Adjuvant therapy for resected stage III melanoma patients: High-dose interferon-alpha versus ipilimumab combined with kinases inhibitors

Tumori

Volumn 98, Issue 2, 2012, Pages 185-190

  Minutilli, Ettore ^a   Feliciani, Claudio ^a  

^a CATHOLIC UNIVERSITY   (Italy)

Author keywords

High dose interferon alpha; Ipilimumab; Metastatic melanoma; Sentinel node biopsy; Tyrosine kinase inhibitors

Indexed keywords

ALPHA INTERFERON; CANCER VACCINE; CORTICOSTEROID; INTERFERON; IPILIMUMAB; PEGINTERFERON ALPHA; PEGINTERFERON ALPHA2A; PEGINTERFERON ALPHA2B; PLACEBO; PROTEIN TYROSINE KINASE INHIBITOR; SORAFENIB; TICILIMUMAB; ANTINEOPLASTIC AGENT; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4; MACROGOL DERIVATIVE; MONOCLONAL ANTIBODY; PROTEIN KINASE INHIBITOR; PROTEIN TYROSINE KINASE; RECOMBINANT PROTEIN;

ADVANCED CANCER; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER IMMUNIZATION; CANCER RESISTANCE; CANCER RISK; CANCER STAGING; CANCER SURVIVAL; CLINICAL EFFECTIVENESS; DOSE RESPONSE; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG EFFECT; DRUG EFFICACY; DRUG HALF LIFE; DRUG MEGADOSE; DRUG SAFETY; DRUG WITHDRAWAL; EARLY CANCER; GASTROINTESTINAL DISEASE; HIGH RISK PATIENT; HUMAN; IMMUNOPATHOLOGY; LOW DRUG DOSE; MELANOMA; METASTASIS; OUTCOME ASSESSMENT; OVERALL SURVIVAL; RECURRENCE FREE SURVIVAL; REVIEW; RISK ASSESSMENT; SKIN DISEASE; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT; ADJUVANT CHEMOTHERAPY; CLINICAL TRIAL (TOPIC); DISEASE FREE SURVIVAL; DRUG ANTAGONISM; PATHOLOGY; PRACTICE GUIDELINE; SKIN TUMOR; TREATMENT OUTCOME;

ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHEMOTHERAPY, ADJUVANT; CLINICAL TRIALS AS TOPIC; CTLA-4 ANTIGEN; DISEASE-FREE SURVIVAL; HUMANS; INTERFERON-ALPHA; MELANOMA; NEOPLASM STAGING; POLYETHYLENE GLYCOLS; PRACTICE GUIDELINES AS TOPIC; PROTEIN KINASE INHIBITORS; PROTEIN-TYROSINE KINASES; RECOMBINANT PROTEINS; SKIN NEOPLASMS; TREATMENT OUTCOME;

EID: 84864866728     PISSN: 03008916     EISSN: 20382529     Source Type: Journal    
DOI: 10.1177/030089161209800202     Document Type: Review

References (42)

