Large randomized study of thymosin α 1, interferon alfa, or both in combination with dacarbazine in patients with metastatic melanoma

Journal of Clinical Oncology

Volumn 28, Issue 10, 2010, Pages 1780-1787

  Maio, Michele ^a   Mackiewicz, Andrzej ^a   Testori, Alessandro ^a   Trefzer, Uwe ^a   Ferraresi, Virginia ^a   Jassem, Jacek ^a   Garbe, Claus ^a   Lesimple, Thierry ^a   Guillot, Bernard ^a   Gascon, Pere ^a   Gilde, Katalin ^a   Camerini, Roberto ^a   Cognetti, Francesco ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA INTERFERON; DACARBAZINE; THYMOSIN ALPHA1; ANTINEOPLASTIC AGENT; DRUG DERIVATIVE; THYMOSIN;

ABDOMINAL PAIN; ADULT; AGED; ARTICLE; ASTHENIA; CHEMOTHERAPY INDUCED EMESIS; CHILL; CONSTIPATION; DIARRHEA; DRUG EFFICACY; DRUG FATALITY; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; EVENING DOSAGE; FATIGUE; FEMALE; FLU LIKE SYNDROME; GASTROINTESTINAL SYMPTOM; HEMATEMESIS; HUMAN; MAJOR CLINICAL STUDY; MALE; MELANOMA; METASTASIS; MORNING DOSAGE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROLOGIC DISEASE; NEUTROPENIA; OVERALL SURVIVAL; PAIN; PERIPHERAL EDEMA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; THORAX PAIN; TREATMENT DURATION; TREATMENT RESPONSE; UPPER ABDOMINAL PAIN; ADOLESCENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; MIDDLE AGED; MORTALITY;

ADOLESCENT; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DACARBAZINE; FEMALE; HUMANS; INTERFERON-ALPHA; MALE; MELANOMA; MIDDLE AGED; THYMOSIN;

EID: 77950469665     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2009.25.5208     Document Type: Article

References (46)

