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Safety and efficacy of non-pegylated liposomal doxorubicin (NPLD) at two different dose levels as compared to conventional doxorubicin in patients (pts) with metastatic breast cancer (MBC): A phase II/III open label mult
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Cancer Science & Therapy

ISSN: 1948-5956

Open Access

Safety and efficacy of non-pegylated liposomal doxorubicin (NPLD) at two different dose levels as compared to conventional doxorubicin in patients (pts) with metastatic breast cancer (MBC): A phase II/III open label mult


2nd World Congress on Cancer Science & Therapy

September 10-12, 2012 Hilton San Antonio Airport, USA

R. H. Jani, D. D. Gambhire, G.V. Daftary, H. Panchal, M. Basade and C. Tamane

Scientific Tracks Abstracts: JCST

Abstract :

This study evaluates safety and efficacy of NPLD (Nudoxa«) in Indian pts, and is being conducted in two parts. We report Part A of study that aimed to determine overall response rate (ORR) to Nudoxa« (60 and 70 mg/m 2 ) in target lesions of MBC using RECIST criteria. Part B of the study is ongoing and will evaluate selected dose of Nudoxa« in determining its safety and efficacy in treatment of MBC compared to conventional doxorubicin. Female pts aged ≥18 years with ECOG status ≤2, histologically confirmed MBC with at least one measurable lesion as determined by RECIST criteria and life expectancy of minimum 6 months were included. Pts were randomized in 1:1 to 60 mg/m 2 (n= 7) or 70 mg/m 2 (n= 6) of Nudoxa«. The ORR was evaluated as complete response (CR) and partial response (PR) in target lesions. In 70 mg/m 2 and 60 mg/m 2 group, the ORR (target lesions) was 66% (4/6) and 16% (1/6), respectively (Table). All adverse events were resolved with or without treatment. No death, cardiotoxicity, and hand-foot syndrome (Palmer Planter Erythrodysesthesia) were reported. Nudoxa« at 70 mg/m2 appeared more effective than 60 mg/m2 with ORR as primary endpoint. This dose is being evaluated in Part B of study in 70 MBC pts in comparison with 70 mg/m2 conventional doxorubicin.

Biography :

Dr. Rajendra Jani earned doctorate in pathology and bacteriology. Currently he is working as Head and Senior Vice President, Clinical R&D at Zydus Cadila. He is responsible for clinical research development program (Phase 1-4) with emphasis new drug discovery. He was also a key team member, which clinically developed first orally acting drug, miltefosine, for the treatment of Kala Azar.

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