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Journal of Clinical Oncology, Vol 14, 7-17, Copyright © 1996 by American Society of Clinical Oncology

ARTICLES

Interferon alfa-2b adjuvant therapy of high-risk resected cutaneous melanoma: the Eastern Cooperative Oncology Group Trial EST 1684

JM Kirkwood, MH Strawderman, MS Ernstoff, TJ Smith, EC Borden and RH Blum
Division of Medical Oncology, University of Pittsburgh, PA 15213-2582, USA.

PURPOSE: Interferon alfa-2b (IFN alpha-2b) exhibits antitumor activity in metastatic melanoma and on this basis has been evaluated as an adjuvant therapy following surgery for deep primary (T4) or regionally metastatic (N1) melanoma. METHODS: A randomized controlled study of IFN alpha-2b (Schering-Plough, Kenilworth, NJ) administered at maximum- tolerated doses of 20 MU/m2/d intravenously (i.v.) for 1 month and 10 MU/m2 three times per week subcutaneously (SC) for 48 weeks versus observation, was conducted by the Eastern Cooperative Oncology Group (ECOG) in 287 patients. RESULTS: A significant prolongation of relapse- free survival (P = .0023, one-sided) and prolongation of overall survival (P = .0237, one-sided) was observed with IFN alpha-2b therapy in this trial, which is now mature with a median follow-up time of 6.9 years. The impact of treatment on relapse rate is most pronounced early during the treatment interval. The overall benefit of treatment in this trial was analyzed stratified by tumor burden and the presence or absence of microscopic nonpalpable and palpable regional lymph node metastasis. The benefit of therapy with IFN alpha-2b was greatest among node-positive strata. Toxicity of IFN alpha-2b required dose modification in the majority of patients, but treatment at > or = 80% of the scheduled dose was feasible in the majority of patients through the IV phase of treatment, and for more than 3 months of SC maintenance therapy. Discontinuation of treatment due to toxicity was infrequent after the fourth month of therapy. CONCLUSION: IFN alpha-2b prolongs the relapse-free interval and overall survival of high-risk resected melanoma patients. The increment in median disease-free survival (from 1 to 1.7 years) and overall survival (from 2.8 to 3.8 years) that results from this therapy is associated with a 42% improvement in the fraction of patients who are continuously disease-free after treatment with IFN (from 26% to 37%) in comparison to observation. IFN alpha-2b is the first agent to show a significant benefit in relapse-free and overall survival of high-risk melanoma patients in a randomized controlled trial.
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I. Astsaturov, T. Petrella, E. U. Bagriacik, M. de Benedette, R. Uger, G. Lumber, N. Berinstein, I. Elias, N. Iscoe, C. Hammond, et al.
Amplification of Virus-Induced Antimelanoma T-Cell Reactivity by High-Dose Interferon-{alpha}2b: Implications for Cancer Vaccines
Clin. Cancer Res., October 1, 2003; 9(12): 4347 - 4355.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
M. S. Sabel and V. K. Sondak
Pros and Cons of Adjuvant Interferon in the Treatment of Melanoma
Oncologist, October 1, 2003; 8(5): 451 - 458.
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 JCOHome page
A. Hauschild, M. Weichenthal, B.-R. Balda, J. C. Becker, H. H. Wolff, W. Tilgen, K.-W. Schulte, J. Ring, D. Schadendorf, S. Lischner, et al.
Prospective Randomized Trial of Interferon Alfa-2b and Interleukin-2 as Adjuvant Treatment for Resected Intermediate- and High-Risk Primary Melanoma Without Clinically Detectable Node Metastasis
J. Clin. Oncol., August 1, 2003; 21(15): 2883 - 2888.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
L. M. Jost
ESMO Minimum Clinical Recommendations for diagnosis, treatment and follow-up of cutaneous malignant melanoma
Ann. Onc., July 1, 2003; 14(7): 1012 - 1013.
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 JCOHome page
J. W. Smith II, E. B. Walker, B. A. Fox, D. Haley, K. P. Wisner, T. Doran, B. Fisher, L. Justice, W. Wood, J. Vetto, et al.
Adjuvant Immunization of HLA-A2-Positive Melanoma Patients With a Modified gp100 Peptide Induces Peptide-Specific CD8+ T-Cell Responses
J. Clin. Oncol., April 15, 2003; 21(8): 1562 - 1573.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
R. F. Kefford
Adjuvant therapy of cutaneous melanoma: the interferon debate
Ann. Onc., March 1, 2003; 14(3): 358 - 365.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
J. W. Jakub, S. Pendas, and D. S. Reintgen
Current Status of Sentinel Lymph Node Mapping and Biopsy: Facts and Controversies
Oncologist, February 1, 2003; 8(1): 59 - 68.
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 J. Leukoc. Biol.Home page
I. D. Davis, M. Jefford, P. Parente, and J. Cebon
Rational approaches to human cancer immunotherapy
J. Leukoc. Biol., January 1, 2003; 73(1): 3 - 29.
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 Arch DermatolHome page
J. Connors, B. Smoller, and S. Dinehart
Sentinel Lymph Node Biopsy and Adjuvant Therapy for Melanoma: Evidence Revisited
Arch Dermatol, January 1, 2003; 139(1): 99 - 100.
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 Clin. Cancer Res.Home page
U. Vaishampayan, J. Abrams, D. Darrah, V. Jones, and M. S. Mitchell
Active Immunotherapy of Metastatic Melanoma with Allogeneic Melanoma Lysates and Interferon {alpha}
Clin. Cancer Res., December 1, 2002; 8(12): 3696 - 3701.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
S. F. Huang, S.-J. Kim, A. T. Lee, T. Karashima, C. Bucana, D. Kedar, P. Sweeney, B. Mian, D. Fan, D. Shepherd, et al.
Inhibition of Growth and Metastasis of Orthotopic Human Prostate Cancer in Athymic Mice by Combination Therapy with Pegylated Interferon-{alpha}-2b and Docetaxel
Cancer Res., October 15, 2002; 62(20): 5720 - 5726.
[Abstract] [Full Text] [PDF]

