Ipilimumab in melanoma

Expert Review of Anticancer Therapy

Volumn 12, Issue 12, 2012, Pages 1511-1521

  Specenier, Pol ^a  

^a ANTWERP UNIVERSITY HOSPITAL   (Belgium)

Author keywords

BRAF inhibitor; immunotherapy; ipilimumab; malignant melanoma; metastatic; overall survival; predictive factors

Indexed keywords

ALPHA2B INTERFERON; ANTIHISTAMINIC AGENT; ATROPINE; BUDESONIDE; CARBOPLATIN; CISPLATIN; CORTICOSTEROID; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4; DACARBAZINE; DACTINOMYCIN; DIPHENOXYLATE; FOTEMUSTINE; GLYCOPROTEIN GP 100; HLA ANTIGEN; IMMUNOSUPPRESSIVE AGENT; INFLIXIMAB; INTERLEUKIN 2; IPILIMUMAB; LOPERAMIDE; MELPHALAN; METHYLPREDNISOLONE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; NY ESO 1 ANTIGEN; PACLITAXEL; PLACEBO; PREDNISONE; RECOMBINANT INTERLEUKIN 2; TEMOZOLOMIDE; UNINDEXED DRUG; VEMURAFENIB;

ADRENAL INSUFFICIENCY; ADVANCED CANCER; AREA UNDER THE CURVE; ARTICLE; AUTOIMMUNE INFLAMMATORY MYOPATHY; BRAIN METASTASIS; CANCER ADJUVANT THERAPY; CANCER IMMUNOTHERAPY; CANCER PROGNOSIS; CANCER STAGING; CD4+ T LYMPHOCYTE; CD8+ T LYMPHOCYTE; COLITIS; CONSTIPATION; CORTICOTROPIN BLOOD LEVEL; COST EFFECTIVENESS ANALYSIS; DIARRHEA; DRUG CLEARANCE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG ERUPTION; DRUG HALF LIFE; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ENDOCRINE DISEASE; GASTROINTESTINAL TOXICITY; GENE EXPRESSION PROFILING; GUILLAIN BARRE SYNDROME; HEMOPHILIA A; HUMAN; HYPOPHYSITIS; HYPOPITUITARISM; HYPOTHYROIDISM; IMMUNOPATHOLOGY; INFLAMMATORY ENTERIC NEUROPATHY; LIVER TOXICITY; LUPUS ERYTHEMATOSUS NEPHRITIS; LYMPHOCYTE COUNT; MAINTENANCE THERAPY; MAXIMUM PLASMA CONCENTRATION; MELANOMA; MENINGORADICULONEURITIS; METASTATIC MELANOMA; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; MYASTHENIA LIKE SYNDROME; MYOSITIS; NEURITIS; NEUROPATHY; NEUTROPENIA; OPTIMAL DRUG DOSE; ORBITAL MYOSITIS; OVERALL SURVIVAL; PATIENT SELECTION; POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME; PROGRESSION FREE SURVIVAL; PRURITUS; QUALITY ADJUSTED LIFE YEAR; RADIATION NECROSIS; RECOMMENDED DRUG DOSE; SARCOIDOSIS; SIDE EFFECT; SKIN DISEASE; SURVIVAL RATE; T LYMPHOCYTE ACTIVATION; TOXIC HEPATITIS; UVEA MELANOMA; VITILIGO;

ANTIBODIES, MONOCLONAL; BRAIN NEOPLASMS; HUMANS; IMMUNOLOGIC FACTORS; MELANOMA; SKIN NEOPLASMS; TREATMENT OUTCOME; UVEAL NEOPLASMS;

EID: 84871477897     PISSN: 14737140     EISSN: 17448328     Source Type: Journal    
DOI: 10.1586/era.12.132     Document Type: Article

References (72)

