Stig Larsen
Norwegian University of Life Science, Oslo Norway
Title: BP-C1 in treatment of metastatic breast cancer: A randomised, double blinded and placebo controlled clinical study
Biography
Biography: Stig Larsen
Abstract
Aim: The aim was to compare the efficacy and tolerability of a new benzene-poly-carboxylic acids complex with cisdiammineplatiumrn(II) (BP-C1) versus equal looking placebo in treatment of metastatic breast cancer patients.
Material & Methods: A randomized, double blind, placebo controlled multi-center study was performed with semi-cross-overrndesign. Patients allocated to placebo switches to BP-C1 after 32 days of treatment. Thirty patients were given daily intramuscularrninjection of 0.035 mg/kg bw BP-C1 or placebo in 32 days. Biochemistry, hematology, NCI Bethesda (CTC-NCI), EORTCrnQOL-C30 & BR23 recorded at screening and after every 16 days of treatment. CT performed at screening and every 32nd day.rnResults: The sum of target lesions increased 2.4% in the BP-C1 group and 14.3% in placebo. The increase in the placebo grouprnwas significant (p=0.013) but not in BP-C1. The difference between the group was significant in favor of BP-C1 (p=0.04).rnSignificant difference (p=0.026) in favor of BP-C1 regarding RECIST classification. CTC-NCI toxicity score increased nonsignificantlyrnin the BP-C1 group, but significantly in placebo (p=0.05). “Breast cancer related pain and discomfort” and “Breastrncancer treatment problem last week” were significantly reduced (p=0.02) in the BP-C1 group and slightly increased in placebo.rnSignificant difference in favor of BP-C1 (p=0.05). “Breast cancer treatment problem last week” was significantly reduced in thernBP-C1 group (p=0.02) and slightly increased in placebo. “Breast cancer related pain and discomfort”.rnConclusion: BP-C1 reduces the cancer growth, is well tolerated, improves quality-of-life and has few mainly mild AE inrnpatients suffering from stage IV MBC
