PATIENTS WITH METASTATIC RENAL-CARCINOMA CANDIDATE FOR IMMUNOTHERAPY WITH CYTOKINES - ANALYSIS OF A SINGLE INSTITUTION STUDY ON 181 PATIENTS

This study was performed with the aim of discovering the characteristi cs and survival of patients with metastatic renal carcinoma who underg o immunotherapy with an Interleukin 2 based regimen. One hundred and e ighty-one patients with metastatic renal carcinoma were referred to ou r institute from October 1987 until August 1991; 129 were treated with Interleukin 2 with or without Interferon alpha in three successive pr otocols. Fifty-two patients were not treated with immunotherapy due to the exclusion criteria of the protocols. Sixty-four patients with the same disease who had been referred to our institute before the initia tion of this programme (1982, 1987) were also analysed as a control gr oup. The main characteristics of the three different cohorts of patien ts were analysed and compared with univariate statistical tests; the m edian survival of the patients was calculated and compared. The referr al rate increased from 13 a year to 45 a year while the IL2 trials wer e being conducted. Patients treated with cytokines have a median survi val of 18 months after occurrence of metastases, compared to 6 and 8 m onths, respectively, in excluded patients and the control group. This parameter is of 15 months when the 181 patients, treated with cytokine s or not, are considered. The survival of treated vs excluded patients is significantly different (P<10(-6)); so is the survival of the 181 patients recently included when compared to the historical group (P:10 (-5)). When the 181 recent patients are compared to the historical con trol group, a number of differences appear in their characteristics, w hich prevent us from drawing any conclusion about the role of immunoth erapy in the improvement of survival observed. This study clearly evid ences the selection of the patients receiving immunotherapy and the mo dification in referrals of a disease induced by a new available therap y. This emphasises the need for prospective studies in this setting.