Transarterial chemotherapy alone versus transarterial chemoembolization for hepatocellular carcinoma: a randomized phase III trial.
OBJECTIVE
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 646 days 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.
Okusaka
Takuji
T
Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. tokusaka@ncc.go.jp
Kasugai
Hiroshi
H
Shioyama
Yasukazu
Y
Tanaka
Katsuaki
K
Kudo
Masatoshi
M
Saisho
Hiromitsu
H
Osaki
Yukio
Y
Sata
Michio
M
Fujiyama
Shigetoshi
S
Kumada
Takashi
T
Sato
Keiko
K
Yamamoto
Seiichiro
S
Hinotsu
Shiro
S
Sato
Tosiya
T
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy*; D016461:Chemoembolization, Therapeutic / Q000009:adverse effects; D005260:Female; D006801:Humans; D007261:Infusions, Intra-Arterial; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy*; D008297:Male; D008299:Maleic Anhydrides / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D011137:Polystyrenes / Q000008:administration & dosage / Q000009:adverse effects; D015996:Survival Rate; D009353:Zinostatin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives
D000970:Antineoplastic Agents; D008299:Maleic Anhydrides; D011137:Polystyrenes; C035755:poly(maleic acid-styrene)neocarzinostatin; D009353:Zinostatin