Dose-intensified bi-weekly temozolomide in patients with asymptomatic brain metastases from malignant melanoma: A phase II DeCOG/ADO study

Annals of Oncology

Volumn 17, Issue 10, 2006, Pages 1592-1597

  Schadendorf, D ^a   Hauschild, A ^b   Ugurel, S ^a   Thoelke, A ^a   Egberts, F ^b   Kreissig, M ^c   Linse, R ^d   Trefzer, U ^e   Vogt, T ^f   Tilgen, W ^g   Mohr, P ^h   Garbe, C ^c  

^a UNIVERSITY OF HEIDELBERG   (Germany)

^b UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^c UNIVERSITY HOSPITAL TÜBINGEN   (Germany)

^d Humboldt University ^*  (Germany)

^e HUMBOLDT UNIVERSITY   (Germany)

^f UNIVERSITY HOSPITAL REGENSBURG   (Germany)

^g SAARLAND UNIVERSITY   (Germany)

^h Elbe Hospital   (Germany)

Author keywords

Brain metastases; Metastatic melanoma; Temozolomide

Indexed keywords

TEMOZOLOMIDE;

ADULT; AGED; ARTICLE; BONE MARROW SUPPRESSION; BRAIN METASTASIS; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE COURSE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HUMAN; HYPERBILIRUBINEMIA; LEUKOPENIA; LIVER DYSFUNCTION; MALE; MELANOMA; MOTOR DYSFUNCTION; MULTICENTER STUDY; NEUTROPENIA; OPEN STUDY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; SENSORY DYSFUNCTION; THROMBOCYTOPENIA;

ADULT; AGED; ANTINEOPLASTIC AGENTS, ALKYLATING; BRAIN NEOPLASMS; DACARBAZINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MALE; MELANOMA; MIDDLE AGED; SKIN NEOPLASMS; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 33749606618     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdl148     Document Type: Article

References (27)

1. Eigentler TK, Caroli UM, Radny P, Garbe C. Palliative therapy of disseminated malignant melanoma: A systematic review of 41 randomised clinical trials. Lancet Oncol 2003; 4: 748-759.
2. Douglas JG, Margolin K. The treatment of brain metastases from malignant melanoma. Sem Oncol 2002; 29: 518-524.
3. Cattell E, Kelly C, Middelton MR. Brain metastases in melanoma: A European perspective. Sem Oncol 2002; 29: 513-517.
4. Sampson JH, Carter JH, Friedman AH, Seigler HF. Demographics, prognosis and therapy in 702 patients with brain metastases from malignant melanoma. J Neurosurg 1998; 88: 11-20.
5. Jacquillat C, Khayat D, Banzet P et al. Final report of the French multicenter phase II study of the nitrosourea fotemustine in 153 evaluable patients with disseminated malignant melanoma including patients with cerebral metastases. Cancer 1990; 66: 1873-1878.
6. Mornex F, Thomas L, Mohr P et al. A prospective randomized multicentre phase III trial of fotemustine plus whole brain irradiation versus fotemustine alone in cerebral metastases of malignant melanoma. Melanoma Res 2003; 13: 97-103.
7. Middelton MR, Grob JJ, Aaronson N et al. Randomized phase III study of temozolomide versus dacarbacine in the treatment of patients with advanced metastatic malignant melanoma. J Clin Oncol 2000; 16: 158-166.
8. Kaufmann R, Spieth K, Leiter U et al. Temozolomide in combination with interferon alfa versus temozolomide alone in patients with advanced metastatic melanoma: A randomized phase III multicenter study of the Dermatologic Cooperative Oncology Group (DeCOG). J Clin Oncol 2005; 23: 9001-9007.
9. Stupp R, Mason WP, van den Bent MJ et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med 2005; 352: 987-996.
10. Langer CJ, Metha MP. Current management of brain metastases, with a focus on systemic options. J Clin Oncol 2005; 23: 6207-6219.
11. Antonadou D, Paraskevaidis M, Serris G et al. Phase II randomized trial of temozolomide and concurrent radiotherapy in patients with brain metastases. J Clin Oncol 2002; 20: 3644-3650.
12. Christodoulou C, Bafaloukis D, Kosmidis P et al. Hellenic Cooperative Oncology Group. Phase II study of temozolomide in heavily pretreated cancer patients with brain metastases. Ann Oncol 2001; 1: 249-254.
13. Margolin K, Atkins MB, Thompson JA et al. Temozolomide and whole brain irradiation in melanoma metastatic to the brain: A phase II trial of the Cytokine Working Group. J Cancer Res Clin Oncol 2002; 128: 214-218.
14. Paul MJ, Summers Y, Calvert AH et al. Effect of temozolomide on central nervous system relapse in patients with advanced melanoma. Melanoma Res 2002; 12: 175-178.
15. Weber RW, O'Day S, Rose M et al. Low-dose outpatient chemobiotherapy with temozolomide, granulocyte-macrophage colony stimulating factor, interferon-alpha2b, and recombinant interleukin-2 for the treatment of metastatic melanoma. J Clin Oncol 2005; 23: 8992-9000.
16. Therasse P, Arbuck SG, Eisenhauer EA et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000; 92: 205-216.
17. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989; 10: 1-10.
18. Gaspar L, Scott C, Rotman M et al. Recursive partitioning analysis (RPA) of prognostic factors in three Radiation Therapy Oncology Group (RTOG) brain metastases trials. Int J Radiat Oncol Biol Phys 1997; 4: 745-751.
19. Gupta G, Robertson AG, Mackie RM. Cerebral metastases of cutaneous melanoma. Br J Cancer 1997; 76: 256-259.
20. Fife KM, Colman MH, Stevens GN et al. Determinants of outcome in melanoma patients with cerebral metastases. J Clin Oncol 2004; 22: 1293-1300.
21. Harrison BE, Johnson JL, Clough RW, Halperin EC. Selection of patients with melanoma brain metastases for aggressive treatment. Am J Clin Oncol 2003; 26: 354-357.
22. Nieder C, Nestle U, Motaref B et al. Prognostic factors in brain metastases: Should patients be selected for agressive treatment according to recursive partitioning analysis (RPA) classes? Int J Radiat Oncol Biol Phys 2000; 46: 297-302.
23. Morris SL, Low SH, A'Hern RP et al. A prognostic index that predicts outcome following palliative whole brain radiotherapy for patients with metastatic malignant melanoma. Br J Cancer 2004; 91: 829-833.
24. Agarwala SS, Kirkwood JM, Gore M et al. Temozolomide for the treatment of brain metastases associated with metastatic melanoma: A phase II study. J Clin Oncol 2004; 22: 2101-2107.
25. Stupp R, Gander M, Leyvraz S, Newlands E. Current and future developments in the use of temozolomide for the treatment of brain tumours. Lancet Oncol 2001; 2: 552-560.
26. Siena S, Landonio G, Baietta E et al. Multicenter phase II study of temozolomide therapy for brain metastasis in patients with malignant melanoma, breast cancer, and non-small cell lung cancer. ASCO 2003; Abstr 407.
27. Atkins MB, Sosman J, Agarwala SS et al. A Cytokine Working Group phase II study of temozolomide (TMZ), thalidomide (THAL) and whole brain radiation therapy (WBRT) for patients with brain metastases from melanoma. ASCO 2005; Abstr 7552.