Clinical observation of CT-guided Ad-P53 intratumoral injection for treatment of recurrent and metastatic female pelvic tumor / 西安交通大学学报(医学版)

ABSTRACT

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)×1012VP (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 ① Objective 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. ② Subjective 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.