摘要
目的:评价重组人p53基因腺病毒注射液(rAdp53)结合放疗、热疗治疗软组织肉瘤的疗效及安全性。方法:自2001年11月～2005年7月,采用rAdp53制剂“今又生”结合放疗、热疗共治疗晚期软组织肉瘤12例。“今又生”用法:每周1次,每次1×1012VP(病毒颗粒),平均8±2次。放疗方案:每次2Gy,每周5次,肿瘤量为16-70Gy/8-35次/2-8周,平均56.3±6.3Gy。热疗方法:采用浅部或深部热疗,每周1-2次,平均9±3次。观察肿瘤变化、患者的自觉症状改变与不良反应,并以CT评价疗效。结果:CR8.3%(1/12),PR33.3%(4/12),SD58.4%(7/12)。7例SD病人中亦达到止痛、减轻局部症状的目的。1年生存率为58.3%(7/12),2年生存率为16.7%(2/12),SD>6个月4例,实际临床获益率(CR+PR+SD>6月)为75%(9/12)。12例患者都接受多次“今又生”瘤内注射,除了出现一时性发热外,未发现其它不良反应。结论:软组织肉瘤瘤内注射rAdp53结合放疗、热疗是安全而有效的。rAdp53是一种很有潜力的治疗恶性软组织肿瘤的基因治疗药物。
Objective： To evaluate the efficacy and safety of the recombinant adenovirus-p53 （rAdp53, trademarked as Gendicine） injection in combination with radiotherapy and hyperthermia for treatment of soft tissue sarcoma. Methods： From November, 2001, to July, 2005, Gendicine, in combination with radiotherapy and thermotherapy, was used for treatment of 12 soft tissue sarcoma cases. Usage of Gendicine：1×10^12 VP （viral particles）, once a week, averaging 8±2 times; Regimen for radiotherapy： 1×2 Gy, 5 times a week, with a tumor dose of 16 to 70 Gy, 8 to 35 times, averaging 56.3±6.3 Gy for every treatment; Thermotherapy： superficial or deep thermotherapy was employed, once or twice a week, averaging 9±3 times. The change in tumor volume and the patients＂ adverse effects were observed, and curative effect was evaluated by CT examination. Results： Among the 12 patients, CR was achieved in one case （8.3%）, PR was achieved in four cases （33.3%）, and no detectable response occurred in seven eases （58.4%）. The 1- and 2-year survival rates were 58.3% （7/12） and 16.7% （2/12）, respectively. The standard deviation was more than 6 months in 4 cases. The actual clinical effectual rateCR＋PR＋SD [〉6 months] was 75%（9/12）. All 12 patients with advanced soft sarcoma received multiple intratumoral injections of Gendicine and neither dose-limiting toxicity nor adverse event was noted, except transient fever after Gendicine administration. Conclusions： Treatment with intratumoral injection of Adp53 plus radiotherapy and/or hyperthermia on advanced soft sarcoma is safe and effective. Our results imply that rAdp53 is an effective gene-therapeutic agent for treatment of soft tissue tumors.
出处
《中国肿瘤临床》
CAS
CSCD
北大核心
2007年第2期65-67,共3页
Chinese Journal of Clinical Oncology
基金
国家973项目基金资助(编号:2004CB518801)
关键词
重组p53基因腺病毒
放疗
热疗
软组织肉瘤
Rrecombinant p53-adenovirus Radiotherapy Hyperthermia Soft tissue sarcoma
