Authors: Livraghi, Tito¹; Meloni, Franca¹; Frosi, Alberto²; Lazzaroni, Sergio³; Bizzarri, Mariano⁴; Frati, Luigi⁴; Biava, Pier Mario⁵

Source: Oncology Research Featuring Preclinical and Clinical Cancer Therapeutics, Volume 15, Numbers 7-8, 2005 , pp. 399-408(10)

Publisher: Cognizant Communication Corporation

Abstract:

There is no standard treatment for patients with advanced hepatocellular carcinoma (HCC). We developed a product containing stem cells differentiation stage factors (SCDSF) that inhibits tumor growth in vivo and in vitro. The aim of this open randomized study was to assess its efficacy in patients with HCC not suitable for resection, transplantation, ablation therapy, or arterial chemoembolization. A total of 179 consecutive patients were enrolled. We randomly assigned the patients to receive either SCDSF or only conservative treatment. Primary end points were tumor response and survival. Secondary end points were performance status and patient tolerance. Randomization was stopped at the second interim analysis (6 months) of the first 32 patients recruited when the inspection detected a significant difference in favor of treatment ( p = 0.037). The responses to the therapy obtained in 154 additional patients confirmed previous results. Evaluation of survival showed a significant difference between the group of patients who responded to treatment versus the group with progression of disease ( p < 0.001). Of the 23 treated patients with a performance status (PS) of 1, 19 changed to 0. The study indicated the efficacy of SCDSF treatment of the patients with intermediate-advanced HCC.

Keywords: Biological response modifiers; Embryo; Stem cells; Differentiation factors; Hepatocellular carcinoma

Document Type: Research article

Affiliations: 1: Department of Radiology, Civil Hospital of Vimercate, Vimercate, Milan, Italy 2: Hepatology-Gastroenterology Unit, Internal Medicine Department, Civil Hospital of Sesto S. Giovanni, Milan, Italy 3: Department of Internal Medicine, San Biagio Hospital, Clusone, Bergamo, Italy 4: Department of Experimental Medicine and Pathology, University of Rome “La Sapienza”, Rome, Italy 5: Foundation for Research into the Biological Therapies of Cancer, Civil Hospital of Sesto S. Giovanni, Milan, Italy

Publication date: 2005-07-01

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• Formerly: Oncology Research Incorporating Anti-Cancer Drug Design
  Oncology Research Featuring Preclinical and Clincal Cancer Therapeutics publishes research of the highest quality that contributes to an understanding of cancer in areas of molecular biology, cell biology, biochemistry, biophysics, genetics, biology, endocrinology, and immunology, as well as studies on the mechanism of action of carcinogens and therapeutic agents, reports dealing with cancer prevention and epidemiology, and clinical trials delineating effective new therapeutic regimens.

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