1. Balch CM, Gershenwald JE, Soong SJ, Thompson JF, Atkins MB, Byrd DR, Buzaid AC, Cochran AJ, Coit DG, Ding S, Eggermont AM, Flaherty KT, Gimotty PA, Kirkwood JM, McMasters KM, Mihm MC Jr, Morton DL, Ross MI, Sober AJ, Sondak VK: Final version of 2009 AJCC melanoma staging and classification. J Clin Oncol, 27: 6199-6206, 2009.
2. van Akkooi AC, Nowecki ZI, Voit C, Schafer-Hesterberg G, Michej W, de Wilt JH, Rutkowski P, Verhoef C, Eggermont AM: Sentinel node tumor burden according to the Rotterdam criteria is the most important prognostic factor for survival in melanoma patients: a multicenter study in 388 patients with positive sentinel nodes. Ann Surg, 248: 949-955, 2008.
3. van der Ploeg AP, van Akkooi AC, Schmitz PI, Kolienovic S, Verhoef C, Eggermont AM: EORTC Melanoma Group sentinel node protocol identifies high rate of submicrometastases according to Rotterdam Criteria. Eur J Cancer, 46: 2414-2421, 2010.
4. van der Ploeg AP, van Akkooi AC, Rutkowski P, Nowecki ZI, Michej W, Mitra A, Newton-Bishop JA, Cook M, van der Ploeg IM, Nieweg OE, van den Hout MF, van Leeuwen PA, Voit CA, Cataldo F, Testori A, Robert C, Hoekstra HJ, Verhoef C, Spatz A, Eggermont AM: Prognosis in patients with sentinel node-positive melanoma is accurately defined by the combined Rotterdam tumor load and Dewar topography criteria. J Clin Oncol, 29: 2206-2214, 2011.
5. Balch CM, Gershenwald JE, Soong SJ, Thompson JF, Ding S, Byrd DR, Cascinelli N, Cochran AJ, Coit DG, Eggermont AM, Johnson T, Kirkwood JM, Leong SP, McMasters KM, Mihm MC Jr, Morton DL, Ross MI, Sondak VK: Multivariate analysis of prognostic factors among 2,313 patients with stage III melanoma: comparison of nodal micrometastases versus macrometastases. J Clin Oncol, 28: 2452-2459, 2010.
6. Kirkwood JM, Strawderman MH, Ernstoff MS, Smith TJ, Borden EC, Blum RH: Interferon alfa-2b adjuvant therapy of high-risk resected cutaneous melanoma: the Eastern Cooperative Oncology Group Trial EST 1684. J Clin Oncol, 14: 7-17, 1996. (Pubitemid 26019991)
7. Kirkwood JM, Ibrahim JG, Sondak VK, Richards J, Flaherty LE, Ernstoff MS, Smith TJ, Rao U, Steele M, Blum RH: High- and low-dose interferon alfa-2b in high-risk melanoma: first analysis of intergroup trial E1690/S9111/C9190. J Clin Oncol, 18: 2444-2458, 2000. (Pubitemid 30415832)
8. Kirkwood JM, Ibrahim JG, Sosman JA, Sondak VK, Agarwala SS, Ernstoff MS, Rao U: High-dose interferon alpha-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 intergroup trial E1694/S9512/C509801. J Clin Oncol, 19: 2370-2380, 2001. (Pubitemid 32391207)
9. Agarwala SS: Randomized phase III trial of high-dose interferon alpha-2b (HDI) for 4 weeks induction only in patients with intermediate- and high-risk melanoma (Intergroup trial E 1697) [abstract 8505]. J Clin Oncol, 29S, 2011.
10. Eggermont AM, Suciu S, MacKie R, Ruka W, Testori A, Kruit W, Punt CJ, Delauney M, Sales F, Groenewegen G, Ruiter DJ, Jagiello I, Stoitchkov K, Keilholz U, Lienard D; EORTC Melanoma Group: Post-surgery adjuvant therapy with intermediate doses of interferon alfa-2b versus observation in patients with stage IIb/III melanoma (EORTC 18952): randomized controlled trial. Lancet, 366(9492): 1189-1196, 2005. (Pubitemid 41393597)
11. Hansson J, Aamdal S, Bastholt L, Brandberg Y, Hernberg M, Nilsson B, Stierner U, von der Maase H; Nordic Melanoma Cooperative Group: Two different durations of adjuvant therapy with intermediate-dose interferon alpha-2b in patients with high-risk melanoma (Nordic IFN trial): a randomized phase 3 trial. Lancet Oncol, 12: 144-152, 2011.
12. Wheatley K, Ives N, Hancock B, Gore M, Eggermont A, Suciu S: Does adjuvant interferon-alpha for high-risk melanoma provide a worthwhile benefit? A metaanalysis of the randomised trials. Cancer Treat Rev, 29: 241-252, 2003. (Pubitemid 37069655)
