PMID- 17111207
OWN - NLM
STAT- MEDLINE
DCOM- 20071220
LR  - 20070816
IS  - 0167-6806 (Print)
IS  - 0167-6806 (Linking)
VI  - 105
IP  - 1
DP  - 2007 Sep
TI  - Phase I trial and antitumor effects of BZL101 for patients with advanced breast 
      cancer.
PG  - 17-28
AB  - BACKGROUND: Botanical therapies are often used by breast cancer patients yet few 
      clinical trials have evaluated their safety and efficacy. We studied mechanisms 
      of activity and performed a phase I clinical trial in patients with advanced 
      breast cancer to evaluate BZL101, an aqueous extract from Scutellaria barbata. 
      METHODS: Preclinical studies were conducted in vitro to characterize cell death 
      induced by BZL101. In a phase I trial, eligible patients had histologically 
      confirmed, measurable metastatic breast cancer. Treatment consisted of 350 ml per 
      day of oral BZL101, administered as sole cancer therapy until disease 
      progression, toxicity or personal preference to discontinue. Primary endpoints 
      were safety, toxicity and tumor response. RESULTS: BZL101 extract induced strong 
      growth inhibition and apoptosis of breast cancer cell lines. In the phase I 
      trial, 21 patients received BZL101. Mean age was 54 years (30-77) and mean number 
      of prior treatments for metastatic disease was 3.9 (0-10). There were no grade 
      III or IV adverse events (AEs). The most frequently reported BZL101-related grade 
      I and II AEs included: nausea (38%), diarrhea (24%), headache (19%) flatulence 
      (14%), vomiting (10%), constipation (10%), and fatigue (10%). Sixteen patients 
      were evaluable for response. Four patients had stable disease (SD) for >90 days 
      (25%) and 3/16 had SD for >180 days (19%). Five patients had objective tumor 
      regression, one of which was 1 mm short of a PR based on RECIST criteria. 
      CONCLUSIONS: BZL 101 inhibits breast cancer cell lines by inducing apoptosis. In 
      a phase I clinical trial, BZL101 was safe and had a favorable toxicity profile. 
      BZL101 demonstrated encouraging clinical activity in this heavily pretreated 
      population.
FAU - Rugo, Hope
AU  - Rugo H
AD  - University of California, San Francisco Carol Franc Buck Breast Care Center, San 
      Francisco, USA.
FAU - Shtivelman, Emma
AU  - Shtivelman E
FAU - Perez, Alejandra
AU  - Perez A
FAU - Vogel, Charles
AU  - Vogel C
FAU - Franco, Sandra
AU  - Franco S
FAU - Tan Chiu, Elizabeth
AU  - Tan Chiu E
FAU - Melisko, Michelle
AU  - Melisko M
FAU - Tagliaferri, Mary
AU  - Tagliaferri M
FAU - Cohen, Isaac
AU  - Cohen I
FAU - Shoemaker, Mark
AU  - Shoemaker M
FAU - Tran, Zung
AU  - Tran Z
FAU - Tripathy, Debu
AU  - Tripathy D
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20061117
PL  - Netherlands
TA  - Breast Cancer Res Treat
JT  - Breast cancer research and treatment
JID - 8111104
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Plant Extracts)
RN  - 0 (Scutellaria barbata extract)
RN  - EC 3.4.22.- (Caspases)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/administration & dosage/*pharmacology
MH  - Apoptosis
MH  - Breast Neoplasms/*drug therapy
MH  - Caspases/metabolism
MH  - Cell Line, Tumor
MH  - DNA Fragmentation
MH  - Enzyme Activation
MH  - Female
MH  - Flow Cytometry/methods
MH  - Humans
MH  - Middle Aged
MH  - Plant Extracts/administration & dosage/*pharmacology
MH  - Scutellaria/metabolism
EDAT- 2006/11/18 09:00
MHDA- 2007/12/21 09:00
CRDT- 2006/11/18 09:00
PHST- 2006/10/04 00:00 [received]
PHST- 2006/10/09 00:00 [accepted]
PHST- 2006/11/18 09:00 [pubmed]
PHST- 2007/12/21 09:00 [medline]
PHST- 2006/11/18 09:00 [entrez]
AID - 10.1007/s10549-006-9430-6 [doi]
PST - ppublish
SO  - Breast Cancer Res Treat. 2007 Sep;105(1):17-28. doi: 10.1007/s10549-006-9430-6. 
      Epub 2006 Nov 17.