Ilya Tsimafeyeu, Lev Demidov, Galina Kharkevich, Natalia Petenko, Maria Volkova and Vsevolod Matveev
This prospective, non-randomized study assessed toxicity and potential efficacy of low-dose granulocytemacrophage colony-stimulating factor (GM-CSF), interferon alpha (IFN) and interleukin 2 (IL-2) postoperatively in patients with high-risk renal cell carcinoma (RCC). Eligibility requirements were resected locally advanced (T3b-4 or N1–2) or metastatic (M1) RCC, no prior systemic therapy, and excellent organ function. Patients received treatment during 6 months: GM-CSF, 1 mcg/kg, 3 tiw, s.c., first week of each month; IFN, 10 MIU, 3 tiw, s.c., second week, and IL- 2, 1 MIU, 3 tiw, i.v., third week. Fourth week of each month was free from treatment. The primary end-point was diseasefree survival (DFS). Secondary end-points were progression rate, overall survival (OS), safety, and toxicity. Using the method of Dixon and Simon, the accrual goal was 35 patients. 35 patients were enrolled onto the study (28m/7f; median age = 46, range 21-71; ECOG 0-1; 14 (40%) pts with stage III and 21 (60%) pts with stage IV). Toxicity was minimal characterized by mainly flu-like syndrome and erythema in injection site. Median DFS was 14.1 months (95% CI, 3–20.2 months). At a median follow-up time of 5.1 years, progression rate was 65.7%, and OS was 40%. The median OS was 53.0 months (95% CI, 40.6–65.4 months). 5-years DFS and OS were similar between locally advanced and N2/M1 groups. Although the toxicities seen in this trial were low grade and regimen was well tolerated, low-dose GM-CSF, IFN and IL-2 did not improve DFS in comparison with historical control in patients with resected high-risk RCC.
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