Long-term survival and immunological parameters in metastatic melanoma patients who responded to ipilimumab 10 mg/kg within an expanded access programme

Cancer Immunology, Immunotherapy

Volumn 62, Issue 6, 2013, Pages 1021-1028

  Di Giacomo, Anna Maria ^a   Calabrò, Luana ^a   Danielli, Riccardo ^a   Fonsatti, Ester ^a   Bertocci, Erica ^a   Pesce, Isabella ^a   Fazio, Carolina ^a   Cutaia, Ornella ^a   Giannarelli, Diana ^b   Miracco, Clelia ^a   Biagioli, Maurizio ^a   Altomonte, Maresa ^a   Maio, Michele ^a  

^a UNIVERSITY HOSPITAL OF SIENA   (Italy)

^b REGINA ELENA NATIONAL CANCER INSTITUTE   (Italy)

Author keywords

Biomarker; Expanded access programme; Ipilimumab; Long term survival; Metastatic melanoma

Indexed keywords

ANTINEOPLASTIC AGENT; INDUCIBLE T CELL COSTIMULATOR; IPILIMUMAB; LEVOTHYROXINE;

ADULT; AGED; ARTICLE; CANCER CONTROL; CANCER IMMUNOTHERAPY; CANCER RADIOTHERAPY; CANCER SURGERY; CD4+ T LYMPHOCYTE; CD8+ T LYMPHOCYTE; CLINICAL ARTICLE; CUTANEOUS MELANOMA; DIARRHEA; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HUMAN; HUMAN CELL; LONG TERM SURVIVAL; LYMPHOCYTE COUNT; MAINTENANCE THERAPY; MALE; METASTATIC MELANOMA; NEUTROPHIL COUNT; OVERALL SURVIVAL; PRIORITY JOURNAL; PROTEIN EXPRESSION; RETROSPECTIVE STUDY; SURVIVAL RATE; THYROIDITIS; TUMOR IMMUNITY; UVEA MELANOMA;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; CD4-POSITIVE T-LYMPHOCYTES; CD8-POSITIVE T-LYMPHOCYTES; FEMALE; HUMANS; INDUCIBLE T-CELL CO-STIMULATOR PROTEIN; LYMPHOCYTE COUNT; MALE; MELANOMA; MIDDLE AGED; NEOPLASM METASTASIS; NEOPLASM STAGING; RETROSPECTIVE STUDIES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84878875962     PISSN: 03407004     EISSN: 14320851     Source Type: Journal    
DOI: 10.1007/s00262-013-1418-6     Document Type: Article

References (31)