1. Weir HK, Marrett LD, Cokkinides V et al. Melanoma in adolescents and young adults (ages 15-39 years): United States, 1999-2006. J. Am. Acad. Dermatol. 65(5 Suppl. 1), S38-S49 (2011
2. Jemal A, Saraiya M, Patel P et al. Recent trends in cutaneous melanoma incidence and death rates in the United States, 1992-2006. J. Am. Acad. Dermatol. 65(5 Suppl. 1), S17-S25.e1 (2011
3. Tsao H, Atkins MB, Sober AJ. Management of cutaneous melanoma. N. Engl. J. Med. 351(10), 998-1012 (2004
4. Pollack LA, Li J, Berkowitz Z et al. Melanoma survival in the United States, 1992 to 2005. J. Am. Acad. Dermatol. 65(5 Suppl. 1), S78-S86 (2011
5. Agarwala SS. Current systemic therapy for metastatic melanoma. Expert Rev. Anticancer Ther. 9(5), 587-595 (2009
6. Peggs KS, Quezada SA, Korman AJ, Allison JP. Principles and use of anti-CTLA4 antibody in human cancer immunotherapy. Curr. Opin. Immunol. 18(2), 206-213 (2006
7. Pennock GK, Waterfield W, Wolchok JD. Patient responses to ipilimumab, a novel immunopotentiator for metastatic melanoma: How different are these from conventional treatment responses? Am. J. Clin. Oncol. doi:10.1097/COC. 0b013e318209cda9 (2011) (Epub ahead of print
8. Maker AV, Attia P, Rosenberg SA Analyses of the cellular mechanism of antitumor responses and autoimmunity in patients treated with CTLA-4 blockade J. Immunol. 175(11), 7746-7754 (2005
9. Weber JS, O'Day S, Urba W et al. Phase I/II study of ipilimumab for patients with metastatic melanoma. J. Clin. Oncol. 26(36), 5950-5956 (2008
10. Hodi FS, O'Day SJ, McDermott DF et al. Improved survival with ipilimumab in patients with metastatic melanoma. N. Engl. J. Med. 363(8), 711-723 (2010
11. Wolchok JD, Hoos A, O'Day S et al. Guidelines for the evaluation of immune therapy activity in solid tumors: Immunerelated response criteria. Clin. Cancer Res. 15(23), 7412-7420 (2009
12. Tuma RS. New response criteria proposed for immunotherapies. J. Natl Cancer Inst. 100(18), 1280-1281 (2008
13. O'Day SJ, Maio M, Chiarion-Sileni V et al. Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: A multicenter single-arm hase II study. Ann. Oncol. 21(8), 1712-1717 (2010
14. Maio M, Testori A, Ascierto PA, Ridolfi R, Santinami M, Pilla L. The NIBIT-M1 trial: Activity of ipilimumab plus fotemustine in patients with melanoma and brain metastases. J. Clin. Oncol. 30(Suppl.), Abstract 8259 (2012
15. Patel SP, Hwu WJ, Kim KB, Papadopoulos NE, Hwu P, Radvanyi LG. Phase II study of the frontline combination of ipilimumab and temozolomide in patients with metastatic melanoma. J. Clin. Oncol. 30(Suppl.), Abstract 8514 (2012
16. Prieto PA, Yang JC, Sherry RM et al. CTLA-4 blockade with ipilimumab: Long-term follow-up of 177 patients with metastatic melanoma. Clin. Cancer Res. 18, 2039-2047 (2012
17. Maker AV, Phan GQ, Attia P et al blockade and interleukin 2: A Phase I/II study. Ann. Surg. Oncol. 12(12), 1005-1016 (2005
18. Hersh EM, O'Day SJ, Powderly J et al. A Phase II multicenter study of ipilimumab with or without dacarbazine in chemotherapy- naive patients with advanced melanoma. Invest. New Drugs 29(3), 489-498 (2011
19. Wolchok JD, Neyns B, Linette G et al. Ipilimumab monotherapy in patients with pretreated advanced melanoma: A randomised, double-blind, multicentre, Phase 2, dose-ranging study. Lancet Oncol. 11(2), 155-164 (2010
