Open AccessBP-C1 in treatment of pretreated metastatic breast cancer: A meta-analysis of two randomized, double-blind and placebo-controlled multicenter studies.
Author(s) -
Stig Larsen,
Kritiya Butthongkomvong,
A. Manikhas,
Hans Fagertun
Publication year - 2019
Publication title -
journal of global oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.002
H-Index - 17
ISSN - 2378-9506
DOI - 10.1200/jgo.2019.5.suppl.12
Subject(s) - medicine , placebo , breast cancer , randomization , metastatic breast cancer , randomized controlled trial , sample size determination , surgery , cancer , urology , pathology , statistics , alternative medicine , mathematics
12 Background: To compare the effect of BP-C1 versus equal looking placebo in heavily pre-treated metastatic breast cancer (MBC) patients and to evaluate the efficacy of BP-C1 according to number of negative receptors. Methods: The study sample consisted of 61 patients from two randomized, double blinded and placebo controlled multicentre studies with semi-cross-over design. By randomization, 31 patients were allocated to BP-C1 and 30 to equal looking placebo treatment for 32 days. Twenty-five of the 30 patient allocated to placebo were switched to BP-C1 after finalizing the placebo period. A joint sample of 56 patients received one daily intramuscular injection of 0.07 ml/kg BW of BP-C1 for at least one cycle of 32 days. Receptor status including Estrogen, Progesterone and Human epidermal growth factor receptor was analysed prior to entering the study and available in 54 of the 56 patients. CT scans were performed at screening and after every 32-days of treatment, and were blindly analysed by one independent radiologist. The sum of target lesion diameters (SLD), RECIST classification and disease control rate (DCR) defined as patients obtaining at least stabile disease (SD) at the end of treatment was the main variables. Results: The SLD increased non-significantly by 1.5mm (5.7%) in the BP-C1 group and significantly (p < 0.001) by 13.6 mm (26.2%) in the placebo group during the 32 days of treatment. The difference between groups with respect to SLD and DCR was significant in favour of BP-C1 (p < 0.001). The tumour growth in the joint BP-C1 group was 2.5mm (5.9%) and DCR was 89.1% [95% CI: 38.1 – 96.0]. Nine of the 56 patients reported 26 Adverse Events (AE) related to BP-C1; all of mild to moderate degree. SLD increased 16.2% (p = 0.03) in patients with three positive receptors, 7.5% (p = 0.02) in the group with one negative receptor, 2.5% in the group of two negative receptors and 0.8% in triple negative patients. The tumor growth declined with increasing number of negative receptors (r = -0.26; p = 0.05). Conclusions: BP-C1 treatment of pre-treated MBC patients controlled the cancer growth with few mainly mild AE’s. The BP-C1 efficacy increased with the number of negative receptors. Clinical trial information: NCT03603197. Clinical trial information: NCT02783794.