Adjuvant therapy for melanoma

Cancer Journal

Volumn 18, Issue 2, 2012, Pages 192-202

  Davar, Diwakar ^a   Tarhini, Ahmad A ^a   Kirkwood, John M ^a  

^a UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

Author keywords

adjuvant therapy; BRAF inhibition; CTLA 4 blockade; high dose interferon 2b; Melanoma

Indexed keywords

ALPHA2A INTERFERON; ALPHA2B INTERFERON; B RAF KINASE; BCG VACCINE; BIOLOGICAL MARKER; CISPLATIN; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4; DACARBAZINE; GAMMA INTERFERON; GLYCOPROTEIN GP 100; INTERFERON; INTERLEUKIN 2; IPILIMUMAB; LEVAMISOLE; LOMUSTINE; MEGESTROL ACETATE; MELACINE; MELANOMA ANTIGEN 3; MELANOMA VACCINE; ONAMELATUCEL L; PEGINTERFERON ALPHA2B; PEPTIDE VACCINE; PLACEBO; RETINOL; TICILIMUMAB; VEMURAFENIB; VINBLASTINE; VINDESINE; VISCUM ALBUM EXTRACT;

CANCER ADJUVANT THERAPY; CANCER IMMUNIZATION; CANCER IMMUNOTHERAPY; CANCER PROGNOSIS; CANCER STAGING; CANCER SURVIVAL; DISEASE FREE SURVIVAL; DISTANT METASTASIS FREE SURVIVAL; DRUG DOSE COMPARISON; DRUG FORMULATION; DRUG MECHANISM; DRUG MEGADOSE; HIGH RISK PATIENT; HUMAN; HYPERTHERMIC THERAPY; LOW DRUG DOSE; MELANOMA; MULTIPLE CYCLE TREATMENT; OVERALL SURVIVAL; PATIENT COMPLIANCE; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECURRENCE FREE SURVIVAL; REVIEW; SURVIVAL RATE; SURVIVAL TIME; SYSTEMATIC REVIEW; TREATMENT INDICATION; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT;

ANTIBODIES, MONOCLONAL; CANCER VACCINES; CTLA-4 ANTIGEN; HUMANS; INTERFERONS; MELANOMA; NEOADJUVANT THERAPY;

EID: 84859447638     PISSN: 15289117     EISSN: 1540336X     Source Type: Journal    
DOI: 10.1097/PPO.0b013e31824f118b     Document Type: Review

References (78)

