This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Leung, T.W.T. Articles by Thuluvath, P.J. Search for Related Content PubMed PubMed Citation Articles by Leung, T.W.T. Articles by Thuluvath, P.J. Social Bookmarking                            What's this?

Phase II Study of the Efficacy and Safety of Cisplatin-Epinephrine Injectable Gel Administered to Patients With Unresectable Hepatocellular Carcinoma

T.W.T. Leung, S. Yu, P.J. Johnson, J. Geschwind, T.J. Vogl, K. Engelmann, G.J. Gores, M. Giovannini, J. O’Grady, M. Heneghan, M. Stewart, E.K. Orenberg, P.J. Thuluvath

From the Chinese University of Hong Kong, Hong Kong SAR, China; Johns Hopkins University Medical Center, Baltimore, MD; Johann Wolfgang Goethe University, Frankfurt, Germany; Mayo Clinic Rochester, MN; Institut Paoli Calmettes, Marseilles, France; Institute of Liver Studies, King’s College Hospital, London, United Kingdom; and Matrix Pharmaceutical, Inc, Fremont, CA.

Address reprint requests to Thomas W.T. Leung, MD, Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong SAR, China; email: waitongleung{at}cuhk.edu.hk.

Purpose: To study the efficacy and safety of percutaneous cisplatin-epinephrine (CDDP-EPI) injectable gel in patients with localized unresectable hepatocellular carcinoma (HCC).

Patients and Methods: Eligible patients had histologically proven HCC, no prior treatment except for surgery, and no more than three tumors (each measured 7 cm, total tumor volume 200 cm³). They were treated percutaneously under ultrasound or computed tomography (CT) guidance, with up to 10 mL of CDDP-EPI gel (1 mL contains 4 mg of CDDP and 0.1 mg of EPI) per treatment and four treatments in 6 weeks to a maximum of eight treatments. The primary end points were tumor response, defined by change of percentage of tumor necrosis according to CT criteria, and safety. Survival parameters were secondary end points.

Results: From June 1997 to April 2000, 58 patients (median age, 65 years) entered the study. All patients were assessable for safety, and 51 were assessable for efficacy. The median number of treatments was four (range, one to eight treatments). Objective response rate was 53% (27 of 51 patients), including 16 complete and 11 partial responses. Of the 27 responders, 14 (52%) subsequently developed progressive disease, but in most of them (93%), a new tumor arose at untreated liver sites. Median survival was 27 months (range, 18.4 to 35.7 months). The 1-, 2-, and 3-year survival rates were 79%, 56%, and 14% respectively. The procedure was well tolerated with only minor side effects.

Conclusion: Percutaneous local ablation with CDDP-EPI injectable gel can induce significant tumor necrosis and local control for localized unresectable HCC, and the treatment is well tolerated.

Supported in part by Matrix Pharmaceutical, Inc, Fremont, CA.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				Z. F. Yang, R. T. Poon, J. To, D. W. Ho, and S. T. Fan The Potential Role of Hypoxia Inducible Factor 1{alpha} in Tumor Progression after Hypoxia and Chemotherapy in Hepatocellular Carcinoma Cancer Res., August 1, 2004; 64(15): 5496 - 5503. [Abstract] [Full Text] [PDF]