BACKGROUND: The safety and efficacy of immunotherapy with histamine dihydrochloride (HDC), interleukin-2 (IL-2) and interferon-alpha2b (IFN) compared with dacarbazine (DTIC) in adult patients with stage IV melanoma was evaluated. PATIENTS AND METHODS: Two hundred and forty-one patients were randomized to either receive repeated 4-week cycles of IFN [3 MIU, s.c., once daily for 7 days], IL-2 (2.4 MIU/m(2), s.c., twice a day for 5 days) and HDC (1 mg, s.c., twice a day for 5 days) or DTIC 850 mg/m(2) i.v. every 3 weeks. The primary endpoint was overall survival. RESULTS:Median survival was longer for patients receiving HDC/IL-2/IFN (271 days) than for patients receiving DTIC (231 days), but this did not achieve statistical significance. Four patients receiving HDC/IL-2/IFN and nine receiving DTIC experienced at least one grade 4 adverse event. Striking differences in overall survival were observed between countries participating in the study. CONCLUSION: Treatment with HDC/IL-2/IFN was safely administered on an outpatient basis, but this immunotherapeutic regimen did not improve upon the response rate and overall survival seen with DTIC.
RCT Entities:
BACKGROUND: The safety and efficacy of immunotherapy with histamine dihydrochloride (HDC), interleukin-2 (IL-2) and interferon-alpha2b (IFN) compared with dacarbazine (DTIC) in adult patients with stage IV melanoma was evaluated. PATIENTS AND METHODS: Two hundred and forty-one patients were randomized to either receive repeated 4-week cycles of IFN [3 MIU, s.c., once daily for 7 days], IL-2 (2.4 MIU/m(2), s.c., twice a day for 5 days) and HDC (1 mg, s.c., twice a day for 5 days) or DTIC 850 mg/m(2) i.v. every 3 weeks. The primary endpoint was overall survival. RESULTS: Median survival was longer for patients receiving HDC/IL-2/IFN (271 days) than for patients receiving DTIC (231 days), but this did not achieve statistical significance. Four patients receiving HDC/IL-2/IFN and nine receiving DTIC experienced at least one grade 4 adverse event. Striking differences in overall survival were observed between countries participating in the study. CONCLUSION: Treatment with HDC/IL-2/IFN was safely administered on an outpatient basis, but this immunotherapeutic regimen did not improve upon the response rate and overall survival seen with DTIC.
Authors: Lindsey R Baden; William A Blattner; Cecilia Morgan; Yunda Huang; Olivier D Defawe; Magdalena E Sobieszczyk; Nidhi Kochar; Georgia D Tomaras; M Juliana McElrath; Nina Russell; Kara Brandariz; Massimo Cardinali; Barney S Graham; Dan H Barouch; Raphael Dolin Journal: J Infect Dis Date: 2011-09-21 Impact factor: 5.226
Authors: Linda Wu; Venessa H M Tsang; Sarah C Sasson; Alexander M Menzies; Matteo S Carlino; David A Brown; Roderick Clifton-Bligh; Jenny E Gunton Journal: Front Endocrinol (Lausanne) Date: 2021-11-05 Impact factor: 5.555
Authors: P Hersey; L Bastholt; V Chiarion-Sileni; G Cinat; R Dummer; A M M Eggermont; E Espinosa; A Hauschild; I Quirt; C Robert; D Schadendorf Journal: Ann Oncol Date: 2009-08 Impact factor: 32.976