20. Weber J, Thompson JA, Hamid O et al. A randomized, double-blind, placebocontrolled, 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. 15(17), 5591-5598 (2009
21. Hamid O, Schmidt H, Nissan A et al. 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 (2011
22. Revicki DA, van den Eertwegh AJ, Lorigan P et al. Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment. Health Qual. Life Outcomes 10, 66 (2012
23. Robert C, Thomas L, Bondarenko I et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N. Engl. J. Med. 364(26), 2517-2526 (2011
24. Hodi FS, Oble DA, Drappatz J et al. CTLA-4 blockade with ipilimumab induces significant clinical benefit in a female with melanoma metastases to the CNS. Nat. Clin. Pract. Oncol. 5(9), 557-561 (2008
25. Margolin KA, Di Giacomo AM, Maio M. Brain metastasis in melanoma: Clinical activity of CTLA-4 antibody therapy. Semin. Oncol. 37(5), 468-472 (2010
26. Schartz NE, Farges C, Madelaine I et al. Complete regression of a previously untreated melanoma brain metastasis with ipilimumab. Melanoma Res. 20(3), 247-250 (2010
27. Weber JS, Amin A, Minor D, Siegel J, Berman D, O'Day SJ. Safety and clinical activity of ipilimumab in melanoma patients with brain metastases: Retrospective analysis of data from a Phase 2 trial. Melanoma Res. 21(6), 530-534 (2011
28. Margolin K, Ernstoff MS, Hamid O et al. Ipilimumab in patients with melanoma and brain metastases: An open-label, Phase 2 trial. Lancet Oncol. 13(5), 459-465 (2012
29. Khan KD, Callahan M, Postow MA, et al. Efficacy and safety of oral MEK162 in patients with locally advanced and unresectable or metastatic cutaneous melanoma harboring BRAFV600 or NRAS mutations. J. Clin. Oncol. 30(Suppl.), Abstract 8549 (2012
30. Danielli R, Ridolfi R, Chiarion-Sileni V et al. Ipilimumab in pretreated patients with metastatic uveal melanoma: Safety and clinical efficacy. Cancer Immunol. Immunother. 61(1), 41-48 (2012
31. Downey SG, Klapper JA, Smith FO et al. Prognostic factors related to clinical response in patients with metastatic melanoma treated by CTL-associated antigen-4 lockade. Clin. Cancer Res. 13(22 Pt 1), 6681-6688 (2007
32. Harmankaya K, Erasim C, Koelblinger C et al. Continuous systemic corticosteroids do not affect the ongoing regression of metastatic melanoma for more than two years following ipilimumab therapy. Med. Oncol. 28(4), 1140-1144 (2011
33. Hunter G, Voll C, Robinson CA. Autoimmune inflammatory myopathy after treatment with ipilimumab. Can. J. Neurol. Sci. 36(4), 518-520 (2009
34. Maur M, Tomasello C, Frassoldati A, Dieci MV, Barbieri E, Conte P. Posterior reversible encephalopathy syndrome during ipilimumab therapy for malignant melanoma. J. Clin. Oncol. 30(6), e76-e78 (2012
35. Lecouflet L, Verschoore M, Giard C et al. Orbital myositis associated with ipilimumab. Melanoma Res. 21(e-Suppl. A), Abstract e24 (2011
36. Delyon J, Mateus C, Lambert T. Hemophilia A induced by ipilimumab. N. Engl. J. Med. 365(18), 1747-1748 (2011
37. Fadel F, El Karoui K, Knebelmann B. Anti-CTLA4 antibody-induced lupus nephritis. N. Engl. J. Med. 361(2), 211-212 (2009
38. Eckert A, Schoeffler A, Dalle S, Phan A, Kiakouama L, Thomas L Anti-CTLA4 monoclonal antibody induced sarcoidosis in a metastatic melanoma patient. Dermatology (Basel) 218(1), 69-70 (2009
