Adjuvant therapy for malignant melanoma

REFERENCES

• Lamberg L. Epidemic of malignant melanoma: true increase or better detection? JAIVIA 287(17), 2201 (2002).
   Google Scholar
• Balch CM, Buzaid AC, Soong SJ et al. Final version of the American Joint Committee on Cancer staging system for cutaneous melanoma. J. Clin. Onto'. 19(16), 3635–3648 (2001).
   Google Scholar
• •Contains the updated staging system for melanoma.
   Google Scholar
• Nestle FO, Burg G, Dummer R. New perspectives on immunobiology and immunotherapy of melanoma. Immund Today20(1), 5–7 (1999).
   PubMed Web of Science ®Google Scholar
• Kirkwood JM, Strawderman MET, Ernstoff MS, Smith TJ, Borden EC, Blum RII. Interferon a2, adjuvant therapy ofhigh-risk resected cutaneous melanoma: the Eastern Co-operative Oncology Group Trial EST 1684../ Clin. Oncol. 14(1), 7–17 (1996).
   Google Scholar
• •Includes the trial results that prompted FDA approval of interferon (IFN)-a for Stage III melanoma.
   Google Scholar
• Kirkwood JM, Ibrahim JG, Sondak VK et al High- and low-dose interferon-a2b in high-risk melanoma: first analysis of intergroup trial E1690/S9111/C9190. Clin. Oncol 18(12), 2444–2458 (2000).
   Google Scholar
• •Another large study supporting the benefit of high-dose IFN-a on relapse-free survival.
   Google Scholar
• Kirkwood JM, Ibrahim JG, Sosman JA et al High-dose interferon-a2b significantly prolongs relapse-free and overall survival compared with the GM2-KLH/QS-21 vaccine in patients with resected stage JIB—ITT melanoma: results of Intergroup trial E1694/S9512/C509801. j Clin. Oncol 19(9), 2370–2380 (2001).
   Google Scholar
• Meyskens FL Jr, Kopecky K, Samson M et al Recombinant human interferon-y: adverse effects in high-risk stage I and II cutaneous malignant melanoma. j Natl Cancer Inst. 82(12), 1071 (1990).
   Google Scholar
• Meyskens FL Jr, Kopecky KJ, Taylor CW et al Randomized trial of adjuvant human interferon-y versus observation in high-risk cutaneous melanoma: a Southwest Oncology Group study. J. Natl Cancer Inst. 87(22), 1710–1713 (1995).
   PubMedGoogle Scholar
• Sabel MS, Sondak VK. Pros and cons of adjuvant interferon in the treatment of melanoma. Oncologist 8(5), 451–458 (2003).
   PubMed Web of Science ®Google Scholar
• Kefford RF. Adjuvant therapy of cutaneous melanoma: the interferon debate. Ann. Oncol 14(3), 358–365 (2003). itPfeffer LM, Dinarello CA, Herberman RB et al Biological properties of recombinant a-interferons: 40th anniversary of the discovery of interferons. Cancer Res. 58(12), 2489–2499 (1998).
   Google Scholar
• Frank SJ, Meyer M. Interferon as adjuvant therapy for high risk melanoma. Melanoma Lett. 13,1–4 (1995).
   Google Scholar
• Parkinson DR, Houghton AN, Hersey P, Borden E. In: Cutaneous Melanoma. Balch CM, Houghton AN, Milton GW (Eds), JB Lippincott, PA, USA, 523–524 (1992).
   Google Scholar
• Atzpodien J, Kirchner H, Jonas U et al Interleukin-2- and interferon-a2,-based immunochemotherapy in advanced renal cell carcinoma: a prospectively randomized trial of the German Co-operative Renal Carcinoma Chemoimmunotherapy Group (DGCIN) Clin. Oncol 22 (7), 1188–1194 (2004).
   Google Scholar
• Astsaturov I, Petrella T, Bagriacik EU et al. Amplification of virus-induced antimelanoma T-cell reactivity by high-dose interferon-a2b: implications for cancer vaccines. Clin. Cancer Res. 9(12), 4347–4355 (2003).
