EORTC 18991 phase III trial: Long-term adjuvant pegylated interferon-α2b (PEG-IFN) versus observation in resected stage III melanoma: Long-term results at 7.6-years follow-up.

2011 ◽  
Vol 29 (15_suppl) ◽  
pp. 8506b-8506b ◽  
Author(s):  
A. M. Eggermont ◽  
S. Suciu ◽  
M. Santinami ◽  
W. Kruit ◽  
A. Testori ◽  
...  
Keyword(s):  
Pegylated Interferon ◽  
Phase Iii ◽  
Stage Iii ◽  
Long Term Results ◽  
Phase Iii Trial ◽  
Stage Iii Melanoma ◽  
Resected Stage ◽  
Interferon Α2b

Long-Term Results of the Randomized Phase III Trial EORTC 18991 of Adjuvant Therapy With Pegylated Interferon Alfa-2b Versus Observation in Resected Stage III Melanoma

2012 ◽  
Vol 30 (31) ◽  
pp. 3810-3818 ◽  
Author(s):  
Alexander M.M. Eggermont ◽  
Stefan Suciu ◽  
Alessandro Testori ◽  
Mario Santinami ◽  
Wim H.J. Kruit ◽  
...  
Keyword(s):  
Pegylated Interferon ◽  
Interferon Alfa ◽  
Stage Iii ◽  
Long Term Results ◽  
Free Survival ◽  
Pegylated Interferon Alfa ◽  
Stage Iii Melanoma ◽  
Resected Stage

Purpose Adjuvant pegylated interferon alfa-2b (PEG-IFN-α-2b) was approved for treatment of resected stage III melanoma in 2011. Here, we present long-term follow-up results of this pivotal trial. Patients and Methods In all, 1,256 patients with resected stage III melanoma were randomly assigned to observation (n = 629) or PEG-IFN-α-2b (n = 627) for an intended duration of 5 years. Stratification factors were microscopic (N1) versus macroscopic (N2) nodal involvement, number of positive nodes, ulceration and tumor thickness, sex, and center. Recurrence-free survival (RFS; primary end point), distant metastasis-free survival (DMFS), and overall survival (OS) were analyzed for the intent-to-treat population. Results At 7.6 years median follow-up, 384 recurrences or deaths had occurred with PEG-IFN-α-2b versus 406 in the observation group (hazard ratio [HR], 0.87; 95% CI, 0.76 to 1.00; P = .055); 7-year RFS rate was 39.1% versus 34.6%. There was no difference in OS (P = .57). In stage III-N1 ulcerated melanoma, RFS (HR, 0.72; 99% CI, 0.46 to 1.13; P = .06), DMFS (HR, 0.65; 99% CI, 0.41 to 1.04; P = .02), and OS (HR, 0.59; 99% CI, 0.35 to 0.97; P = .006) were prolonged with PEG-IFN-α-2b. PEG-IFN-α-2b was discontinued for toxicity in 37% of patients. Conclusion Adjuvant PEG-IFN-α-2b for stage III melanoma had a positive impact on RFS, which was marginally significant and slightly diminished versus the benefit seen at prior follow-up (median, 3.8 years). No significant increase in DMFS or OS was noted in the overall population. Patients with ulcerated melanoma and lower disease burden had the greatest benefit.

scholarly journals Adjuvant therapy with pegylated interferon alfa-2b versus observation alone in resected stage III melanoma: final results of EORTC 18991, a randomised phase III trial

The Lancet ◽  
2008 ◽  
Vol 372 (9633) ◽  
pp. 117-126 ◽  
Author(s):  
Alexander MM Eggermont ◽  
Stefan Suciu ◽  
Mario Santinami ◽  
Alessandro Testori ◽  
Wim HJ Kruit ◽  
...  
Keyword(s):  
Adjuvant Therapy ◽  
Pegylated Interferon ◽  
Interferon Alfa ◽  
Phase Iii ◽  
Stage Iii ◽  
Phase Iii Trial ◽  
Pegylated Interferon Alfa ◽  
Stage Iii Melanoma ◽  
Resected Stage

Ipilimumab versus placebo after complete resection of stage III melanoma: Long-term follow-up results the EORTC 18071 double-blind phase 3 randomized trial.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 2512-2512 ◽  
Author(s):  
Alexander M. M. Eggermont ◽  
Vanna Chiarion-Sileni ◽  
Jean Jacques Grob ◽  
Reinhard Dummer ◽  
Jedd D. Wolchok ◽  
...  
Keyword(s):  
Lymph Node ◽  
Complete Resection ◽  
Phase Iii ◽  
Stage Iii ◽  
Long Term Results ◽  
Double Blind ◽  
Free Survival ◽  
Stage Iii Melanoma

2512 Background: Since 2015, ipilimumab (Ipi) is an approved treatment for stage III melanoma based on a significantly (P=0.0013) prolonged recurrence-free survival (RFS) (Eggermont et al, Lancet Oncology, 2015). At a median follow-up of 5.3 years, RFS (HR=0.76) and distant metastasis-free survival (DMFS) (HR=0.76), assessed by an IRC, and overall survival (OS) (HR=0.72) were prolonged in the Ipi group as compared to the placebo (Pbo) group (Eggermont et al, NEJM, 2016), despite a 53.3% (Ipi) vs 4.6% (Pbo) treatment discontinuation rate due to adverse events. Methods: In this randomized double-blind trial, eligible patients (pts) included those ≥18 yrs of age who underwent complete resection of stage III cutaneous melanoma (excluding lymph node metastasis ≤1 mm or in-transit metastasis). 951 pts were randomized (stratified by stage and region) 1:1 to Ipi 10 mg/kg (n=475) or placebo (Pbo, n=476) q3w for 4 doses, then every 3 mos for up to 3 yrs until completion, disease recurrence, or unacceptable toxicity. Here, we report the comparison between the Ipi and Pbo groups regarding the long-term efficacy outcomes using the local investigator assessments. Results: Overall, 20%/44%/36% of pts had AJCC-7 stage IIIA/IIIB/IIIC, 42% ulcerated primary, and 58% macroscopic lymph node involvement. Median follow-up was 6.9 yrs. The RFS, DMFS and OS benefit observed in the Ipi group was long-lasting (almost 10% difference at 7 years) and consistent across subgroups: no significant predictive factors could be detected. Conclusions: In this phase III trial, Ipi, administered at 10 mg/kg, as adjuvant therapy provided, at a 6.9 yr median follow-up, a sustained improvement in the RFS, DMFS, and OS long-term results in patients with high-risk stage III melanoma. Clinical trial information: NCT00636168. [Table: see text]

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