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Journal of Clinical Oncology, Vol 18, Issue 12 (June), 2000: 2444-2458
© 2000 American Society for Clinical Oncology

High- and Low-Dose Interferon Alfa-2b in High-Risk Melanoma: First Analysis of Intergroup Trial E1690/S9111/C9190

By John M. Kirkwood, Joseph G. Ibrahim, Vernon K. Sondak, Jon Richards, Lawrence E. Flaherty, Marc S. Ernstoff, Thomas J. Smith, Uma Rao, Mary Steele, Ronald H. Blum

From the Department of Pathology, University of Pittsburgh Medical Center, and Department of Medicine, Division of Hematology-Oncology, University of Pittsburgh Cancer Institute Melanoma Center, Pittsburgh, PA; Dana-Farber Cancer Institute and Department of Biostatistics, Harvard School of Public Health, Boston; Department of Data Management, Eastern Cooperative Oncology Group Coordinating Center, Brookline, MA; Department of Surgery, Division of Surgical Oncology, University of Michigan, Ann Arbor; Department of Medicine, Division of Hematology/Oncology, Karmanos Cancer Center/Wayne State University, Detroit, MI; Department of Medicine, Division of Hematology-Oncology, Lutheran General Hospital, Chicago, IL; Department of Medicine, Division of Hematology-Oncology, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Department of Surgery, Division of Surgical Oncology, Morristown Memorial Hospital, Morristown, NJ; and Department of Medicine, Section of Oncology, St Vincent’s Hospital and Medical Center, New York, NY.

Address reprint requests to John M. Kirkwood, MD, University of Pittsburgh Cancer Institute, 200 Lothrop St, Pittsburgh, PA 15213-2582; email jmk{at}jimmy.harvard.edu © 2000 by American Society of Clinical Oncology. 0732-183X/0-2000/00-1

PURPOSE: Pivotal trial E1684 of adjuvant high-dose interferon alfa-2b (IFN{alpha}2b) therapy in high-risk melanoma patients demonstrated a significant relapse-free and overall survival (RFS and OS) benefit compared with observation (Obs).

PATIENTS AND METHODS: A prospective, randomized, three-arm, intergroup trial evaluated the efficacy of high-dose IFN{alpha}2b (HDI) for 1 year and low-dose IFN{alpha}2b (LDI) for 2 years versus Obs in high-risk (stage IIB and III) melanoma with RFS and OS end points.

RESULTS: A total of 642 patients were enrolled (608 patients eligible), of whom a majority (75%) had nodal metastasis (50% had nodal recurrence). Unlike E1684, E1690 allowed entry of patients with T4 (> 4 mm) deep primary tumors, regardless of nodal dissection, and 25% of the patients entered onto this trial had deep primary tumors (compared with 11% in E1684). At 52 months’ median follow-up, HDI demonstrated an RFS benefit exceeding that of LDI compared with Obs. The 5-year estimated RFS rates for the HDI, LDI, and Obs arms were 44%, 40%, and 35%, respectively. The hazards ratio for the intent-to-treat analysis of HDI versus Obs was 1.28 (P2 = .05); for LDI versus Obs, it was 1.19 (P2 = .17). By Cox analysis, the impact of HDI on RFS achieved significance (P2 = .03). The RFS benefit was equivalent for node-negative and node-positive patients. Neither HDI nor LDI has demonstrated an OS benefit compared with Obs at this time. A major improvement in the median OS of patients in the E1690 Obs arm was noted in comparison with E1684 (6 years v 2.8 years). An analysis of salvage therapy for patients who relapsed on E1690 demonstrated that a significantly larger proportion of patients in the Obs arm received IFN{alpha}-containing salvage therapy compared with the HDI arm; this therapy was unavailable to patients during E1684, and patients with undissected regional nodes were not included in E1684. This study did not specify therapy at recurrence. Analysis of treatments received at recurrence demonstrated significantly more frequent use of IFN{alpha}2b at relapse from Obs than from HDI, which may have confounded interpretation of the survival benefit of assigned treatments in E1690.

CONCLUSION: The results of the intergroup E1690 trial demonstrate an RFS benefit of IFN{alpha}2b that is dose-dependent and significant for HDI by Cox multivariable analysis.

J.M.K., J.I., T.J.S., U.R., M.S., and R.H.B. are affiliated with the Eastern Cooperative Oncology Group. V.K.S. and L.E.F. are affiliated with the Southwest Oncology Group. J.R. and M.S.E. are affiliated with Cancer and Leukemia Group B.


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U.N.M. Rao, J. Ibrahim, L.E. Flaherty, J. Richards, and J.M. Kirkwood
Implications of Microscopic Satellites of the Primary and Extracapsular Lymph Node Spread in Patients With High-Risk Melanoma: Pathologic Corollary of Eastern Cooperative Oncology Group Trial E1690
J. Clin. Oncol., April 15, 2002; 20(8): 2053 - 2057.
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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
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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.
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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.
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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
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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.
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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.
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P. Lee, F. Wang, J. Kuniyoshi, V. Rubio, T. Stuges, S. Groshen, C. Gee, R. Lau, G. Jeffery, K. Margolin, et al.
Effects of Interleukin-12 on the Immune Response to a Multipeptide Vaccine for Resected Metastatic Melanoma
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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.
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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.
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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.
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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.
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M. H. Kanzler and S. Mraz-Gernhard
Treatment of Primary Cutaneous Melanoma
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J. M. Kirkwood, J. Ibrahim, D. H. Lawson, M. B. Atkins, S. S. Agarwala, K. Collins, R. Mascari, D. M. Morrissey, and P. B. Chapman
High-Dose Interferon Alfa-2b Does Not Diminish Antibody Response to GM2 Vaccination in Patients With Resected Melanoma: Results of the Multicenter Eastern Cooperative Oncology Group Phase II Trial E2696
J. Clin. Oncol., March 1, 2001; 19(5): 1430 - 1436.
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L. E. Spitler and J. M. Kirkwood
Adjuvant Therapy of Melanoma: At What Cost?
J. Clin. Oncol., February 15, 2001; 19(4): 1226 - 1228.
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L. A. Doughty, K. B. Nguyen, J. E. Durbin, and C. A. Biron
A Role for IFN-{{alpha}}{{beta}} in Virus Infection-Induced Sensitization to Endotoxin
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K. L. Kilbridge, J. C. Weeks, A. J. Sober, F. G. Haluska, C. L. Slingluff, M. B. Atkins, D. E. Sock, J. M. Kirkwood, and R. F. Nease
Patient Preferences for Adjuvant Interferon Alfa-2b Treatment
J. Clin. Oncol., February 1, 2001; 19(3): 812 - 823.
[Abstract] [Full Text] [PDF]

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S S Rayatt, S P Hettiaratchy, S. Wookey, B. Powell, M D. Humzah, R. Russell-Jones, E. Calonje, C. Healy, M. Doherty, P. Butler, et al.
Sentinel node biopsy for malignant melanoma
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