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

Steen Lindkær-Jensen, Stig Larsen, Nina Habib-Lindkær-Jensen, Hans E Fagertun, Steen Lindkær-Jensen, Stig Larsen, Nina Habib-Lindkær-Jensen, Hans E Fagertun

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.

Methods: The 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.

Results: Hemoglobin (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(+), Ca(2+), and PO4 (3-) was most pronounced in patients with low baseline levels (P≤0.02). A similar pattern detected for Mg(2+), 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.

Conclusion: Our 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.

Keywords: albumin; electrolytes; hematocrit; hemoglobin; neutrophils; thrombocytes.

Figures

Figure 1
Figure 1
Hematology findings: regression between the increase from baseline to day 32 of BP-C1 treatment, and baseline. Notes: The full line represents the estimated regression line, the shaded area represents the 95% confidence interval of the regression line, and the dotted line represents the 95% prediction interval. The observed values are given as circles. Abbreviation: BP-C1, benzene-poly-carboxylic acid complex with cis-diammineplatinum(II).
Figure 2
Figure 2
Clinical chemistry findings: regression between the increase from baseline to day 32 of BP-C1 treatment, and baseline. Notes: The full line represents the estimated regression line, the shaded area represents the 95% confidence interval of the regression line, and the dotted line represents the 95% prediction interval. The observed values are given as circles. Abbreviation: BP-C1, benzene-poly-carboxylic acid complex with cis-diammineplatinum(II).

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Source: PubMed

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