INTERLEUKIN-2-BASED IMMUNOTHERAPY FOR THE TREATMENT OF METASTATIC RENAL-CELL CARCINOMA - AN ANALYSIS OF 203 CONSECUTIVELY TREATED PATIENTS

PURPOSE This article analyzes the long-term results of 203 consecutive patients with metastatic renal cell carcinoma who were treated sith v arious recombinant interleukin-2 (rIL-2)-based immunotherapy regimens, and describes factors that may influence response to therapy and long -term survival. PATIENTS AND METHODS The response and survival of 203 patients with metastatic renal cell carcinoma treated consecutively be tween July 1987 and October 1995 at tile UCLA Medical Center Kidney Ca ncer Program with rIL-2-based immunotherapy were analyzed. Patients we re divided into four groups: (ii no prior nephrectomy (n = 24), (2) ne phrectomy > 6 months Trier to rIL-2 therapy (n = 76), (3) nephrectomy less than or equal to 6 months prior to rIL-2 therapy (n = 47), and (4 ) nephrectomy followed bq treatment with rIL-2 and tumor-infiltrating lymphocytes +/- interferon-alpha (n = 56). Response and survival for e ach of these patient groups and survival per response to therapy were compared. RESULTS The overall median survival for all patients was 18 months, and survival at 1, 2, and 3 years after therapy nas 61%, 40%, and 31% percent, respectively. A total of 12 patients (6%) achieved a complete response, and ail were alive at 3 > ears. Of 36 patients (18% ) who achieved a partial response and 41 patients (20%) with stable di s ease, 3-year survival was 37% and 50%, respectively. The survival of patients with a partial response or stable disease was significantly better than that of patients who exhibited progressive disease. patien ts with nephrectomy > 6 months prior to rIL-2 therapy had a 46% 3-year survival rate, compared with a 9% 3-year survival rate for patients w ith nephrectomy less than or equal to 6 months prior to rIL-2 therapy and a 4% 3-year survival rate for patients with no nephrectomy. Patien ts treated with tumor-infiltrating lymphocytes had a 38% 3-year surviv al rate, which was also significantly better than patients treated wit h nephrectomy less than or equal to 6 months prior to rIL-2 therapy or with no nephrectomy. CONCLUSION This analysis demonstrated that rIL-2 -based therapy offers a significant survival benefit to patients with advanced metastatic renal cell carcinoma, compared with historical con trols. Furthermore, we have shown that nephrectomy > 6 months prior to rIL-2 therapy and nephrectomy followed by treatment with tumor-infilt rating lymphocytes/rIL-2 +/- interferon-alpha was associated with the greatest survival benefit. Tumor response to rIL-2-based therapy and t ime from nephrectomy to treatment were the most important predictors o f survival. Randomized studies in a large group of patients are needed to confirm these observations.