39. Vogel WV, Guislain A, Kvistborg P, Schumacher TN, Haanen JB, Blank CU. Ipilimumab-induced sarcoidosis in a patient with metastatic melanoma undergoing complete remission. J. Clin. Oncol. 30(2), e7-e10 (2012
40. Wilgenhof S, Neyns B. Anti-CTLA-4 antibody-induced Guillain-Barré syndrome in a melanoma patient. Ann. Oncol. 22(4), 991-993 (2011
41. Bompaire F, Mateus C, Taillia H et al. Severe meningo-radiculo-nevritis associated with ipilimumab. Invest. New Drugs 30(6), 2407-2410 (2012
42. Akhtari M, Waller EK, Jaye DL et al Neutropenia in a patient treated with ipilimumab (anti-CTLA-4 antibody J. Immunother. 32(3), 322-324 (2009
43. Bhatia S, Huber BR, Upton MP, Thompson JA. Inflammatory enteric neuropathy with severe constipation after ipilimumab treatment for melanoma: A case report. J. Immunother. 32(2), 203-205 (2009
44. Du Four S, Wilgenhof S, Duerinck J et al. Radiation necrosis of the brain in melanoma patients successfully treated with ipilimumab, three case studies. Eur. J. Cancer 8(16), 3045-3051 (2012
45. Thompson JA, Hamid O, Minor D et al. Ipilimumab in treatment-naive and previously treated patients with metastatic melanoma: Retrospective analysis of efficacy and safety data from a Phase II trial. J. Immunother. 35(1), 73-77 (2012
46. Ackerman A, McDermott DF, Lawrence DP, Gunturi A, Flaherty KT, Giobbie- Hurder A. Outcomes of patients with malignant melanoma treated with immunotherapy prior to or after vemurafenib. J. Clin. Oncol. 30(Suppl.), Abstract 8569 (2012
47. 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 116(7), 1767-1775 (2010
48. Postow MA, Yuan J, Panageas KS, Bogatch K, Callahan M, Cheng M. Evaluation of the absolute lymphocyte count as a biomarker for melanoma patients treated with the commercially available dose of ipilimumab (3 mg/kg). J. Clin. Oncol. 30Suppl.), Abstract 8575 (2012
49. Di Giacomo AM, Danielli R, Calabrò L et al. Ipilimumab experience in heavily pretreated patients with melanoma in an expanded access program at the University Hospital of Siena (Italy). Cancer Immunol. Immunother. 60(4), 467-477 (2011
50. Wilgenhof S, Seghers AC, Dufour S et al. Single-center experience with ipilimumab in patients with pretreated advanced melanoma. J. Clin. Oncol. 30(Suppl.), Abstract e19026 (2012
51. Kitano S, Postow MA, Cortez C et al. Myeloid-derived suppressor cell quantity prior to treatment with ipilimumab at 10 mg/kg to predict for overall survival in patients with metastatic melanoma. J. Clin. Oncol. 30(Suppl.), Abstract 2518 (2012
52. Yuan J, Adamow M, Ginsberg BA et al 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(40), 16723-16728 (2011
53. Ellis SG, Wheater M, Tier K, Cazaly A, Smart J, Theaker J. Biomarker for benefit from ipilimumab: Correlation of breadth of humoral tumor-antigen- specific immunity with outcome. J. Clin. Oncol. 30(Suppl.), Abstract 8566 (2012
54. Attia P, Phan GQ, Maker AV et al. Autoimmunity correlates with tumor regression in patients with metastatic melanoma treated with anti-cytotoxic T-lymphocyte antigen-4. J. Clin. Oncol. 23(25), 6043-6053 (2005
55. Lutzky J, Wolchok JD, Hamid O et al. Association between immune-related adverse events (irAEs) and disease control or overall survival in patients (pts) with advanced melanoma treated with 10 mg/kg ipilimumab in three Phase II clinical trials. J. Clin. Oncol. 27(Suppl. 15), Abstract 9034 (2009