1. Cancer Research UK: CancerStats Key Facts on Skin Cancer. http://info.cancerresearchuk.org/cancerstats/types/skin/?a=5441
2. Korn EL, Liu PY, Lee SJ, et al: Meta-analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival benchmarks for future phase II trials. J Clin Oncol 26:527-534, 2008 (Pubitemid 351264344)
3. Bedikian AY, Millward M, Pehamberger H, et al: Bcl-2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma: The Oblimersen Melanoma Study Group. J Clin Oncol 24:4738-4745, 2006 (Pubitemid 46630937)
4. Eggermont AM, Kirkwood JM: Re-evaluating the role of dacarbazine in metastatic melanoma: What have we learned in 30 years? Eur J Cancer 40:1825-1836, 2004
5. Avril MF, Aamdal S, Grob JJ, et al: Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma: A phase III study. J Clin Oncol 22:1118-1125, 2004 (Pubitemid 41095046)
6. Chiarion Sileni V, Nortilli R, Aversa SM, et al: Phase II randomized study of dacarbazine, carmustine, cisplatin and tamoxifen versus dacarbazine alone in advanced melanoma patients. Melanoma Res 11:189-196, 2001 (Pubitemid 32385824)
7. Flaherty KT: Chemotherapy and targeted therapy combinations in advanced melanoma. Clin Cancer Res 12:2366s-2370s, 2006
8. Schadendorf D, Ugurel S, Schuler-Thurner B, et al: Dacarbazine (DTIC) versus vaccination with autologous peptide-pulsed dendritic cells (DC) in first-line treatment of patients with metastatic melanoma: A randomized phase III trial of the DC study group of the DeCOG. Ann Oncol 17:563-570, 2006
9. Fang L, Lonsdorf AS, Hwang ST: Immunotherapy for advanced melanoma. J Invest Dermatol 128:2596-2605, 2008
10. Barnetson RS, Halliday GM: Regression in skin tumours: A common phenomenon. Australas J Dermatol 38:S63-S65, 1997 (suppl 1)
11. Lee PP, Yee C, Savage PA, et al: Characterization of circulating T cells specific for tumor-associated antigens in melanoma patients. Nat Med 5:677-685, 1999 (Pubitemid 29289432)
12. Sasse AD, Sasse EC, Clark LG, et al: Chemoimmunotherapy versus chemotherapy for metastatic malignant melanoma. Cochrane Database Syst Rev CD005413, 2007
13. Eton O, Legha SS, Bedikian AY, et al: Sequential biochemotherapy versus chemotherapy for metastatic melanoma: Results from a phase III randomized trial. J Clin Oncol 20:2045-2052, 2002 (Pubitemid 34408794)
14. Keilholz U, Goey SH, Punt CJ, et al: Interferon alfa-2a and interleukin-2 with or without cisplatin in metastatic melanoma: A randomized trial of the European Organization for Research and Treatment of Cancer Melanoma Cooperative Group. J Clin Oncol 15:2579-2588, 1997 (Pubitemid 27289888)
15. Atkins MB, Hsu J, Lee S, et al: Phase III trial comparing concurrent biochemotherapy with cisplatin, vinblastine, dacarbazine, interleukin-2, and interferon alfa-2b with cisplatin, vinblastine, and dacarbazine alone in patients with metastatic malignant melanoma (E3695): a trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol 26:5748-5754, 2008
16. Hauschild A, Garbe C, Stolz W, et al: Dacarbazine and interferon alpha with or without interleukin 2 in metastatic melanoma: A randomized phase III multicentre trial of the Dermatologic Cooperative Oncology Group (DeCOG). Br J Cancer 84:1036-1042, 2001 (Pubitemid 32448498)
17. Goldstein AL: History of the discovery of the thymosins. Ann N Y Acad Sci 1112:1-13, 2007
18. Ahmed A, Wong DM, Thurman GB, et al: T-lymphocyte maturation: Cell surface markers and immune function induced by T-lymphocyte cell-free products and thymosin polypeptides. Ann N Y Acad Sci 332:81-94, 1979
19. di Francesco P, Gaziano R, Casalinuovo IA, et al: Combined effect of fluconazole and thymosin alpha 1 on systemic candidiasis in mice immunosuppressed by morphine treatments. Clin Exp Immunol 97:347-352, 1994 (Pubitemid 24283873)
20. Romani L, Bistoni F, Gaziano R, et al: Thymosin alpha 1 activates dendritic cells for antifungal Th1 resistance through toll-like receptor signaling. Blood 103:4232-4239, 2004 (Pubitemid 38685368)
21. Kabelitz D, Wesch D, Oberg HH: Regulation of regulatory T cells: Role of dendritic cells and toll-like receptors. Crit Rev Immunol 26:291-306, 2006
22. Sztein MB, Serrate SA: Characterization of the immunoregulatory properties of thymosin alpha 1 on interleukin-2 production and interleukin-2 receptor expression in normal human lymphocytes. Int J Immunopharmacol 11:789-800, 1989 (Pubitemid 19252366)
23. Rasi G, Terzoli E, Izzo F, et al: Combined treatment with thymosin-alpha1 and low dose interferon-alpha after dacarbazine in advanced melanoma. Melanoma Res 10:189-192, 2000 (Pubitemid 30256882)