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 JCOHome page
P. Hersey, A. S. Coates, W. H. McCarthy, J. F. Thompson, R. W. Sillar, R. McLeod, P. G. Gill, B. J. Coventry, A. McMullen, H. Dillon, et al.
Adjuvant Immunotherapy of Patients With High-Risk Melanoma Using Vaccinia Viral Lysates of Melanoma: Results of a Randomized Trial
J. Clin. Oncol., October 15, 2002; 20(20): 4181 - 4190.
[Abstract] [Full Text] [PDF]

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 JCOHome page
B. Mellado, M. del Carmen Vela, D. Colomer, L. Gutierrez, T. Castel, L. Quinto, M. Fontanillas, N. Reguart, J. M. Domingo-Domenech, C. Montagut, et al.
Tyrosinase mRNA in Blood of Patients With Melanoma Treated With Adjuvant Interferon
J. Clin. Oncol., October 1, 2002; 20(19): 4032 - 4039.
[Abstract] [Full Text] [PDF]

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 JCOHome page
J. M. Kirkwood, J. Ibrahim, V. K. Sondak, M. S. Ernstoff, L. Flaherty, F. J. Haluska, M.B. Lens, and M. Dawes
Use and Abuse of Statistics in Evidence-Based Medicine
J. Clin. Oncol., October 1, 2002; 20(19): 4122 - 4124.
[Full Text] [PDF]

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 JCOHome page
R. Bukowski, M. S. Ernstoff, M. E. Gore, J. J. Nemunaitis, R. Amato, S. K. Gupta, and C. L. Tendler
Pegylated Interferon Alfa-2b Treatment for Patients With Solid Tumors: A Phase I/II Study
J. Clin. Oncol., September 15, 2002; 20(18): 3841 - 3949.
[Abstract] [Full Text] [PDF]

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 JCOHome page
J. M. Kirkwood, C. Bender, S. Agarwala, A. Tarhini, J. Shipe-Spotloe, B. Smelko, S. Donnelly, and L. Stover
Mechanisms and Management of Toxicities Associated With High-Dose Interferon Alfa-2b Therapy
J. Clin. Oncol., September 1, 2002; 20(17): 3703 - 3718.
[Abstract] [Full Text] [PDF]

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 Mayo Clin Proc.Home page
S. D. Thome, C. L. Loprinzi, and M. P. Heldebrant
Determination of Potential Adjuvant Systemic Therapy Benefits for Patients With Resected Cutaneous Melanomas
Mayo Clin. Proc., September 1, 2002; 77(9): 913 - 917.
[Abstract] [PDF]

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 BMJHome page
D Johnson and I H Whitworth
Recent developments in plastic surgery
BMJ, August 10, 2002; 325(7359): 319 - 322.
[Full Text] [PDF]

