PMID- 21439823
OWN - NLM
STAT- MEDLINE
DCOM- 20111201
LR  - 20151119
IS  - 1532-3080 (Electronic)
IS  - 0960-9776 (Linking)
VI  - 20
IP  - 4
DP  - 2011 Aug
TI  - Phase II trial of paclitaxel and uracil--tegafur in metastatic breast cancer. 
      TEGATAX trial.
PG  - 329-33
LID - 10.1016/j.breast.2011.02.018 [doi]
AB  - This Phase II trial investigated the combination paclitaxel (P) and 
      uracil-tegafur (UFT) in patients with metastatic breast cancer (MBC). METHODS: 
      Main eligibility criteria included HER-2 negative MBC, ECOG performance status of 
      0-2, exposure to 1-2 prior chemotherapy regimen in the metastatic setting, 
      previous exposure to an anthracycline containing regimen either at metastatic or 
      adjuvant setting. Each 35-day cycle consisted of P at 80 mg/m(2) by intravenous 
      infusion on days 1, 8, 15, 22 and 29 and oral UFT at 300 mg/m(2) TID (three time 
      a day) from days 1-28 and oral folinic acid at 90 mg QD (one a day). RESULTS: 
      Between March 2003 and December 2007, 31 patients were enrolled. Median age was 
      66 years (range 44-78). All tumours were HER-2 negative and 7% were triple 
      negative (ER, PgR, HER-2). The majority of patients had visceral disease (81%). 
      All patients had received an anthracycline containing regimen and 74% had a 
      previous docetaxel containing treatment. Median of 4 and 3 cycles of P and UFT 
      were administered with a relative dose intensity of 85.3% and 94.3%, 
      respectively. Twelve (40%)(95% CI: 22.5-57.5) confirmed ORR were observed. Stable 
      and progression disease were reported in 43% and 17% of cases. Median Response 
      duration was 8.4 month (95% CI: 4.9-11.7), median Time to progression was 9.5 
      months (95% CI: 6.6-13.8) and median Overall Survival was 23.5 months (95% CI: 
      16.8-37.2). Thirteen pts (43%) experienced a grade 3 or 4 adverse events (AEs): 
      One death occurred related to the study drugs (febrile neutropenia). Chemotherapy 
      was discontinued due to toxicity in 30% of pts CONCLUSIONS: Accrual was closed in 
      January 2008 due to concerns regarding the degree and accumulative nature of AEs. 
      Nonetheless, the ORR is encouraging and warranted further studies with adapted 
      doses and schedules.
CI  - Copyright (c) 2011 Elsevier Ltd. All rights reserved.
FAU - Villanueva, C
AU  - Villanueva C
AD  - Centre Hospitalier Universitaire de Besancon, Service d'Oncologie Medicale, 25030 
      Besancon cedex, France. cvillanueva@chu-besancon.fr
FAU - Chaigneau, L
AU  - Chaigneau L
FAU - Dufresne, A
AU  - Dufresne A
FAU - Thierry Vuillemin, A
AU  - Thierry Vuillemin A
FAU - Stein, U
AU  - Stein U
FAU - Demarchi, M
AU  - Demarchi M
FAU - Bazan, F
AU  - Bazan F
FAU - N'guyen, T
AU  - N'guyen T
FAU - Pivot, X
AU  - Pivot X
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20110324
PL  - Netherlands
TA  - Breast
JT  - Breast (Edinburgh, Scotland)
JID - 9213011
RN  - 0 (Antineoplastic Agents, Phytogenic)
RN  - 1548R74NSZ (Tegafur)
RN  - 56HH86ZVCT (Uracil)
RN  - P88XT4IS4D (Paclitaxel)
RN  - 1-UFT protocol
SB  - IM
MH  - Aged
MH  - Antineoplastic Agents, Phytogenic/administration & dosage/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse 
      effects
MH  - Breast Neoplasms/*drug therapy/pathology
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Paclitaxel/*administration & dosage/adverse effects
MH  - Tegafur/administration & dosage/adverse effects
MH  - Treatment Outcome
MH  - Uracil/administration & dosage/adverse effects
EDAT- 2011/03/29 06:00
MHDA- 2011/12/13 00:00
CRDT- 2011/03/29 06:00
PHST- 2010/11/30 00:00 [received]
PHST- 2011/02/08 00:00 [revised]
PHST- 2011/02/21 00:00 [accepted]
PHST- 2011/03/29 06:00 [entrez]
PHST- 2011/03/29 06:00 [pubmed]
PHST- 2011/12/13 00:00 [medline]
AID - S0960-9776(11)00054-3 [pii]
AID - 10.1016/j.breast.2011.02.018 [doi]
PST - ppublish
SO  - Breast. 2011 Aug;20(4):329-33. doi: 10.1016/j.breast.2011.02.018. Epub 2011 Mar 
      24.