24. Lopez M, Carpano S, Cavaliere R, et al: Biochemotherapy with thymosin alpha 1, interleukin-2 and dacarbazine in patients with metastatic melanoma: Clinical and immunological effects. Ann Oncol 5:741-746, 1994
25. Stefanini GF, Foschi FG, Castelli E, et al: Alpha-1-thymosin and transcatheter arterial chemoembolization in hepatocellular carcinoma patients: A preliminary experience. Hepatogastroenterology 45:209-215, 1998 (Pubitemid 28067555)
26. Salvati F, Rasi G, Portalone L, et al: Combined treatment with thymosin-alpha1 and low-dose interferon-alpha after ifosfamide in non-small cell lung cancer: A phase-II controlled trial. Anticancer Res 16:1001-1004, 1996 (Pubitemid 26182047)
27. Schulof RS, Lloyd MJ, Cleary PA, et al: A randomized trial to evaluate the immunorestorative properties of synthetic thymosin-alpha 1 in patients with lung cancer. J Biol Response Mod 4:147-158, 1985 (Pubitemid 15101417)
28. SciClone Pharmaceuticals: Zadaxin prescribing information. http://www.scicloneinternational.com/language-support/inserts/english/ C2785-02-Philippines-insert2.pdf
29. Balch CM, Soong SJ, Gershenwald JE, et al: Prognostic factors analysis of 17,600 melanoma patients: Validation of the American Joint Committee on Cancer melanoma staging system. J Clin Oncol 19:3622-3634, 2001 (Pubitemid 32786275)
30. Keilholz U, Punt CJ, Gore M, et al: Dacarbazine, cisplatin, and interferon-alfa-2b with or without interleukin-2 in metastatic melanoma: A randomized phase III trial (18951) of the European Organisation for Research and Treatment of Cancer Melanoma Group. J Clin Oncol 23:6747-6755, 2005 (Pubitemid 46190270)
31. Ridolfi R, Chiarion-Sileni V, Guida M, et al: Cisplatin, dacarbazine with or without subcutaneous interleukin-2, and interferon alpha-2b in advanced melanoma outpatients: Results from an Italian multicenter phase III randomized clinical trial. J Clin Oncol 20:1600-1607, 2002 (Pubitemid 34260541)
32. Rosenberg SA, Yang JC, Schwartzentruber DJ, et al: Prospective randomized trial of the treatment of patients with metastatic melanoma using chemotherapy with cisplatin, dacarbazine, and tamoxifen alone or in combination with interleukin-2 and interferon alfa-2b. J Clin Oncol 17:968-975, 1999 (Pubitemid 29109330)
33. Rosenberg SA, Yang JC, Restifo NP: Cancer immunotherapy: Moving beyond current vaccines. Nat Med 10:909-915, 2004 (Pubitemid 39273730)
34. Hamid O: Dose effect of ipilimumab in patients with advanced melanoma: Results from a phase II, randomized, dose-ranging study. J Clin Oncol 26:489s, 2008 (abstr 9025)
35. Maio M, Hoos A, Ibrahim R, 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. Ann Oncol 19:241, 2008 (suppl 8; abstr 776PD)
36. Ridolfi R, Berman D, Siegel J, et al: Efficacy and safety of treatment-naïve and previously treated patients with advanced melanoma receiving ipilimumab. Ann Oncol 19:242, 2008 (suppl 8; abstr 778PD)
37. 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 26:485s, 2008 (abstr LBA9011)
38. McDermott DF, Sosman JA, Gonzalez R, et al: Double-blind randomized phase II study of the combination of sorafenib and dacarbazine in patients with advanced melanoma: A report from the 11715 Study Group. J Clin Oncol 26:2178-2185, 2008
39. O'Day S, Gonzalez R, Lawson D, et al: 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 25:479s, 2007 (abstr 8528)
40. Khan MA, Andrews S, Ismail-Khan R, et al: Overall and progression-free survival in metastatic melanoma: Analysis of a single-institution database. Cancer Control 13:211-217, 2006 (Pubitemid 44469742)
41. Nowak AK, Lake RA, Marzo AL, et al: Induction of tumor cell apoptosis in vivo increases tumor antigen cross-presentation, cross-priming rather than cross-tolerizing host tumor-specific CD8 T cells. J Immunol 170:4905-4913, 2003 (Pubitemid 36554719)
42. van der Most RG, Currie A, Robinson BW, et al: Cranking the immunologic engine with chemotherapy: Using context to drive tumor antigen cross-presentation towards useful antitumor immunity. Cancer Res 66:601-604, 2006 (Pubitemid 43165917)
43. Romani L, Bistoni F, Montagnoli C, et al: Thymosin alpha1: An endogenous regulator of inflammation, immunity, and tolerance. Ann N Y Acad Sci 1112:326-338, 2007 (Pubitemid 47598643)
44. Haynes NM, van der Most RG, Lake RA, et al: Immunogenic anti-cancer chemotherapy as an emerging concept. Curr Opin Immunol 20:545-557, 2008
45. Krieg AM: Toll-like receptor 9 (TLR9) agonists in the treatment of cancer. Oncogene 27:161-167, 2008
46. Hodi FS: Novel efficacy criteria for antitumor activity to immunotherapy using the example of ipilimumab, an anti-CTLA-4 monoclonal antibody. J Clin Oncol 26:134s, 2008 (abstr 3008)