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Annals of Oncology Advance Access published online on August 20, 2007
Annals of Oncology, doi:10.1093/annonc/mdm331
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© 2007 European Society for Medical Oncology

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

M Middleton1,{dagger}, A Hauschild2, D Thomson3, R Anderson4, S Burdette-Radoux5,{ddagger}, K Gehlsen6,§, K Hellstrand7 and P Naredi8,*

1 Department of Medical Oncology, Christie Hospital, Manchester, UK
2 Department of Dermatology, University of Kiel, Kiel, Germany
3 Department of Medical Oncology, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
4 Departments of Oncology, Umeå University Hospital, Umeå, Sweden
5 Department of Oncology, McGill University, Montreal, Canada
6 EpiCept Corporation, San Diego, CA, USA
7 Dept of Virology, University of Göteborg, Göteborg
8 Departments of Surgery, Umeå University Hospital, Umeå, Sweden

* Correspondence to: Peter Naredi, Department of Surgery, Umeå University Hospital, S-90185 Umeå, Sweden. Tel: +46 90 7851153; Fax: +46 90 7851156; E-mail: peter.naredi{at}surgery.umu.se

Background: The safety and efficacy of immunotherapy with histamine dihydrochloride (HDC), interleukin-2 (IL-2) and interferon-{alpha}2b (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/m2, s.c., twice a day for 5 days) and HDC (1 mg, s.c., twice a day for 5 days) or DTIC 850 mg/m2 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.

clinical trials, dacarbazine, histamine dihydrochloride, immunotherapy, interferon alpha, interleukin-2, melanoma, phase III

{dagger} Now at Cancer Research UK Medical Oncology Unit, Churchill Hospital, Oxford, UK

{ddagger} Now at Vermont Cancer Center, University of Vermont, Burlington, VT, USA

§ Now at Research Corporation Technologies, Tucson, AZ, USA

Received for publication February 23, 2007. Revision received May 14, 2007. Accepted for publication May 20, 2007.


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