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      Adjuvant autologous melanoma vaccine for macroscopic stage III disease: survival, biomarkers, and improved response to CTLA-4 blockade

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      Author(s)
      Lotem, M.
      Merims, S.
      Frank, S.
      Hamburger, T.
      Nissan, A.
      Kadouri, L.
      Cohen, J.
      Straussman, R.
      Eisenberg, G.
      Frankenburg, S.
      Carmon, E.
      Alaiyan, B.
      Shneibaum, S.
      Ayyildiz, Z. O.
      Isbilen, M.
      Senses, K. M.
      Ron, I.
      Steinberg, H.
      Smith, Y.
      Shiloni, E.
      Gure, A. O.
      Peretz, T.
      Date
      2016
      Source Title
      Journal of Immunology Research
      Print ISSN
      2314-8861
      Publisher
      Hindawi Limited
      Volume
      2016
      Pages
      8121985-1 - 8121985-12
      Language
      English
      Type
      Article
      Item Usage Stats
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      86
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      Abstract
      Background. There is not yet an agreed adjuvant treatment for melanoma patients with American Joint Committee on Cancer stages III B and C. We report administration of an autologous melanoma vaccine to prevent disease recurrence. Patients and Methods. 126 patients received eight doses of irradiated autologous melanoma cells conjugated to dinitrophenyl and mixed with BCG. Delayed type hypersensitivity (DTH) response to unmodified melanoma cells was determined on the vaccine days 5 and 8. Gene expression analysis was performed on 35 tumors from patients with good or poor survival. Results. Median overall survival was 88 months with a 5-year survival of 54%. Patients attaining a strong DTH response had a significantly better (p = 0.0001) 5-year overall survival of 75% compared with 44% in patients without a strong response. Gene expression array linked a 50-gene signature to prognosis, including a cluster of four cancer testis antigens: CTAG2 (NY-ESO-2), MAGEA1, SSX1, and SSX4. Thirty-five patients, who received an autologous vaccine, followed by ipilimumab for progressive disease, had a significantly improved 3-year survival of 46% compared with 19% in nonvaccinated patients treated with ipilimumab alone (p = 0.007). Conclusion. Improved survival in patients attaining a strong DTH and increased response rate with subsequent ipilimumab suggests that the autologous vaccine confers protective immunity.
      Keywords
      2,4 dinitrophenol
      Autologous melanoma vaccine
      B Raf kinase
      BCG vaccine
      Cancer testis antigen
      Cyclophosphamide
      Cytotoxic T lymphocyte antigen 4
      Ipilimumab
      Melanoma vaccine
      Unclassified drug
      Antineoplastic agent
      Biological marker
      Cancer vaccine
      Cytotoxic T lymphocyte antigen 4
      Immunological adjuvant
      tumor antigen
      Cancer recurrence
      Cancer staging
      Cancer survival
      Comparative study
      Delayed hypersensitivity
      Disease free survival
      Drug safety
      Female
      Gene expression
      Human
      Injection site erythema
      Major clinical study
      Male
      Melanoma
      Melanoma metastasis
      Outcome assessment
      Overall survival
      Phase 2 clinical trial
      Prospective study
      Treatment duration
      Very elderly
      Adolescent
      Animal
      Antagonists and inhibitors
      Clinical trial
      Cluster analysis
      Kaplan Meier method
      Metabolism
      Middle aged
      Molecularly targeted therapy
      Mortality
      Mouse
      Multimodality cancer therapy
      Pathology
      Treatment outcome
      Tumor cell line
      Vaccination
      Young adult
      Adjuvants, Immunologic
      Adolescent
      Aged, 80 and over
      Combined Modality Therapy
      CTLA-4 Antigen
      Gene Expression Profiling
      Permalink
      http://hdl.handle.net/11693/37186
      Published Version (Please cite this version)
      https://doi.org/10.1155/2016/8121985
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