   Google Scholar
• Williams MV, De Takats P, Parmar M. Survival benefit in melanoma. j Clin. Oncol 15(5), 2172 (1997).
   Google Scholar
• Kirkwood JM, Ibrahim J, Manola J. High-dose interferon versus GM2 vaccine in high-risk malignant melanoma: letter. Clin. Oncol 19(23), 4350 (2001).
   Google Scholar
• Kirkwood JM, Manola J, Ibrahim J, Sondak V, Ernstoff MS, Rao U. A pooled analysis of Eastern Co-operative Oncology Group and Intergroup trials of adjuvant high-dose interferon for melanoma. Clin. Cancer Res. 10(5), 1670–1677 (2004).
   PubMed Web of Science ®Google Scholar
• ••Updated analysis on the pivotal high-doseIFN-a cooperative group trials.
   Google Scholar
• Gonzalez-Larriba JL, Serrano S, Alvarez-Mon M et al Cost-effectiveness analysis of interferon as adjuvant therapy in high-risk melanoma patients in Spain. Eur j Cancer36(18), 2344–2352 (2000).
   PubMed Web of Science ®Google Scholar
• Hillner BE, Kirkwood JM, Atkins MB, Johnson ER, Smith TJ. Economic analysis of adjuvant interferon-a2b in high-risk melanoma based on projections from Eastern Co-operative Oncology Group 1684../. Clin. Onto]. 15(6), 2351–2358 (1997).
   Google Scholar
• Creagan ET, Dalton RJ, Ahmann DL et al Randomized, surgical adjuvant clinical trial of recombinant interferon-a2b in selected patients with malignant melanoma. j Clin. Oncol 13(11), 2776–2783 (1995).
   Google Scholar
• Lens MB, Dawes M. Interferon-a therapy for malignant melanoma: a systematic review of randomized controlled trials. Clin. Oncol 20(7), 1818–1825 (2002).
   Web of Science ®Google Scholar
• Morton DL. Sentinel node mapping and an International Sentinel Node Society: current issues and future directions. Ann. Surg. Oncolll (Suppl. 3), 137S-143S (2004).
   Google Scholar
• McMasters KM. The Sunbelt Melanoma Trial. Ann. Surg. Oncol 8\(Suppl. 9), 41S-43S (2001).
   Google Scholar
• Cascinelli N, Bufalino R, Morabito A, Mackie R. Results of adjuvant interferon study in WHO melanoma programme. Lancet 343(8902), 913–914 (1994).
   PubMed Web of Science ®Google Scholar
• Cascinelli N, Belli F, MacKie RM, Santinami M, Bufalino R, Morabito A. Effect of long-term adjuvant therapy with interferon-a& in patients with regional node metastases from cutaneous melanoma: a randomised trial. Lancet 358(9285), 866–869 (2001).
   PubMed Web of Science ®Google Scholar
• Cameron DA, Cornbleet MC, Mackie RM et al Adjuvant interferon-a2b in high risk melanoma — the Scottish study. BE Cancer84(9), 1146–1149 (2001).
   Google Scholar
• Kleeberg UR, Suciu S, Brocker EB et al Final results of the EORTC 18871/DKG 80–1 randomised Phase III trial. rIFN-a2b versus rIFN-y versus ISCADOR M versus observation after surgery in melanoma patients with either high-risk primary (thickness >3 mm) or regional lymph node metastasis. Eur.j Cancer 40(3), 390–402 (2004).
   Google Scholar
• Hancock BW, Wheatley K, Harris S et al Adjuvant interferon in high-risk melanoma: the MM HIGH Study-United Kingdom Co-ordinating Committee on Cancer Research randomized study of adjuvant low-dose extended-duration interferon-a& in high-risk resected malignant melanoma. Clin. Oncol 22(1), 53–61 (2004).
   Web of Science ®Google Scholar
• Schuchter LM. Adjuvant interferon therapy for melanoma: high-dose, low-dose, no dose, which dose?' Clin. Oncol 22(1), 7–10 (2004).
