Randomized trial of an allogeneic melanoma lysate vaccine with low-dose interferon alfa-2b compared with high-dose interferon alfa-2b for resected stage III cutaneous melanoma

Malcolm S. Mitchell, Judith Abrams, John A. Thompson, Mohammed Kashani-Sabet, Ronald C. DeConti, Wen Jen Hwu, Michael B. Atkins, Eric Whitman, Marc S. Ernstoff, Frank G. Haluska, James G. Jakowatz, Tapas K. Das Gupta, Jon M. Richards, Wolfram E. Samlowski, John J. Costanzi, Frederick R. Aronson, Albert B. Deisseroth, Arkadiusz Z. Dudek, Vicky E. Jones

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Abstract

Purpose: To compare the overall survival (OS) of patients with resected stage III melanoma administered active specific immunotherapy and low-dose interferon alfa-2b (IFN-α-2b) with the OS achieved using high-dose IFN-α-2b. Patients and Methods: An Ad Hoc Melanoma Working Group of 25 investigators treated 604 patients from April 1997 to January 2003. Patients were stratified by sex and number of nodes and were randomly assigned to receive either 2 years of treatment with active specific immunotherapy with allogeneic melanoma lysates and low-dose IFN-α-2b (arm 1) or high-dose IFN-α-2b alone for 1 year (arm 2). Active specific immunotherapy was injected subcutaneously (SC) weekly for 4 weeks, at week 8, and bimonthly thereafter. IFN-α-2b SC was begun on week 4 and continued thrice weekly at 5 MU/m 2 for 2 years. IFN-α-2b in arm 2 was administered according to the Eastern Cooperative Oncology Group 1684 study regimen. Results: Median follow-up time was 32 months for all patients and 42 months for surviving patients. Median OS time exceeds 84 months in arm 1 and is 83 months in arm 2 (P = .56). Five-year OS rate is 61 % in arm 1 and 57% in arm 2. Estimated 5-year relapse-free survival (RFS) rate is 50% in arm 1 and 48% in arm 2, with median RFS times of 58 and 50 months, respectively. The incidence of serious adverse events as a result of treatment was the same in both arms, but more severe neuropsychiatric toxicity was seen in arm 2. Conclusion: OS and RFS achieved by active specific immunotherapy and low-dose IFN-α-2b were indistinguishable from those achieved by high-dose IFN-α-2b. Long RFS and OS times were observed in both treatment arms.

Original languageEnglish (US)
Pages (from-to)2078-2085
Number of pages8
JournalJournal of Clinical Oncology
Volume25
Issue number15
DOIs
StatePublished - May 20 2007

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interferon alfa-2b
Melanoma
Vaccines
Active Immunotherapy
Skin
Survival
Recurrence
Survival Rate