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 Clin. Cancer Res.Home page
M. Islam, R. F. Frye, T. J. Richards, I. Sbeitan, S. S. Donnelly, P. Glue, S. S. Agarwala, and J. M. Kirkwood
Differential Effect of IFN{alpha}-2b on the Cytochrome P450 Enzyme System: A Potential Basis of IFN Toxicity and Its Modulation by Other Drugs
Clin. Cancer Res., August 1, 2002; 8(8): 2480 - 2487.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
T. Belhocine, G. Pierard, M. de Labrassinne, T. Lahaye, and P. Rigo
Staging of Regional Nodes in AJCC Stage I and II Melanoma: 18FDG PET Imaging versus Sentinel Node Detection
Oncologist, August 1, 2002; 7(4): 271 - 278.
[Abstract] [Full Text] [PDF]

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 PsychosomaticsHome page
O. I. Okereke
Neuropsychiatric Complications Associated With Interferon-Alpha-2b Treatment of Malignant Melanoma
Psychosomatics, June 1, 2002; 43(3): 237 - 240.
[Full Text] [PDF]

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 JNMHome page
G. Mariani, M. Gipponi, L. Moresco, G. Villa, M. Bartolomei, G. Mazzarol, M. C. Bagnara, A. Romanini, F. Cafiero, G. Paganelli, et al.
Radioguided Sentinel Lymph Node Biopsy in Malignant Cutaneous Melanoma*
J. Nucl. Med., June 1, 2002; 43(6): 811 - 827.
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 JCOHome page
L. Kretschmer, C. Neumann, B. Coldiron, S. Dinehart, J. M. Kirkwood, S. S. Agarwala, J. Ibrahim, J. Manola, V. K. Sondak, M. S. Ernstoff, et al.
Sentinel-Node Technique Will Change the Design of Clinical Trials in Malignant Melanoma
J. Clin. Oncol., April 15, 2002; 20(8): 2208 - 2210.
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 JCOHome page
M. B. Lens and M. Dawes
Interferon Alfa Therapy for Malignant Melanoma: A Systematic Review of Randomized Controlled Trials
J. Clin. Oncol., April 1, 2002; 20(7): 1818 - 1825.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
A. Sulkes and J. Schlachter
Comment on "Perhaps not everyone knows that...", (Ann Oncol 2001; 12: 1186)
Ann. Onc., April 1, 2002; 13(4): 637 - 637.
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 JCOHome page
W. J. Urba and W. G. Alvord
Are All Hypotheses Generated Before Data Analysis Prospective?
J. Clin. Oncol., March 15, 2002; 20(6): 1431 - 1433.
[Full Text] [PDF]

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 JCOHome page
R. Ridolfi, V. Chiarion-Sileni, M. Guida, A. Romanini, R. Labianca, A. Freschi, G. Lo Re, R. Nortilli, S. Brugnara, P. Vitali, et al.
Cisplatin, Dacarbazine With or Without Subcutaneous Interleukin-2, and Interferon Alfa-2b in Advanced Melanoma Outpatients: Results From an Italian Multicenter Phase III Randomized Clinical Trial
J. Clin. Oncol., March 15, 2002; 20(6): 1600 - 1607.
[Abstract] [Full Text] [PDF]

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 JCOHome page
K. L. Kilbridge, B. F. Cole, J. M. Kirkwood, F. G. Haluska, M. A. Atkins, J. C. Ruckdeschel, D. E. Sock, R. F. Nease Jr, and J. C. Weeks
Quality-of-Life-Adjusted Survival Analysis of High-Dose Adjuvant Interferon Alfa-2b for High-Risk Melanoma Patients Using Intergroup Clinical Trial Data
J. Clin. Oncol., March 1, 2002; 20(5): 1311 - 1318.
[Abstract] [Full Text] [PDF]

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 Arch Otolaryngol Head Neck SurgHome page
S. A. Eicher, G. L. Clayman, J. N. Myers, and A. M. Gillenwater
A Prospective Study of Intraoperative Lymphatic Mapping for Head and Neck Cutaneous Melanoma
Arch Otolaryngol Head Neck Surg, March 1, 2002; 128(3): 241 - 246.
[Abstract] [Full Text] [PDF]

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 Arch SurgHome page
G. I. Salti, A. Kansagra, M. A. Warso, S. G. Ronan, and T. K. Das Gupta
Clinical Node-Negative Thick Melanoma
Arch Surg, March 1, 2002; 137(3): 291 - 295.
[Abstract] [Full Text] [PDF]

