Treatment of metastatic renal cell carcinoma with high-dose bolus interleukin-2 in a non-intensive care unit: An analysis of 124 consecutively treated patients

PURPOSE In prior studies of high-dose interleukin-2 (IL-2) therapy in the t reatment of metastatic renal cell carcinoma, the majority of patients were asymptomatic (65% of patients had Eastern Cooperative Oncology Group [ECOG] scores of 0 [no cancer-related symptoms]). These studies demonstrated that an ECOG scare of 0 predicted an objective antitumor response to IL-2 (P = 0.03). The current study determined the response frequency to high-dose IL- 2 therapy in a primarily symptomatic patient population (ECOG = 1 [presence of cancer-related symptoms] for 57.3% of patients). The IL-2 therapy was a dministered in a non-intensive care unit (non-ICU). PATIENTS AND METHODS In this single-institution study of high-dose IL-2 the rapy, 124 patients were consecutively enrolled and treated with the drug. A ntitumor responses and safety were assessed by radiographic methods and the occurrence of grade 3 and 4 adverse events, respectively. RESULTS The frequency of objective responses was 14.5% (18 of 124 patients) . Seven patients (5.6%) and 11 patients (8.9%) experienced complete respons es (CRs) and partial responses (PRs), respectively. Two of 7 patients (28.6 %) with CR and 7 of 11 patients (63.6%) with PR had ECOG scores of 1. The m edian response duration is 18 months for all responders (CR plus PR). The m edian survival duration is 15 months for all patients. It was not possible to estimate the median survival duration for all responders because the maj ority of responding patients were alive at close of study. All patients wit h CR and 5 patients with PR were alive at close of study, The frequency of grade 3 and 4 adverse events was comparable to or less than published data and IL-2 was safely administered in a non-intensive care unit. CONCLUSION The frequency of objective antitumor responses in patients with ECOG scores of 1 suggests that high-dose IL-2 therapy may have comparable e ffectiveness in symptomatic and asymptomatic patients. High-dose IL-2 can b e administered in a non-ICU setting with acceptable toxicity and the chance of clinical benefit.