1. Howlader N, Noone AM, Krapcho M, et al. SEER Stat Fact Sheets: Melanoma of the Skin. National Cancer Institute SEER Database. Available at: http://seer.cancer.gov/statfacts/html/melan.html. Accessed November 29, 2011.
2. Hodi FS, O'Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010; 363:711-723.
3. Robert C, Thomas L, Bondarenko I, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011; 364:2517-2526.
4. Chapman PB, Hauschild A, Robert C, et al, Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011;364:2507-2516.
5. Garbe C, Eigentler TK. Diagnosis and treatment of cutaneous melanoma: state of the art 2006. Melanoma Res. 2007;17:117-127. (Pubitemid 46673905)
6. Tarhini AA, Kirkwood JM. Clinical and immunologic basis of interferon therapy in melanoma. Ann N Y Acad Sci. 2009;1182:47-57.
7. Lens MB, Dawes M. Interferon alfa therapy for malignant melanoma: a systematic review of randomized controlled trials. J Clin Oncol. 2002;20:1818-1825. (Pubitemid 34273271)
8. Wheatley K, Ives N, Hancock B, et al. Does adjuvant interferon-alpha for high-risk melanoma provide a worthwhile benefit? A meta-analysis of the randomised trials. Cancer Treat Rev. 2003;29:241-252. (Pubitemid 37069655)
9. Wheatley K, Hancock B, Gore M, et al. Interferon-{alpha} as adjuvant therapy for melanoma: an individual patient data meta-analysis of randomised trials. J Clin Oncol. 2007;25[suppl 18]: Abstract 8526.
10. Mocellin S, Pasquali S, Rossi CR, et al. Interferon alpha adjuvant therapy in patients with high-risk melanoma: a systematic review and metaanalysis. J Natl Cancer Inst. 2010;102:493-501.
11. Balch CM, Buzaid AC, Soong SJ, et al. Final version of the American Joint Committee on Cancer staging system for cutaneous melanoma. J Clin Oncol. 2001;19:3635-3648. (Pubitemid 32786276)
12. Kettlewell S, Moyes C, Bray C, et al. Value of sentinel node status as a prognostic factor in melanoma: prospective observational study. BMJ. 2006;332:1423.
13. L and Mcl-1, but not Bcl-2 proteins. Mod Pathol. 2010;23:45-53.
14. Kirkwood JM, Farkas DL, Chakraborty A, et al. Systemic interferon-alpha (IFN-alpha) treatment leads to Stat3 inactivation in melanoma precursor lesions. Mol Med. 1999;5:11-20. (Pubitemid 29282093)
15. Gajewski TF. The expanding universe of regulatory T cell subsets in cancer. Immunity. 2007;27:185-187. (Pubitemid 47284925)
16. Gajewski TF, Fuertes M, Spaapen R, et al. Molecular profiling to ide-ntifyrelevant immune resistance mechanisms in the tumor microenvi-ronment. Curr Opin Immunol. 2011;23:286-292.
17. Moschos SJ, Edington HD, Land SR, et al. Neoadjuvant treatment of regional stage IIIB melanoma with high-dose interferon alfa-2b induces objective tumor regression in association with modulation of tumor infiltrating host cellular immune responses. J Clin Oncol. 2006;24:3164-3171. (Pubitemid 46638955)
18. Creagan ET, Dalton RJ, Ahmann DL, et al. Randomized, surgical adjuvant clinical trial of recombinant interferon alfa-2a in selected patients with malignant melanoma. J Clin Oncol. 1995;13:2776-2783.
19. Kirkwood JM, Strawderman MH, Ernstoff MS, et al. Interferon alfa-2b adjuvant therapy of high-risk resected cutaneous melanoma: the Eastern Cooperative Oncology Group Trial EST 1684. J Clin Oncol. 1996;14:7-17. (Pubitemid 26019991)
20. Kirkwood JM, Ibrahim JG, Sondak VK, et al. High-and low-dose int-erferon alfa-2b in high-risk melanoma: first analysis of intergroup trial E1690/S9111/C9190. J Clin Oncol. 2000;18:2444-2458. (Pubitemid 30415832)
21. Kirkwood JM, et al. High-dose interferon alfa-2b significantly prolongs relapse-free and overall survival compared with the GM2-KLH/QS-21 vaccine in patients with resected stage IIB-III melanoma: results of inter-group trial E1694/S9512/C509801. J Clin Oncol. 2001;19(9):2370-2380. (Pubitemid 32391207)
22. Kirkwood JM, Ibrahim J, Lawson DH, et al. High-dose interferon alfa-2b does not diminish antibody response to GM2 vaccination in patients with resected melanoma: results of the Multicenter Eastern Cooperative Oncology Group Phase II Trial E2696. J Clin Oncol. 2001;19:1430-1436. (Pubitemid 32202550)
23. Chiarion-Sileni V, Guida M, Romanini A, et al. Intensified high-dose intravenous interferon alpha 2b (IFNa2b) for adjuvant treatment of stage III melanoma: a randomized phase III Italian Melanoma Intergroup (IMI) trial [ISRCTN75125874]. J Clin Oncol. 2011;29[suppl]: Abstract 8506.
