Transarterial chemotherapy alone versus transarterial chemoembolization for hepatocellular carcinoma: A randomized phase III trial☆

Received 21 February 2009; received in revised form 29 June 2009; accepted 27 July 2009. published online 01 October 2009.

Refers to article:

Transarterial therapies in HCC: Does embolization increase survival? , 30 September 2009
Alejandro Forner, Jean-Claude Trinchet
Journal of Hepatology
December 2009 (Vol. 51, Issue 6, Pages 981-983)
Full Text | Full-Text PDF (85 KB)

Background/Aims

Transcatheter arterial chemoembolization (TACE) is a combination of transarterial infusion chemotherapy (TAI) and embolization, and has been widely used to treat patients with hepatocellular carcinoma (HCC). However, since the impact of adding embolization on the survival of patients treated with TAI had never been evaluated in a phase III study, we conducted a multi-center, open-label trial comparing TACE and TAI to assess the effect of adding embolization on survival.

Methods

Patients with newly diagnosed unresectable HCC were randomly assigned to either a TACE group or a TAI group. Zinostatin stimalamer was injected into the hepatic artery, together with gelatin sponge in the TACE group and without gelatin sponge in the TAI group. Treatment was repeated when follow-up computed tomography showed the appearance of new lesions in the liver or re-growth of previously treated tumors.

Results

Seventy-nine patients were assigned to the TACE group, and 82 were assigned to the TAI group. The two groups were comparable with respect to their baseline characteristics. At the time of the analysis, 51 patients in the TACE group and 58 in the TAI group had died. The median overall survival time was 646days in the TACE group and 679days in the TAI group (p=0.383).

Conclusions

The results of this study suggest that treatment intensification by adding embolization did not increase survival over TAI with zinostatin stimalamer alone in patients with HCC.

Associate Editor: J.M. Llovet

Abbreviations: HCC, hepatocellular carcinoma, AFP, α-fetoprotein, TACE, transarterial chemoembolization, TAI, transarterial infusion chemotherapy, SMANCS, zinostatin stimalamer, CT, computed tomography, TE, therapeutic effect, SMA, styrene maleic acid, NCS, neocarzinostatin

Keywords: Zinostatin stimalamer, Survival benefit, Overall survival, Lipiodol emulsion, Gelatin sponge

1 Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan

2 Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan

3 Department of Radiology, Central Hospital and Cancer Center of Ibaraki, Ibaraki, Japan

4 Gastroenterological Center, Yokohama City University Medical Center, Kanagawa, Japan

5 Department of Gastroenterology and Hepatology, Kinki University, Osaka, Japan

6 Department of Medicine and Clinical Oncology, Chiba University, Chiba, Japan

7 Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital, Osaka, Japan

8 Division of Gastroenterology, Kurume University, Fukuoka, Japan

9 Third Department of Internal Medicine, Kumamoto University, Kumamoto, Japan

10 Department of Gastroenterology, Ogaki Municipal Hospital, Gifu, Japan

11 Genetic Counseling and Clinical Research Unit, Kyoto University School of Public Health, Kyoto, Japan

12 Cancer Information Services and Surveillance Division, Center for Cancer Control and Information Services, National Cancer Center, Tokyo, Japan

13 Institute of Clinical Medicine, University of Tsukuba, Ibaraki, Japan

14 Department of Biostatistics, Kyoto University School of Public Health, Kyoto, Japan

Corresponding author. Tel.: +81 3 3542 2511; fax: +81 3 3542 3815.

☆ The authors who have taken part in this trial do not have a relationship with the manufacturers of the drugs involved either in the past or present and did not receive funding from the manufacturers to carry out their research. This study was supported by a Grant-in-Aid for Cancer Research (Grant No. 11-15) from the Ministry of Health, Labour and Welfare of Japan. Trial registration: UMIN C000000111.

PII: S0168-8278(09)00588-1

doi:10.1016/j.jhep.2009.09.004

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