Randomized phase III study of 1 month versus 1 year of adjuvant high-dose interferon alfa-2b in patients with resected high-risk melanoma

Journal of Clinical Oncology

Volumn 27, Issue 6, 2009, Pages 939-944

  Pectasides, Dimitrios ^a   Dafni, Urania ^a   Bafaloukos, Dimitrios ^a   Skarlos, Dimosthenis ^a   Polyzos, Aristidis ^a   Tsoutsos, Dimosthenis ^a   Kalofonos, Haralambos ^a   Fountzilas, George ^a   Panagiotou, Petros ^a   Kokkalis, George ^a   Papadopoulos, Othon ^a   Castana, Ourania ^a   Papadopoulos, Stefanos ^a   Stavrinidis, Elias ^a   Vourli, Georgia ^a   Ioannovich, John ^a   Gogas, Helen ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

RECOMBINANT ALPHA2B INTERFERON;

ADULT; ADULT RESPIRATORY DISTRESS SYNDROME; AGED; ALOPECIA; ANEMIA; ARTICLE; BEDTIME DOSAGE; BRAIN TOXICITY; CANCER STAGING; CANCER SURGERY; CANCER SURVIVAL; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE FREE SURVIVAL; DOSAGE SCHEDULE COMPARISON; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG FATALITY; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FLU LIKE SYNDROME; FOLLOW UP; HUMAN; LEUKOPENIA; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; MELANOMA; MENTAL DISEASE; NAUSEA AND VOMITING; NEUROLOGIC DISEASE; NEUTROPENIA; OVERALL SURVIVAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RELAPSE FREE SURVIVAL; THROMBOCYTOPENIA; TREATMENT DURATION;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CHEMOTHERAPY, ADJUVANT; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INTERFERON ALFA-2B; MALE; MELANOMA; MIDDLE AGED; SKIN NEOPLASMS; SURVIVAL ANALYSIS; TIME FACTORS;

EID: 60849108348     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2008.16.3121     Document Type: Article

References (14)

1. Jemal A, Siegel R, Ward E, et al: Cancer statistics, 2006. CA Cancer J Clin 56:106-130, 2006
2. 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
3. Balch CM, Buzaid AC, Soong SJ, et al: Final version of the American Joint Committee on Cancer staging system for cutaneous melanoma. J Clin Oncol 19:3635-3648, 2001
4. Kirkwood JM, Strawderman MH, Ernstoff MS, et al: 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
5. Kirkwood JM, Ibrahim JG, Sondak VK, et al: 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
6. Kirkwood JM, Ibrahim JG, Sosman JA, et al: High-dose interferon alfa-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
7. Kirkwood JM, Manola J, Ibrahim J, et al: Eastern Cooperative Oncology Group: A pooled analysis of Eastern Cooperative Oncology Group and Intergroup trials of adjuvant high-dose interferon for melanoma. Clin Cancer Res 10:1670-1677, 2004
8. Greekmore SP, Longo DL, Urba WJ: Principles of the clinical evaluation of biologic agents, in DeVita VT Jr, Hellman S, Rosenberg SA (eds): Biologic Therapy of Cancer. Philadelphia, PA, J.B. Lippincott, 1991, pp 67-86
9. Machin D, Campbell MJ, Fayers PM, et al: Sample size tables for clinical studies (ed 2). Oxford, United Kingdom, Blackwell Scientific, 1995
10. Atherton Skaff P, Sloan JA: Design and analysis of equivalence clinical trials via the SAS System. Proc SUGI 23:1166-1171, 1998
11. Com-Nougue C, Rodary C, Patte C: How to establish equivalence when data are censored: A randomized trial of treatments for B Non-Hodgkin lymphoma. Stat Med 12:1353-1364, 1993
12. Eggermont AM, Suciu S, MacKie R, et al: 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)-Randomised controlled trial. Lancet 366:1189-1196, 2005
13. Wheatley K, Ives N, Hancock B, et al: Does adjuvant interferon-alpha for high-risk melanoma provide a worthwhile benefit? A meta-analysis of the randomised trials. Cancer Treat Rev 29:241-252, 2003
14. Wheatley K, Ives N, Eggermont A, et al: Interferon-a as adjuvant therapy for melanoma: An individual patient data meta-analysis of randomised trials. J Clin Oncol 25:478s, 2007 (suppl, abstr 8526)