Perrone F, Gallo C, Daniele B, Gaeta G B, Izzo F, Capuano G, Adinolfi L E, Mazzanti R, Farinati F, Elba S, Piai G, Calandra M, Stanzione M, Mattera D, Aiello A, De Sio I, Castiglione F, Russo M, Persico M, Felder M, Manghisi O G, De Maio E, Di Maio M, Pignata S
CLIP secretariat, Ufficio Sperimentazioni Cliniche Controllate, Istituto Nazionale Tumori, Via Mariano Semmola, Napoli, 80131, Italy.
Curr Pharm Des. 2002;8(11):1013-9. doi: 10.2174/1381612024607063.
In 1998, when data of a meta-analysis on tamoxifen in the treatment of hepatocellular carcinoma (HCC) had suggested a little advantage for this treatment, we published the results of a multicenter randomised controlled trial, that showed no survival benefit for tamoxifen vs. control. Here we report an updated analysis of the study results 4.5 years after the closure of enrollment.
The study had a planned sample size of 480 patients. Patients with any stage HCC were eligible, irrespective of locoregional treatment. Tamoxifen was given orally, 40 mg/die, from randomisation until death.
496 patients were randomised by 30 Institutions from January 1995 to January 1997. Information was available for 477 patients. As of July 2001, 374 deaths (78%) were recorded, and median survival times were 16 and 15 months (p=0.54), in the control and tamoxifen arm. Data were further analysed separately for advanced patients and for those eligible to potentially curative locoregional treatments: relative hazard of death for patients receiving tamoxifen was equal to 0.98 (95% CI 0.76-1.25) for the former group and 1.38 (95% CI 0.95-2.01) for the latter. The prognostic score recently devised by our group (CLIP score) was, as expected, strictly correlated (p<0.0001) to the locoregional treatment received and strongly correlated with prognosis.
the update of the present study confirms that tamoxifen is not effective in prolonging survivals, both in advanced patients and in those potentially curable and that the CLIP score is able to predict prognosis.
1998年，一项关于他莫昔芬治疗肝细胞癌（HCC）的荟萃分析数据显示该治疗有少许优势，彼时我们发表了一项多中心随机对照试验的结果，该结果表明他莫昔芬与对照组相比并无生存获益。在此，我们报告入组结束4.5年后对研究结果的更新分析。
该研究计划样本量为480例患者。任何阶段的HCC患者均符合条件，无论其局部区域治疗情况如何。从随机分组至死亡，他莫昔芬口服给药，剂量为40mg/日。
1995年1月至1997年1月，30个机构对496例患者进行了随机分组。477例患者有可用信息。截至2001年7月，对照组和他莫昔芬组分别记录到374例死亡（78%），中位生存时间分别为16个月和15个月（p = 0.54）。对晚期患者和有潜在根治性局部区域治疗资格的患者的数据进一步进行了单独分析：前一组接受他莫昔芬治疗患者的死亡相对风险等于0.98（95%CI 0.76 - 1.25），后一组为1.38（95%CI 0.95 - 2.01）。正如预期的那样，我们团队最近设计的预后评分（CLIP评分）与接受的局部区域治疗密切相关（p < 0.0001），且与预后高度相关。
本研究的更新证实，他莫昔芬在延长晚期患者和潜在可治愈患者的生存期方面均无效，且CLIP评分能够预测预后。
