IMPROVED LONG-TERM SURVIVAL FOR UNRESECTABLE HEPATOCELLULAR-CARCINOMA(HCC) WITH A COMBINATION OF SURGERY AND INTRAHEPATIC ARTERIAL INFUSION OF I-131 ANTI-HCC MAB - PHASE I II CLINICAL-TRIALS/

Resectional therapy has been accepted as the only curative therapy for hepatocellular carcinoma (HCC). Unfortunately, it is estimated that o nly 10% of HCC are resectable at the time of diagnosis. Cytoreduction and sequential resection offer a new hope for patients with unresectab le HCC. Radioimmunotherapy (RIT) is an attractive approach for cytored uction. We have previously shown that intrahepatic arterial I-131-labe lled anti-HCC monoclonal antibody (I-131-Hepama-1 mAb) could be used s afely in combination with hepatic artery ligation for treatment of unr esectable HCC, and encouraging results have been achieved. In this pap er, the long-term survival and the prognostic factors in HCC patients treated with radioimmunotherapy will be analysed. Sixty-five patients with surgically verified unresectable HCC were treated with hepatic ar tery ligation plus hepatic artery cannulation and infusion from 1990 t o 1992. Thirty-two patients were enrolled in a phase I-II clinical tri al with infusion of I-131-radiolabelled anti-HCC monoclonal antibody ( Hepama-1 mAb) via the hepatic artery (the RIT group). Another 33 patie nts formed the group treated with intrahepatic-arterial chemotherapy ( the non-RIT group). T cell subsets were measured in 24 patients and hu man anti-(murine Ig) antibody (HAMA) were monitored in the RIT group. The 5-year survival rate was significantly higher in the RIT group tha n in the chemotherapy group, being 28.1% compared to 9.1% (P < 0.05); this was mainly a result of better cytoreduction and a higher sequenti al resection rate (53.1% compared to 9.1%). Significant prognostic fac tors in the RIT group included tumour capsule status and the number of tumour nodules. HAMA incidence and CD4+ T lymphocytes influenced shor t-term, but not long-term survival. It is suggested that intrahepatic- arterial RIT, using I-131-Hepama-1 mAb, combined with hepatic artery l igation might be an effective approach to improve long-term survival i n some patients with unresectable HCC, which may successfully be made resectable by intra-arterial infusion of I-131-Hepama-1 mAb.