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Eggermont, AMM; Rutkowski, P; Dutriaux, C; Hofman-Wellenhof, R; Dziewulski, P; Marples, M; Grange, F; Lok, C; Pennachioli, E; Robert, C; van Akkooi, ACJ; Bastholt, L; Minisini, A; Marshall, E; Sales, F; Grob, JJ; Bechter, O; Schadendorf, D; Marreaud, S; Kicinski, M; Suciu, S; Testori, AAE.
Adjuvant therapy with pegylated interferon-alfa2b vs observation in stage II B/C patients with ulcerated primary: Results of the European Organisation for Research and Treatment of Cancer 18081 randomised trial
EUR J CANCER. 2020; 133: 94-103.
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Autor/innen der Med Uni Graz:
Hofmann-Wellenhof Rainer

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Background: Subgroup analyses of two large EORTC adjuvant interferon-alpha2b (IFN alpha-2b) vs observation randomised trials demonstrated that a treatment benefit was observed only in patients with an ulcerated melanoma without palpable nodes (hazard ratio [HR] for recurrence-free survival [RFS] was 0.69). This was confirmed by a meta-analysis of 15 adjuvant IFN trials (HR: 0.79). Patients and methods: In the EORTC 18081 trial, sentinel node-negative stage II patients with an ulcerated primary melanoma were 1: 1 randomised between pegylated (PEG)-IFN alpha-2b at 3 mu g/kg/week subcutaneously and observation, for 2 years, or until disease recurrence or unacceptable toxicity in spite of dose adjustments to maintain an Eastern Cooperative Oncology Group performance status of 0 or 1. Main end-point was RFS. Secondary end-points included distant metastasis-free survival (DMFS), overall survival, and safety (EudraCT Number: 2009-010273-20). Results: Between February 2013 and January 2017, only 112 patients were randomised, 56 in each arm. The trial was stopped early for lack of recruitment. At a 3.4-year median follow-up, the estimated HR for the PEG-IFN alpha-2b group compared with the observation group regarding RFS was 0.66 (95% confidence interval [CI]: 0.32-1.37), and the 3-year RFS rate was 80.0% (95% CI: 65.7-88.8%) and 72.9% (95% CI: 58.3-83.0%), respectively. DMFS was prolonged: HR: 0.39 (95% CI: 0.15-0.97), and the 3-year DMFS rate was 90.6% (95% CI: 78.9-96.0%) vs 76.4% (95% CI: 62.1-85.9%). One patient in the PEG-IFN alpha-2b group died compared with 4 in the observation group. Fifty-four patients started PEG-IFN alpha-2b treatment, 16 (29%) completed 2 years of treatment, 2 (4%) stopped due to recurrence, 23 (43%) due to toxicity and 14 (25%) due to other reasons. Conclusions: The EORTC 18081 PEG-IFN alpha-2b randomised trial, observed a similar HR (0.69) for RFS as the previous EORTC trials (0.69). In countries without access to new drugs, adjuvant (PEG)-IFN alpha-2b treatment is an option for patients with ulcerated melanomas without palpable nodes. (C) 2020 Elsevier Ltd. All rights reserved.

Find related publications in this database (Keywords)
Ulcerated melanoma
Adjuvant therapy
Pegylated interferon
Randomized trial
Stage II
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