Purpose: Clinical characteristics prognostic of survival in patients with metastatic renal cell carcinoma treated with biological response modifiers are poorly understood. Understanding these prognostic features may help with better stratification of patients in clinical trials and define further appropriate treatment for each prognostic subgroup. Materials and Methods: A retrospective study of 84 patients with recurrent or metastatic renal cancer was conducted to identify prognostic factors for survival in patients who received biological response modifiers (alpha-interferon, beta-interferon, gamma-interferon and interleukin-2). Results: Univariate analysis identified Eastern Cooperative Oncology Group (ECOG) performance status (1 versus 0, p less than 0.001), bone metastasis (p = 0.008), recent weight loss (greater than 10 percent of total body weight versus no loss, p = 0.028), history of nephrectomy (no versus yes, p = 0.025), recurrence at the renal bed (p = 0.043) and sarcomatoid histology (yes versus no, p less than 0.001) as important prognostic indicators. Multivariate analysis of prognostic factors in this patient population indicated that ECOG performance status, sarcomatoid histology and bone metastasis were most significant, while other factors were less significant (p greater than 0.05) after adjusting for ECOG performance status and sarcomatoid histology. Based on the total positive number of 5 risk factors defined previously the study population separates into 3 risk groups, with a median survival from the low to high risk groups of 14.4, 10.9 and 1.3 months, respectively. Prognostic scores based only on ECOG performance status, sarcomatoid histology and bone metastasis allowed for stratification of our patients into 3 distinct groups with median survivals of 18.6, 8.4 and 3.8 months, which were also predictive of survival (p less than 0.05). Conclusions: Risk factors of ECOG performance status, sarcomatoid histology, bone metastasis, history of nephrectomy, recent weight loss and recurrence at the renal bed are predictive of survival in patients treated with biological response modifiers. In addition to previous findings of prognostic factors in renal cancer patients treated with chemotherapy, we identified sarcomatoid histology as an important risk factor in patients treated with biological response modifiers.
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