A phase II study of the vitamin D analogue Seocalcitol in patients with inoperable hepatocellular carcinoma.
A phase II study of the vitamin D analogue Seocalcitol in patients with inoperable hepatocellular carcinoma.
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维生素D模拟seocalcitol的II期研究对无法手术的肝细胞癌患者。
DOI：
10.1038/sj.bjc.6601104
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发表时间：
2003-07-21
影响因子：
8.8
通讯作者：
中科院分区：
文献类型：
--
作者：
肝细胞癌（HCC）是一种常见的恶性肿瘤，预后较差。手术切除可以治愈，但大多数患者无法手术，并且大多数化疗药物对这种疾病的活性很小。 Seocalcitol 是一种维生素 D 类似物，可诱导癌细胞系和体内的分化并抑制生长。维生素 D 受体在肝细胞中表达，在 HCC 细胞中表达更为丰富。总共 56 名无法手术的晚期 HCC 患者被纳入一项为期长达 1 年的口服西奥骨化醇治疗的非对照研究（有反应者可能会延长）。根据血清钙水平滴定剂量。通过定期CT扫描评估治疗效果。在 33 名可评估肿瘤反应的患者中，2 名患者达到完全缓解 (CR)，12 名患者病情稳定，19 名患者病情进展。 CR 在治疗 6 个月和 24 个月后出现，并持续了 29 个月和至少 36 个月（数据审查时患者仍处于缓解状态）。西奥骨化醇耐受性良好；最常见的毒性是高钙血症和相关症状。大多数患者可以耐受每日 10μg 西奥骨化醇剂量。这是第一项研究显示，通过减小肿瘤尺寸，分化剂对患有晚期大块实体瘤的患者具有活性。西奥骨化醇可能对 HCC 的治疗有效，尤其是在可以开始长期治疗的早期疾病中。有或没有肿瘤反应的生存获益应在对照研究中确定。
Hepatocellular carcinoma (HCC) is a common malignant tumour, which has a poor prognosis. Surgical resection can be curative but most patients are inoperable and most chemotherapy agents have minimal activity in this disease. Seocalcitol, a vitamin D analogue, induces differentiation and inhibits growth in cancer cell lines and in vivo. The vitamin D receptor is expressed in hepatocytes and more abundantly in HCC cells. In total, 56 patients with inoperable advanced HCC were included in an uncontrolled study of oral Seocalcitol treatment for up to 1 year (with possible extension for responders). The dose was titrated according to serum calcium levels. The treatment effect was evaluated by regular CT scans. Out of 33 patients evaluable for tumour response, two had complete response (CR), 12 stable disease and 19 progressive disease. The CRs appeared after 6 and 24 months of treatment, and lasted for 29 and at least 36 months (patient still in remission when data censored). Seocalcitol was well tolerated; the most frequent toxicity was hypercalcaemia and related symptoms. Most patients tolerated a daily dose of 10 μg of Seocalcitol. This is the first study showing activity, by reduction in tumour dimensions, of a differentiating agent in patients with an advanced bulky, solid tumour. Seocalcitol may have an effect in the treatment of HCC, especially in early disease when a prolonged treatment can be instituted. The survival benefit with or without tumour response should be determined in controlled studies.
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影响因子：
45.3
作者：
Grimaldi, C;Bleiberg, H;Wils, J
通讯作者：
Wils, J
影响因子：
56.9
作者：
MCDONNELL, DP;MANGELSDORF, DJ;OMALLEY, BW
通讯作者：
OMALLEY, BW
DOI：
10.1016/0960-0760(93)90226-m
发表时间：
1993-09-01
影响因子：
4.1
作者：
MATHIASEN, IS;COLSTON, KW;BINDERUP, L
通讯作者：
BINDERUP, L
影响因子：
8.8
作者：
Gulliford, T;English, J;Coombes, RC
通讯作者：
Coombes, RC
DOI：
10.1016/0167-4781(91)90159-j
发表时间：
1991-01-17
期刊：
BIOCHIMICA ET BIOPHYSICA ACTA
影响因子：
--
作者：
MAHONEN, A;PIRSKANEN, A;MAENPAA, PH
通讯作者：
MAENPAA, PH