Toxicity of adjuvant high-dose interferon-alpha-2b in patients with cutaneous melanoma at high risk of recurrence.

Author(s):  
J Schachter ◽  
B Brenner ◽  
E Fenig ◽  
J Yahav ◽  
G Marshak ◽  
...  
2015 ◽  
Vol 5 (1) ◽  
pp. 17-23 ◽  
Author(s):  
Agnieszka Malczewski ◽  
Andrea Marshall ◽  
Miranda J. Payne ◽  
Lili Mao ◽  
Dimitrios Bafaloukos ◽  
...  

2011 ◽  
Vol 34 (6) ◽  
pp. 509-515 ◽  
Author(s):  
Valerie P. Grignol ◽  
Thomas Olencki ◽  
Kiran Relekar ◽  
Cynthia Taylor ◽  
Amanda Kibler ◽  
...  

1999 ◽  
Vol 80 (11) ◽  
pp. 1767-1769 ◽  
Author(s):  
A Ravaud ◽  
C Bedane ◽  
L Geoffrois ◽  
T Lesimple ◽  
M Delaunay

2014 ◽  
Vol 32 (3) ◽  
pp. 185-190 ◽  
Author(s):  
Miranda J. Payne ◽  
Katerina Argyropoulou ◽  
Paul Lorigan ◽  
James J. McAleer ◽  
David Farrugia ◽  
...  

Purpose High-dose interferon alfa-2b (HDI) has emerged as a potentially effective adjuvant therapy in patients with resected melanoma at high risk of recurrence. Evidence suggests it may be the early, very-high-dose part of the regimen that is critical. This pilot study sought to provide an early indication of whether the same effects can be achieved with the intravenous component of HDI alone and inform the feasibility and design of a phase III trial. Patients and Methods Patients with stage 2B, 2C, 3B, and 3C melanoma were randomly assigned to receive interferon alfa-2b (IFN-α-2b) 20 MIU/m2 intravenously (IV) daily 5 days per week for 4 weeks (arm A) versus the same regimen followed by IFN-α-2b 10 MIU/m2 administered subcutaneously three times per week for 48 weeks (arm B) and observed for relapse-free survival (RFS) and overall survival. Results Between 2003 and 2009, 194 patients were enrolled (arm A, 96; arm B, 98). After median follow-up of 39.5 months, RFS was 22.7 months (95% CI, 14.1 to 38.1 months) in arm A versus 33.3 months (95% CI, 18.2 to not reached) in arm B (P = .28). The proportions of patients free of relapse at 2 years were 50% and 54.1% (P = .569; hazard ratio, 0.89), respectively. Overall survival favored arm B (median, 41.5 months v not reached; P = .05). Conclusion Clinical outcomes were better in patients who had the longer regimen. Our results do not support either the use of a month of IV HDI alone in place of the year-long regimen or the initiation of a larger trial on this question.


2010 ◽  
Vol 28 (15_suppl) ◽  
pp. 8524-8524 ◽  
Author(s):  
A. A. Tarhini ◽  
S. J. Moschos ◽  
H. Tawbi ◽  
Y. Shuai ◽  
W. E. Gooding ◽  
...  

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20027-e20027
Author(s):  
Lu Si ◽  
Xuan Wang ◽  
Yan Kong ◽  
Bin Lian ◽  
Zhi Hong Chi ◽  
...  

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.


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