Single case of a complete response in a metastatic urothelial carcinoma patient treated with zoptarelin doxorubicin

Background: Zoptarelin doxorubicin (AEZS-108, AN-152) is an luteinising hormone-releasing hormone (LHRH)-cytotoxic hybrid drug consisting of an agonist coupled to the cytotoxic radical, doxorubicin. Methods: This is a single case report of a 66-year-old male who was diagnosed in May 2009 with metastatic urothelial carcinoma (UC) of the prostatic urethra. He presented with pelvic and retroperitoneal lymph nodes (LNs). Initially he was treated with cisplatin and gemzar, followed by radical cystoprostatectomy in October 2009. He relapsed in December 2009 and he received two more lines of chemotherapy with no response. The patient entered a phase I clinical trial with zoptarelin doxorubicin, in 2011. He received zoptarelin doxorubicin every 3 weeks for nine cycles from May to October 2011. Results: After two cycles of the investigational drug, all pain and palpable lymph neck nodes disappeared. A computed tomography (CT) scan 20 months post-treatment showed a complete response. Thirty months after treatment started, the patient is symptom free with no evidence of disease. Conclusions: This is the first case of a patient with LHRH-receptor (LHRH-R) positive UC treated with zoptarelin doxorubicin that has been reported. Considering the generally poor outcome of progressive UC and the short survival of these patients, the effect of this drug in this patient has been remarkable.