   Google Scholar
• Rusciani L, Petraglia S, Alotto M, Calvieri S, Vezzoni G. Postsurgical adjuvant therapy for melanoma. Evaluation of a 3-year randomized trial with recombinant interferon-a after 3 and 5 years of follow-up. Cancer79(12), 2354–2360 (1997).
   Google Scholar
• Grob JJ, Dreno B, de la Salmoniere P et al Randomised trial of interferon-a& as adjuvant therapy in resected primary melanoma thicker than 1.5 mm without clinically detectable node metastases. French Co-operative Group on Melanoma. Lancet 351(9120), 1905-1910 (1998).
   Google Scholar
• Pehamberger H, Soyer HP, Steiner A et al Adjuvant interferon-a& treatment in resected primary stage II cutaneous melanoma. Austrian Malignant Melanoma Co-operative Group. j Clin. Oncol 16(4), 1425–1429 (1998).
   Google Scholar
• Hauschild A, Weichenthal M, Balda BR et al Prospective randomized trial of interferon-a2b and interleukin-2 as adjuvant treatment for resected intermediate- and high-risk primary melanoma without clinically detectable node metastasis. j Clin. Oncol 21(15), 2883–2888 (2003).
   Google Scholar
• Eggermont AM, Kleeberg UR, Ruiter DJ, Suciu S. European Organization for Research and Treatment of Cancer Melanoma Group trial experience with more than 2,000 patients, evaluating adjuvant treatment with low or intermediate doses of interferon-a2b. In: American Society of Clinical Oncology Educational Book, 88–93 (2001).
   Google Scholar
• Eggermont AM, Punt CJ. Does adjuvant systemic therapy with interferon-a for stage II—III melanoma prolong survival? Am. Clin. Detmatol 4(8), 531–536 (2003). vaccines. Immunol Rev 188,147–154 (2002).
   Google Scholar
• Von Wussow P, Mohr P. Adjuvant intermittent high-dose interferon-aa, therapy in stage TIC/ITT malignant melanoma: a Phase II study. Proc. Am. Soc. Clin. Oncol 22 (2003) (Abstract 2912).
   Google Scholar
• Dranoff. GM-CSF-bwdonor vacant* Immiml for. 188. 147–154 (2002).
   Google Scholar
• Dranoff G, Jaffee E, Lazenby A et al Vaccination with irradiated tumor cells engineered to secrete murine granulocyte—macrophage colony- stimulating factor stimulates potent,
   Google Scholar
• Soiffer R, Lynch T, Mihm M et al Varclr-jlli>Ti with IiraDUira aiitolcgiau m-lanoma cdb enginronl to wctmf human granifotylc-mjcfDplnj^ inlaiy simulating fxtor goirraia pou-ra wtMimacr immunity in pjtimo »ith mrunxic melanoma. /Jrc Xh/AgkI 5a. ISA 95(22). 13141-13M6 (190ft
   Google Scholar
• Mach N, Gillessen S, Wilson SB, stimulating factor or F1t3-ligand. Cancer Res. 60(12), 3239–3246 (2000).
   Google Scholar
• Haddad D, Ramprakash J, Sedegah Metal. granulocyte—macrophage colony-stimulating factor attracts infiltrates including immature dendritic cells into injected muscles. J. Immunol 165(7),
   Google Scholar
• Kass E, Panicali DL, Mazzara G, Schlom J, Greiner JW. Granulocyte/macrophage colony-stimulating factor produced by regional lymph nodes with antigen- presenting cells and acts as an immunoadjuvant. Cancer Res. 61 (1), 206–214 (2001).
   PubMed Web of Science ®Google Scholar
• Spitler LE, Grossbard ML, Ernstoff MS et al. Adjuvant therapy of stage III and IV malignant melanoma using
   Google Scholar
• Weber J, Sondak VK, Scotland R et al Granulocyte—macrophage colony-stimulating factor added to a multipeptide vaccine for resected Stage II melanoma. Cancer 97 (1), 186–200 (2003) .
   PubMed Web of Science ®Google Scholar
• Atkins MB. Interleukin-2: clinical applications, jemm. Uhcol. 29(3 Suppl. 7), 12-17(2002).
