Compound aluminum sulfate injection monotherapy in non-muscle invasive bladder cancer in Chinese patients: A multi-center, open-label phase I / II clinical trial

21^st Annual European Pharma Congress

May 20-22, 2019 | Zurich, Switzerland

Fenghua Xu, Yonghe Chen, Chunxi Wang, Lindong Du, Baofa Hong, Lei Zhang, Wenying Wang, Yuchuan Hou, Yaofu Chen, Xiaoqing Wang,Bing Cong, Weijun Fu, Xinyuan Tong, Xiaoxiong Wang, Axiang Xu and Ping Ping

PLA General Hospital, China
Beijing Friendship Hospital, China
First Bethune Hospital of Jilin University, China

Scientific Tracks Abstracts: Pharmaceut Reg Affairs

Abstract :

Objective: To evaluate the efficacy and safety of compound aluminum sulfate injection (CASI) in the treatment of non-muscle invasive bladder cancer(NMIBC) in patients.

Methods: A multi-center, open and non-controlled phase I/II clinical trial was designed. We enrolled 101 patients (age �18 years) with NMIBC at three clinical trial centers. CASI was directly injected into the root of NMIBC through catheter needle. Injection dose was determined by tumor size: <1cm: 2-6ml; 1-2cm: 4-8ml; 2-3cm: 6-10ml; >3cm: 8-16ml. Therapeutic effects was evaluated by effective rate (patients with complete tumor necrosis or tumor necrosis > 2/3) / all patients �� 100%). Electrocardiogram, blood routine, urine routine and blood biochemistry examination were performed for safety evaluation. All data were input by EPI DATA 3.0 and analyzed by SAS 9.13.

Results: Eight of the 101 patients were detected blood aluminum concentration to evaluate the absorbance of aluminum sulfate after local administration. Only two patients in the middle dosage group showed significant elevation of aluminum concentration after injection, which decreased to the concentration around baseline within 24 hours. The rich blood supplement of the injection site might explain the aluminum absorption. The overall effective rate was 97.03% (98/101 patients), including 93.07% tumor necrosis completely (94/101 patients). Treatmentrelated adverse events (AE) occurred in 20 patients (19.80%). Nine patients (8.91%) experienced AE related to drug administration, including local pain, abdominal pain and anal irritation in. Other AE were related to urethral injury caused by cystoscopy. All AE were endurable and disappeared within 2-3 days without any treatment. The maximum tolerated single dose of CASI was 21ml.

Conclusion: As a convenient and compliant regimen, CASI had good efficacy and safety in the treatment of NMIBC.

Key Words: Compound aluminum sulfate injection, non-muscle invasive bladder cancer, efficacy, adverse effect, clinical trial.

Recent Publications

1. Perlis N, Zlotta AR, Beyene J, Finelli A, Fleshner NE, Kulkarni GS(2013). Immediate post-transurethral resection of bladder tumor intravesical chemotherapy prevents non-muscle-invasive bladder cancer recurrences: an updated meta-analysis on 2548 patients and quality-of-evidence review. Eur Urol 64: 421�30.

2. Yap S.A., Brunson A, Pugashetti N, Cress R. D., Keegan T. H.M., White R, Wun T. Immediate intravesical chemotherapy for low-grade bladder tumors in California: An underutilized practice and its impact on recurrence. Urologic Oncology: https://doi.org/10.1016/j.urolonc.2018.08.004

3. Xu F, Chen Y, Fang Y, Gao X (2006). Pharmacokinetic study on compound aluminum sulfate injection after iv and in situ administration. Chin J Clin Pharmacol Ther 11(6): 691-695.

4. Xu F, Fu W, Zhang Z, Wang X(2006). Experimental studies and evaluation on safety of compound aluminum sulfate injection. Chin J Clin Pharmacol Ther 11(5): 510-514.

5. Shi L, Xu A, Hong B, Wang X, Zhang L(2005). Three managements of bladder tumors under cystoscopy. Chin Med Equip J 26(8): 11-12.

Biography :

Fenghua Xu got her degree in Pharmaceutics in Peking University Health Science Center. She has her expertise in anti-cancer drug development and novel drug delivery system. She dedicate herself to develop therapeutic drugs with low adverse effect and easygoing administration method to relieve the patients and provide them better care. Her study involves natural entities, nanoscale and self-regulated drug delivery system. She has finished the preclinical studies of several new drug and hospital preparations for cancer treatment, four of which have got approval for clinical trial. She also practices in the manufacture and quality control of drug preparations and has set up a series of product quality standard.