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- W2242947409 abstract "4605 Background: Previously we have shown that a chronic maintenance therapy with a low-dose regimen of IL-2 + IFN induces a persistent stimulation of the immune system with no relevant toxic effects (Cancer 2001, 92:2286–96). In this trial we tested the hypothesis that a maintenance treatment with IL-2 + IFN produces a prolongation of time from the first progression to death (TFPTD) and overall survival (OS) in RCC. Methods: 183 immunotherapy naïve, metastatic RCC were randomized to receive: A) chronic treatment with a 4-week cycle of s.c. IL-2 (5 days/wk, 1 million UI/sqm bid d 1,2 and 1 million UI/sqm x 1 d 3,4,5) + IFN (1,8 million UI/sqm d 3,5 im) on months 1,3,5 and then every three months, irrespective of their response, until death or intolerable toxicity; B) the same regimen until the first documented disease progression. Patients should have an ECOG PS of 0–2 and no brain metastasis. All the evaluations were made using Recist criteria and according to the intention to treat principle. Results: At this preliminary analysis 120 out of the 140 planned events were registered. Median age was 63 in both arms. ECOG PS was 0 in 52% and 56%, nefrectomy was performed in 84% and 85%; 57% and 55% had only one metastatic site; histology was clear cell in 87% and 86% in arm A and B, respectively. We observed a response rate of 14.3% (5.5% CR). Using the Cox regression analysis, the use of chemotherapy after the first progression to IL-2 and IFN (OR=2.43;1.47–4.04; p=0.0005), previous nefrectomy (OR=1.78;1.01–3.12; p=0.044) and PS (OR=1.65;1.05–2.58; p=0.027), were significantly associated with TFPTD. Treatment arm was not significant (OR=0.70;0.46–1.05; p=0.09). Toxicity was mainly limited to WHO grade 1 or 2; grade 3 fever was present in 15% of patients. Conclusions: The use of chemotherapy is the main factor influencing TFPTD. Chronic maintenance treatment with biotherapy after disease progression is feasible. Definitive efficacy results will be presented at the meeting. No significant financial relationships to disclose." @default.
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- W2242947409 date "2005-06-01" @default.
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- W2242947409 title "Phase III, randomized, multicentre trial of maintenance biotherapy with interleukin-2 (IL-2) and interferon-alpha (IFN) for metastatic renal cell cancer (RCC)" @default.
- W2242947409 doi "https://doi.org/10.1200/jco.2005.23.16_suppl.4605" @default.
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