Phase II study of continuous intravenous infusion of recombinant interleukin-2 in patients with advanced renal cell carcinoma.
BACKGROUND
The goal of this study was to evaluate the therapeutic efficacy and toxicity of recombinant interleukin-2 (rIL-2) administered by continuous intravenous (CIV) infusion to patients with metastatic renal cell cancer (RCC).


METHODS
Thirty patients with RCC were given rIL-2 18 MIU/m2/d CIV. The schedule consisted of two induction cycles and four maintenance cycles with a 3-week rest period between cycles. Each induction cycle consisted of two infusion periods lasting 120 and 108 hours, respectively, separated by a 6-day rest period. Each maintenance cycle consisted of a 120-hour infusion period.


RESULTS
Among 29 assessable patients, the objective response rate was 14% (95% confidence interval, 2% to 26%); one patient achieved a complete response, and 3 partial responses. Ten patients (34%) had stable disease (SD). Median survival was 11 months. Toxicity was generally manageable. Hypotension was universal, but required dose reduction in only 2 patients. Increase in serum creatinine levels was observed in 20 patients, and returned to normal in all but 4 patients after discontinuation of treatment.


CONCLUSIONS
Results confirm the efficacy of rIL-2 in patients with RCC and the feasibility of the treatment in a normal oncology ward. However, responses are observed in a minority of patients, and treatment-related toxicity, as well as technical problems, may be troublesome to many patients.
Lopez
M
M
Regina Elena Institute for Cancer Research, Rome, Italy.
Carpano
S
S
Cancrini
A
A
Marcellini
M
M
Del Medico
P
P
Rinaldi
M
M
Vici
P
P
Paoletti
G
G
Di Lauro
L
L
D000328:Adult; D000368:Aged; D002292:Carcinoma, Renal Cell / Q000628:therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007022:Hypotension / Q000209:etiology; D007262:Infusions, Intravenous / Q000379:methods; D007376:Interleukin-2 / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D007680:Kidney Neoplasms / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012074:Remission Induction
D007376:Interleukin-2; D011994:Recombinant Proteins