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Mitchell, Malcolm S. ; Abrams, Judith ; Thompson, John A. ; Kashani-Sabet, Mohammed ; DeConti, Ronald C. ; Hwu, Wen Jen ; Atkins, Michael B. ; Whitman, Eric ; Ernstoff, Marc S. ; Haluska, Frank G. ; Jakowatz, James G. ; Das Gupta, Tapas K. ; Richards, Jon M. ; Samlowski, Wolfram E. ; Costanzi, John J. ; Aronson, Frederick R. ; Deisseroth, Albert B. ; Dudek, Arkadiusz Z. ; Jones, Vicky E. / Randomized trial of an allogeneic melanoma lysate vaccine with low-dose interferon alfa-2b compared with high-dose interferon alfa-2b for resected stage III cutaneous melanoma. In: Journal of Clinical Oncology. 2007 ; Vol. 25, No. 15. pp. 2078-2085.
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title = "Randomized trial of an allogeneic melanoma lysate vaccine with low-dose interferon alfa-2b compared with high-dose interferon alfa-2b for resected stage III cutaneous melanoma",
abstract = "Purpose: To compare the overall survival (OS) of patients with resected stage III melanoma administered active specific immunotherapy and low-dose interferon alfa-2b (IFN-α-2b) with the OS achieved using high-dose IFN-α-2b. Patients and Methods: An Ad Hoc Melanoma Working Group of 25 investigators treated 604 patients from April 1997 to January 2003. Patients were stratified by sex and number of nodes and were randomly assigned to receive either 2 years of treatment with active specific immunotherapy with allogeneic melanoma lysates and low-dose IFN-α-2b (arm 1) or high-dose IFN-α-2b alone for 1 year (arm 2). Active specific immunotherapy was injected subcutaneously (SC) weekly for 4 weeks, at week 8, and bimonthly thereafter. IFN-α-2b SC was begun on week 4 and continued thrice weekly at 5 MU/m 2 for 2 years. IFN-α-2b in arm 2 was administered according to the Eastern Cooperative Oncology Group 1684 study regimen. Results: Median follow-up time was 32 months for all patients and 42 months for surviving patients. Median OS time exceeds 84 months in arm 1 and is 83 months in arm 2 (P = .56). Five-year OS rate is 61 {\%} in arm 1 and 57{\%} in arm 2. Estimated 5-year relapse-free survival (RFS) rate is 50{\%} in arm 1 and 48{\%} in arm 2, with median RFS times of 58 and 50 months, respectively. The incidence of serious adverse events as a result of treatment was the same in both arms, but more severe neuropsychiatric toxicity was seen in arm 2. Conclusion: OS and RFS achieved by active specific immunotherapy and low-dose IFN-α-2b were indistinguishable from those achieved by high-dose IFN-α-2b. Long RFS and OS times were observed in both treatment arms.",
author = "Mitchell, {Malcolm S.} and Judith Abrams and Thompson, {John A.} and Mohammed Kashani-Sabet and DeConti, {Ronald C.} and Hwu, {Wen Jen} and Atkins, {Michael B.} and Eric Whitman and Ernstoff, {Marc S.} and Haluska, {Frank G.} and Jakowatz, {James G.} and {Das Gupta}, {Tapas K.} and Richards, {Jon M.} and Samlowski, {Wolfram E.} and Costanzi, {John J.} and Aronson, {Frederick R.} and Deisseroth, {Albert B.} and Dudek, {Arkadiusz Z.} and Jones, {Vicky E.}",
year = "2007",
month = "5",
day = "20",
doi = "10.1200/JCO.2006.10.1709",
language = "English (US)",
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pages = "2078--2085",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
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}

Mitchell, MS, Abrams, J, Thompson, JA, Kashani-Sabet, M, DeConti, RC, Hwu, WJ, Atkins, MB, Whitman, E, Ernstoff, MS, Haluska, FG, Jakowatz, JG, Das Gupta, TK, Richards, JM, Samlowski, WE, Costanzi, JJ, Aronson, FR, Deisseroth, AB, Dudek, AZ & Jones, VE 2007, 'Randomized trial of an allogeneic melanoma lysate vaccine with low-dose interferon alfa-2b compared with high-dose interferon alfa-2b for resected stage III cutaneous melanoma', Journal of Clinical Oncology, vol. 25, no. 15, pp. 2078-2085. https://doi.org/10.1200/JCO.2006.10.1709

Randomized trial of an allogeneic melanoma lysate vaccine with low-dose interferon alfa-2b compared with high-dose interferon alfa-2b for resected stage III cutaneous melanoma. / Mitchell, Malcolm S.; Abrams, Judith; Thompson, John A.; Kashani-Sabet, Mohammed; DeConti, Ronald C.; Hwu, Wen Jen; Atkins, Michael B.; Whitman, Eric; Ernstoff, Marc S.; Haluska, Frank G.; Jakowatz, James G.; Das Gupta, Tapas K.; Richards, Jon M.; Samlowski, Wolfram E.; Costanzi, John J.; Aronson, Frederick R.; Deisseroth, Albert B.; Dudek, Arkadiusz Z.; Jones, Vicky E.

In: Journal of Clinical Oncology, Vol. 25, No. 15, 20.05.2007, p. 2078-2085.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Randomized trial of an allogeneic melanoma lysate vaccine with low-dose interferon alfa-2b compared with high-dose interferon alfa-2b for resected stage III cutaneous melanoma

AU - Mitchell, Malcolm S.

AU - Abrams, Judith

AU - Thompson, John A.

