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Title: Long-term survival of high-risk melanoma patients immunized with a Hyper-IL-6-modified allogeneic whole-cell vaccine after complete resection
Authors: Mackiewicz, Andrzej
Mackiewicz, Jacek
Wysocki, Piotr J.
Wiznerowicz, Maciej
Kapcinska, Malgorzata
Laciak, Maria
Rose-John, Stefan
Izycki, Dariusz
Burzykowski, Tomasz 
Karczewska-Dzionk, Aldona
Issue Date: 2012
Abstract: Objective: Two single arm, Phase II trials (3 and 5) were undertaken to determine the efficacy and toxicity of an adjuvant treatment using Hyper-IL-6 gene-modified whole-cell allogeneic melanoma vaccine in patients with stage IIIB-IV resected disease. Research design and methods: Ninety-seven and 99 patients were enrolled into Trials 3 and 5, respectively. The primary endpoint was disease-free survival (DFS), and the secondary was overall survival (OS). Vaccine was administered eight times every 2 weeks (induction), every month (maintenance) until patient's death. At progression, maintenance was continued or induction was repeated followed by maintenance. Results: Median follow-up was 10.5 and 6.2 years for Trials 3 and 5, respectively. No grade 3 or 4 toxicities were observed. An extension of DFS and OS was observed, when compared with historical non-treated controls. DFS probability at 5 years for Trials 3 and 5 was, respectively, 54.8% and 40.6% for stage IIIB, 25.0% and 24.0% for IIIC, and 8.5% and 17.7% for IV. OS probability at 5 years was, respectively, 66.7% and 56.3% for IIIB, 43.8% and 39.8% for IIIC, and 26.1% and 41.2% for IV. Conclusions: Continuous vaccination, regardless of the disease progression, re-induction, and immunization of patients until death resulted in patients a long-term survival.
Notes: [Mackiewicz, Andrzej; Wysocki, Piotr J.; Wiznerowicz, Maciej; Kapcinska, Malgorzata; Laciak, Maria; Rose-John, Stefan; Burzykowski, Tomasz] Poznan Univ Med Sci, Chair Med Biotechnol, Poznan, Poland. [Mackiewicz, Andrzej; Mackiewicz, Jacek; Kapcinska, Malgorzata] Greater Poland Canc Ctr, Dept Canc Diagnost & Immunol, Poznan, Poland. [Mackiewicz, Andrzej; Laciak, Maria; Rose-John, Stefan] BioContract Sp Zoo, Poznan, Poland. [Wiznerowicz, Maciej] Greater Poland Canc Ctr, Dept Chemotherapy, Poznan, Poland. [Izycki, Dariusz] Inst Biochem, D-24098 Kiel, Germany. [Izycki, Dariusz] Univ Kiel, Kiel, Germany. [Karczewska-Dzionk, Aldona] Hasselt Univ, Interuniv Inst Biostat & Stat Bioinformat, Diepenbeek, Belgium.
Keywords: advanced melanoma; genetic melanoma vaccine; long-term survivals; Phase II clinical trials; re-induction;Pharmacology & Pharmacy, advanced melanoma; genetic melanoma vaccine; long-term survivals; Phase II clinical trials; re-induction
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ISSN: 1354-3784
e-ISSN: 1744-7658
DOI: 10.1517/13543784.2012.684753
ISI #: 000304063400003
Category: A1
Type: Journal Contribution
Validations: ecoom 2013
Appears in Collections:Research publications

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