7022 POSTER High dose interferon alpha 2b as adjuvant therapy in high-risk resected malignant melanoma: 10 year experience of patients treated in Northern Ireland

2007 ◽  
Vol 5 (4) ◽  
pp. 401
Author(s):  
S.K. Jain ◽  
L. Mulholland ◽  
C. McCourt ◽  
D. Connolly ◽  
E.E. Khan ◽  
...  
Keyword(s):  
High Risk ◽  
Malignant Melanoma ◽  
Northern Ireland ◽  
Adjuvant Therapy ◽  
Interferon Alpha ◽  
High Dose ◽  
Interferon Alpha 2B ◽  
High Dose Interferon

A phase II randomized study of adjuvant imatinib versus high-dose interferon alpha-2b for resected high-risk c-kit mutated melanoma.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20027-e20027
Author(s):  
Lu Si ◽  
Xuan Wang ◽  
Yan Kong ◽  
Bin Lian ◽  
Zhi Hong Chi ◽  
...  
Keyword(s):  
High Risk ◽  
Adjuvant Therapy ◽  
Randomized Study ◽  
Growth Factor Receptor ◽  
High Dose ◽  
Interferon Alpha 2B ◽  
Risk Melanoma ◽  
Exon 11 ◽  
One Year ◽  
High Dose Interferon

e20027 Background: Imatinib, a selective inhibitor targeting Abl as well as C-Kit and the platelet-derived growth factor receptor, has been tested for the efficacy and toxicities in metastatic melanoma patients harboring mutations in C-Kit gene. High-dose interferon for one year (HDI) is the FDA approved adjuvant therapy for patients (pts) with high-risk melanoma. This study (NCT01782508) aims to see whether imatinib is more effective than interferon alfa-2b in adjuvant therapy for patients with C-Kit mutated melanomas. Methods: This study enrolled C-Kit mutated(exon 9,11 or 13)pts who were high risk (stage IIB to stage IIIC) and randomized them to receive either imatinib (400mg daily for a year) or HDI (interferon a-2b 15X106 U/m2 d1–5/wX4w + 9X106U tiwX48w) in the absence of disease progression or unacceptable toxicity. 40 pts of each group were planned to enroll. Routine tests including blood tests, medical history updates, physical exams and Brain/Chest/Abdomen/Pelvic CT were performed every 2 months. The endpoints were recurrence-free survival (RFS) and overall survival. Results: Through Jan 2013,7 pts were recruited F3 in imatinib arm and 4 in HDI arm. The three pts received imatinib haven’t had recurrence or metastasis. The RFS were 6m+ (Exon 11: W577S), 5m+ (Exon 11: L576P), 5m+ (Exon 11: L576P) respectively. Two pts have already had lung or regional lymphnode at 4 months (Exon 13: K642E) and 5 months (Exon 11: V560D) in the HDI arm. The other two pts (both Exon 11: 579 insert) in the HDI arm were still disease free for 6 months. The toxicities were consistent with the usual reported studies. Conclusions: In the C-Kit mutated melanoma pts, it’s promising that imatinib may provide more beneficial effect than HDI for high-risk melanomas. (Supported by the National Natural Science Foundation of China (30973483, 81172196, 81102068.) Clinical trial information: NCT01782508.

scholarly journals Malignant Melanoma: Adjuvant Therapy With Interferon Alpha 2b And Nivolumab

2019 ◽  
Vol 4 (2) ◽  
pp. S50
Author(s):  
M. Abdul Wajid ◽  
Gupta Aditya Kumar ◽  
S. Rachna ◽  
P Meena Jagdish ◽  
Sahoo Debasish
Keyword(s):  
Malignant Melanoma ◽  
Adjuvant Therapy ◽  
Interferon Alpha ◽  
Interferon Alpha 2B

scholarly journals A pilot study of interferon-alpha-2b dose reduction in the adjuvant therapy of high-risk melanoma

2019 ◽  
Vol 68 (4) ◽  
pp. 619-629 ◽  
Author(s):  
Lorena P. Suarez-Kelly ◽  
Kala M. Levine ◽  
Thomas E. Olencki ◽  
Sara E. Martin del Campo ◽  
Elizabeth A. Streacker ◽  
...  
Keyword(s):  
Pilot Study ◽  
High Risk ◽  
Adjuvant Therapy ◽  
Dose Reduction ◽  
Interferon Alpha ◽  
Interferon Alpha 2B ◽  
High Risk Melanoma ◽  
Risk Melanoma

scholarly journals A Phase 2 Trial of Bevacizumab and High-dose Interferon Alpha 2B in Metastatic Melanoma

2011 ◽  
Vol 34 (6) ◽  
pp. 509-515 ◽  
Author(s):  
Valerie P. Grignol ◽  
Thomas Olencki ◽  
Kiran Relekar ◽  
Cynthia Taylor ◽  
Amanda Kibler ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Interferon Alpha ◽  
High Dose ◽  
Phase 2 ◽  
Interferon Alpha 2B ◽  
Phase 2 Trial ◽  
High Dose Interferon

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]

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