Metastatic renal carcinoma comprehensive prognostic system

The purpose of the study was to identify a comprehensive prognostic system of pretreatment clinical parameters in 425 patients (pts) with metastatic renal-cell carcinoma treated with different subcutaneous (s.c.) recombinant cytokine-based home therapies in consecutive trials. Treatment consisted of (A) s.c. interferon-alpha2a (INF-alpha), s.c. interleukin-2 (IL-2) (n = 102 pts), (B) s.c. IFN-alpha2a, s.c. IL-2, and i.v. 5-fluorouracil (5-FU) (n = 235 pts) or (C) s.c. IFN-alpha2a, s.c. IL-2, and i.v. 5-FU combined with p.o. 13-cis-retinoic acid (13cRA) (n = 88 pts). Kaplan-Meier survival analysis, log-rank statistics, and Cox regression analysis were employed to identify risk factors and. to create a multiple risk factor model. The following pretreatment risk factors were identified by univariate analysis: (1) three and more metastatic sites, (2) presence of liver, lymph node or bone metastases, (3) neutrophil count greater than or equal to 6500 cells mul(-1). (4) serum lactate dehydrogenase level (LDH) greater than or equal to 220 Ul(-1), and (5) serum C-reactive protein level (CRP) greater than or equal to 11 mg l(-1). Cox regression analysis with forward stepwise variable selection identified neutrophil count as the major prognostic factor (hazard ratio = 1.9, P < 0.001), while serum levels of LDH and CRP, time between diagnosis of tumour and onset of metastatic disease, number of metastatic sites, and bone metastases were significant but somewhat less important prognostic variables within the multiple risk factor model (hazard ratio < 15). Patients were assigned to one of the three risk groups according to cumulative risk defined as the sum of simplified risk scores for six pretreatment variables. Low-, intermediate-, and high-risk patients achieved a median overall survival of 32+ months (95% Cl 24, 43; 5-year survival of 27%), 18+ months (95% Cl 15, 20; 5-year survival of 11%), and 18+ months (95% Cl 6, 10; 5-year survival of 5%), respectively. These prognostic categories are helpful both in individual patient care and in the assessment of patients entering prospective clinical trials. (C) 2003 Cancer Research UK.