13. Wheatley K: Interferon-α as adjuvant therapy for melanoma: an individual patient data meta-analysis of randomized trials [abstract]. Proc Am Soc Clin Oncol, 25: 478S, 2007.
14. Mocellin S, Pasquali S, Rossi CR, Nitti D: Interferon alpha adjuvant therapy in patients with high-risk melanoma: a systematic review and meta-analysis. J Natl Cancer Inst, 102: 493-501, 2010.
15. Eggermont AM, Suciu S, Santinami M, Testori A, Kruit WH, Marsden J, Punt CJ, Salès F, Gore M, Mackie R, Kusic Z, Dummer R, Hauschild A, Musat E, Spatz A, Keilholz U; EORTC Melanoma Group: Adjuvant therapy with pegylated interferon alpha-2b versus observation alone in resected stage III melanoma: final results of EORTC 18991, a randomized phase III trial. Lancet, 372: 117-126, 2008. (Pubitemid 351952257)
16. Eggermont AM: EORTC 18991 phase III trial: long-term adjuvant pegylated interferon-α2b (PEG-IFN) versus observation in resected stage III melanoma: long-term results at 7.6-years follow-up [abstract 8506b]. J Clin Oncol, 29S, 2011.
17. Dummer R, Garbe C, Thompson JA, Eggermont AM, Yoo K, Maier T, Bergstrom B: Randomized dose-escalation study evaluating peg-interferon alpha-2a in patients with metastatic malignant melanoma. J Clin Oncol, 24: 1188-1194, 2006. (Pubitemid 46638817)
18. Ascierto PA, Kirkwood JM: Adjuvant therapy of melanoma with interferon: lessons of the past decade. J Trans Med, 6: 62, 2008.
19. Elliott B, Scolyer RA, Suciu S, Lebecque S, Rimoldi D, Gugerli O, Musat E, Sharma RN, Lienard D, Keilholz U, Testori A, Eggermont A, MacKie R, Robert C, Cook M, Thompson JF, Angevin E, Spatz A; European Organization for Research and Treatment of Cancer Melanoma Group: Long-term protective effect of mature DC-LAMP+ dendritic cell accumulation in sentinel lymph nodes containing micrometastatic melanoma. Clin Cancer Res, 13: 3825-3830, 2007. (Pubitemid 47037587)
20. Ott PA, Hamilton A, Min C, Safarzadeh-Amiri S, Goldberg L, Yoon J, Yee H, Buckley M, Christos PJ, Wright JJ, Polsky D, Osman I, Liebes L, Pavlick AC: A phase II trial of sorafenib in metastatic melanoma with tissue correlates. PLos One, 5: e15588, 2010.
21. Chapman PB, Hauschild A, Robert C, Haanen JB, Ascierto P, Larkin J, Dummer R, Garbe C, Testori A, Maio M, Hogg D, Lorigan P, Lebbe C, Jouary T, Schadendorf D, Ribas A, O'Day SJ, Sosman JA, Kirkwood JM, Eggermont AM, Dreno B, Nolop K, Li J, Nelson B, Hou J, Lee RJ, Flaherty KT, McArthur GA; BRIM-3 Study Group: Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med, 364: 2507-2516, 2011.
22. Flaherty KT, Puzanov I, Kim KB, Ribas A, McArthur GA, Sosman JA, O'Dwyer PJ, Lee RJ, Grippo JF, Nolop K, Chapman PB: Inhibition of mutated, activated BRAF in metastatic melanoma. N Engl J Med, 363: 809-819, 2010.
23. Egberts F, Gutzmer R, Ugurel S, Becker JC, Trefzer U, Degen A, Schenck F, Frey L, Wilhelm T, Hassel JC, Schadendorf D, Livingstone E, Mauch C, Garbe C, Berking C, Rass K, Mohr P, Kaehler KC, Weichenthal M, Hauschild A: Sorafenib and pegylated interferon-alpha-2b in advanced metastatic melanoma: a multicenter phase II DeCOG trial. Ann Oncol, 22: 1667-1674, 2011.
24. 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, Lebbè C, Peschel C, Quirt I, Clark JI, Wolchok JD, Weber JS, Tian J, Yellin MJ, Nichol GM, Hoos A, Urba WJ: Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med, 363: 711-723, 2010.
25. Wolchok JD, Neyns B, Linette G, Negrier S, Lutzky J, Thomas L, Waterfield W, Schadendorf D, Smylie M, Guthrie T Jr, Grob JJ, Chesney J, Chin K, Chen K, Hoos A, O'Day SJ, Lebbé C: Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol, 11: 155-164, 2010.
