Efficacy and safety of Specific Conjugate Particle (SCP)- Doxorubicinin Patients with Recurrent High-Grade Gliomas, a Randomized Clinical Study
Journal Title: Journal of Vaccine & Immunotechnology - Year 2017, Vol 3, Issue 1
Abstract
Objective: Doxorubicin has proven to be partly efficacious in treating glioblastoma multiforme. However, the conventional formulation of doxorubicin has not been used clinically, due to poor penetration of the blood-brain barrier.To overcome these obstacles, authors compared the use of Specific conjugate particle doxorubicin (Group 1), a proven efficacious agent with advanced technical drug, and pegylated liposomal Doxorubicin (Group 2) in a randomized prospective Phase III trial involving patients with recurrent high-grade glioma. Methods: We recruited eighty (80) patients with WHO grade III-IV high-grade glioma, according to 2 independent pathology reports, tumor recurrence identified on gadolinium-enhanced Magnetic Resonance Imaging (MRI). The participants were between the ages of 18 and 70 years, with a life expectancy of more than two months. Patients were randomized to receive either Specific Conjugate Particle Doxorubicin (SCP-Doxorubicin) or the conventionally accepted PEGylated Liposomal Doxorubicin (PEG- Doxorubicin). Study subjects received 20 mg/m2 of either PEG-Doxorubicin or SCP-Doxorubicin by an intravenous infusion over 30 minutes per day, with a range of 1-28 courses administered per patient. Results: In the patients evaluated, overall response rate was 40% is it for both groups, what is the percentage for each group. Two patients achieved Complete Responses (CRs) and two Partial Responses (PRs) in the SCP-Doxorubicin arm. We noted Stable Disease (SD) lasting greater than eight weeks in 28 patients. Patients receiving SCPDoxorubicin had a significantly better response to therapy (more CR, PR, and SD) than those receiving PEG-Doxorubicin (p<0.05). Patients had also a significantly better survival (more PFS6, TTP and OS) to SCPDoxorubicin therapy than those receiving PEG- Doxorubicin (p<0.05) {where is the PFS6, TTP, OS}. Twenty-five adverse events occurred in patients receiving PEG-Doxorubicin, whereas there were only four adverse events in patients who received SCP-Doxorubicin. Palmar Plantar Erythrodysesthesi (PPE) was the most common adverse event in both the groups (p<0.05). Conclusion: SCP-Doxorubicin had superior efficacy when compared to PEG-Doxorubicin independent of the patient’s prior therapeutic regime and stage of carcinoma. Furthermore, SCPDoxorubicin was found to be a comparatively safer treatment regimen with no major side effects and a significantly lower adverse event rate than PEG- Doxorubicin.
Authors and Affiliations
Timothy Allen
Keywords
Related Articles
- EP ID EP245947
- DOI 10.13188/2377-6668.1000008
- Views 73
- Downloads 0
Signaling Networks Responsible for the Dynamic Modulation of IL-12 in Response to Varying Dosages of LPS in Macrophages
The innate immune response to lipopolysaccharide (LPS) has many possible outcomes depending on the dose, from acute endotoxic shock to broad immunomodulation. High doses (>10 ng/mL) evoke both pro- and anti-inflammatory...
Efficacy and safety of Specific Conjugate Particle (SCP)- Doxorubicin in Patients with Soft Tissue Sarcoma, a Randomized Clinical Study
Objective: Doxorubicin has been the mainstay of treatment foradvanced STS. However, the conventional formulation of doxorubicinhas not been used clinically, due to poor penetration of the naturalphysiologic barriers, poo...
Autophagic Control of Listeria Determines the Infection-Induced Death of Macrophages
Listeria induces cell death in macrophages, hepatocytes and dendritic cells. It is accepted that the cell death is induced by listeriolysin O (LLO), which has a crucial role in the escape of Listeria from the vacuole. To...
Enhancing Solubilization of Hydrophobic ORF3 Product of Hepatitis E Virus in Bacterial Expression System
Hepatitis E Virus (HEV) is a major cause of acute clinical hepatitis in developing countries. HEV genome has three open reading frames: ORF1, ORF2 and ORF3. ORF3 encodes a small 13 kDa protein (hereinafter called vp13)....
Immunization with Live Promastigote Antigen of Leishmania donovani induces Protection against Experimental Visceral Leishmaniasis Infection in BALB/c Mice.
Visceral leishmaniasis (VL) also commonly known as kala-azar is a vector borne parasitic disease which is endemic in Indian subcontinent. At present treatment of this disease relies on chemotherapy and no vaccine is avai...