1. Ferlay J, Parkin DM, Steliarova-Foucher E (2010) Estimates of cancer incidence and mortality in Europe in 2008. Eur J Cancer 46:765-781
2. Jemal A, Siegel R, Xu J, Ward E (2010) Cancer statistics, 2010. CA Cancer J Clin 60:277-300
3. Korn EL, Liu PY, Lee SJ, Chapman JA, Niedzwiecki D, Suman VJ, Moon J, Sondak VK, Atkins MB, Eisenhauer EA, Parulekar W, Markovic SN, Saxman S, Kirkwood JM (2008) Meta-analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival benchmarks for future phase II trials. J Clin Oncol 26:527-534
4. Tarhini AA, Agarwala SS (2006) Cutaneous melanoma: available therapy for metastatic disease. Dermatol Ther 19:19-25
5. Eggermont AM (2010) Advances in systemic treatment of melanoma. Ann Oncol 21(Suppl 7):vii339-vii344
6. Serrone L, Zeuli M, Sega FM, Cognetti F (2000) Dacarbazine-based chemotherapy for metastatic melanoma: thirty-year experience overview. J Exp Clin Cancer Res 19:21-34
7. Peggs KS, Quezada SA, Korman AJ, Allison JP (2006) Principles and use of anti-CTLA4 antibody in human cancer immunotherapy. Curr Opin Immunol 18:206-213
8. Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, Gonzalez R, Robert C, Schadendorf D, Hassel JC, Akerley W, van den Eertwegh AJ, Lutzky J, Lorigan P, Vaubel JM, Linette GP, Hogg D, Ottensmeier CH, Lebbe C, Peschel C, Quirt I, Clark JI, Wolchok JD, Weber JS, Tian J, Yellin MJ, Nichol GM, Hoos A, Urba WJ (2010) Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 363:711-723
9. Robert C, Thomas L, Bondarenko I, O'Day S, Garbe JWC, Lebbe C, Baurain JF, Testori A, Grob JJ, Davidson N, Richards J, Maio M, Hauschild A, Miller WH Jr, Gascon P, Lotem M, Harmankaya K, Ibrahim R, Francis S, Chen TT, Humphrey R, Hoos A, Wolchok JD (2011) Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med 364:2517-2526
10. Hamid O, Schmidt H, Nissan A, Ridolfi L, Aamdal S, Hansson J, Guida M, Hyams DM, Gomez H, Bastholt L, Chasalow SD, Berman D (2011) A prospective phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma. J Transl Med 9:204
11. Wang W, Yu D, Sarnaik AA, Yu B, Hall M, Morelli D, Zhang Y, Zhao X, Weber JS (2012) Biomarkers on melanoma patient T cells associated with ipilimumab treatment. J Transl Med 10:146
12. Yuan J, Adamow M, Ginsberg BA, Rasalan TS, Ritter E, Gallardo HF, Xu Y, Pogoriler E, Terzulli SL, Kuk D, Panageas KS, Ritter G, Sznol M, Halaban R, Jungbluth AA, Allison JP, Old LJ, Wolchok JD, Gnjatic S (2011) Integrated NY-ESO-1 antibody and CD8 + T-cell responses correlate with clinical benefit in advanced melanoma patients treated with ipilimumab. Proc Natl Acad Sci USA 108:16723-16728
13. Di Giacomo AM, Danielli R, Calabro L, Bertocci E, Nannicini C, Giannarelli D, Balestrazzi A, Vigni F, Riversi V, Miracco C, Biagioli M, Altomonte M, Maio M (2011) Ipilimumab experience in heavily pretreated patients with melanoma in an expanded access program at the university hospital of Siena (Italy). Cancer Immunol Immunother 60:467-477
14. Ku GY, Yuan J, Page DB, Schroeder SE, Panageas KS, Carvajal RD, Chapman PB, Schwartz GK, Allison JP, Wolchok JD (2010) Single-institution experience with ipilimumab in advanced melanoma patients in the compassionate use setting: lymphocyte count after 2 doses correlates with survival. Cancer 116:1767-1775
15. Simeone E, Gentilcore G, Romano A, Daponte A (2012) Immunological and biological changes during ipilimumab (Ipi) treatment and their correlation with clinical response and survival. J Clin Oncol 30(Suppl): abstract 8573
16. Berrocal A, Lopez-Martin JA, Arance AM, Soriano VEE (2012) Spanish experience with the ipilimumab Expanded Access Program. J Clin Oncol 30(Suppl): abstract e19023
17. Danielli R, Ridolfi R, Chiarion-Sileni V, Queirolo P, Testori A, Plummer R, Boitano M, Calabro L, Rossi CD, Di Giacomo AM, Ferrucci PF, Ridolfi L, Altomonte M, Miracco C, Balestrazzi A, Maio M (2012) Ipilimumab in pretreated patients with metastatic uveal melanoma: safety and clinical efficacy. Cancer Immunol Immunother 61:41-48
18. Wilgenhof S, Four SD, Everaert H, Neyns B (2012) Patterns of response in patients with pretreated metastatic melanoma who received ipilimumab 3 mg/kg in a European expanded access program: five illustrative case reports. Cancer Invest 30:712-720
19. Di Giacomo AM, Calabrò L, Danielli R, Fonsatti E, Bertocci E, Pesce I, Giannarelli D, Biagioli M, Altomonte M, Maio M (2012) Long term survival and immunological correlates in metastatic melanoma treated with ipilimumab at 10 mgs within an expanded access program. Ann Oncol 23(Suppl 9):abstract 1117PD
20. Lebbe C, Weinberg AD, Maio M, Neyns B, Harmankaya K, Chin K, Opatt McDowell D, Cykowski L, McHenry MB, Wolchok JD (2012) Five-year survival rates for patients (Pts) with metastatic melanoma (MM) treated with ipilimumab (Ipi) in phase II trials. Ann Oncol 23(Suppl 9):abstract 1116PD
21. Prieto PA, Yang JC, Sherry RM, Hughes MS, Kammula US, White DE, Levy CL, Rosenberg SA, Phan GQ (2012) CTLA-4 blockade with ipilimumab: long-term follow-up of 177 patients with metastatic melanoma. Clin Cancer Res 18:2039-2047
22. Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbe C, Maio M, Binder M, Bohnsack O, Nichol G, Humphrey R, Hodi FS (2009) Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res 15:7412-7420
23. Weber J (2007) Review: anti-CTLA-4 antibody ipilimumab: case studies of clinical response and immune-related adverse events. Oncologist 12:864-872
24. YERVOY™ Summary of Product Characteristics (2012) Available at: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/ human/002213/WC500109299.pdf. Accessed December 2012
25. Weber JS, Kahler KC, Hauschild A (2012) Management of immune-related adverse events and kinetics of response with ipilimumab. J Clin Oncol 30:2691-2697
26. Hutloff A, Dittrich AM, Beier KC, Eljaschewitsch B, Kraft R, Anagnostopoulos I, Kroczek RA (1999) ICOS is an inducible T-cell co-stimulator structurally and functionally related to CD28. Nature 397:263-266
27. Schenk AD, Gorbacheva V, Rabant M, Fairchild RL, Valujskikh A (2009) Effector functions of donor-reactive CD8 memory T cells are dependent on ICOS induced during division in cardiac grafts. Am J Transplant 9:64-73
28. Yoshinaga SK, Whoriskey JS, Khare SD, Sarmiento U, Guo J, Horan T, Shih G, Zhang M, Coccia MA, Kohno T, Tafuri-Bladt A, Brankow D, Campbell P, Chang D, Chiu L, Dai T, Duncan G, Elliott GS, Hui A, McCabe SM, Scully S, Shahinian A, Shaklee CL, Van G, Mak TW, Senaldi G (1999) T-cell co-stimulation through B7RP-1 and ICOS. Nature 402:827-832
29. An X, Ding PR, Li YH, Wang FH, Shi YX, Wang ZQ, He YJ, Xu RH, Jiang WQ (2010) Elevated neutrophil to lymphocyte ratio predicts survival in advanced pancreatic cancer. Biomarkers 15:516-522
30. Sarraf KM, Belcher E, Raevsky E, Nicholson AG, Goldstraw P, Lim E (2009) Neutrophil/lymphocyte ratio and its association with survival after complete resection in non-small cell lung cancer. J Thorac Cardiovasc Surg 137:425-428
31. Walsh SR, Cook EJ, Goulder F, Justin TA, Keeling NJ (2005) Neutrophil-lymphocyte ratio as a prognostic factor in colorectal cancer. J Surg Oncol 91:181-184