PHASE-II STUDY OF TRANSARTERIAL EMBOLIZATION IN EUROPEAN PATIENTS WITH HEPATOCELLULAR-CARCINOMA - NEED FOR CONTROLLED TRIALS

Our uncontrolled phase II study was aimed at assessing the efficacy of transarterial embolization in patients with hepatocellular carcinoma and to determine the parameters associated with a favorable response t o treatment, improved survival or both. Fifty consecutive patients (25 corresponding to Okuda's stage I and 25 to stage II) with hepatocellu lar carcinoma (41 being multinodular or massive) were included. Transa rterial embolization induced a self-limited postembolization syndrome that was well tolerated. Nevertheless, three patients died shortly aft er the procedure because of tumor progression (two cases) or progressi ve liver failure. A favorable response (extensive necrosis with reduct ion of tumor area greater than 50%) was achieved in 81% of the cases, and this result was independently (p < 0.05) related to a preserved pe rformance status and to a lower alphafetoprotein concentration. The su rvival of the patients at 1 and 2 yr was 65% and 38%, respectively, be tter than the expected survival according to a mathematical model obta ined from a historical series of untreated cases (42% and 20%, respect ively). Cox regression analysis disclosed that both a favorable therap eutic response and a preserved physical condition (reflected by perfor mance status of 0 or 1) were independently associated with better surv ival (regression coefficient -2.248 and 0.869, respectively). These da ta indicate that transarterial embolization has a marked antitumoral e ffect in patients with inoperable hepatocellular carcinoma and that th e therapeutic success is associated with improved survival. Neverthele ss, because the potential benefit for survival observed in this uncont rolled study appears to be moderate, prospective controlled trials to ascertain the real usefulness of this therapeutic approach are mandato ry.