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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
Wysocki, Piotr J.
|Issue Date:||2012||Publisher:||INFORMA HEALTHCARE||Source:||EXPERT OPINION ON INVESTIGATIONAL DRUGS, 21 (6), p. 773-783||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||Document URI:||http://hdl.handle.net/1942/13787||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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