Positive effects on hematological and biochemical imbalances in patients with metastatic breast cancer stage IV, of BP-C1, a new anticancer substance

Abstract

A benzene-poly-carboxylic acid complex with cis-diammineplatinum(II) dihydrocholride, BP-C1 is currently used in clinical trials in treating metastatic breast cancer. BP-C1 controls tumor growth with a few mild side-effects, improving quality of life.MethodsThe data consisted of prospectively collected laboratory results from 47 patients in two controlled clinical trials of daily intramuscular injections of BP-C1 for 32 days. Study I was performed as an open, nonrandomized, Phase I dose–response, multicenter study with a three-level, between-patient, response surface pathway design. The second study was a randomized, double-blind, and placebo-controlled, multicenter study with a stratified semi-crossover design.ResultsHemoglobin (Hb) and hematocrit (Hct) increased significantly (P<0.01) during BP-C1 treatment, while red blood cell (RBC) count increased but not significantly. The most pronounced increase in Hb, RBC, Hct, and white blood cell (WBC) was in anemic patients (P≤0.01). WBC count and neutrophils increased significantly (P=0.01) in the overall data. WBCs and neutrophils (P<0.01), eosinophils (P=0.05) and monocytes (P<0.01) increased significantly and markedly in patients with lowest baseline levels. Additionally, low levels of thrombocytes significantly increased. No changes in liver parameters, amylase, glucose, creatinine, or albumin, were detected except for albumin in the subgroup with low baseline levels, where levels increased significantly (P=0.04). An increase in K+, Ca2+, and PO43− was most pronounced in patients with low baseline levels (P≤0.02). A similar pattern detected for Mg2+, prothrombin time (PT), coagulation factors II, VII, X (KFNT), and C-reactive protein (CRP), which increased significantly (P≤0.05) in the groups with the lowest values.ConclusionOur findings support the safety profile of BP-C1 use in cancer patients. BP-C1 did not induce anemia, infection, bleeding, hepatic insufficiency or electrolyte imbalances. In contrast, BP-C1 corrected abnormalities. No hematological and biochemical toxicity was observed.

An Innovative Cis-Diammineplatinum (II) Benzene-Polycarboxylic-Acids Complex Inhibits Growth of Burkitt`s Cell Lymphoma In Vitro and In Vivo

“…The CBPDA has been tested in clinical trials and has shown to exert anti-tumor activity in breast cancer patients stage IV [13][14][15][16]. To understand whether this anti-tumor activity is associated with a direct effect on tumor cells and/or indirectly through activation of the immune system, we have tested the effect of CBPDA on human peripheral mononuclear cells comprising lymphocytes and monocytes, as well as cytotoxic lymphocytes with specificity to tumor cells [15,16].…”

“…To understand whether this anti-tumor activity is associated with a direct effect on tumor cells and/or indirectly through activation of the immune system, we have tested the effect of CBPDA on human peripheral mononuclear cells comprising lymphocytes and monocytes, as well as cytotoxic lymphocytes with specificity to tumor cells [15,16]. CBPDA demonstrated that it stimulated the production of cytokines such as TNF-alpha, IL-1 beta, GM-CSF, IL-6, Il-25 and INF-gamma [31].…”

“…as a mixture once every 7 days and rituximab was administrered i.p. every 7 days where first day was the days of allocation into groups [14,15]. Prednisolone was administered p.o.…”

“…CDBPA was administered in three doses (31.5, 47 and 62.5 mg/kg and the effects were compared to groups treated with either vehicle or reference treatment R-CHOP [14,15].…”

“…The complex has an anti-cancer tumor growth efficacy and improves quality of life, decreased number of adverse effects and decrease tumor toxicity in patients with stage IV breast cancer patients [12][13][14][15][16]. The aims of the present study were to investigate, if the text article CDBPA has an inhibitory effect on Ramos cells in vitro and to describe the effects of CDBPA on cell cycle, apoptotic pathways and its gene expressions in vitro.…”