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 JCOHome page
D. Bafaloukos, H. Gogas, V. Georgoulias, E. Briassoulis, G. Fountzilas, E. Samantas, Ch. Kalofonos, D. Skarlos, A. Karabelis, and P. Kosmidis
Temozolomide in Combination With Docetaxel in Patients With Advanced Melanoma: A Phase II Study of the Hellenic Cooperative Oncology Group
J. Clin. Oncol., January 15, 2002; 20(2): 420 - 425.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
C. L. Slingluff Jr., G. Yamshchikov, P. Neese, H. Galavotti, S. Eastham, V. H. Engelhard, D. Kittlesen, D. Deacon, S. Hibbitts, W. W. Grosh, et al.
Phase I Trial of a Melanoma Vaccine with gp100280-288 Peptide and Tetanus Helper Peptide in Adjuvant: Immunologic and Clinical Outcomes
Clin. Cancer Res., October 1, 2001; 7(10): 3012 - 3024.
[Abstract] [Full Text] [PDF]

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 BloodHome page
M. Talpaz, S. O'Brien, E. Rose, S. Gupta, J. Shan, J. Cortes, F. J. Giles, S. Faderl, and H. M. Kantarjian
Phase 1 study of polyethylene glycol formulation of interferon {alpha}-2B (Schering 54031) in Philadelphia chromosome-positive chronic myelogenous leukemia
Blood, September 15, 2001; 98(6): 1708 - 1713.
[Abstract] [Full Text] [PDF]

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 Arch DermatolHome page
R. W. Dubois, S. M. Swetter, M. Atkins, K. McMasters, R. Halbert, S. J. Miller, R. Shiell, and J. Kirkwood
Developing Indications for the Use of Sentinel Lymph Node Biopsy and Adjuvant High-Dose Interferon Alfa-2b in Melanoma
Arch Dermatol, September 1, 2001; 137(9): 1217 - 1224.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
J. W. Slaton, T. Karashima, P. Perrotte, K. Inoue, S. J. Kim, J. Izawa, D. Kedar, D. J. McConkey, R. Millikan, P. Sweeney, et al.
Treatment with Low-Dose Interferon-{alpha} Restores the Balance between Matrix Metalloproteinase-9 and E-Cadherin Expression in Human Transitional Cell Carcinoma of the Bladder
Clin. Cancer Res., September 1, 2001; 7(9): 2840 - 2853.
[Abstract] [Full Text] [PDF]

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 JCOHome page
C. M. Balch, S.-J. Soong, J. E. Gershenwald, J. F. Thompson, D. S. Reintgen, N. Cascinelli, M. Urist, K. M. McMasters, M. I. Ross, J. M. Kirkwood, et al.
Prognostic Factors Analysis of 17,600 Melanoma Patients: Validation of the American Joint Committee on Cancer Melanoma Staging System
J. Clin. Oncol., August 15, 2001; 19(16): 3622 - 3634.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
J.-C. Bystryn, A. Zeleniuch-Jacquotte, R. Oratz, R. L. Shapiro, M. N. Harris, and D. F. Roses
Double-Blind Trial of a Polyvalent, Shed-Antigen, Melanoma Vaccine
Clin. Cancer Res., July 1, 2001; 7(7): 1882 - 1887.
[Abstract] [Full Text] [PDF]

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 JCOHome page
K. M. McMasters, D. S. Reintgen, M. I. Ross, J. E. Gershenwald, M. J. Edwards, A. Sober, N. Fenske, F. Glass, C. M. Balch, and D. G. Coit
Sentinel Lymph Node Biopsy for Melanoma: Controversy Despite Widespread Agreement
J. Clin. Oncol., June 1, 2001; 19(11): 2851 - 2855.
[Abstract] [Full Text] [PDF]

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 JCOHome page
J. M. Kirkwood, J. G. Ibrahim, J. A. Sosman, V. K. Sondak, S. S. Agarwala, M. S. Ernstoff, and U. Rao
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., May 1, 2001; 19(9): 2370 - 2380.
[Abstract] [Full Text] [PDF]

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 Psychosom. Med.Home page
L. Capuron, A. Ravaud, and R. Dantzer
Timing and Specificity of the Cognitive Changes Induced by Interleukin-2 and Interferon-{alpha} Treatments in Cancer Patients
Psychosom Med, May 1, 2001; 63(3): 376 - 386.
[Abstract] [Full Text] [PDF]


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