[Phase II study of etoposide (VP-16-213) in genitourinary tumors. VP-16-213 Genitourinary Study Group]

A co-operative phase II study of the semisynthetic podophyllotoxin derivative Etoposide (VP-16) was undertaken in patients with genitourinary tumors. A total of 83 out of 115 patients entered into the study were evaluable for response. Antitumor effects were evaluated according to "Standards for the Evaluation of Direct Effects of Chemotherapy in Solid Tumors" (otherwise known as the Koyama-Saito Group Criteria). Objective response was noted in 2 patients (6.3%) out of 32 with testicular cancer, whereas no responders were seen in bladder and renal cancer patients. In patients with prostatic cancer, 1 out of 13 (7.7%) responded. Major clinical side effects were alopecia and gastrointestinal toxicities (anorexia, nausea and vomiting). Mucositis, abdominal pain, diarrhea and general fatigue were also noted. Anomalies in laboratory test findings were mainly myelosuppression-related, with leukopenia being observed in 66.3% of patients.