Abstract
357 Background: In Japan, transarterial infusion chemotherapy (TAI) with cisplatin (CDDP) is used for advanced hepatocellular carcinoma (HCC) patients (pts), and the response rate (RR) was 33.8% in previous phase (P) II study. S-1, oral systematic chemotherapy, is also promised for advanced HCC pts, and achieved 23.1% RR in previous P-II study. The clinical feasibility and efficacy of CDDP for TAI plus S-1 in pts with advanced HCC has not yet been investigated. Thus, we performed this trial to determine the recommended dose (RD). Methods: Although 13 Child–Pugh class A or B pts with advanced HCC entered themselves for this P-I trial, 1 pts of them was excluded from this trial due to the breach of criteria. The pts received TAI with CDDP (infusion on day 1 of the courses) plus S-1 (daily oral administration on days 1–21 of the courses), every 5 weeks until disease progression. The dose-escalation scheme is provided in the table below. Results: Three dose levels were used for the 12 pts. Dose-limiting toxicity was not observed in 3 pts at level 1, 3 pts at level 2, and 7 pts at level 3; therefore, the RDs for CDDP and S-1 were considered to be 65 mg/m2 and 80–120 mg/day, respectively (level 3). Grade 3 adverse events were reported for 10 pts and were considered to be related to the study drugs for 6 pts: 2 pts, increased alanine aminotransferase level; 2 pts, increased aspartate aminotransferase level; 1 pt, anemia; and 1 pt, decreased platelet count. The total number of treatment courses was 25, with a mean of 1.5 courses per pt (range, 1–6 courses). The median progression-free survivaltime was 73 days. The disease control rate was 58% (7/12) ; 2 pts (16%) achieved partial response and 5 (42%) had stable disease. Conclusions: TAI with CDDP plus S-1 can be used safely with promising tumor control for treating advanced HCC. The RD to be used for a P-II study of this regimen was determined to be level 3. [Table: see text]
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