CT引导下瘤体内注射Ad-P53治疗女性盆腔复发转移肿瘤的疗效观察

Clinical observation of CT-guided Ad-P53 intratumoral injection for treatment of recurrent and metastatic female pelvic tumor

目的观察P53瘤体内注射的治疗效果及毒副反应,为临床治疗提供更为安全有效的方法。方法纳入2012年10月―2014年7月西安交通大学第一附属医院肿瘤放疗科妇瘤病区收治的28例盆腔复发转移患者,给予行CT引导下的腺病毒介导P53基因(Ad-P53)瘤体内注射治疗。每次(1～2)×1012 VP(病毒颗粒),加入生理盐水稀释至4～8mL,每周1次,共1～6次。28例患者共完成41次瘤体内注射Ad-P53治疗,平均每例患者用药(3±1)支。治疗期间无再次放疗及化疗。以肿瘤消退或者患者不能耐受或不愿继续接受治疗为治疗终点。疗效评价分为客观疗效评价和主观疗效评价:(1)客观疗效评价是在治疗前和停止治疗后1月,以盆腔MRI为依据,测量肿瘤最大径,计算出肿瘤缩小率(%),评定疗效;(2)主观疗效评价以患者主诉疼痛或减轻程度以及阴道排液等进行评价。结果 28例患者每2～4周随访1次,至2014年12月,随访时间6～27个月,中位随访17个月。治疗结束1月进行主观及客观疗效评价,疼痛程度明显减轻者24例(24/28,85.7%);客观临床获益率82.1%(23/28),中位生存时间11个月;病情再度进展者21例,占91.3%(21/23),中位无疾病进展时间为5个月;2例因疼痛减轻后进食及睡眠改善,再次接受姑息性化疗;死亡13例,占46.4%(13/28)。结论 CT引导下Ad-P53局部注射作为女性盆腔复发转移肿瘤的姑息性治疗手段,可改善患者症状,提高生活质量。

Objective To observe the clinical efficacy and toxic side effects of CT-guided Ad-P53 intratumoral injection in patient with recurrent and metastatic female pelvic tumor.Methods From October 2012 to July 2014,the Gynecological Oncology Division,Tumor Radiotherapy Department of The First Affiliated Hospital of Xi'an Jiaotong University,received 79 patients with recurrent and metastatic pelvic tumor,of whom 28 were subjected to CT-guided Ad-P53 injection therapy.The 28 patients were treated by CT-guided local multi-point injection into the tumor.In each injection,(1-2)×10^12 VP(viral particles)were used and diluted to 4-8 mL with normal saline;administration once a week and 1-6 times altogether.The 28 patients received treatment 41 times in total,with dosage of(3±1)pieces on average.The treatment was performed with no more radiotherapy or chemotherapy,and considered to come to an end when the tumor regressed or the patient could not tolerate or refused further treatment.Therapeutic evaluation:①Objective therapeutic evaluation:The efficacy was evaluated one month before and after the treatment,according to the WHO s Response Evaluation Criteria in Solid Tumors in combination with the maximum sectional area of the tumor measured through pelvis MRI scanning and the regression rate(%)obtained.②Subjective therapeutic evaluation:It was based on the extent of pain relief and vaginal discharge of the patient.Results The 28 patients all received regular follow-up,with the duration of 6-27 months,and median follow-up time of 17 months by December 2014.Therapeutic evaluation,both subjective and objective,was made one month after completion of the treatment.The results showed that 24 patients achieved notable remission(24/28,85.7%),with objective clinical benefit ratio(CR+PR+SD>one month)of 82.1%(23/28),and median survival time of 11 months.Twenty-one patients,comprising 91.3%(21/23),experienced worsened conditions,with median progression-free survival of five months.Two patients,whose appetite and sleeping quality were improved after pain relief,received palliative chemotherapy again.Thirteen patients died,comprising 46.4%(13/28).Conclusion Management of recurrent and metastatic gynecological tumors by CT-guided intratumoral injection of Gendicine allows effective pain relief and improvement in patients quality of life,and at the same time exhibits high safety level and minor side effects and reduces costs.