   Google Scholar
• ClarkJI, Atkins MB, Urba WJ et al. Adjuvant high-dose bolus interleukin-2 for patients with high-risk renal cell carcinoma: a cytokine working group randomized trial. Clin. Oncol 21(16), 3133–3140 (2003).
   Google Scholar
• Elias EG, Zapas JL, Beam SL, Brown SD. Granulocyte—macrophage colony stimulating factor (GM-CSF) and interleukin-2 (IL-2) combination as adjuvant therapy in cutaneous melanoma. Early results of a Phase II clinical trial. Proc. Am. Soc. Clin. Oncol (2004) (Abstract 7559).
   Google Scholar
• Bystryn JC, Zeleniuch-Jacquotte A, Oratz R, Shapiro Fl, Harris MN, Roses DF. Double-blind trial of a polyvalent, shed-antigen, melanoma vaccine. Clin. Cancer Res. 7(7), 1882–1887 (2001).
   PubMed Web of Science ®Google Scholar
• Sondak VK, Liu PY, Tuthill RJ et al Adjuvant immunotherapy of resected, intermediate-thickness, node-negative melanoma with an allogeneic tumor vaccine: overall results of a randomized trial of the Southwest Oncology Group. j Clin. Oncol 20(8), 2058–2066 (2002).
   Google Scholar
• Sosman JA, Unger JM, Liu PY et al Adjuvant immunotherapy of resected, intermediate-thickness, node-negative melanoma with an allogeneic tumor vaccine: impact of HLA class I antigen expression on outcome. j Clin. Oncol 20(8), 2067–2075 (2002).
   Google Scholar
• •Suggests that there may be a survival benefit for human leukocyte antigen (HLA)-A2 and -C3 patients treated with an allogeneic whole-cell vaccine in the adjuvant setting.
   Google Scholar
• Hsueh EC, Morton DL. Antigen-based immunotherapy of melanoma: Canvaxin therapeutic polyvalent cancer vaccine. Semin. Cancer Biol. 13(6), 401–407 (2003).
   PubMed Web of Science ®Google Scholar
• Schadendorf D, Nestle FO, Broecker E-B et al Dacarbazine (DTIC) versus vaccination with autologous peptide-pulsed dendritic cells (DC) as first-line treatment of patients with metastatic melanoma: results of a prospective-randomized Phase III study. Proc. Am. Soc. Clin. Oncol (2004) (Abstract 7508).
   Google Scholar
• Kirkwood JM, Lee S, Land S et al E1696: final analysis of the clinical and immunological results of a multicenter ECOG Phase II trial of multi-epitope peptide vaccination for stage IV melanoma with MART-1 (27–35), gp100 (209–217, 210M), and tyrosinase (368–376,370D) (MGT) ± IFN-a2, and GM-CSE Proc. Am. Soc. Clin. Oncol (2004) (Abstract 7502).
   Google Scholar
• Chambers CA, Kuhns MS, Egen JG, Allison JR CTLA-4-mediated inhibition in regulation of T-cell responses: mechanisms and manipulation in tumor immunotherapy. Ann. Rev Immunol 19, 565–594 (2001).
   Google Scholar
• Casares N, Arribillaga L, Sarobe P et al CD4*/CD25* regulatory cells inhibit activation of tumor-primed CD4+ T-cells with IFN-y-dependent anti-angiogenic activity, as well as long-lasting tumor immunity elicited by peptide vaccination. Imumno1171(11), 5931–5939 (2003).
   Google Scholar
• Eigentler TK, Caroli UM, Radny P, Garbe C. Palliative therapy of disseminated malignant melanoma: a systematic review of 41 randomised clinical trials. Lancet Oncol 4(12), 748–759 (2003).
   Google Scholar
• Bajetta E, Del Vecchio M, Bernard-Marty C et al. Metastatic melanoma: chemotherapy. Semin. Oncol 29(5), 427–445 (2002).
   PubMed Web of Science ®Google Scholar
• Veronesi U, Adamus J, Aubert C et al A randomized trial of adjuvant chemotherapy and immunotherapy in cutaneous melanoma. N Engl. I Merl 307(15), 913–916 (1982).
