Efficacy, quality of life, and tolerability of BP-C1, a benzene-poly-carboxylic acids complex with cis-diammineplatinum (II) dichloride, in patients with stage IV breast cancer: A randomized double-blinded placebo controlled study.

Abstract

e12016 Background: The aim was to compare the efficacy, tolerability and quality of life of BP-C1versus Placebo in stage IV breast cancer. Methods: A randomized, double blind placebo controlled multicenter study with a sequential parallel group design with treatment duration of 32 days was performed. Placebo group was switched to BP-C1 at the end of the study. Twenty-nine stage IV breast cancer patients were allocated to either BP-C1 or Placebo. Patients were given daily i.m. injections of 0.035 mg/kg BW of BP-C1 or Placebo, continuously for 32 days. CT was performed at screening, after 32 days and 28 days after the last injection. Lesions were measured and classified with the RECIST criteria. EORTC QOL-C30 and BR23 were used for QOL registration, and NCI Bethesda (CTC-NCI) for tolerability. Results: Mean sum diameter of lesions increased non-significantly with 0.8 % (CI: -7.7 – 9.3%) in the BP-C1 group and significantly with 12.7% (CI: 4.1 – 21.1%) in the placebo group. The difference was significant in ...