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SHR Neuro Cancer Cardio Lipid Metab Microb
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; Salès, 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(8):94-103
Doi: 10.1016/j.ejca.2020.04.015
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PubMed
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- Hofmann-Wellenhof Rainer
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- Abstract:
- Subgroup analyses of two large EORTC adjuvant interferon-alpha2b (IFNα-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). In the EORTC 18081 trial, sentinel node-negative stage II patients with an ulcerated primary melanoma were 1:1 randomised between pegylated (PEG)-IFNα-2b at 3 μg/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). 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-IFNα-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-IFNα-2b group died compared with 4 in the observation group. Fifty-four patients started PEG-IFNα-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. The EORTC 18081 PEG-IFNα-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)-IFNα-2b treatment is an option for patients with ulcerated melanomas without palpable nodes. Copyright © 2020 Elsevier Ltd. All rights reserved.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult -
- Aged -
- Chemotherapy, Adjuvant -
- Combined Modality Therapy -
- Drug Administration Schedule -
- Drug Administration Schedule - epidemiology
- Female -
- Humans -
- Injections, Subcutaneous -
- Interferon alpha-2 - administration & dosage
- Interferon-alpha - administration & dosage
- Male -
- Medical Oncology - organization & administration
- Melanoma - complications
- Melanoma - mortality
- Melanoma - pathology
- Melanoma - therapy
- Middle Aged -
- Neoplasm Staging -
- Polyethylene Glycols - administration & dosage
- Recombinant Proteins - administration & dosage
- Skin Neoplasms - complications
- Skin Neoplasms - mortality
- Skin Neoplasms - pathology
- Skin Neoplasms - therapy
- Skin Ulcer - complications
- Skin Ulcer - mortality
- Skin Ulcer - pathology
- Skin Ulcer - therapy
- Societies, Medical - organization & administration
- Survival Analysis -
- Watchful Waiting - methods
- Find related publications in this database (Keywords)
- Ulcerated melanoma
- Adjuvant therapy
- Pegylated interferon
- Randomized trial
- Stage II