35. Melanoma clinical trials in the United States

Abstract

not submitted. 35. Melanoma clinical trials in the United States J. Economou 1 UCLA School of Medicine, Division of Surgical Oncology, Los Angeles, USA Current clinical trials for advanced melanoma provide insights into the direction of modern small molecule therapies targeting signaling pathways and oncogenes, and immune-based therapies benefiting from an improved understanding of tumor immunobiology. Immunotherapy is the only treatment that can reproducibly produce cures in a small percentage of patients with metastatic melanoma. High-dose interleukin 2, dendritic cell-based vaccines, and anti CTLA4 blockage (Ipilimumab) are characterized by a low frequency of highly durable tumors responses and moderate toxicity. Anti PD1 blockade is currently in trials. Adoptive cell transfer of tumorinfiltrating lymphocytes, T cell receptor or chimeric antigen receptor-engineered T cells produce higher response rates, variable durability, significant toxicity and requires cell processing. Small molecules targeting Braf (vemurafenib, dabrafenib), alone or in combination with MEK inhibitors (trematenib, TAK 733) currently produce significant response rates with occasional prolonged disease control. Small molecules targeted therapies in combination with immune therapies can potentially be complementary. 36. Future cancer surgery trials in the EU P. Naredi 1 University Hospital Umea, Department of Surgery, Umea, Sweden Recently an analyses of research and development in global cancer surgery (Purushotham et al, Ann Surg 2012) showed that surgical oncology (SO) represents only 9% of all cancer research. Clinical trials and studies represents only 6% of published SO papers but six European countries are the most productive with over 10% and in the US, as a comparison, only 5% of published SO papers are clinical trials and studies. How can we retain and also improve our activity in performing cancer surgery trials when Europe’s health economy is under pressure and resources are sparse? There are several strong research fields that should be expanded. First, surgery is the most efficient treatment for cure from cancer and well-defined randomised trials comparing different surgical-based treatments can improve outcomes without adding much extra study cost. Secondly, surgeons have taken the lead in many European countries to initiate population-based quality registries for different cancer diseases and treatments. The data from the registries will generate large amount of important information to be published. Surgeons have also taken the lead in European quality assurance (QA) projects looking at outcome variables from diagnostics and treatments. These QA projects will generate the kind of information that will be used as basis for reaching consensus on guidelines but more importantly initiate a discussion on relevant study objectives in future clinical cancer trials. Thirdly, improved coordination and established tissue bio-banking will facilitate collaboration between basic scientists and clinicians to faster implement novel and innovative treatments in the clinic. The challenge is to create a research environment where costefficient cancer surgery trials benefit not only patients in trials but all patients. 19 September 2012: 17:15 e 18:45 Symposium: Upper GI e Neoadjuvant and surgical treatments 37. Surveillance of Barrett’s oesophagus M. Pera 1 Hospital Universitario del Mar, Gastrointestinal Surgery, Barcelona, Spain All major gastroenterology societies and published guidelines recommend endoscopic surveillance of patients with Barrett«s esophagus (BE) to detect early stage esophageal adenocarcinoma (EAC) and subsequently improve survival. Current guidelines suggest obtaining systematic 4-quadrant biopsies at 1-2 cm intervals along the entire length of the BE segment. Surveillance every 3-5 years is recommended as adequate in patients without dysplasia after two negative examinations. If low-grade dysplasia (LGD) is found and confirmed by an expert pathologist, surveillance every 6 months is recommended until two consecutive endoscopies demonstrates no dysplasia and then increase every 2-3 years. Results of uncontrolled studies found that patients who had undergone some form of endoscopic surveillance were operated on at significantly earlier stages of their diseases. However, EAC diagnosed among patients known to have BE represent less than 10% of all incidents EAC. The true annual incidence of EAC in BE is critical to determining the cost-effectiveness of surveillance endoscopy. Shaheen was the first to acknowledge that cancer risk in BE was overestimated in the literature, and a more realistic cancer risk would be 0.5% per year (1 case per 200 cases). Two recent population-based studies in North Ireland and Demark estimated the risk of EAC to be 0.12%-0.13% or one case per 769 or 860 patients-year. In a recent large multicenter cohort, the incidence of EAC in non-dysplastic BE was found to be 0.27% per year. Cost-utility of surveillance has been analyzed with a decision model by several investigators. Inadoni suggested that current surveillance practice