Adjuvant ipilimumab versus placebo after complete resection of stage III melanoma: long-term follow-up results of the European Organisation for Research and Treatment of Cancer 18071 double-blind phase 3 randomised trial

2019 ◽  
Vol 119 ◽  
pp. 1-10 ◽  
Author(s):  
Alexander M.M. Eggermont ◽  
Vanna Chiarion-Sileni ◽  
Jean-Jacques Grob ◽  
Reinhard Dummer ◽  
Jedd D. Wolchok ◽  
...  
Keyword(s):  
Randomised Trial ◽  
Complete Resection ◽  
Stage Iii ◽  
Phase 3 ◽  
Double Blind ◽  
European Organisation ◽  
Long Term Follow Up ◽  
Stage Iii Melanoma

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]

Long-term follow-up of patients treated by adoptive transfer of melanoma tumor-infiltrating lymphocytes as adjuvant therapy for stage III melanoma

2007 ◽  
Vol 56 (11) ◽  
pp. 1853-1860 ◽  
Author(s):  
Amir Khammari ◽  
Jean-Michel Nguyen ◽  
Marie Christine Pandolfino ◽  
Gaëlle Quereux ◽  
Anabelle Brocard ◽  
...  
Keyword(s):  
Adjuvant Therapy ◽  
Adoptive Transfer ◽  
Tumor Infiltrating Lymphocytes ◽  
Stage Iii ◽  
Melanoma Tumor ◽  
Long Term Follow Up ◽  
Stage Iii Melanoma ◽  
Infiltrating Lymphocytes

Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial

2015 ◽  
Vol 16 (5) ◽  
pp. 522-530 ◽  
Author(s):  
Alexander M M Eggermont ◽  
Vanna Chiarion-Sileni ◽  
Jean-Jacques Grob ◽  
Reinhard Dummer ◽  
Jedd D Wolchok ◽  
...  
Keyword(s):  
High Risk ◽  
Complete Resection ◽  
Stage Iii ◽  
Phase 3 ◽  
Double Blind ◽  
Stage Iii Melanoma

scholarly journals Improvements in Submental Contour Up to 3 Years After ATX-101: Efficacy and Safety Follow-Up of the Phase 3 REFINE Trials

2021 ◽  
Author(s):  
Shannon Humphrey ◽  
Joel L Cohen ◽  
Ashish C Bhatia ◽  
Lawrence J Green ◽  
Jeremy B Green ◽  
...  
Keyword(s):  
Adverse Events ◽  
Rating Scale ◽  
Psychological Impact ◽  
Group Versus ◽  
Phase 3 ◽  
Double Blind ◽  
Patient Reported ◽  
Long Term Follow Up

Abstract Background ATX-101 (deoxycholic acid) significantly reduced submental fat (SMF) severity in two 24-week phase 3 studies (REFINE-1 and REFINE-2). Objectives To evaluate durability of effect and long-term safety of ATX-101. Methods REFINE study patients with maintenance of ≥1-grade improvement on the Clinician-Reported SMF Rating Scale (CR-1 responders) 12 weeks after last REFINE treatment were eligible for enrollment in this multicenter, double-blind, nontreatment, long-term, follow-up study (NCT02163902). Primary endpoint was CR-1 response at years 1, 2, and 3. Patient-reported satisfaction, psychological impact, and adverse events were monitored. Results 224 patients (ATX-101, n=113; placebo, n=111) were enrolled. Maintenance of CR-1 response was significantly better in the ATX-101 group versus placebo at year 1 (86.4%, 56.8%; P<.001), year 2 (90.6%, 73.8%; P=.014), and year 3 (82.4%, 65.0%; P=.03). Most (74%) ATX-101‒treated patients satisfied at 12 weeks remained satisfied at year 3. Significant reductions from baseline in psychological impact scores were sustained through year 3 (P<.001). No new treatment-related adverse events were reported. Conclusions Improvements in submental contour achieved with ATX-101 are maintained for 3 years in most patients. No new safety signals emerged.

Stage III follicular lymphoma: long-term follow-up and patterns of failure

2003 ◽  
Vol 57 (3) ◽  
pp. 748-754 ◽  
Author(s):  
Chul S Ha ◽  
Joseph S Kong ◽  
Peter McLaughlin ◽  
Susan L Tucker ◽  
Luis E Fayad ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
Stage Iii ◽  
Patterns Of Failure ◽  
Long Term Follow Up
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