24. Eggermont AM, Suciu S, MacKie R, et al. Post-surgery adjuvant therapy with intermediate doses of interferon alfa 2b versus observation in patients with stage IIb/III melanoma (EORTC 18952): randomised controlled trial. Lancet. 2005;366:1189-1196. (Pubitemid 41393597)
25. Bouwhuis MG, Suciu S, Testori A, et al. Phase III trial comparing adjuvant treatment with pegylated interferon alfa-2b versus observation: prognostic significance of autoantibodiesVEORTC 18991. J Clin Oncol. 2010;28: 2460-2466.
26. Pehamberger H, Soyer HP, Steiner A, et al. Adjuvant interferon alfa-2a treatment in resected primary stage II cutaneous melanoma. Austrian Malignant Melanoma Cooperative Group. J Clin Oncol. 1998;16: 1425-1429. (Pubitemid 28175761)
27. Grob JJ, Dreno B, de la Salmonière P, et al. Randomised trial of interferon alpha-2a as adjuvant therapy in resected primary melanoma thicker than 1.5 mm without clinically detectable node metastases. French Cooperative Group on Melanoma. Lancet. 1998;351:1905-1910. (Pubitemid 28297445)
28. Cascinelli N, Belli F, MacKie RM, et al. Effect of long-term adjuvant therapy with interferon alpha-2a in patients with regional node metastases from cutaneous melanoma: a randomised trial. Lancet. 2001;358:866-869. (Pubitemid 32900567)
29. Cameron DA, Cornbleet MC, Mackie RM, et al. Adjuvant interferon alpha 2b in high risk melanomaVthe Scottish study. Br J Cancer. 2001;84: 1146-1149. (Pubitemid 32511329)
30. Kleeberg UR, Suciu S, Bröcker EB, et al. Final results of the EORTC 18871/DKG 80-1 randomised phase III trial. rIFN-alpha2b versus rIFN-gamma versus ISCADOR M versus observation after surgery in melanoma patients with either high-risk primary (thickness 93 mm) or regional lymph node metastasis. Eur J Cancer. 2004;40:390-402. (Pubitemid 38121277)
31. Hancock BW, Wheatley K, Harris S, et al. Adjuvant interferon in high-risk melanoma: the AIM HIGH StudyVUnited Kingdom Coordinating Committee on Cancer Research randomized study of adjuvant low-dose extended-duration interferon alfa-2a in high-risk resected malignant melanoma. J Clin Oncol. 2004;22:53-61. (Pubitemid 41095114)
32. Hauschild A, Weichenthal M, Rass K, et al. Efficacy of low-dose interferon {alpha}2a 18 versus 60 months of treatment in patients with primary melanoma of 9= 1.5 mm tumor thickness: results of a randomized phase III DeCOG trial. J Clin Oncol. 2010;28:841-846.
33. Garbe C, Radny P, Linse R, et al. Adjuvant low-dose interferon {alpha}2a with or without dacarbazine compared with surgery alone: a prospective- randomized phase III DeCOG trial in melanoma patients with regional lymph node metastasis. Ann Oncol. 2008;19:1195-1201. (Pubitemid 351796347)
34. Pectasides D, Dafni U, Bafaloukos D, et al. Randomized phase III study of 1 month versus 1 year of adjuvant high-dose interferon alfa-2b in patients with resected high-risk melanoma. J Clin Oncol. 2009;27: 939-944.
35. Agarwala SS, Lee SJ, Flaherty LE, et al. Randomized phase III trial of high-dose interferon alfa-2b (HDI) for 4 weeks induction only in patients with intermediate-and high-risk melanoma (Intergroup Trial E 1697). J Clin Oncol. 2011;29[suppl]: Abstract 8505.
36. Kirkwood JM, Manola J, Ibrahim J, et al. A pooled analysis of eastern cooperative oncology group and intergroup trials of adjuvant high-dose interferon for melanoma. Clin Cancer Res. 2004;10:1670-1677. (Pubitemid 38435557)
37. Bukowski R, Ernstoff MS, Gore ME, et al. Pegylated interferon alfa-2b treatment for patients with solid tumors: a phase I/II study. J Clin Oncol. 2002;20:3841-3849.
38. Eggermont AM, Suciu S, Santinami M, et al. Adjuvant therapy with pegylated interferon alfa-2b versus observation alone in resected stage III melanoma: final results of EORTC 18991, a randomised phase III trial. Lancet. 2008;372:117-126. (Pubitemid 351952257)
39. Eggermont AM, Suciu S, Testori A, et al. Ulceration and stage are predictive of interferon efficacy in melanoma: Results of the phase III adjuvant trials EORTC 18952 and EORTC 18991. Eur J Cancer. 2012;48:218-225.
40. Grob JJ, Jouary T, Dreno B, et al. Adjuvant therapy with pegylated inter-feron alfa-2b (36 months) versus low-dose interferon alfa-2b (18months) in melanoma patients without macro-metastatic nodes: EADOtrial. J Clin Oncol. 2010;28[suppl 15]: Abstract LBA8506.
