BACKGROUND: To confirm the usefulness of a combination therapy of interleukin-2 (IL-2) and interferon-alpha (IFN-alpha) against metastatic renal cell carcinoma, the recommended dose of IFN-alpha to use in combination with low-dose IL-2 was determined (phase 1). Efficacy and safety at this dose was evaluated (phase 2). METHODS: In phase 1, the dose of IL-2 was fixed at 0.7 x 10(6) Japan reference unit (JRU)/person for 5 days a week. The dose of IFN-alpha was increased from 3 x 10(6) IU for 3 days a week (level I) to 6 x 10(6) IU for 3 days a week (level II) and to 6 x 10(6) IU for 5 days a week (level III). RESULTS: In phase 1, 10 patients were registered, with 9 (3 at each level) able to be evaluated. Because grade 3 and grade 4 neutropenia were observed at level III in 1 patient each, level II was found to be the recommended regimen. The response rate in phase 1 was 44.4% (4/9). In phase 2, 46 patients were registered, with a response rate in 37 patients, classified as per protocol set (PPS), of 21.6% (8/37). Toxicities observed were primarily flu-like symptoms due to cytokines, and gastrointestinal symptoms. Leukocyte abnormalities were observed, but they were milder and tolerable. CONCLUSION: In the 46 patients evaluated in phase 1 and phase 2, the response rate was 26.1% (12/46), being highest in 38.7% (12/31) of those who were nephrectomized, and with only lung metastases.
BACKGROUND: To confirm the usefulness of a combination therapy of interleukin-2 (IL-2) and interferon-alpha (IFN-alpha) against metastatic renal cell carcinoma, the recommended dose of IFN-alpha to use in combination with low-dose IL-2 was determined (phase 1). Efficacy and safety at this dose was evaluated (phase 2). METHODS: In phase 1, the dose of IL-2 was fixed at 0.7 x 10(6) Japan reference unit (JRU)/person for 5 days a week. The dose of IFN-alpha was increased from 3 x 10(6) IU for 3 days a week (level I) to 6 x 10(6) IU for 3 days a week (level II) and to 6 x 10(6) IU for 5 days a week (level III). RESULTS: In phase 1, 10 patients were registered, with 9 (3 at each level) able to be evaluated. Because grade 3 and grade 4 neutropenia were observed at level III in 1 patient each, level II was found to be the recommended regimen. The response rate in phase 1 was 44.4% (4/9). In phase 2, 46 patients were registered, with a response rate in 37 patients, classified as per protocol set (PPS), of 21.6% (8/37). Toxicities observed were primarily flu-like symptoms due to cytokines, and gastrointestinal symptoms. Leukocyte abnormalities were observed, but they were milder and tolerable. CONCLUSION: In the 46 patients evaluated in phase 1 and phase 2, the response rate was 26.1% (12/46), being highest in 38.7% (12/31) of those who were nephrectomized, and with only lung metastases.
Authors: J A Hank; J Surfus; J Gan; M Albertini; M Lindstrom; J H Schiller; K M Hotton; M Khorsand; P M Sondel Journal: Clin Cancer Res Date: 1999-02 Impact factor: 12.531
Authors: Dirk Strumberg; Heike Richly; Ralf A Hilger; Norbert Schleucher; Sonke Korfee; Mitra Tewes; Markus Faghih; Erich Brendel; Dimitris Voliotis; Claus G Haase; Brian Schwartz; Ahmad Awada; Rudolf Voigtmann; Max E Scheulen; Siegfried Seeber Journal: J Clin Oncol Date: 2004-12-21 Impact factor: 44.544
Authors: S Negrier; B Escudier; C Lasset; J Y Douillard; J Savary; C Chevreau; A Ravaud; A Mercatello; J Peny; M Mousseau; T Philip; T Tursz Journal: N Engl J Med Date: 1998-04-30 Impact factor: 91.245
Authors: G Procopio; E Verzoni; S Bracarda; S Ricci; C Sacco; L Ridolfi; C Porta; R Miceli; N Zilembo; E Bajetta Journal: Br J Cancer Date: 2011-03-29 Impact factor: 7.640