PMID- 15800309
OWN - NLM
STAT- MEDLINE
DCOM- 20050421
LR  - 20220311
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 23
IP  - 10
DP  - 2005 Apr 1
TI  - Phase II study of efficacy, safety, and pharmacokinetics of trastuzumab 
      monotherapy administered on a 3-weekly schedule.
PG  - 2162-71
AB  - PURPOSE: This phase II study investigated the efficacy, safety, and 
      pharmacokinetics of trastuzumab monotherapy given as first-line treatment once 
      every 3 weeks (3-weekly) in women with human epidermal growth factor receptor 2 
      (HER2) -positive metastatic breast cancer (MBC). PATIENTS AND METHODS: Patients 
      with previously untreated HER2-positive MBC received a loading dose of 
      trastuzumab, 8 mg/kg intravenously (IV) and then 6 mg/kg IV at 3-week intervals 
      until disease progression or patient withdrawal. RESULTS: In total, 105 patients 
      received a median of five cycles of therapy (range, 1 to 35+). The overall 
      response rate was 19% (23% in patients with measurable centrally confirmed 
      immunohistochemistry [IHC] 3+ and/or fluorescence in situ hybridization [FISH] 
      -positive disease) and clinical benefit rate (complete and partial responses plus 
      stable disease for at least 6 months) was 33% (36% in patients with measurable 
      centrally confirmed IHC 3+ and/or FISH-positive disease). Median time to 
      progression was 3.4 months (range, 0.6 to 23.6 months). The most common 
      treatment-related adverse events were rigors, pyrexia, headache, nausea, and 
      fatigue. Median baseline left ventricular ejection fraction was 63%; this did not 
      significantly change over the course of the study. The average exposure to 
      trastuzumab observed in this study was similar to that in previous studies of the 
      weekly regimen. However, as expected, mean trough trastuzumab concentrations were 
      lower and peak levels were higher with 3-weekly trastuzumab compared with weekly 
      treatments. CONCLUSION: Administering higher doses on a 3-weekly schedule did not 
      compromise the efficacy and safety of trastuzumab in women with HER2-positive 
      MBC, and average exposure was similar to that observed with weekly therapy. 
      Three-weekly trastuzumab may represent a convenient alternative to weekly 
      administration.
FAU - Baselga, Jose
AU  - Baselga J
AD  - Vall d'Hebron, University Hospital, Department of Medical Oncology, Pg Vall 
      d'Hebron, 119-129, E-08035 Barcelona, Spain. jbaselga@vhebron.net
FAU - Carbonell, Xavier
AU  - Carbonell X
FAU - Castaneda-Soto, Noel-Jaime
AU  - Castaneda-Soto NJ
FAU - Clemens, Michael
AU  - Clemens M
FAU - Green, Michael
AU  - Green M
FAU - Harvey, Vernon
AU  - Harvey V
FAU - Morales, Serafin
AU  - Morales S
FAU - Barton, Claire
AU  - Barton C
FAU - Ghahramani, Parviz
AU  - Ghahramani P
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antineoplastic Agents)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - P188ANX8CK (Trastuzumab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal/adverse effects/*pharmacokinetics/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Agents/adverse effects/*pharmacokinetics/*therapeutic use
MH  - Breast Neoplasms/*drug therapy/pathology
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence
MH  - Infusions, Intravenous
MH  - Middle Aged
MH  - Receptor, ErbB-2/*analysis
MH  - Trastuzumab
MH  - Treatment Outcome
EDAT- 2005/04/01 09:00
MHDA- 2005/04/22 09:00
CRDT- 2005/04/01 09:00
PHST- 2005/04/01 09:00 [pubmed]
PHST- 2005/04/22 09:00 [medline]
PHST- 2005/04/01 09:00 [entrez]
AID - 23/10/2162 [pii]
AID - 10.1200/JCO.2005.01.014 [doi]
PST - ppublish
SO  - J Clin Oncol. 2005 Apr 1;23(10):2162-71. doi: 10.1200/JCO.2005.01.014.