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. Efficacy and safety of Specific Conjugate Particle (SCP)- Doxorubicinin Patients with Recurrent High-Grade Gliomas, a Randomized Clinical Study(08-June-2017)


Glioma; Glioblastoma; SCP-Doxorubicin; PEGDoxorubicin; Phase III trial; Conjugate particle; Adverse events; Efficacy

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