PMID- 30666153
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231005
IS  - 1179-1314 (Print)
IS  - 1179-1314 (Electronic)
IS  - 1179-1314 (Linking)
VI  - 11
DP  - 2019
TI  - Efficacy and tolerability of BP-C1 in metastatic breast cancer: a Phase II, 
      randomized, double-blind, and placebo-controlled Thai multi-center study.
PG  - 43-51
LID - 10.2147/BCTT.S174298 [doi]
AB  - AIMS: The aim of this study was to compare the efficacy and tolerability of BP-C1 
      vs equal-looking placebo in metastatic breast cancer. MATERIALS AND METHODS: A 
      randomized, double-blind, placebo-controlled multi-center study with a 
      semicross-over design was performed. Sixteen patients received daily 
      intramuscular injection of 0.035 mg/kg bodyweight of BP-C1 and 15 patients 
      received equal-looking placebo for 32 days. After 32 days, the placebo patients 
      crossed to BP-C1 with the last observation in the placebo period as baseline. The 
      status of receptors including estrogen receptor (ER), progesterone receptor 
      (PtR), and human EGF receptor 2 (HER2) was analyzed prior to inclusion in the 
      study. Thoracoabdominal CT scan was blindly analyzed by the same independent 
      radiologist in accordance with the RECIST criteria 1.1. Toxicity was assessed 
      according to the NCI Bethesda Version 2.0 (CTC-NCI), and the quality of life 
      (QOL) was assessed according to European Organization for the Research and 
      Treatment of Cancer QOL-C30 and QOL-BR23. RESULTS: The sum of target lesion 
      diameters (sum lesions) after 32 days of treatment increased by 8.9% (P=0.08) in 
      the BP-C1 arm compared to 37.6% (P<0.001) in placebo patients. Twelve of the 15 
      placebo patients subsequently had BP-C1 treatment. The increase in sum lesions 
      was 3.5% in these patients. The sum of CTC-NCI was increased 18.7% in the BP-C1 
      arm (P=0.38) compared to 50.9% (P=0.04) in placebo patients. Four mild/moderate 
      adverse events (AEs) present in BP-C1. Two mild/moderate AEs and one severe AE 
      present in placebo. The QOL benchmarks "breast cancer problems last week", 
      "sexual interest and activity last 4 weeks", and "breast cancer-related pain and 
      discomfort last week" were stable in the BP-C1 arm but deteriorated in placebo 
      patients. The sum lesions increased significantly in ER+ (P=0.02) and PtR+ 
      (P=0.03) but not in HER2+. The increase in sum lesions significantly decreased 
      (P=0.02) with an increasing number of negative receptors. CONCLUSION: A total of 
      32 days of BP-C1 treatment inhibited cancer growth and was well tolerated with 
      few and mainly mild AEs. The efficacy of BP-C1 was superior in receptor-negative 
      patients. CLINICALTRIALSGOV IDENTIFIER: NCT03603197.
FAU - Butthongkomvong, Kritiya
AU  - Butthongkomvong K
AD  - Udonthani Cancer Hospital, Udonthani, Thailand.
FAU - Raunroadroong, Nilubol
AU  - Raunroadroong N
AD  - Lampang Cancer Hospital, Lampang, Thailand.
FAU - Sorrarichingchai, Sirikul
AU  - Sorrarichingchai S
AD  - Lampang Cancer Hospital, Lampang, Thailand.
FAU - Sangsaikae, Isaraporn
AU  - Sangsaikae I
AD  - Ubonratchathani Cancer Hospital, Ubonratchathani, Thailand.
FAU - Srimuninnimit, Vichien
AU  - Srimuninnimit V
AD  - Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Mahidol 
      University, Bangkok, Thailand.
FAU - Harling, Henrik
AU  - Harling H
AD  - Bispebjerg University Hospital, Department of Gastroenterology, Center for 
      Digestive Disease, Copenhagen, Denmark.
FAU - Larsen, Stig
AU  - Larsen S
AD  - Digestive Disease Center, Centre for Epidemiology and Biostatistics, Norwegian 
      University of Life Sciences, Oslo, Norway, stig.larsen@nmbu.no.
LA  - eng
SI  - ClinicalTrials.gov/NCT03603197
PT  - Journal Article
DEP - 20190114
PL  - New Zealand
TA  - Breast Cancer (Dove Med Press)
JT  - Breast cancer (Dove Medical Press)
JID - 101591856
PMC - PMC6336026
OTO - NOTNLM
OT  - BP-C1
OT  - benzene-polycarboxylic acid complex
OT  - breast cancer
OT  - hormone receptors
OT  - low-dose cisplatin
OT  - randomized double-blind
OT  - stage IV
COIS- Disclosure The authors report no conflicts of interest in this work.
EDAT- 2019/01/23 06:00
MHDA- 2019/01/23 06:01
PMCR- 2019/01/14
CRDT- 2019/01/23 06:00
PHST- 2019/01/23 06:00 [entrez]
PHST- 2019/01/23 06:00 [pubmed]
PHST- 2019/01/23 06:01 [medline]
PHST- 2019/01/14 00:00 [pmc-release]
AID - bctt-11-043 [pii]
AID - 10.2147/BCTT.S174298 [doi]
PST - epublish
SO  - Breast Cancer (Dove Med Press). 2019 Jan 14;11:43-51. doi: 10.2147/BCTT.S174298. 
      eCollection 2019.