26. O'Day SJ, Maio M, Chiarion-Sileni V, Gajewski TF, Pehamberger H, Bondarenko IN, Queirolo P, Lundgren L, Mikhailov S, Roman L, Verschraegen C, Humphrey R, Ibrahim R, de Pril V, Hoos A, Wolchok JD: Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter single-arm phase II study. Ann Oncol, 21: 1712-1717, 2010.
27. Ku GY, Yuan J, Page DB, Schroeder SE, Panageas KS, Carvajal RD, Chapman PB, Schwartz GK, Allison JP, Wolchok JD: 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, 2010.
28. Stoffels I, Dissemond J, Korber A, Schulz A, Hillen U, Schadendorf D, Klode J: Reliability and cost-effectiveness of sentinel lymph node excision under local anaesthesia versus general anaesthesia for malignant melanoma. J Eur Acad Dermatol Venereol, 25: 306-310, 2011.
29. Stoffels I, Poeppel T, Boy C, Mueller S, Wichmann F, Dissemond J, Schadendorf D, Rosenbaum-Krumme S, Klode J: Radio-guided surgery: advantages of a new portable γ-camera (Sentinella) for intraoperative real time imaging and detection of sentinel lymph nodes in cutaneous malignancies. J Eur Acad Dermatol Venereol, 26: 308-313, 2012.
30. Okuyama S, Gonzalez R, Lewis KD: Pegylated interferon alpha-2b as adjuvant treatment of stage III malignant melanoma: an evidence-based review. Core Evidence, 5: 39-48, 2010.
31. Eggermont AM, Robert C: New drugs in melanoma: it's a whole new world. Eur J Cancer, 47: 2150-2157, 2011.
32. Tarhini AA: Neoadjuvant ipilimumab in patients with stage IIIB/C melanoma: immunogenicity and biomarker analysis [abstract 8536]. J Clin Oncol, 29S, 2011.
33. Khan N, Khan MK, Almasan A, Singh AD, Macklis R: The evolving role of radiation therapy in the management of malignant melanoma. Int J Radiation Oncology Biol Phys, 80: 645-654, 2011.
34. Agrawal S, Kane JM 3rd, Guadagnolo BA, Kraybill WG, Ballo MT: The benefits of adjuvant radiation therapy after therapeutic lymphadenectomy for clinically advanced, high-risk, lymph node-metastatic melanoma. Cancer, 115: 5836-5844, 2009.
35. Henderson MA: Adjuvant radiotherapy and regional lymph node field control in melanoma patients after lymphadenectomy: results of an intergroup randomized trial [abstract LBA9084]. J Clin Oncol, 27: 18s, 2009.
36. van der Ploeg AP, van Akkooi AC, Schmitz PI, van Geel AN, de Wilt JH, Eggermont AM, Verhoef C: Therapeutic surgical management of palpable melanoma groin metastases: superficial or combined superficial and deep groin lymph node dissection. Ann Surg Oncol, 18: 3300-3308, 2011.
37. Ascierto PA, De Maio E, Bertuzzi S, Palmieri G, Halaban R, Hendrix M, Kashani-sabet M, Ferrone S, Wang E, Cochran A, Rivoltini L, Lee PP, Fox BA, Kirkwood JM, Ullmann CD, Lehmann FF, Sznol M, Schwartzentruber DJ, Maio M, Flaherty K, Galon J, Ribas A, Yang J, Stroncek DF, Mozzillo N, Marincola FM: Future perspectives in melanoma research. Meeting report from the "Melanoma Research: a bridge Naples-USA. Naples, December 6th-7th 2010". J Transl Med, 9: 32, 2011.
38. Simons DL, Lee G, Kirkwood JM, Lee PP: Interferon signaling patterns in peripheral blood lymphocytes may predict clinical outcome after high-dose interferon therapy in melanoma patients. J Transl Med, 9: 52, 2011.
39. Bouwhuis MG, ten Hagen TL, Eggermont AM: Immunologic functions as prognostic indicators in melanoma. Mol Oncol, 5: 183-189, 2011.
40. Romano E, Schwartz GK, Chapman PB, Wolchock JD, Carvajal RD: Treatment implications of the emerging molecular classification system for melanoma. Lancet Oncol, 12: 913-922, 2011.
41. Eggermont AM, Suciu S, Testori A, Kruit WH, Marsden J, Punt CJ, Santinami M, Salès F, Schadendorf D, Patel P, Dummer R, Robert C, Keilholz U, Yver A, Spatz A: 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, 48: 218-225, 2012.
42. Blank CU, Hooijkaas AI, Haanen JB, Schumacher TN: Combination of targeted therapy and immunotherapy in melanoma. Cancer Immunol Immunother, 60: 1359-1371, 2011.