Hepatic intra-arterial versus intravenous fotemustine in patients with liver metastases from uveal melanoma (EORTC 18021): a multicentric randomized trial

Despite an improved antitumor efficacy as noticed by an enhanced response rate and an improved progression-free survival, the hepatic intra-arterial fotemustine did not increase the overall survival of uveal melanoma patients with liver metastases only. We propose to consider intrahepatic treatment as an experimental approac

Efficacy, Safety, and Quality of Life (Qol) Data from the Eortc 18071 Phase III Trial of Ipilimumab (Ipi) Versus Placebo After Complete Resection of Stage III Melanoma

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From chemoprevention and organ preservation programs to post-operative management: Major achievements and strategies of the EORTC Head & Neck Cancer Group

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EORTC 22071-24071:Randomized, phase III trial of EGFR-antibody combined with adjuvant chemoradiation for patients with head and neck squamous cell carcinoma (HNSCC) at high risk of recurrence

TPS197 Background: The clinical outcome of patients (pts) with resected HNSCC at high risk of recurrence remains poor. Disease free survival (DFS) at 5 years is around 40% after standard adjuvant chemoradiation (CRT). The use of anti-EGFR monoclonal antibodies combined with radiotherapy was shown to be effective in pts with HNSCC, and combination with CRT showed to be safe. METHODS: This open-label phase III randomized trial will investigate whether the addition of the anti-EGFR antibody panitumumab to adjuvant CRT significantly prolongs DFS in HNSCC at high risk of recurrence. Pts with high-risk HNSCC, due to the presence of close resection margins (<5 mm) or extracapsular extension, will be randomized to receive 7 weeks of concomitant CRT (three cycles of cisplatin or two cycles of cisplatin and 5-fluorouracil with 66 Gy radiotherapy), +/- weekly panitumumab 2.5 mg/kg. Both IMRT and 3D-RT are allowed in the study, the use of simultaneous integrated boost technique is mandatory. The protocol includes an extensive quality assurance program for radiotherapy. The primary study endpoint is DFS. The study is powered to 80% for showing a 10% increase in 5-year DFS, from 36% to 46% (corresponding to a hazard ratio 0.76) at the 2-sided 5% significance level. Hence, 800 pts must be randomized over 5 years. A restricted cohort of pts participating in the study will also receive a single dose of panitumumab prior to surgery. The aim of this sub-study is to test the predictive potential of a gene expression classifier to identify a subgroup of pts most likely to benefit from the experimental treatment. Two correlative studies are part of the trial, which will investigate the predictive role of biologic assays (lymphocyte apoptosis test and SNPs analysis) and pt/treatment-related parameters on the development of late radiation-induced side effects, and the relationship between treatment toxicity and quality of life. Biomarker evaluation will be performed on tissue and serum samples collected from all consenting pts. The trial opened to recruitment in January 2011

EORTC Melanoma Group achievements

Since its inception in 1969, the EORTC Melanoma Group has employed a multidisciplinary approach in the fight against melanoma and has registered significant achievements in many areas of melanoma treatment and research. The group showed that sentinel node (SN) tumor burden according to the Rotterdam Criteria and the microanatomic location were the most important prognostic factors for melanoma-specific survival and non-SN positivity in the completion lymph node dissection specimen. They demonstrated that extended schedule escalated dose temozolomide is feasible and has an acceptable safety profile. They also showed that the interferon-a targeted therapy should occur in a targeted patient population, and should probably not be offered to 70% of the patients that are currently being given this treatment. Through EORTC trial 18991, Sylatron™, pegylated interferon a-2b, for the treatment of melanoma patients with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy, was approved by the US FDA. The present article describes the achievements and future strategies of the Melanoma Group. © 2012 European Organisation for Research and Treatment of Cancer.SCOPUS: ar.jinfo:eu-repo/semantics/publishe