41. Hansson J, Aamdal S, Bastholt L, et al. Two different durations of adjuvant therapy with intermediate-dose interferon alfa-2b in patients with high-risk melanoma (Nordic IFN trial): a randomised phase 3 trial. Lancet Oncol. 2011;12:144-152.
42. Morton DL, Mozzillo N, Thompson JF, et al. An international, randomized, phase III trial of bacillus Calmette-Guerin (BCG) plus allogeneic melanoma vaccine (MCV) or placebo after complete resection of melanoma metastatic to regional or distant sites. Presented at: 58th Annual Meeting of the Society of Surgical Oncology. Atlanta, GA; March 3-6, 2006. Abstract 8508.
43. Lawson DH, Lee SJ, Tarhini AA, et al. E4697: Phase III cooperative group study of yeast-derived granulocyte macrophage colony-stimulating factor (GM-CSF) versus placebo as adjuvant treatment of patients with completely resected stage III-IV melanoma. J Clin Oncol. 2010;28[suppl]:15S Abstract 8504.
44. Markovic S, Burch PA, LaPlant B, et al. Adjuvant GM-CSF therapy for patients with resected stage III/IV melanoma: a retrospective review of a single-center experience. J Clin Oncol. 2011;29[suppl]: Abstract 8596.
45. Stuckert JJ, Tarhini AA, Lee S, et al. Interferon alfa-induced autoim-munity and serum S100 levels as predictive and prognostic biomarkers in high-risk melanoma in the ECOG-intergroup phase II trial E2696. J Clin Oncol. 2007;25[18S]: Abstract 8506.
46. Tarhini AA, Stuckert J, Lee S, et al. Prognostic significance of serum S100B protein in high-risk surgically resected melanoma patients participating in Intergroup Trial ECOG 1694. J Clin Oncol. 2009;27:38-44.
47. Gogas H, Ioannovich J, Dafni U, et al. Prognostic significance of au-toimmunity during treatment of melanoma with interferon. N Engl J Med. 2006;354:709-718. (Pubitemid 43247141)
48. Davar D, Tarhini A, Kirkwood JM. Adjuvant therapy: melanoma. J Skin Cancer. 2011;2011:274382.
49. V600E inhibition enhances T-cell recognition of melanoma without affecting lymphocyte function. Cancer Res. 2010;70:5213-5219.
50. Livingston PO, Wong GY, Adluri S, et al. Improved survival in stage III melanoma patients with GM2 antibodies: a randomized trial of adjuvant vaccination with GM2 ganglioside. J Clin Oncol. 1994;12:1036-1044. (Pubitemid 24145334)
51. Eggermont AM, Suciu S, Ruka W, et al. EORTC 18961: Post-operative adjuvant ganglioside GM2-KLH21 vaccination treatment vs observation in stage II (T3-T4N0M0) melanoma: 2nd interim analysis led to an early disclosure of the results. J Clin Oncol. 2008;26[suppl]: Abstract 9004.
52. Hersey P, Coates AS, McCarthy WH, et al. Adjuvant immunotherapy of patients with high-risk melanoma using vaccinia viral lysates of melanoma: results of a randomized trial. J Clin Oncol. 2002;20: 4181-4190. (Pubitemid 35191020)
53. Vantomme V, Boël P, De Plaen E, et al. A new tumor-specific antigenic peptide encoded by MAGE-6 is presented to cytolytic T lymphocytes by HLA-Cw16. Cancer Immun. 2003;3:17.
54. 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-3Ypositive tumors. J Immun-other. 2004;27:124-135. (Pubitemid 38282732)
55. Morton DL, Hsueh EC, Essner R, et al. Prolonged survival of patients receiving active immunotherapy with Canvaxin therapeutic polyvalent vaccine after complete resection of melanoma metastatic to regional lymph nodes. Ann Surg. 2002;236:438-448; discussion 448-449.
56. Morton DL, Mozzillo N, Thompson JF, et al. An international, randomized, phase III trial of bacillus Calmette-Guerin (BCG) plus allo-geneic melanoma vaccine (MCV) or placebo after complete resection of melanoma metastatic to regional or distant sites. J Clin Oncol. 2007;25[18S]: Abstract 8508.
57. Kirkwood JM, Lorigan P, Hersey P, et al. Phase II trial of tremelimumab (CP-675,206) in patients with advanced refractory or relapsed melanoma. Clin Cancer Res. 2010;16:1042-1048.
58. Ribas A, Hauschild A, Kefford R, et al. Phase III, open-label, randomized, comparative study of tremelimumab (CP-675,206) and chemotherapy (temozolomide [TMZ] or dacarbazine [DTIC]) in patients with advanced melanoma. J Clin Oncol. 2008;26[suppl]: Abstract LBA9011.
59. Maio M, et al. Efficacy and safety of ipilimumab in patients with advanced melanoma who had progressed on one or more prior therapies: results from a single-arm, multicenter study. Presented at: European Society for Medical Oncology 2008 (Study 008); September 15, 2008. Poster No. 776PD.
