Treating refractory advanced or metastatic urothelial carcinoma with interleukin-2: a phase II study.
Patients with refractory advanced or metastatic urothelial carcinoma derive only minor benefit from chemotherapy. Based on evidence that urothelial carcinoma may be associated with impaired immunological reactivity, we conducted a phase II trial of interleukin-2 (IL-2), a biologic response modifier, to assess its efficacy and toxicity in treating refractory advanced or metastatic urothelial carcinoma. Seventeen patients with urothelial carcinoma who had undergone no more than 1 cisplatin-containing chemotherapy regimen were treated with IL-2 at a dose of 3 x 10(6) IU/m(2)/day by continuous intravenous infusion for 4 consecutive days each week for 4 weeks. Cycles were to be repeated every 6 weeks until disease progression. Toxic effects could be assessed in all 17 patients and response in 13. The most common grade III and IV toxic effects included hypotension (13/17); anemia (6/17); thrombocytopenia (4/17); granulocytopenia (3/17); and, in 1 patient each, cardiac ischemia, bowel perforation, and an increase in creatinine level. One sudden death was assumed to be treatment related. Although we found no objective antitumor activity for IL-2, median patient survival was 10.5 months (95% confidence interval, 5.8 to 17.1 months), with a 15.9-month median survival for 3 patients with poor performance status and visceral metastases. Further clinical investigation of the biological effect of IL-2 in urothelial carcinoma may be warranted.
Kim
Jeri
J
Department of Genitourinary Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Box 427, 1515 Holcombe Boulevard, Houston, TX 77030, USA. jekim@mdanderson.org
Millikan
Randall E
RE
Smith
Terry L
TL
Tu
Shi Ming
SM
Pagliaro
Lance C
LC
Logothetis
Christopher J
CJ
D000328:Adult; D000368:Aged; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage; D015331:Cohort Studies; D019008:Drug Resistance, Neoplasm; D005260:Female; D005334:Fever / Q000139:chemically induced; D006801:Humans; D007022:Hypotension / Q000139:chemically induced; D007155:Immunologic Factors / Q000009:adverse effects / Q000627:therapeutic use*; D007376:Interleukin-2 / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016879:Salvage Therapy; D016019:Survival Analysis; D017211:Treatment Failure; D014571:Urologic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology
D007155:Immunologic Factors; D007376:Interleukin-2; D002945:Cisplatin