Thalidomide in the treatment of patients with hepatocellular carcinoma: a phase II trial.

摘要: BACKGROUND The treatment of patients with hepatocellular carcinoma (HCC) presents a major challenge, because associated cirrhosis limits the choice chemotherapeutic agents. However, abundant vascularity HCC an attractive target for antiangiogenic therapy that potentially may be tolerated by cirrhotic patients. The current study was conducted to assess antitumor activity, tolerance, treatment-related toxicity, and patient survival after administration thalidomide in Phase II trial. METHODS Thirty-seven were accrued between March, 1999, 2000. Initially, dose oral escalated from 400 mg per day during first week 1000 fifth week, delivering one-third morning remaining two-thirds evening prior bedtime. Changes daily drug schedule allowed based on tolerance. Response assessed at 8-week intervals. RESULTS Thirty-two 37 registered evaluable response. One had partial response (PR), 1 minor (MR), 10 stable disease (SD) (31%; 95% confidence interval [95%CI], 16–51%), 20 patients) (61%; 95%CI, 42–78%) progression. most commonly encountered toxicity somnolence, Grade 3–4 somnolence (≥ 4 hours sleep normal waking hours) 9 (35%) 2 (≤ 3 30% In fact, only 48% > 800 if it delivered skin reactions observed 20% patients, exfoliative dermatitis responding patient. overall median 6.8 months. CONCLUSIONS With 5% PR rate, MR 31% SD results indicate mostly offer stabilization. It is possible that, different dosage, or combined other chemotherapy agents, use analogue, longer achieved. view significant neurologic among these monotherapy high doses studied cannot recommended HCC. Cancer 2005. © 2005 American Society.