Breast Neoplasms/chemistry/*drug therapy/mortality/pathology
MH  - Capecitabine
MH  - Deoxycytidine/administration & dosage/adverse effects/*analogs & derivatives
MH  - Estradiol/administration & dosage/*analogs & derivatives
MH  - Female
MH  - Fluorouracil/administration & dosage/adverse effects/*analogs & derivatives
MH  - Fulvestrant
MH  - Humans
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Postmenopause
MH  - Receptor, ErbB-2/analysis
MH  - Receptors, Estrogen/analysis
MH  - Receptors, Progesterone/analysis
OTO - NOTNLM
OT  - Chemoendocrine
OT  - ER-/PR-positive
OT  - Faslodex
OT  - Low dose chemotherapy
OT  - Progression-free survival
OT  - Xeloda
EDAT- 2013/11/26 06:00
MHDA- 2014/10/23 06:00
CRDT- 2013/11/26 06:00
PHST- 2013/05/07 00:00 [received]
PHST- 2013/09/17 00:00 [revised]
PHST- 2013/09/24 00:00 [accepted]
PHST- 2013/11/26 06:00 [entrez]
PHST- 2013/11/26 06:00 [pubmed]
PHST- 2014/10/23 06:00 [medline]
AID - S1526-8209(13)00216-4 [pii]
AID - 10.1016/j.clbc.2013.09.003 [doi]
PST - ppublish
SO  - Clin Breast Cancer. 2014 Feb;14(1):13-9. doi: 10.1016/j.clbc.2013.09.003. Epub 
      2013 Sep 27.