60. Lebbe C, Hoos A, Chin K, et al. Effect of dose on efficacy and safety in ipilimumab-treated patients with advanced melanoma: results from a phase II, randomized, dose-ranging study. Presented at: European Society for Medical Oncology 2008 (Study 022); September 15, 2008. Oral Presentation No. 769O.
61. Ridolfi R, et al. Efficacy and safety of treatment naBve and previously treated patients with advanced melanoma receiving ipilimumab. Presented at: European Society for Medical Oncology 2008 (Study 007); September 15, 2008. Poster no. 778PD.
62. Wolchok JD, Thomas L, Bondarenko IN, et al. Phase III randomized study of ipilimumab (IPI) plus dacarbazine (DTIC) versus DTIC alone as first-line treatment in patients with unresectable stage III or IV melanoma. J Clin Oncol. 2011;29[suppl]: Abstract LBA5.
63. Ribas A, et al. BRIM-2: an open-label, multicenter phase II study of vem-urafenib in previously treated patients with BRAF V600E mutation-positive metastatic melanoma. J Clin Oncol. 2011;29[suppl]: Abstract 8509.
64. Hamid O, Chasalow SD, Tsuchihashi Z, et al. Association of baseline and on study tumor biopsy markers with clinical activity in patients (pts) with advanced melanoma treated with ipilimumab. J Clin Oncol. 2009;27:15s[suppl]: Abstract 9008.
65. Hi regulatory T cells. Int Immunol. 2009;21:1065-1077.
66. Veronesi U, et al. A randomized trial of adjuvant chemotherapy and imm-unotherapy in cutaneous melanoma. N Engl J Med. 1982;307(15):913-916. (Pubitemid 12011039)
67. Lejeune FJ, et al. An assessment of DTIC versus levamisole or placebo in the treatment of high risk stage I patients after surgical removal of a primary melanoma of the skin. A phase III adjuvant study. EORTC protocol 18761. Eur J Cancer Clin Oncol. 1988;24[suppl 2]:S81-S90.
68. Fisher RI, et al. Adjuvant immunotherapy or chemotherapy for malignant melanoma. Preliminary report of the National Cancer Institute randomised clinical trial. Surg Clin North Am. 1981;61(6):1267-1277. (Pubitemid 12152889)
69. Koops HS, et al. Prophylactic isolated limb perfusion for localized, high-risk limb melanoma: results of a multicenter randomized phase III trial. European Organization for Research and Treatment of Cancer Malignant Melanoma Cooperative Group Protocol 18832, the World Health Organization Melanoma Program Trial 15, and the North American Perfusion Group Southwest Oncology Group-8593. J Clin Oncol. 1998;16(9): 2906-2912.
70. DeVita VT, Lawrence TS, Rosenberg SA. DeVita, Hellman, and Rosenberg's Cancer: Principles & Practice of Oncology. Philadelphia, PA: Lippincott Williams & Wilkins; 2008:1929-1930.
71. Agarwala SS, Neuberg D, Park Y, et al. Mature results of a phase III randomized trial of bacillus Calmette-Guerin (BCG) versus observation and BCG plus dacarbazine versus BCG in the adjuvant therapy of American Joint Committee on Cancer Stage IYIII melanoma (E1673): a trial of the Eastern Oncology Group. Cancer. 2004;100:1692-1698. (Pubitemid 38456347)
72. Chang DT, Amdur RJ, Morris CG, et al. Adjuvant radiotherapy for cutaneous melanoma: comparing hypofractionation to conventional fractionation. Int J Radiat Oncol Biol Phys. 2006;66:1051-1055. (Pubitemid 44637160)
73. Henderson MA, Burmeister B, Thompson JF, et al. Adjuvant radiotherapy and regional lymph node field control in melanoma patients after lymp-hadenectomy: results of an intergroup randomized trial (ANZMTG 01.02/TROG 02.01). J Clin Oncol. 2009;27:18s[suppl]: Abstract LBA9084.
74. Weber JS, Yu B, Hall M, et al. Pharmacodynamic and predictive markers of ipilimumab on melanoma patients' T-cells. J Clin Oncol. 2011;29[suppl]: Abstract 2503.
75. Tarhini AA, Edington H, Butterfield LH, et al. Neoadjuvant ipilimumab in patients with stage IIIB/C melanoma: immunogenicity and biomarker analysis. J Clin Oncol. 2011;29[suppl]: Abstract 8536.
76. Sarnaik AA, Yu B, Yu D, et al. Extended dose ipilimumab with a peptide vaccine: immune correlates associated with clinical benefit in patients with resected high-risk stage IIIc/IV melanoma. Clin Cancer Res. 2011;17:896-906.
77. Dematteo RP, Ballman KV, Antonescu CR, et al. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet. 2009;373:1097-1104.
78. Joensuu H, Eriksson M, Hartmann J, et al. Twelve vs 36 months of adjuvant imatinib as treatment of operable GIST with a high risk of recurrence: final results of a randomized trial (SSGXVIII/AIO). Presented at: 2011 ASCO Annual Meeting. Abstract LBA1.