Zusammenfassung
Das maligne Melanom stellt derzeit mit 4–5% aller Tumoren des Menschen und steigender Inzidenz eine der häufigsten Krebsarten dar. Basierend auf interdisziplinär erstellten Leitlinien ist die Versorgung von Melanompatienten in Deutschland weitgehend standardisiert. Dennoch ist festzustellen, dass die therapeutischen Ergebnisse sowohl für die adjuvante, insbesondere aber für die palliative Therapie des Melanoms unbefriedigend sind. Daher besteht zum gegenwärtigen Zeitpunkt ein großer Bedarf an kontrollierten klinischen Studien mit dem Ziel, bisherige Therapieverfahren zu optimieren und den Einsatz neuer Substanzen zu prüfen. Die Behandlung betroffener Patienten im Rahmen von klinischen Studien kann derzeit als Standardvorgehen betrachtet werden. In der vorliegenden Übersicht werden die wichtigsten, aktuell durchgeführten klinischen Studien zur adjuvanten und palliativen Therapie des malignen Melanoms dargestellt.
Abstract
Malignant melanoma is one of the most common cancers accounting for 4–5% of all human malignancies and steadily increasing in incidence. The medical management of melanoma patients in Germany can be regarded as largely standardized based upon interdisciplinary guide lines. The results of adjuvant and especially palliative treatment of melanoma are unsatisfactory. Thus there is an urgent need for controlled clinical trials in order to optimize standard treatment approaches and to evaluate new drugs. The treatment of patients affected with high risk or metastatic melanoma within those clinical trials should be standard of care. This overview delineates the most important clinical trials currently conducted or planned in the adjuvant and palliative setting of melanoma treatment.
Literatur
Agarwala SS, Keilholz U, Hogg D et al. (2007) Randomized phase III study of paclitaxel plus carboplatin with or without sorafenib as second-line treatment in patients with advanced melanoma. J Clin Oncol ASCO Annual Meeting Proceedings Part I. 25(18S): 8510
Balch CM, Buzaid AC, Soong SJ et al. (2001) Final version of the American Joint Committee on Cancer staging system for cutaneous melanoma. J Clin Oncol 19: 3635–3648
Bedikian AY, Millward M, Pehamberger H et al. (2006) Bcl-2 antisense (oblimersen sodium) plus Dacarbazine in patients with advanced melanoma: the Oblimersen Melanoma Study Group. J Clin Oncol 24: 4738–4745
Berkenblit A, Eder JP Jr, Ryan DP et al. (2007) Phase I clinical trial of STA-4783 in combination with paclitaxel in patients with refractory solid tumors. Clin Cancer Res 13: 584–590
Cascinelli N, Belli F, MacKie RM et al. (2001) Effect of long-term adjuvant therapy with interferon alpha-2a in patients with regional node metastases from cutaneous melanoma: a randomised trial. Lancet 358: 866–869
Curtin JA, Busam K, Pinkel D, Bastian BC (2006) Somatic activation of KIT in distinct subtypes of melanoma. J Clin Oncol 24: 4340–4346
Eggermont AMM, Suciu S, MacKie R et al. (2005) 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 366: 1189–1196
Eggermont AM, Suciu S, Santinami M et al (2007) EORTC 18991: Long-term adjuvant pegylated interferon-alpha2b (PEG-IFN) compared to observation in resected stage III melanoma, final results of a randomized phase III trial. J Clin Oncol ASCO Annual Meeting Proceedings Part I. 25(18S): 8504
Eigentler TK, Caroli UM, Radny P, Garbe C (2003) Palliative therapy of disseminated malignant melanoma: a systematic review of 41 randomised clinical trials. Lancet Oncol 4: 748–759
Garbe C, Radny P, Linse R et al. (2008) Adjuvant low-dose interferon α2a 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 Feb 14 (Epub ahead of print)
Garbe C, Schadendorf D, Stolz W et al. (2008) Malignes Melanom der Haut. In: Garbe C, Adler G, Beckmann MW et al. (Hrsg) Kurzgefasste interdisziplinäre Leitlinien 2008. W. Zuckschwerdt, Germering, S 142–151
