Results of a multicenter randomized study to evaluate the safety and efficacy of combined immunotherapy with interleukin-2, interferon α2b and histamine dihydrochloride versus dacarbazine in patients with stage IV melanoma

2.50
Hdl Handle:
http://hdl.handle.net/10541/70263
Title:
Results of a multicenter randomized study to evaluate the safety and efficacy of combined immunotherapy with interleukin-2, interferon α2b and histamine dihydrochloride versus dacarbazine in patients with stage IV melanoma
Authors:
Middleton, Mark R; Hauschild, Axel; Thomson, D; Anderson, R; Burdette-Radoux, S; Gehlsen, Kurt; Hellstrand, K; Naredi, Peter
Abstract:
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.
Affiliation:
Department of Medical Oncology, Christie Hospital, Manchester, UK.
Citation:
Results of a multicenter randomized study to evaluate the safety and efficacy of combined immunotherapy with interleukin-2, interferon-{alpha}2b and histamine dihydrochloride versus dacarbazine in patients with stage IV melanoma. 2007, 18 (10):1691-7 Ann. Oncol.
Journal:
Annals of Oncology
Issue Date:
Oct-2007
URI:
http://hdl.handle.net/10541/70263
DOI:
10.1093/annonc/mdm331
PubMed ID:
17709802
Type:
Article
Language:
en
ISSN:
1569-8041
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorMiddleton, Mark R-
dc.contributor.authorHauschild, Axel-
dc.contributor.authorThomson, D-
dc.contributor.authorAnderson, R-
dc.contributor.authorBurdette-Radoux, S-
dc.contributor.authorGehlsen, Kurt-
dc.contributor.authorHellstrand, K-
dc.contributor.authorNaredi, Peter-
dc.date.accessioned2009-06-12T10:24:34Z-
dc.date.available2009-06-12T10:24:34Z-
dc.date.issued2007-10-
dc.identifier.citationResults of a multicenter randomized study to evaluate the safety and efficacy of combined immunotherapy with interleukin-2, interferon-{alpha}2b and histamine dihydrochloride versus dacarbazine in patients with stage IV melanoma. 2007, 18 (10):1691-7 Ann. Oncol.en
dc.identifier.issn1569-8041-
dc.identifier.pmid17709802-
dc.identifier.doi10.1093/annonc/mdm331-
dc.identifier.urihttp://hdl.handle.net/10541/70263-
dc.description.abstractBACKGROUND: 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.en
dc.language.isoenen
dc.subjectCancer Stagingen
dc.subject.meshAdult-
dc.subject.meshAged-
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols-
dc.subject.meshDacarbazine-
dc.subject.meshFemale-
dc.subject.meshHistamine-
dc.subject.meshHumans-
dc.subject.meshImmunotherapy-
dc.subject.meshInterferon Alfa-2b-
dc.subject.meshInterleukin-2-
dc.subject.meshMale-
dc.subject.meshMelanoma-
dc.subject.meshMiddle Aged-
dc.subject.meshMultivariate Analysis-
dc.subject.meshNeoplasm Staging-
dc.titleResults of a multicenter randomized study to evaluate the safety and efficacy of combined immunotherapy with interleukin-2, interferon α2b and histamine dihydrochloride versus dacarbazine in patients with stage IV melanomaen
dc.typeArticleen
dc.contributor.departmentDepartment of Medical Oncology, Christie Hospital, Manchester, UK.en
dc.identifier.journalAnnals of Oncologyen

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