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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.
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
html.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.


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