56. Ji RR, Chasalow SD, Wang L et al. An immune-active tumor microenvironment favors clinical response to ipilimumab. Cancer Immunol. Immunother. 61(7), 1019-1031 (2012
57. Shahabi V, Berman D, Chasalow SD et al. Gene expression profiling of whole blood in ipilimumab-treated patients for identification of potential biomarkers of immune-mediate gastrointestinal adverse events. J. Clin. Oncol. 30(Suppl.), Abstract 8593 (2012
58. 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. 61(5), 733-737 (2012
59. Wolchok JD, Weber JS, Hamid O et al. Ipilimumab efficacy and safety in patients with advanced melanoma: A retrospective analysis of HLA subtype from four trials. Cancer Immun. 10, 9 (2010
60. Hanaizi Z, van Zwieten-Boot B, Calvo G et al. The European Medicines Agency review of ipilimumab (Yervoy) for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy: Summary of the scientific assessment of the Committee for Medicinal Products for Human Use. Eur. J. Cancer 48(2), 237-242 (2012
61. Ledford H. Melanoma drug wins US approval. Nature 471(7340), 561 (2011
62. Kaehler KC, Piel S, Livingstone E, Schilling B, Hauschild A, Schadendorf D. Update on immunologic therapy with anti-CTLA-4 antibodies in melanoma: Identification of clinical and biological response patterns, immune-related adverse events, and their management. Semin. Oncol. 37(5), 485-498 (2010
63. Weber JS, Kähler KC, Hauschild A. Management of immune-related adverse events and kinetics of response with ipilimumab. J. Clin. Oncol. 30(21), 2691-2697 (2012
64. Minor DR, Chin K, Kashani-Sabet M. Infliximab in the treatment of anti-CTLA4 antibody (ipilimumab) induced immunerelated colitis. Cancer Biother. Radiopharm. 24(3), 321-325 (2009
65. Flaherty KT, Robert C, Hersey P et al. Improved survival with MEK inhibition in braf-mutated melanoma. N. Engl. J. Med. 367(2), 107-114 (2012
66. Chapman PB, Hauschild A, Robert C et al.; BRIM-3 Study Group. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N. Engl. J. Med. 364(26), 2507-2516 (2011
67. Hauschild A, Grob JJ, Demidov LV et al. Phase III, randomized, open-label, multicenter trial (BREAK-3) comparing the BRAF kinase inhibitor dabrafenib (GSK2118436) with dacarbazine (DTIC in patients with BRAFV600E-mutated melanoma. J. Clin. Oncol. 30(Suppl.), Abstract LBA8500 (2012
68. Kudchadkar R, Gallenstein D, Martinez AJ, Yu B, Weber JS. Phase I trial of extended-dose anti-PD-1 antibody BMS-936558 with a multipeptide vaccine for previously treated stage IV melanoma. J. Clin. Oncol. 30(Suppl.), Abstract 8582 (2012
69. Brahmer JR, Tykodi SS, Chow LQ et al. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N. Engl. J. Med. 366(26), 2455-2465 (2012
70. Topalian SL, Brahmer JR, Hodi FS et al. PD-1 (BMS-936558, MDX-1106) in patients with advanced solid tumors: Clinical activity, safety, and a potential biomarker for response. J. Clin. Oncol. 30(Suppl.), Abstract CRA2509 (2012
71. Patnaik A, Kang SP, Tolcher AW et al Phase I study of MK-3475 (anti-PD-1 monoclonal antibody) in patients with advanced solid tumors. J. Clin. Oncol. 30(Suppl.), Abstract 2512 (2012
72. 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. 10, 107 (2012)