Department of Oncology, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China.
World J Gastroenterol. 2011 Apr 28;17(16):2143-9. doi: 10.3748/wjg.v17.i16.2143.
To evaluate the efficacy and safety of combination therapy with recombinant adenovirus p53 injection (rAdp53) and transcatheter hepatic arterial chemoembolization (TACE) for advanced hepatocellular carcinoma (HCC).
A total of 82 patients with advanced HCC treated only with TACE served as control group. Another 68 patients with HCC treated with TACE in combination with recombinant adenovirus-p53 injection served as p53 treatment group. Patients were followed up for 12 mo. Safety and therapeutic effects were evaluated according to the improvement in clinical symptoms, leukocyte count, Karnofsky and RECIST criteria. Survival rate was calculated with Kaplan-Meier method.
The total effective rate was 58.3% for p53 treatment group, and 26.5% for control group (P < 0.05). The incidence of gastrointestinal symptoms was lower in p53 treatment group than in control group (P < 0.05). The 3-, 6- and 12-mo survival rates were significantly higher for p53 treatment group than for control group (P < 0.01). The combination treatment was well tolerated with such adverse events as fever (51.5%, P = 0.006) and pain of muscles and joints (13.2%, P = 0.003), which were significantly higher than the chemotherapy. Except for these minor adverse effects, no severe vector-related complications were identified. With respect to the efficacy, patients in p53 treatment group had less gastrointerestinal symptoms (P = 0.062), better improvement in tumor-related pain (P = 0.003), less downgrade of leukocyte counts (P = 0.003) and more upgrade of Karnofsky performance score (P = 0.029) than those in control group. The total effective rate (CR + PR) for p53 treatment group and control group was 58.3% and 26.5%, respectively, with distributions of different effect in two groups (P = 0.042). The survival rates were 89.71%, 76.13%, and 43.30% for p53 treatment group, and 68.15%, 36.98%, and 24.02% for control group, respectively, 3, 6 and 12 mo after treatment, suggesting that the survival rates are significantly higher for p53 treatment group than for control group (P = 0.0002).
The rAd-p53 gene therapy in combination with TACE is a safe and effective treatment modality for advanced HCC.
评估重组腺病毒 p53 注射液（rAdp53）联合经导管肝动脉化疗栓塞（TACE）治疗晚期肝细胞癌（HCC）的疗效和安全性。
将仅接受 TACE 治疗的 82 例晚期 HCC 患者作为对照组，另将 68 例接受 TACE 联合重组腺病毒-p53 注射液治疗的 HCC 患者作为 p53 治疗组。患者均随访 12 个月。根据临床症状改善、白细胞计数、卡诺夫斯基和 RECIST 标准评价安全性和治疗效果。采用 Kaplan-Meier 法计算生存率。
p53 治疗组总有效率为 58.3%，对照组为 26.5%（P＜0.05）。p53 治疗组胃肠道症状发生率低于对照组（P＜0.05）。p53 治疗组 3、6、12 个月生存率均明显高于对照组（P＜0.01）。联合治疗的不良反应有发热（51.5%，P=0.006）和肌肉关节痛（13.2%，P=0.003），明显高于化疗组。除这些轻微的不良反应外，未发现严重的载体相关并发症。在疗效方面，p53 治疗组胃肠道症状较少（P=0.062），肿瘤相关疼痛改善较好（P=0.003），白细胞计数下降较少（P=0.003），卡诺夫斯基表现评分升高较多（P=0.029）。p53 治疗组和对照组的总有效率（CR+PR）分别为 58.3%和 26.5%，两组疗效分布差异有统计学意义（P=0.042）。p53 治疗组和对照组的 3、6、12 个月生存率分别为 89.71%、76.13%和 43.30%、68.15%、36.98%和 24.02%，治疗后 3、6、12 个月时 p53 治疗组生存率明显高于对照组（P=0.0002）。
rAd-p53 基因治疗联合 TACE 是治疗晚期 HCC 的一种安全有效的治疗方法。
