BP-C1 in treatment of metastatic breast cancer: A randomised, double blinded and placebo controlled clinical study
Aim: The aim was to compare the efficacy and tolerability of a new benzene-poly-carboxylic acids complex with cisdiammineplatium (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-over design. Patients allocated to placebo switches to BP-C1 after 32 days of treatment. Thirty patients were given daily intramuscular injection of 0.035 mg/kg bw BP-C1 or placebo in 32 days. Biochemistry, hematology, NCI Bethesda (CTC-NCI), EORTC QOL-C30 & BR23 recorded at screening and after every 16 days of treatment. CT performed at screening and every 32nd day. Results: The sum of target lesions increased 2.4% in the BP-C1 group and 14.3% in placebo. The increase in the placebo group was significant (p=0.013) but not in BP-C1. The difference between the group was significant in favor of BP-C1 (p=0.04). Significant difference (p=0.026) in favor of BP-C1 regarding RECIST classification. CTC-NCI toxicity score increased nonsignificantly in the BP-C1 group, but significantly in placebo (p=0.05). “Breast cancer related pain and discomfort” and “Breast cancer treatment problem last week” were significantly reduced (p=0.02) in the BP-C1 group and slightly increased in placebo. Significant difference in favor of BP-C1 (p=0.05). “Breast cancer treatment problem last week” was significantly reduced in the BP-C1 group (p=0.02) and slightly increased in placebo. “Breast cancer related pain and discomfort”. Conclusion: BP-C1 reduces the cancer growth, is well tolerated, improves quality-of-life and has few mainly mild AE in patients suffering from stage IV MBC.
No comments:
Post a Comment