Selection of immunostimulant AS15 for active immunization with MAGE-A3 protein: Results of a randomized phase II study of the European organisation for research and treatment of cancer melanoma group in metastatic melanoma

Journal of Clinical Oncology

Volumn 31, Issue 19, 2013, Pages 2413-2420

  Kruit, Wim H J ^a   Suciu, Stefan ^b   Dreno, Brigitte ^d   Mortier, Laurent ^e   Robert, Caroline ^f   Chiarion Sileni, Vanna ⁱ   Maio, Michele ^j   Testori, Alessandro ^k   Dorval, Thierry ^g   Grob, Jean Jacques ^h   Becker, Juergen C ^l   Spatz, Alan ^m   Eggermont, Alexander M M ^f   Louahed, Jamila ^c   Lehmann, Frédéric F ^c   Brichard, Vincent G ^c   Keilholz, Ulrich ⁿ  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b EORTC DATA CENTER   (Belgium)

^c GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^d Centre Hospitalier Universitaire CHU   (France)

^e LILLE UNIVERSITY HOSPITAL   (France)

^f INSTITUT GUSTAVE ROUSSY   (France)

^g INSTITUT CURIE   (France)

^h AIX MARSEILLE UNIVERSITY   (France)

ⁱ VENETO INSTITUTE OF ONCOLOGY IOV IRCCS   (Italy)

^j UNIVERSITY HOSPITAL OF SIENA   (Italy)

^k EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

^l MEDICAL UNIVERSITY OF GRAZ   (Austria)

^m MCGILL UNIVERSITY   (Canada)

ⁿ CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

more..

Author keywords

[No Author keywords available]

Indexed keywords

AS 02B; AS 15; IMMUNOSTIMULATING AGENT; MELANOMA ANTIGEN 3; PROTEIN ANTIBODY; UNCLASSIFIED DRUG; CANCER VACCINE; IMMUNOLOGICAL ADJUVANT; MAGEA3 PROTEIN, HUMAN; RECOMBINANT PROTEIN; TUMOR ANTIGEN; TUMOR PROTEIN;

ACTIVE IMMUNIZATION; ADULT; AGED; ANTIBODY BLOOD LEVEL; ANTIBODY TITER; ANTIGEN ANTIBODY COMPLEX; ARTICLE; CANCER PATIENT; CANCER PREVENTION; CANCER RADIOTHERAPY; CANCER STAGING; CANCER SURGERY; CANCER SURVIVAL; CELLULAR IMMUNITY; CHILL; CONTROLLED STUDY; FATIGUE; FEMALE; FEVER; HUMAN; IMMUNE RESPONSE; INJECTION SITE PAIN; INJECTION SITE REACTION; INJECTION SITE REDNESS; INJECTION SITE SWELLING; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; METASTATIC MELANOMA; MULTICENTER STUDY; MULTIMODALITY CANCER THERAPY; NAUSEA; OPEN STUDY; OVERALL SURVIVAL; PATIENT SAFETY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT RESPONSE; VACCINE IMMUNOGENICITY; CONTROLLED CLINICAL TRIAL; IMMUNOLOGY; INTRAMUSCULAR DRUG ADMINISTRATION; KAPLAN MEIER METHOD; MELANOMA; METHODOLOGY; MIDDLE AGED; SKIN TUMOR; TREATMENT OUTCOME; VACCINATION; VERY ELDERLY;

ADJUVANTS, IMMUNOLOGIC; ADULT; AGED; AGED, 80 AND OVER; ANTIGENS, NEOPLASM; CANCER VACCINES; FEMALE; HUMANS; INJECTIONS, INTRAMUSCULAR; KAPLAN-MEIER ESTIMATE; MALE; MELANOMA; MIDDLE AGED; NEOPLASM PROTEINS; RECOMBINANT PROTEINS; SKIN NEOPLASMS; TREATMENT OUTCOME; VACCINATION;

EID: 84880730418     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2012.43.7111     Document Type: Article

References (38)