   Google Scholar
• Lejeune F, Macher E, Kleeberg UR. 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 thee skin: a Phase III adjuvant study. EORTC protocol 18761. Eur j Cancer Clin. Oncol 24,81–90 (1988).
   Google Scholar
• Hill GJ II, Moss SE, Golomb FM et al DTIC and combination therapy for melanoma: III. DTIC (NSC 45388) Surgical Adjuvant Study COG Protocol 7040. Cancer47(11), 2556–2562 (1981).
   Google Scholar
• Banzet P, Jacquillat C, Civatte J et al Adjuvant chemotherapy in the management of primary malignant melanoma. Cancer 41(4), 1240–1248 (1978).
   PubMed Web of Science ®Google Scholar
• Retsas S, Quigley M, Pectasides D, Macrae K, Henry K. Clinical and histologic involvement of regional lymph nodes in malignant melanoma. Adjuvant vindesine improves survival. Cancer 73(8), 2119–2130 (1994).
   Google Scholar
• Hansson J, Ringborg U, Lagerlof B, Strander H. Adjuvant chemotherapy of malignant melanoma. A pilot study. Am. Clin. Oncol 8(1), 47–50 (1985).
   Google Scholar
• Tranum BL, Dixon D, Quagliana J et al Lack of benefit of adjunctive chemotherapy in stage I malignant melanoma: a Southwest Oncology Group Study. Cancer 7i-eat. Rep. 71(6), 643–644 (1987).
   Google Scholar
• Karakousis CP, Emrich U. Adjuvant treatment of malignant melanoma with DTIC plus estracyt or BCG. I Surg. Oncol 36(4), 235–238 (1987).
   Google Scholar
• Karakousis C, Blumenson L. Adjuvant chemotherapy with a nitrosourea-based protocol in advanced malignant melanoma. Eurj Cancer29A(13), 1831–1835 (1993).
   PubMed Web of Science ®Google Scholar
• Pectasides D, Alevizakos N, Bafaloukos D et al Adjuvant chemotherapy with dacarbazine, vindesine, and cisplatin in pathological stage II malignant melanoma. Ainj Clin. Oncol 17(1), 55–59 (1994).
   Google Scholar
• Kretschmer L, Helmbold P, Emmert S, Marsch WC. Long-term results of adjuvant chemotherapy after therapeutic lymph node dissection in patients with cutaneous malignant melanoma. Hautatzt 53(8), 536–541 (2002).
   PubMed Web of Science ®Google Scholar
• Spitler LE. A randomized trial of levamisole versus placebo as adjuvant therapy in malignant melanoma. J. Clin. Oncol 9(5), 736–740 (1991).
   Google Scholar
• Markovic S, Suman VJ, Dalton RJ et al Randomized, placebo-controlled, Phase III surgical adjuvant clinical trial of megestrol acetate (Megace) in selected patients with malignant melanoma. Am. J. Clin. Oncol 25(6), 552–556 (2002).
   Google Scholar
• Thatcher N, Mene A, Banerjee SS, Craig P, Gleave N, Orton, C. Randomized study of Corynebacteriumparvum adjuvant therapy following surgery for (stage II) malignant melanoma. Br. Surg. 73 (2), 111–115 (1986).
   Google Scholar
• Meyskens FL Jr, Liu PY, Tuthill RJ et al Randomized trial of vitamin A versus observation as adjuvant therapy in high-risk primary malignant melanoma: a Southwest Oncology Group study. J. Clin. Oncol 12(10), 2060-2065 (1994).
   Google Scholar
• Middleton MR, Grob JJ, Aaronson N et al Randomized Phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma. J. Clin. Oncol 18(1), 158–166 (2000).
   Google Scholar
• •Supports the use of temozolomide in the metastatic setting.
   Google Scholar
• Bafaloukos D, Aravantinos G, Fountzilas G et al Docetaxel in combination with dacarbazine in patients with advanced melanoma. Oncology63(4), 333–337 (2002).
