PMID- 22154117
OWN - NLM
STAT- MEDLINE
DCOM- 20120720
LR  - 20151119
IS  - 1938-0666 (Electronic)
IS  - 1526-8209 (Linking)
VI  - 12
IP  - 2
DP  - 2012 Apr
TI  - Phase II multicenter trial of albumin-bound paclitaxel and capecitabine in 
      first-line treatment of patients with metastatic breast cancer.
PG  - 87-93
LID - 10.1016/j.clbc.2011.10.004 [doi]
AB  - BACKGROUND: Capecitabine, a tumor-activated oral fluoropyrimidine, and 
      albumin-bound paclitaxel (ab-paclitaxel) have substantial single-agent activity 
      in patients with metastatic breast cancer (MBC). Taxane and antimetabolite 
      doublets have improved efficacy compared with single agents. This phase II 
      open-label trial was designed to test the safety and efficacy of capecitabine and 
      ab-paclitaxel in previously untreated MBC. PATIENTS AND METHODS: Patients 
      received capecitabine (825 mg/m(2) orally twice daily, approximately 12 hours 
      apart, on days 1 to 15) and ab-paclitaxel (125 mg/m(2) intravenously on days 1 
      and 8 of each cycle with no premedication) every 3 weeks. The primary endpoint 
      was overall objective response rate (ORR), with evaluation performed after every 
      2 cycles. Entry criteria included measurable MBC, human epidermal growth factor 
      receptor 2 (HER2) negativity, Eastern Cooperative Oncology Group (ECOG) 
      performance status 0-2, no previous chemotherapy for metastatic disease, and > 6 
      months since adjuvant fluoropyrimidine or paclitaxel treatment. RESULTS: Fifty 
      patients received at least 1 dose of study drug, with 46 patients evaluable for 
      efficacy evaluation. Three hundred seventy-four cycles of therapy were delivered. 
      Eighty percent of patients completed 8 cycles. The ORR was 61% (complete response 
      [CR], 4%; partial response [PR], 57%), and 7 patients had sustained (>/= 24 weeks) 
      stable disease for a clinical benefit rate of 76.1%. The median progression-free 
      survival (PFS) was 10.6 months, and the median overall survival was 19.9 months. 
      The most common adverse events (AEs) that were >/= grade 3 were pain, hand-foot 
      syndrome, and neutropenia. CONCLUSION: The combination of weekly ab-paclitaxel 
      plus daily capecitabine orally at these doses and scheduling was well tolerated 
      and showed substantial efficacy.
CI  - Copyright A(c) 2012 Elsevier Inc. All rights reserved.
FAU - Schwartzberg, Lee S
AU  - Schwartzberg LS
AD  - The West Clinic, Memphis, TN 38120, USA. lschwartzberg@westclinic.com
FAU - Arena, Francis P
AU  - Arena FP
FAU - Mintzer, David M
AU  - Mintzer DM
FAU - Epperson, Amanda L
AU  - Epperson AL
FAU - Walker, Mark S
AU  - Walker MS
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20111206
PL  - United States
TA  - Clin Breast Cancer
JT  - Clinical breast cancer
JID - 100898731
RN  - 0 (Albumin-Bound Paclitaxel)
RN  - 0 (Albumins)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - P88XT4IS4D (Paclitaxel)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Albumin-Bound Paclitaxel
MH  - Albumins/administration & dosage/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Breast Neoplasms/*drug therapy
MH  - Capecitabine
MH  - Deoxycytidine/administration & dosage/adverse effects/analogs & derivatives
MH  - Female
MH  - Fluorouracil/administration & dosage/adverse effects/analogs & derivatives
MH  - Humans
MH  - Middle Aged
MH  - Paclitaxel/administration & dosage/adverse effects
MH  - Young Adult
EDAT- 2011/12/14 06:00
MHDA- 2012/07/21 06:00
CRDT- 2011/12/14 06:00
PHST- 2011/07/26 00:00 [received]
PHST- 2011/10/03 00:00 [accepted]
PHST- 2011/12/14 06:00 [entrez]
PHST- 2011/12/14 06:00 [pubmed]
PHST- 2012/07/21 06:00 [medline]
AID - S1526-8209(11)00206-0 [pii]
AID - 10.1016/j.clbc.2011.10.004 [doi]
PST - ppublish
SO  - Clin Breast Cancer. 2012 Apr;12(2):87-93. doi: 10.1016/j.clbc.2011.10.004. Epub 
      2011 Dec 6.