AU - Kashani-Sabet, Mohammed

AU - DeConti, Ronald C.

AU - Hwu, Wen Jen

AU - Atkins, Michael B.

AU - Whitman, Eric

AU - Ernstoff, Marc S.

AU - Haluska, Frank G.

AU - Jakowatz, James G.

AU - Das Gupta, Tapas K.

AU - Richards, Jon M.

AU - Samlowski, Wolfram E.

AU - Costanzi, John J.

AU - Aronson, Frederick R.

AU - Deisseroth, Albert B.

AU - Dudek, Arkadiusz Z.

AU - Jones, Vicky E.

PY - 2007/5/20

Y1 - 2007/5/20

N2 - Purpose: To compare the overall survival (OS) of patients with resected stage III melanoma administered active specific immunotherapy and low-dose interferon alfa-2b (IFN-α-2b) with the OS achieved using high-dose IFN-α-2b. Patients and Methods: An Ad Hoc Melanoma Working Group of 25 investigators treated 604 patients from April 1997 to January 2003. Patients were stratified by sex and number of nodes and were randomly assigned to receive either 2 years of treatment with active specific immunotherapy with allogeneic melanoma lysates and low-dose IFN-α-2b (arm 1) or high-dose IFN-α-2b alone for 1 year (arm 2). Active specific immunotherapy was injected subcutaneously (SC) weekly for 4 weeks, at week 8, and bimonthly thereafter. IFN-α-2b SC was begun on week 4 and continued thrice weekly at 5 MU/m 2 for 2 years. IFN-α-2b in arm 2 was administered according to the Eastern Cooperative Oncology Group 1684 study regimen. Results: Median follow-up time was 32 months for all patients and 42 months for surviving patients. Median OS time exceeds 84 months in arm 1 and is 83 months in arm 2 (P = .56). Five-year OS rate is 61 % in arm 1 and 57% in arm 2. Estimated 5-year relapse-free survival (RFS) rate is 50% in arm 1 and 48% in arm 2, with median RFS times of 58 and 50 months, respectively. The incidence of serious adverse events as a result of treatment was the same in both arms, but more severe neuropsychiatric toxicity was seen in arm 2. Conclusion: OS and RFS achieved by active specific immunotherapy and low-dose IFN-α-2b were indistinguishable from those achieved by high-dose IFN-α-2b. Long RFS and OS times were observed in both treatment arms.

AB - Purpose: To compare the overall survival (OS) of patients with resected stage III melanoma administered active specific immunotherapy and low-dose interferon alfa-2b (IFN-α-2b) with the OS achieved using high-dose IFN-α-2b. Patients and Methods: An Ad Hoc Melanoma Working Group of 25 investigators treated 604 patients from April 1997 to January 2003. Patients were stratified by sex and number of nodes and were randomly assigned to receive either 2 years of treatment with active specific immunotherapy with allogeneic melanoma lysates and low-dose IFN-α-2b (arm 1) or high-dose IFN-α-2b alone for 1 year (arm 2). Active specific immunotherapy was injected subcutaneously (SC) weekly for 4 weeks, at week 8, and bimonthly thereafter. IFN-α-2b SC was begun on week 4 and continued thrice weekly at 5 MU/m 2 for 2 years. IFN-α-2b in arm 2 was administered according to the Eastern Cooperative Oncology Group 1684 study regimen. Results: Median follow-up time was 32 months for all patients and 42 months for surviving patients. Median OS time exceeds 84 months in arm 1 and is 83 months in arm 2 (P = .56). Five-year OS rate is 61 % in arm 1 and 57% in arm 2. Estimated 5-year relapse-free survival (RFS) rate is 50% in arm 1 and 48% in arm 2, with median RFS times of 58 and 50 months, respectively. The incidence of serious adverse events as a result of treatment was the same in both arms, but more severe neuropsychiatric toxicity was seen in arm 2. Conclusion: OS and RFS achieved by active specific immunotherapy and low-dose IFN-α-2b were indistinguishable from those achieved by high-dose IFN-α-2b. Long RFS and OS times were observed in both treatment arms.

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U2 - 10.1200/JCO.2006.10.1709

DO - 10.1200/JCO.2006.10.1709

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