Dose-Dependent Treatment Benefit in High-Risk Melanoma Patients Receiving Adjuvant High-Dose Interferon Alfa-2b

2005 ◽  
Vol 20 (3) ◽  
pp. 280-289 ◽  
Author(s):  
Michael Fluck ◽  
Darab Kamanabrou ◽  
Andrea Lippold ◽  
Martina Reitz ◽  
Jens Atzpodien
Keyword(s):  
High Risk ◽  
Interferon Alfa ◽  
High Dose ◽  
Treatment Benefit ◽  
High Risk Melanoma ◽  
Risk Melanoma ◽  
Melanoma Patients ◽  
Dose Dependent ◽  
High Dose Interferon

Duration of High-Dose Interferon Alfa-2b Regimen for Resected High-Risk Melanoma

2009 ◽  
Vol 27 (25) ◽  
pp. e82-e83 ◽  
Author(s):  
Sanjiv S. Agarwala ◽  
Robert J. Gray ◽  
Michael K.K. Wong
Keyword(s):  
High Risk ◽  
Interferon Alfa ◽  
High Dose ◽  
High Risk Melanoma ◽  
Risk Melanoma ◽  
High Dose Interferon

Lymphocyte Subpopulations and Interleukin Levels in High-Risk Melanoma Patients Treated With High-Dose Interferon A-2B

2002 ◽  
Vol 25 (6) ◽  
pp. 591-596 ◽  
Author(s):  
Helen Gogas ◽  
George Paterakis ◽  
Konstantina Frangia ◽  
Dimitrios Bafaloukos ◽  
Dimitrios Pectasides ◽  
...  
Keyword(s):  
High Risk ◽  
Lymphocyte Subpopulations ◽  
High Dose ◽  
High Risk Melanoma ◽  
Risk Melanoma ◽  
Melanoma Patients ◽  
High Dose Interferon

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

2001 ◽  
Vol 19 (5) ◽  
pp. 1430-1436 ◽  
Author(s):  
John M. Kirkwood ◽  
Joseph Ibrahim ◽  
David H. Lawson ◽  
Michael B. Atkins ◽  
Sanjiv S. Agarwala ◽  
...  
Keyword(s):  
High Risk ◽  
Phase Ii ◽  
Interferon Alfa ◽  
Immunoglobulin M ◽  
Phase Iii ◽  
High Dose ◽  
High Risk Melanoma ◽  
Risk Melanoma ◽  
High Dose Interferon ◽  
Very High

PURPOSE: High-dose interferon alfa-2b (IFNα2b) is the only established adjuvant therapy of resectable high-risk melanoma. GM2-KLH/QS-21 (GMK) is a chemically defined vaccine that is one of the best developed of a range of vaccine candidates for melanoma. A single-institution phase III trial conducted at Memorial Hospital served as the impetus for an intergroup adjuvant E1694/S9512/C509801 trial, which recently completed enrollment of 880 patients. To build on the apparent benefit of IFNα2b in resectable high-risk American Joint Committee on Cancer (AJCC) stage IIB or III melanoma, this phase II study was designed to evaluate the combination of GMK and IFNα2b. The E2696 trial was undertaken to evaluate the toxicity and other effects of the established adjuvant high-dose IFNα2b regimen in relation to immune responses to GMK and to evaluate the potential clinical and immunologic effects of the combined therapies. PATIENTS AND METHODS: This trial enrolled 107 patients with resectable high- or very high–risk melanoma (AJCC stages IIB, III, and IV). RESULTS: The results demonstrate that IFNα2b does not significantly inhibit immunoglobulin M or G serologic responses to the vaccine and that the combination of high-dose IFNα2b and GMK is well tolerated in this patient population. CONCLUSION: Cox analysis of the results of the combination with IFNα2b show improvement in the relapse-free survival of patients with very high–risk melanoma (including those with resectable M1 disease).

A phase III randomized study of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon alfa-2b for resected high-risk melanoma (U.S. Intergroup E1609): Preliminary safety and efficacy of the ipilimumab arms.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 9500-9500 ◽  
Author(s):  
Ahmad A. Tarhini ◽  
Sandra J. Lee ◽  
F. Stephen Hodi ◽  
Uma N. M. Rao ◽  
Gary I Cohen ◽  
...  
Keyword(s):  
High Risk ◽  
Adjuvant Therapy ◽  
Interferon Alfa ◽  
Regulatory Approval ◽  
High Dose ◽  
Safety And Efficacy ◽  
High Risk Melanoma ◽  
Relative Safety ◽  
Risk Melanoma ◽  
High Dose Interferon

