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

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          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 PO 4 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.

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          Most cited references 30

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            Mortality, morbidity, and cost associated with febrile neutropenia in adult cancer patients.

            Hospitalization for febrile neutropenia (FN) in cancer patients is associated with considerable morbidity, mortality, and cost. The study was undertaken to better define mortality, length of stay (LOS), cost, and risk factors associated with mortality and prolonged hospitalization in cancer patients with FN. The longitudinal discharge database derived from 115 US medical centers was used to study all adult cancer patients hospitalized with FN between 1995 and 2000, comprising a total of 41,779 patients. Primary outcomes included mortality, LOS, and cost per episode. Overall, in-hospital mortality was 9.5%. Patients without any major comorbidities had a 2.6% risk of mortality, whereas 1 major comorbidity was associated with a 10.3% and more than 1 major comorbidity with a > or = 21.4% risk of mortality, respectively. Mean (median) length of stay was 11.5 (6) days, and the mean (median) cost was $19,110 ($8,376) per episode of FN. Patients hospitalized for > or = 10 days (35% of all patients) accounted for 78% of overall cost. Independent major risk factors for inpatient mortality included invasive fungal infections, Gram-negative sepsis, pneumonia and other lung disease, cerebrovascular, renal, and liver disease. Main predictors for LOS > or = 10 days included leukemia, invasive fungal infections, other types of infection, and several comorbid conditions. Factors associated with increased mortality, LOS, and cost in hospitalized adult cancer patients with FN include patient characteristics, type of malignancy, comorbidities, and infectious complications. These factors may be useful in identifying patients at increased risk of serious medical complications and mortality for more aggressive supportive care measures. Copyright 2006 American Cancer Society
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              An Introduction to Multivariate Statistical Analysis

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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Des Devel Ther
                Drug Design, Development and Therapy
                Drug Design, Development and Therapy
                Dove Medical Press
                1177-8881
                2015
                13 March 2015
                : 9
                : 1481-1490
                Affiliations
                [1 ]Department of Surgery and Cancer, Hammersmith Hospital Campus, Imperial College, London, UK
                [2 ]Center of Epidemiology and Biostatistics, Faculty of Veterinary Medicine, University of Life Science, Oslo, Norway
                [3 ]Meddoc Research AS, Skjetten, Norway
                Author notes
                Correspondence: Steen Lindkær-Jensen, Department of Surgery and Cancer, B Block 2nd Floor, Hammersmith Hospital Campus, Imperial College, Du Cane Road, W12 0NN, London, UK, Email slindkaer@ 123456gmail.com
                Article
                dddt-9-1481
                10.2147/DDDT.S80451
                4364592
                © 2015 Lindkær-Jensen et al. This work is published by Dove Medical Press Limited, and licensed under a Creative Commons Attribution License

                The full terms of the License are available at http://creativecommons.org/licenses/by/4.0/. The license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                Categories
                Original Research

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