Single-center study under a French Temporary Authorization for use (TAU)) protocol for ipilimumab in metastatic melanoma: Negative impact of baseline corticosteroids

European Journal of Dermatology

Volumn 25, Issue 1, 2015, Pages 36-44

  Chasset, François ^a   Pages, Cécile ^a   Biard, Lucie ^a   Roux, Jennifer ^a   Sidina, Irina ^a   Madelaine, Isabelle ^a   Basset Seguin, Nicole ^a   Viguier, Manuelle ^a   Madjlessi Ezra, Nika ^a   Schneider, Pierre ^a   Bagot, Martine ^a   Resche Rigon, Matthieu ^a   Lebbe, Céleste ^a  

^a SAINT LOUIS HOSPITAL   (France)

Author keywords

Baseline corticosteroids; Ipilimumab; Melanoma

Indexed keywords

B RAF KINASE; CORTICOSTEROID; IPILIMUMAB; LACTATE DEHYDROGENASE; METHYLPREDNISOLONE; PREDNISOLONE; PREDNISONE; GLUCOCORTICOID; MONOCLONAL ANTIBODY;

ADRENAL DISEASE; ADULT; AGED; ARTICLE; BACTERIAL ARTHRITIS; BRAIN METASTASIS; CANCER STAGING; CLINICAL ARTICLE; COLITIS; DIARRHEA; DISEASE CONTROL; EOSINOPHIL COUNT; FATIGUE; FEMALE; FEVER; FOLLOW UP; HEMATOLOGIC DISEASE; HEPATITIS; HUMAN; HYPOPHYSIS DISEASE; LYMPHOCYTE COUNT; MALE; METASTATIC MELANOMA; MUTATION; OBSERVATIONAL STUDY; OVERALL SURVIVAL; RETROSPECTIVE STUDY; THYROID DISEASE; TREATMENT RESPONSE; VITILIGO; DIAGNOSTIC IMAGING; DOSE RESPONSE; FRANCE; INTRAVENOUS DRUG ADMINISTRATION; MELANOMA; METASTASIS; MIDDLE AGED; PATHOLOGY; SECONDARY; SKIN NEOPLASMS; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; DIAGNOSTIC IMAGING; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FOLLOW-UP STUDIES; FRANCE; GLUCOCORTICOIDS; HUMANS; INJECTIONS, INTRAVENOUS; MALE; MELANOMA; MIDDLE AGED; NEOPLASM METASTASIS; RETROSPECTIVE STUDIES; SKIN NEOPLASMS;

EID: 84926653062     PISSN: 11671122     EISSN: 19524013     Source Type: Journal    
DOI: 10.1684/ejd.2014.2471     Document Type: Article

References (43)

1. Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, et al. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer 1990 2013; 49: 1374-403.
2. Garbe C, Eigentler TK, Keilholz U, Hauschild A, Kirkwood JM. Systematic review of medical treatment in melanoma: current status and future prospects. Oncologist 2011; 16: 5-24.
3. Bedikian AY, DeConti RC, Conry R, et al. Phase 3 study of docosahexaenoic acid-paclitaxel versus dacarbazine in patients with metastatic malignant melanoma. Ann Oncol 2011; 22: 787-93.
4. Patel PM, Suciu S, Mortier L, et al. Extended schedule, escalated dose temozolomide versus dacarbazine in stage IV melanoma: final results of a randomised phase III study (EORTC 18032). Eur J Cancer 2011; 47: 1476-83.
5. Chapman PB, Hauschild A, Robert C, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med 2011; 364: 2507-16.
6. Das Thakur M, Salangsang F, Landman AS, et al. Modelling vemurafenib resistance in melanoma reveals a strategy to forestall drug resistance. Nature 2013; 494: 251-5.
7. Engelhardt JJ, Sullivan TJ, Allison JP. CTLA-4 overexpression inhibits T cell responses through a CD28-B7-dependent mechanism. J Immunol Baltim Md 1950 2006; 177: 1052-61.
8. Hodi FS, O’Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 2010; 363: 711-23.
9. Robert C, Thomas L, Bondarenko I, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med 2011; 364: 2517-26.
10. Wolchok JD, Hoos A, O’Day S, et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res 2009; 15: 7412-20.
11. Squibb BM. YERVOY ™ (ipilimumab) Immune-mediated adverse reaction management guide 2011. https://www.hcp.yervoy.com/ pdf/rems-managementguide.pdf (14 January 2012, date last accessed).
12. Cox D.R. Regression models and life-tables. J R Stat Soc Series B Stat Methodol, 1972: 187-220.
13. Grambsch PM, Therneau TM. Proportional hazards tests and diagnostics based on weighted residuals. Biometrika 1994; 81: 515-26.
14. Ku GY, Yuan J, Page DB, et al. Single-institution experience with ipilimumab in advanced melanoma patients in the compassionate use setting: lymphocyte count after 2 doses correlates with survival. Cancer 2010; 116: 1767-75.
15. Wiater K, Switaj T, Mackiewicz J, et al. Efficacy and safety of ipilimumab therapy in patients with metastatic melanoma: a retrospective multicenter analysis. Contemp Oncol (Pozn) 2013; 17: 257-62.
16. Delyon J, Mateus C, Lefeuvre D, et al. Experience in daily practice with ipilimumab for the treatment of patients with metastatic melanoma: an early increase in lymphocyte and eosinophil counts is associated with improved survival. Ann Oncol 2013; 24: 1697-703.
17. Wilgenhof S., Du Four S., Vandenbroucke F., et al. Singlecenter experience with ipilimumab in an expanded access program for patients with pretreated advanced melanoma. J Immunother 2013; 36: 215-22.
18. Di Giacomo AM, Calabrò L, Danielli R, et al. Long-term survival and immunological parameters in metastatic melanoma patients who responded to ipilimumab 10 mg/kg within an expanded access programme. Cancer Immunol Immunother 2013; 62: 1021-8.
19. Altomonte M, Di Giacomo A, Queirolo P, et al. Clinical experience with ipilimumab 10 mg/kg in patients with melanoma treated at Italian centres as part of a European expanded access programme. J Exp Clin Cancer Res 2013; 32: 82.
20. Konstantinou MP, Dutriaux C, Gaudy-Marqueste C, et al. Ipilimumab in melanoma patients with brain metastasis: a retro-spective multicentre evaluation of thirty-eight patients. Acta Derm Venereol 2014; 94: 45-9.
21. Shapira-Frommer R, Stephen F, Ben-Ami E, et al. Ipilimumab for advanced, refractory melanoma: A report of the Israeli cohort of expanded access program. J Clin Oncol 2013; 15(Suppl. 1).
22. Ahmad S, Qian W, Ellis SG, et al. Ipilimumab in the real world: The U.K. expanded access programme (EAP) experience in advanced melanoma. J Clin Oncol 2013; 15(Suppl. 1).
23. Simeone E, Gentilcore G, Giannarelli D, et al. l. Immunological and biological changes during ipilimumab treatment and their potential correlation with clinical response and survival in patients with advanced melanoma. Cancer Immunol Immunother 2014; 63: 675-83.
24. Kelderman S, Heemskerk B, van Tinteren H, et al. Lactate dehydrogenase as a selection criterion for ipilimumab treatment in metastatic melanoma. Cancer Immunol Immunother 2014; 63: 449-58.
25. Chiarion Sileni V, Pigozzo J, Ascierto PA, et al. Efficacy and safety of ipilimumab in elderly patients with pretreated advanced melanoma treated at Italian centres through the expanded access programme. J Exp Clin Cancer Res 2014; 33: 30.
26. Queirolo P, Spagnolo F, Ascierto PA, et al. Efficacy and safety of ipilimumab in patients with advanced melanoma and brain metastases. J Neurooncol 2014; 118: 109-16.
27. Ascierto PA, Simeone E, Sileni VC, et al. Clinical experience with ipilimumab 3 mg/kg: real-world efficacy and safety data from an expanded access programme cohort. J Transl Med 2014; 12: 116.
28. Alexander M, Mellor JD, McArthur G, Kee D. Ipilimumab in pretreated patients with unresectable or metastatic cutaneous, uveal and mucosal melanoma. Med J Aust 2014; 201: 49-53.
29. Berrocal A, Arance A, Lopez Martin JA, et al. Ipilimumab for advanced melanoma: experience from the Spanish Expanded Access Program. Melanoma Res 2014; 24: 577-83.
30. Di Giacomo AM, Biagioli M, Maio M. The emerging toxicity profiles of anti-CTLA-4 antibodies across clinical indications. Semin Oncol 2010; 37: 499-507.
31. Pagès C, Gornet JM, Monsel G, et al. Ipilimumab-induced acute severe colitis treated by infliximab. Melanoma Res 2013; 23: 227-30.
32. Sampson JH, Carter JH, Friedman AH, Seigler HF. Demographics, prognosis, and therapy in 702 patients with brain metastases from malignant melanoma. J Neurosurg 1998; 88: 11-20.
33. Margolin K, Ernstoff MS, Hamid O, et al. Ipilimumab in patients with melanoma and brain metastases: an open-label, phase 2 trial. Lancet Oncol 2012; 13: 459-65.
34. Xia M, Gasser J, Feige U. Dexamethasone enhances CTLA-4 expression during T cell activation. Cell Mol Life Sci 1999; 1649-56: 5.
35. Weber J, Thompson JA, Hamid O, et al. A randomized, doubleblind, placebo-controlled, phase II study comparing the tolerability and efficacy of ipilimumab administered with or without prophylactic budesonide in patients with unresectable stage III or IV melanoma. Clin Cancer Res 2009; 15: 5591-8.
36. Amin A, DePril V, Hamid O, et al. Evaluation of the effect of systemic corticosteroids for the treatment of immune-related adverse events (irAEs) on the development or maintenance of ipilimumab clinical activity. J Clin Oncol 2009; 27(15 suppl): abstr9037.
37. Shahabi V, Whitney G, Hamid O, et al. Assessment of association between BRAF-V600E mutation status in melanomas and clinical response to ipilimumab. Cancer Immunol Immunother 2012; 61: 733-7.
38. Jang S, Atkins MB. Which drug, and when, for patients with BRAFmutant melanoma? Lancet Oncol 2013; 14: e60-9.
39. Hauschild A, Grob J-J, Demidov LV, et al. Dabrafenib in BRAFmutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial. Lancet 2012; 380: 358-65.
40. Ascierto PA, Simeone E, Giannarelli D, Grimaldi AM, Romano A, Mozzillo N. Sequencing of BRAF inhibitors and ipilimumab in patients with metastatic melanoma: a possible algorithm for clinical use. J Transl Med 2012; 10: 107.
41. Ackerman A, Klein O, McDermott DF, et al. Outcomes of patients with metastatic melanoma treated with immunotherapy prior to or after BRAF inhibitors. Cancer 2014; 120: 1695-701.
42. Garbe C, Peris K, Hauschild A, et al. Diagnosis and treatment of melanoma. European consensus-based interdisciplinary guideline– Update 2012. Eur J Cancer 2012; 48: 2375-90.
43. Ott PA, Hodi FS, Robert C. CTLA-4 and PD-1/PD-L1 blockade: new immunotherapeutic modalities with durable clinical benefit in melanoma patients. Clin Cancer Res 2013; 19: 5300-9.