9500 Background: In the U.S., 3 regimens have regulatory approval as adjuvant therapy for high-risk melanoma, including high-dose interferon-alfa (HDI) and ipilimumab 10 mg/kg (ipi10). Ipilimumab 3 mg/kg (ipi3) has regulatory approval for metastatic inoperable melanoma. The toxicity of ipi is dose- dependent, and following the recent approval of adjuvant ipi10, it has become urgent to evaluate the relative safety and efficacy of adjuvant ipi at the 2 dose levels that have been tested in E1609. Methods: E1609 randomized patients (pts) with resected high-risk melanoma (stratified by stages IIIB, IIIC, M1a, M1b) to ipi10 or ipi3 versus HDI. Co-primary endpoints were RFS and OS. The current analysis investigates the relative safety and preliminary, non-comparative RFS of the ipi arms as of 3/2/17. Results: E1609 was activated on 5/25/11 and completed adult pt accrual on 8/15/14. Accrual to ipi10 was suspended due to toxicity between 9/23-11/16/2013. Final adult pt accrual was 1670 including 511 ipi10, 636 HDI and 523 ipi3 pts. Treatment related adverse events (AEs) were reported among 503 ipi10 and 516 ipi3 pts. Worst degree (Gr 3+) AEs were experienced by 57% ipi10 and 36.4% ipi3 pts and were mostly immune related (Table 1). AEs led to discontinuation of treatment in 271 (53.8 %) of 503 ipi10 and in 180 (35.2 %) of 512 ipi3 pts during the initial 4 dose induction phase. Gr5 AEs considered at least possibly related were 8 with ipi10 and 2 with ipi3. At a median follow-up of 3.1 years, an unplanned RFS analysis of ipi3 and ipi10 on concurrently randomized pts showed no difference between the 2 arms. Three-year RFS rate was 54% (95% CI: 49, 60) with ipi10 and 56% (50, 61) with ipi3. Conclusions: Adjuvant therapy of pts with high-risk melanoma is associated with significantly more toxicity at ipi10 compared to ipi3. An unplanned RFS analysis of concurrently randomized pts on the 2 ipi arms showed no difference in RFS. Clinical trial information: NCT01274338. [Table: see text]

Quality of Life in Patients Receiving High-Dose Interferon Alfa-2b After Resected High-Risk Melanoma

2009 ◽  
Vol 27 (24) ◽  
pp. e70-e70 ◽  
Author(s):  
Peter Mohr ◽  
Axel Hauschild ◽  
Uwe Trefzer ◽  
Michael Weichenthal
Keyword(s):  
Quality Of Life ◽  
High Risk ◽  
Interferon Alfa ◽  
High Dose ◽  
High Risk Melanoma ◽  
Risk Melanoma ◽  
High Dose Interferon

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

2001 ◽  
Vol 19 (9) ◽  
pp. 2370-2380 ◽  
Author(s):  
John M. Kirkwood ◽  
Joseph G. Ibrahim ◽  
Jeffrey A. Sosman ◽  
Vernon K. Sondak ◽  
Sanjiv S. Agarwala ◽  
...  
Keyword(s):  
Overall Survival ◽  
High Risk ◽  
Interferon Alfa ◽  
High Dose ◽  
Treatment Benefit ◽  
Significant Treatment ◽  
Melanoma Patients ◽  
Intergroup Trial ◽  
Resected Stage ◽  
High Dose Interferon

PURPOSE: Vaccine alternatives to high-dose interferon alfa-2b therapy (HDI), the current standard adjuvant therapy for high-risk melanoma, are of interest because of toxicity associated with HDI. The GM2 ganglioside is a well-defined melanoma antigen, and anti-GM2 antibodies have been associated with improved prognosis. We conducted a prospective, randomized, intergroup trial to evaluate the efficacy of HDI for 1 year versus vaccination with GM2 conjugated to keyhole limpet hemocyanin and administered with QS-21 (GMK) for 96 weeks (weekly × 4 then every 12 weeks × 8). PATIENTS AND METHODS: Eligible patients had resected stage IIB/III melanoma. Patients were stratified by sex and number of positive nodes. Primary end points were relapse-free survival (RFS) and overall survival (OS). RESULTS: Eight hundred eighty patients were randomized (440 per treatment group); 774 patients were eligible for efficacy analysis. The trial was closed after interim analysis indicated inferiority of GMK compared with HDI. For eligible patients, HDI provided a statistically significant RFS benefit (hazard ratio [HR] = 1.47, P = .0015) and OS benefit (HR = 1.52, P = .009) for GMK versus HDI. Similar benefit was observed in the intent-to-treat analysis (RFS HR = 1.49; OS HR = 1.38). HDI was associated with a treatment benefit in all subsets of patients with zero to ≥ four positive nodes, but the greatest benefit was observed in the node-negative subset (RFS HR = 2.07; OS HR = 2.71 [eligible population]). Antibody responses to GM2 (ie, titers ≥ 1:80) at days 29, 85, 365, and 720 were associated with a trend toward improved RFS and OS (P2 = .068 at day 29). CONCLUSION: This trial demonstrated a significant treatment benefit of HDI versus GMK in terms of RFS and OS in melanoma patients at high risk of recurrence.

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