Gonzalez R, Hutchins L, Nemunaitis J et al. (2006) Phase II trial of Allovectin-7 in advanced metastatic melanoma. Melanoma Res 16: 521–526
Grob JJ, Dreno B, de la Salmoniere P et al. (1998) 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 351: 1905–1910
Hancock BW, Wheatley K, Harris S et al. (2004) Adjuvant interferon in high-risk melanoma: the AIM HIGH Study – United 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 22: 53–61
Hauschild A, Schadendorf D, Garbe C et al. (2007) New promises in the adjuvant, and palliative treatment of melanoma. Cancer Treat Res 135: 277–292
Katalinic A, Kunze U, Schäfer T (2003) Epidemiology of cutaneous melanoma and non-melanoma skin cancer in Schleswig-Holstein, Germany: incidence, clinical subtypes, tumor stages and localization (epidemiology of skin cancer). Br J Dermatol 149: 1200–1206
Kirkwood JM, Strawderman MH, Ernstoff MS et al. (1996) 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
Kirkwood JM, Ibrahim JG, Sondak VK et al. (2000) 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
McDermott DF, Sosman JA, Hodi FS et al. (2007) Randomized phase II study of dacarbazine with or without sorafenib in patients with advanced melanoma. J Clin Oncol ASCO Annual Meeting Proceedings Part I. 25(18S): 8511
Middleton MR, Grob JJ, Aaronson N et al. (2000) Randomized phase III study of temozolomide versus Dacarbazine in the treatment of patients with advanced metastatic malignant melanoma. J Clin Oncol 18: 158–166
Moreno-Aspitia A, Perez EA (2005) Nanoparticle albumin-bound paclitaxel (ABI-007): a newer taxane alternative in breast cancer. Future Oncol 1: 755–762
O’Day SJ, Hamid O, Urba WJ (2007) Targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4): a novel strategy for the treatment of melanoma and other malignancies. Cancer 110: 2614–2627
O’Day S, Gonzalez R, Lawson D et al. (2007) Subgroup analysis of efficacy and safety analysis of a randomized, double-blinded controlled phase II study of STA-4783 in combination with paclitaxel in patients with metastatic melanoma. J Clin Oncol ASCO Annual Meeting Proceedings Part I. 25(18S): 8528
Pehamberger H, Soyer HP, Steiner A et al. (1998) Adjuvant interferon alfa-2a treatment in resected primary stage II cutaneous melanoma. Austrian Malignant Melanoma Cooperative Group. J Clin Oncol 16: 1425–1429
Rass K, Tadler D, Tilgen W (2006) Therapie des metastasierten Melanoms: Von First-, Second- und Pathogenese-orientierten Third-line-Therapien. Hautarzt 57: 773–784
Ugurel S, Schadendorf D, Pföhler C et al. (2006) In vitro drug sensitivity predicts response and survival after individualized sensitivity-directed chemotherapy in metastatic melanoma: a multicenter phase II trial of the Dermatologic Cooperative Oncology Group. Clin Cancer Res 12: 5454–5463
Wheatley K, Ives N, Eggermont AM et al. (2007) Interferon-α as adjuvant therapy for melanoma: an individual patient data meta-analysis of randomised trials. J Clin Oncol ASCO Annual Meeting Proceedings Part I. 25(18S): 8526
Interessenkonflikt
Der korrespondierende Autor weist auf folgende Beziehungen hin (Beratungsmitglied/beratende Tätigkeit oder Vortragshonorare): MEDA Pharma (Deutschland), Abraxis Oncology (USA), Bayer/Schering (Deutschland, USA), BMS (USA, Europa), Celgene (Europa), essex pharma/Schering-Plough (Deutschland, USA), Galderma (Deutschland), Genta (USA), GSK (USA, Europa), Hermal (Deutschland), La Roche Posay (Deutschland), Merck (Deutschland), Onyx (USA), Pfizer (USA, Deutschland), Roche Pharma (Deutschland), Synta (USA).
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Hauschild, A., Rass, K. & Tilgen, W. Systemische Therapie des Melanoms. Hautarzt 59, 484–491 (2008). https://doi.org/10.1007/s00105-008-1569-0
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DOI: https://doi.org/10.1007/s00105-008-1569-0
Schlüsselwörter
- Malignes Melanom
- Kontrollierte randomisierte Studien
- Targeted Therapie
- Adjuvante Therapie
- Palliative Therapie