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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 recombinant adenovirus p53 (rAdp53) combined with radiotherapy and hyperthermia in the treatment of soft tissue sarcoma. Methods: From November 2001 to July 2005, 12 cases of advanced soft tissue sarcoma were treated with rAdp53 preparation and present-day combined with radiotherapy and hyperthermia. “Now and then” usage: 1 times a week, each time 1 × 1012VP (virus particles), an average of 8 ± 2 times. Radiotherapy: Each 2Gy, 5 times a week, the tumor volume was 16-70 Gy / 8-35 times / 2-8 weeks with an average of 56.3 ± 6.3 Gy. Hyperthermia methods: shallow or deep hyperthermia, 1-2 times a week, an average of 9 ± 3 times. Observation of tumor changes, the patient’s symptoms and adverse reactions, and evaluation of CT. Results: CR8.3% (1/12), PR33.3% (4/12), SD58.4% (7/12). 7 cases of SD patients also achieve analgesia, reduce the symptoms of local purposes. The 1-year survival rate was 58.3% (7/12), the 2-year survival rate was 16.7% (2/12), SD> 6 months, and the actual clinical benefit rate was CR + PR + SD> 75% (9/12). Twelve patients underwent multiple intratumoral injections. In addition to transient fever, no other adverse reactions were observed. CONCLUSIONS: Soft tissue sarcoma tumors are treated with rAdp53 in combination with radiotherapy. Hyperthermia is safe and effective. rAdp53 is a promising drug for the treatment of malignant soft tissue tumors.