1. Jungbluth AA, Busam KJ, Kolb D, et al: Expression of MAGE-antigens in normal tissues and cancer. Int J Cancer 85:460-465, 2000
2. De Plaen E, Arden K, Traversari C, et al: Structure, chromosomal localization, and expression of 12 genes of the MAGE family. Immunogenetics 40:360-369, 1994
3. Gure AO, Chua R, Williamson B, et al: Cancer-testis genes are coordinately expressed and are markers of poor outcome in non-small cell lung cancer. Clin Cancer Res 11:8055-8062, 2005
4. Bolli M, Kocher T, Adamina M, et al: Tissue microarray evaluation of melanoma antigen E (MAGE) tumor-associated antigen expression: Potential indications for specific immunotherapy and prognostic relevance in squamous cell lung carcinoma. Ann Surg 236:785-793, 2002
5. Brasseur F, Rimoldi D, Liénard D, et al: Expression of MAGE genes in primary and metastatic cutaneous melanoma. Int J Cancer 63:375-380, 1995
6. Van den Eynde BJ, van der Bruggen P: T cell defined tumor antigens. Curr Opin Immunol 9:684-693, 1997
7. De Pas T, Kim A, Zaragoulidis K, et al: MAGRIT phase III trial in adjuvant NSCLC: MAGE-A3 gene expression frequency on the first 2150 patients screened and demographics of first patients randomized. 13th World Conference on Lung Cancer, San Francisco, CA, July 31-August 4, 2009 (abstr B4.3)
8. Patard JJ, Brasseur F, Gil-Diez S, et al: Expression of MAGE genes in transitional-cell carcinomas of the urinary bladder. Int J Cancer 64:60-64, 1995
9. Sharma P, Shen Y, Wen S, et al: Cancer-testis antigens: Expression and correlation with survival in human urothelial carcinoma. Clin Cancer Res 12: 5442-5447, 2006
10. Luo G, Huang S, Xie X, et al: Expression of cancer-testis genes in human hepatocellular carcinomas. Cancer Immun 2:11, 2002
11. Marchand M, Weynants P, Rankin E, et al: Tumor regression responses in melanoma patients treated with a peptide encoded by gene MAGE-3. Int J Cancer 63:883-885, 1995
12. Weber JS, Hua FL, Spears L, et al: A phase I trial of an HLA-A1 restricted MAGE-3 epitope peptide with incomplete Freund’s adjuvant in patients with resected high-risk melanoma. J Immunother 22:431-440, 1999
13. Schnurr M, Chen Q, Shin A, et al: Tumor antigen processing and presentation depend critically on dendritic cell type and the mode of antigen delivery. Blood 105:2465-2472, 2005
14. Kruit WH, van Ojik HH, Brichard VG, et al: Phase 1/2 study of subcutaneous and intradermal immunization with a recombinant MAGE-3 protein in patients with detectable metastatic melanoma. Int J Cancer 117:596-604, 2005
15. Marchand M, Punt CJ, Aamdal S, et al: Im-munisation of metastatic cancer patients with MAGE-3 protein combined with adjuvant SBAS-2: A clinical report. Eur J Cancer 39:70-77, 2003
16. Atanackovic D, Altorki NK, Cao Y, et al: Booster vaccination of cancer patients with MAGE-A3 protein reveals long-term immunological memory or tolerance depending on priming. Proc Natl Acad Sci U S A 105:1650-1655, 2008
17. Cluff CW: Monophosphoryl lipid A (MPL) as an adjuvant for anti-cancer vaccines: Clinical results. Adv Exp Med Biol 667:111-123, 2009
18. National Cancer Institute: Common Terminology Criteria for Adverse Events Version 3.0. http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf
19. Therasse P, Arbuck SG, Eisenhauer EA, et al: New guidelines to evaluate the response to treatment in solid tumors: European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92:205-216, 2000
20. Hodi FS, O’Day SJ, McDermott DF, et al: Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 363:711-723, 2010