   PubMed Web of Science ®Google Scholar
• Damon S, Lorigan P, Arance A et al. Randomized Phase II study of temozolomide given every 8 h or daily with either interferon-aa, or thalidomide in metastatic malignant melanoma. J. Clin. Oncol 21(13), 2551–2557 (2003).
   Google Scholar
• Hwu WJ, Krown SE, Menell JH etal. Phase II study of temozolomide plus thalidomide for the treatment of metastatic melanoma.j Clin. awl 21(17), 3351–3356 (2003).
   Google Scholar
• Rajkumar SV. Current status of thalidomide in the treatment of cancer. Oncology aluntingt) 15 (7), 867–874 (2001) .
   PubMed Web of Science ®Google Scholar
• Eisen T, Boshoff C, Mak I et al Continuous low-dose thalidomide: a Phase II study in advanced melanoma, renal cell, ovarian and breast cancer. BE J. Cancer 82 (4), 812–817 (2000) .
   Web of Science ®Google Scholar
• Hwu WJ, Coit DG, Jaques D, Panageas KS, Lamb LA, Quinn CJ. Temodar and thalidomide as adjuvant therapy in patients with stage III and IV malignant melanoma. Proc. Am. Soc. Clin. Oncol (2004) (Abstract 7574).
   Google Scholar
• El-Maraghi R, Verma S, Charette M, Markman B, Quirt I. A meta-analysis of biochemotherapy (BCT) for the treatment of metastatic malignant melanoma (MM). Pmc. Am. Soc. Clin. Oncol (2004) (Abstract 7529).
   Google Scholar
• Sasson HN, Poo WJ, Bakas MET, Ariyan S. Prolonged survival in patients with advanced melanoma treated with neoadjuvant chemotherapy followed by resection. Ann. Bast. Surg: 37(3), 286–292 (1996).
   Google Scholar
• Buzaid AC, Colome M, Bedikian A et al. Phase II study of neoadjuvant concurrent biochemotherapy in melanoma patients with local-regional metastases. Melanoma Res. 8(6), 549–556 (1998).
   Google Scholar
• Creagan ET, Cupps RE, Ivins JC et al. Adjuvant radiation therapy for regional nodal metastases from malignant melanoma: a randomized, prospective study. Cancer 42(5), 2206–2210 (1978).
   PubMed Web of Science ®Google Scholar
• Ang KK, Peters LJ, Weber RS et al. Postoperative radiotherapy for cutaneous melanoma of the head and neck region. Int. Radiat. Oncol Biol. Phys. 30(4), 795–798 (1994).
   Google Scholar
• •Nonrandomized data that suggests a role for adjuvant radiation therapy and lends support to a randomized Phase HI trial.
   Google Scholar
• Owens JM, Roberts DB, Myers JN. The role of postoperative adjuvant radiation therapy in the treatment of mucosal melanomas of the head and neck region. Arch. Otolaryngiol Head Neck Sur& 129(8), 864–868 (2003).
   Google Scholar
• Bonnen MD, Ballo MT, Myers JN et al Adjuvant radiotherapy for cutaneous melanoma of the head and neck. Proc. Am. Soc. Clin. Oncol (2002) (Abstract 1397).
   Google Scholar
• Shen P, Wanek LA, Morton DL. Is adjuvant radiotherapy necessary after positive lymph node dissection in head and neck melanomas? Ann. Sing Oncol 7(8), 554–559 (2000).
   PubMed Web of Science ®Google Scholar
• Ballo MT, Ang K.K. Radiotherapy for cutaneous malignant melanoma: rationale and indications. Oncology ffluntingt)18(1), 99–107 (2004).
   PubMed Web of Science ®Google Scholar
• Ballo MT, Bonnen MD, Garden AS et al Adjuvant irradiation for cervical lymph node metastases from melanoma. Cancer 97(7), 1789–1796 (2003).
   PubMed Web of Science ®Google Scholar
• Pawlik TM, Sondak VK. Malignant melanoma: current state of primary and adjuvant treatment. Grit. Rev Oncol Hematol 45(3), 245–264 (2003).
   PubMed Web of Science ®Google Scholar