1. Interleukin-2/interferon-alpha2a/13-retinoic acid-based chemoimmunotherapy in advanced renal cell carcinoma: results of a prospectively randomised trial of the German Cooperative Renal Carcinoma Chemoimmunotherapy Group (DGCIN).
- Author
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Atzpodien, J, Kirchner, H, Rebmann, U, Soder, M, Gertenbach, U, Siebels, M, Roigas, J, Raschke, R, Salm, S, Schwindl, B, Müller, S C, Hauser, S, Leiber, C, Huland, E, Heinzer, H, Siemer, S, Metzner, B, Heynemann, H, Fornara, P, and Reitz, M
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ANTINEOPLASTIC agents , *COMPARATIVE studies , *FLUOROURACIL , *INTERLEUKIN-2 , *ISOTRETINOIN , *KIDNEY tumors , *LUNG tumors , *RESEARCH methodology , *MEDICAL cooperation , *PROGNOSIS , *PROTEINS , *RECOMBINANT proteins , *RENAL cell carcinoma , *RESEARCH , *STATISTICAL sampling , *SURVIVAL analysis (Biometry) , *EVALUATION research , *RANDOMIZED controlled trials , *DISEASE progression , *DEOXYCYTIDINE - Abstract
We performed a prospectively randomised clinical trial to compare the efficacy of four subcutaneous interleukin-2-(sc-IL-2) and sc interferon-alpha2a (sc-IFN-alpha2a)-based outpatient regimens in 379 patients with progressive metastatic renal cell carcinoma. Patients with lung metastases, an erythrocyte sedimentation rate < or =70 mm h(-1) and neutrophil counts < or =6000 microl(-1) (group I) were randomised to arm A: sc-IL-2, sc-IFN-alpha2a, peroral 13-cis-retinoic acid (po-13cRA) (n=78), or arm B: arm A plus inhaled-IL-2 (n=65). All others (group II) were randomised to arm C: arm A plus intravenous 5-fluorouracil (iv-5-FU) (n=116), or arm D: arm A plus po-Capecitabine (n=120). Median overall survival (OS) was 22 months (arm A; 3-year OS: 29.7%) and 18 months (arm B; 3-year OS: 29.2%) in group I, and 18 months (arm C; 3-year OS: 25.7%) and 16 months (arm D; 3-year OS: 32.6%) in group II. There were no statistically significant differences in OS, progression-free survival, and objective response between arms A and B, and between arms C and D, respectively. Given the known therapeutic efficacy of sc-IL-2/sc-INF-alpha2a/po-13cRA-based outpatient chemoimmunotherapies, our results did not establish survival advantages in favour of po-Capecitabine vs iv-5-FU, and in favour of short-term inhaled-IL-2 in patients with advanced renal cell carcinoma receiving systemic cytokines. [ABSTRACT FROM AUTHOR]
- Published
- 2006
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