Leung T W T, Yu S, Johnson P J, Geschwind J, Vogl T J, Engelmann K, Gores G J, Giovannini M, O'Grady J, Heneghan M, Stewart M, Orenberg E K, Thuluvath P J
Department of Clinical Oncology, Prince of Wales Hospital, Chinese University of Hong Kong, Shatin, New Territories, Hong Kong SAR, China.
J Clin Oncol. 2003 Feb 15;21(4):652-8. doi: 10.1200/JCO.2003.04.152.
To study the efficacy and safety of percutaneous cisplatin-epinephrine (CDDP-EPI) injectable gel in patients with localized unresectable hepatocellular carcinoma (HCC).
Eligible patients had histologically proven HCC, no prior treatment except for surgery, and no more than three tumors (each measured < or = 7 cm, total tumor volume < or = 200 cm(3)). They were treated percutaneously under ultrasound or computed tomography (CT) guidance, with up to 10 mL of CDDP-EPI gel (1 mL contains 4 mg of CDDP and 0.1 mg of EPI) per treatment and four treatments in 6 weeks to a maximum of eight treatments. The primary end points were tumor response, defined by change of percentage of tumor necrosis according to CT criteria, and safety. Survival parameters were secondary end points.
From June 1997 to April 2000, 58 patients (median age, 65 years) entered the study. All patients were assessable for safety, and 51 were assessable for efficacy. The median number of treatments was four (range, one to eight treatments). Objective response rate was 53% (27 of 51 patients), including 16 complete and 11 partial responses. Of the 27 responders, 14 (52%) subsequently developed progressive disease, but in most of them (93%), a new tumor arose at untreated liver sites. Median survival was 27 months (range, 18.4 to 35.7 months). The 1-, 2-, and 3-year survival rates were 79%, 56%, and 14% respectively. The procedure was well tolerated with only minor side effects.
Percutaneous local ablation with CDDP-EPI injectable gel can induce significant tumor necrosis and local control for localized unresectable HCC, and the treatment is well tolerated.
研究经皮注射顺铂 - 肾上腺素（CDDP - EPI）凝胶治疗局部不可切除肝细胞癌（HCC）患者的疗效和安全性。
符合条件的患者经组织学证实为HCC，除手术外未接受过其他治疗，且肿瘤不超过3个（每个肿瘤直径≤7 cm，肿瘤总体积≤200 cm³）。在超声或计算机断层扫描（CT）引导下对患者进行经皮治疗，每次治疗使用最多10 mL CDDP - EPI凝胶（1 mL含4 mg CDDP和0.1 mg EPI），6周内进行4次治疗，最多进行8次治疗。主要终点为根据CT标准通过肿瘤坏死百分比变化定义的肿瘤反应以及安全性。生存参数为次要终点。
1997年6月至2000年4月，58例患者（中位年龄65岁）进入研究。所有患者均可进行安全性评估，51例可进行疗效评估。治疗次数中位数为4次（范围为1至8次）。客观缓解率为53%（51例患者中的27例），包括16例完全缓解和11例部分缓解。在27例缓解者中，14例（52%）随后出现疾病进展，但其中大多数（93%）是在未治疗的肝脏部位出现新肿瘤。中位生存期为27个月（范围为18.4至35.7个月）。1年、2年和3年生存率分别为79%、56%和14%。该治疗耐受性良好，仅出现轻微副作用。
经皮注射CDDP - EPI凝胶进行局部消融可诱导局部不可切除HCC出现显著的肿瘤坏死并实现局部控制，且该治疗耐受性良好。
