Department of Obstetrics and Gynecology, Shengjing Hospital of China Medical University , Shenyang, China .
Hum Gene Ther. 2018 Feb;29(2):242-250. doi: 10.1089/hum.2017.206.
This study evaluated the efficacy of rAd-p53 (Gendicine) followed by chemotherapy for the treatment of uterine sarcoma. Twelve cases of uterine sarcoma treated at Shengjing Hospital were retrospectively analyzed. Among the 12 patients, one had primary cancer, and 11 had recurrent cancer. For the recurrent cases, the interval between the first operation and diagnosis of recurrence, or progression-free survival time 1 (PFS1), was 1-18 months (median 3 months). All patients were treated with local application of rAd-p53 followed by chemotherapy (local injection of bleomycin and i.v. infusion of cisplatin, epirubicin, and isocyclophosphamide). Efficacy was evaluated, and the rates of complete remission (CR) and partial remission (PR) were calculated. During follow-up, PFS time 2 (PFS2) after the baseline period and overall survival (OS) time after the baseline period of rAd-p53 treatment data were obtained. The treatment resulted in one CR, seven PR, three with stable disease (SD), and one with progressive disease (PD). The remission rate (CR + PR) was 66.7%, and the responsive (CR + PR + SD) rate was 91.7%. PFS2 ranged from 2 to 62 months, with a median of 13 months, which is 10 months longer than that of PFS1; this difference was statistically significant (p = 0.0038). The OS time ranged from 6 to 62 months, with a median of 24 months. Following the combined treatment, four of the patients underwent a second debulking surgery. Of the two patients with liver metastases, one had CR of liver foci, and one had PR. Up to the follow-up date of the two patients who survived, one was tumor-free for 60 months. The PFS2 for the other patient was 39 months. This patient survived with tumor for 53 months with slow disease progression. The remaining 10 patients died. Local application of rAd-p53 combined with local injection of bleomycin and intravenous infusion of cisplatin, epirubicin and isocyclophosphamide was effective for treatment of uterine sarcoma, especially for patients with liver metastases. For patients with uterine sarcoma who do not have the opportunity for surgery, this regimen can be used as a new adjuvant therapy to obtain a surgical opportunity that allows further debulking of the tumor mass.
本研究评估了腺病毒载体制剂 p53（今又生）联合化疗治疗子宫肉瘤的疗效。回顾性分析盛京医院收治的 12 例子宫肉瘤患者，其中原发 1 例，复发 11 例。复发患者中，第 1 次手术后至复发或无进展生存期 1（PFS1）的间隔时间为 1-18 个月（中位数 3 个月）。所有患者均采用腺病毒载体制剂 p53 局部应用联合化疗（局部注射博来霉素和静脉注射顺铂、表柔比星和异环磷酰胺）治疗。评估疗效，计算完全缓解（CR）和部分缓解（PR）率。随访中，获得基线后 PFS2 时间（无进展生存期 2）和基线后 rAd-p53 治疗的总生存期（OS）数据。治疗结果为 1 例 CR，7 例 PR，3 例 SD，1 例 PD。缓解率（CR + PR）为 66.7%，有效率（CR + PR + SD）为 91.7%。PFS2 范围为 2-62 个月，中位数为 13 个月，较 PFS1 延长 10 个月，差异有统计学意义（p = 0.0038）。OS 时间范围为 6-62 个月，中位数为 24 个月。联合治疗后，4 例患者行二次减瘤术。2 例肝转移患者中，1 例肝转移灶 CR，1 例 PR。随访至生存的 2 例患者，1 例肿瘤无进展 60 个月，另 1 例 PFS2 为 39 个月。该患者肿瘤进展缓慢，生存 53 个月。其余 10 例患者死亡。腺病毒载体制剂 p53 局部应用联合局部注射博来霉素和静脉滴注顺铂、表柔比星和异环磷酰胺治疗子宫肉瘤有效，尤其对肝转移患者有效。对于无手术机会的子宫肉瘤患者，可作为新的辅助治疗方法，获得进一步减瘤的手术机会。