21. Burch PA, Croghan GA, Gastineau DA, et al: Immunotherapy (APC8015, Provenge) targeting prostatic acid phosphatase can induce durable remission of metastatic androgen-independent prostate cancer: A phase 2 trial. Prostate 60:197-204, 2004
22. Weber J: Overcoming immunologic tolerance to melanoma: Targeting CTLA-4 with ipilimumab (MDX-010). Oncologist 13:16-25, 2008 (suppl 4)
23. Vantomme V, Dantinne C, Amrani N, et al: Immunologic analysis of a phase I/II study of vaccination with MAGE-3 protein combined with the AS02B adjuvant in patients with MAGE-3-positive tumors. J Immunother 27:124-135, 2004
24. Wheatley K, Ives N, Eggermont A, et al: Interferon- as adjuvant therapy for melanoma: An individual patient data meta-analysis of randomised trials. J Clin Oncol 25:478s, 2007 (suppl; abstr 8526)
25. Verma S, Quirt I, McCready D, et al: Systematic review of systemic adjuvant therapy for patients at high risk for recurrent melanoma. Cancer 106: 1431-1442, 2006
26. Garbe C, Eigentler TK: Diagnosis and treatment of cutaneous melanoma: State of the art 2006. Melanoma Res 17:117-127, 2007
27. Prins RM, Vo DD, Khan-Farooqi H, et al: NK and CD4 cells collaborate to protect against melanoma tumor formation in the brain. J Immunol 177:8448-8455, 2006
28. Atanackovic D, Altorki NK, Stockert E, et al: Vaccine-induced CD4 T cell responses to MAGE-3 protein in lung cancer patients. J Immunol 172: 3289-3296, 2004
29. Vansteenkiste J, Zielinski M, Linder A, et al: Final results of a multi-center, double-blind, randomized, placebo-controlled phase II study to assess the efficacy of MAGE-A3 immunotherapeutic as adjuvant therapy in stage IB/II non-small cell lung cancer (NSCLC). J Clin Oncol 25:398s, 2007 (suppl; abstr 7554)
30. Ulloa-Montoya F, Louahed J, Dizier B, et al: Predictive gene signature in MAGE-A3 antigen-specific cancer immunotherapy. J Clin Oncol 31: 2388-2395, 2013
31. Roeder C, Schuler-Thurner B, Berchtold S, et al: MAGE-A3 is a frequent tumor antigen of metastasized melanoma. Arch Dermatol Res 296:314-319, 2005
32. Lally KM, Mocellin S, Ohnmacht GA, et al: Unmasking cryptic epitopes after loss of immuno-dominant tumor antigen expression through epitope spreading. Int J Cancer 93:841-847, 2001
33. Corbière V, Chapiro J, Stroobant V, et al: Antigen spreading contributes to MAGE vaccination-induced regression of melanoma metastases. Cancer Res 71:1253-1262, 2011
34. Valmori D, Souleimanian NE, Tosello V, et al: Vaccination with NY-ESO-1 protein and CpG in Mon-tanide induces integrated antibody/Th1 responses and CD8 T cells through cross-priming. Proc Natl Acad Sci U S A 104:8947-8952, 2007
35. Cioca DP, Deak E, Cioca F, et al: Monoclonal antibodies targeted against melanoma and ovarian tumors enhance dendritic cell-mediated cross-presentation of tumor-associated antigens and efficiently cross-prime CD8 T cells. J Immunother 29:41-52, 2006
36. Vansteenkiste J, Zielinski M, Linder A, et al: Adjuvant MAGE-A3 immunotherapy in resected NSCLC: phase II randomized study results. J Clin Oncol (in press)
37. Marchand M, van Baren N, Weynants P, et al: Tumor regressions observed in patients with metastatic melanoma treated with an antigenic peptide encoded by gene MAGE-3 and presented by HLA-A1. Int J Cancer 80:219-230, 1999
38. Chaux P, Vantomme V, Coulie P, et al: Estimation of the frequencies of anti-MAGE-3 cytolytic T-lymphocyte precursors in blood from individuals without cancer. Int J Cancer 77:538-542, 1998