Safety and primary efficacy of recombinant human adenovirus-p53 injection on advanced solid tumor
- VernacularTitle:重组人p53腺病毒注射液治疗晚期实体肿瘤的安全性和近期疗效评价
- Author:
Ya DING
;
Xiaoshi ZHANG
;
Ruiqing PENG
;
Rong ZHANG
;
Nianhua ZHANG
;
Zhiming LI
;
Jiyan LIU
;
Jin MA
;
Xia CHENG
;
Yishun SU
;
Yi ZENG
- Publication Type:Journal Article
- Keywords:
p53;
adenovirus;
gene therapy;
tumor;
chemotherapy;
side effect;
efficacy;
clinical trial
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2004;0(09):-
- CountryChina
- Language:Chinese
-
Abstract:
AIM: Recombinant human adenovirus-p53 injection (rAd-p53) is the first marketed gene therapeutic drug worldwide. This study aimed to evaluate the safety and primary efficacy of rAd-p53 administrated on advanced solid tumors. METHODS: 24 patients with advanced solid tumor treated with rAd-p53 were reviewed, including 5 cases of renal carcinoma, 4 of nasopharyngeal carcinoma, 4 of colorectal carcinoma, 2 of melanoma, 1 of non-small-celllung cancer, 1 of esophageal carcinoma, 1 of gastric cardia carcinoma, 1 of thymic carcinoma, 1 of duodenal carcinoma, 1 of thyroid carcinoma, 1 of pancreatic carcinoma, 1 of endometrial carcinoma and 1 of rhabdomyosarcoma. RAd-p53 was weekly administrated at the dose of 1?10~ 12 VP, and 4 times of administration was defined as one cycle. Administration approach included intratumoral injection,intrabronchial drop in, intraperitoneal injection, intra-arterial infusion and intravenous drip. Combined therapy was given with chemotherapy in 18 cases, radiotherapy in 2, concomitant chemotherapy and radiotherapy in 1, abdominal thermotherapy and orally gefitinib in 1, cytokine immunotherapy in 1 and without combination therapy in 1. RESULTS: 23 cases underwent 35 cycles of therapy except for 1 case discontinued because of early progression. Among the 21 evaluable cases 5 PR, 5 SD and 11 PD were observed. Overall response rate was 23.8%(5/21) and disease control rate was 47.6%(10/21). Grade I-II injection site pain, chill, fever and myalgia were the most frequent side effects. Grade III fever developed in 2 cases and grade III-IV myelosuppression in 4 cases combined with chemotherapy. Furthermore, severe ostealgia occurred in 2 cases and transient hypotension in 1. CONCLUSION: RAd-p53 is tolerable in patients with advanced solid tumor. A further randomized clinical trial is necessary to confirm the antitumor activity of rAd-p53 combined with conventional strategies.
