OmA multicenter phase II study of induction chemotherapy with FOLFOX-4 and cetuximab followed by radiation and cetuximab in locally sophisticated oesophageal cancerF De Vita1,9, M Orditura1,eight, E Martinelli1, L Vecchione1, R Innocenti2, VC Sileni3, C Pinto4, M Di Maio5, A Farella6, T Troiani1, F Morgillo1, V Napolitano7, E Ancona8, N Di Martino7, A Ruol8, G Galizia7, A Del Genio7 and F Ciardiello,1 Division of Medical Oncology, Department of Clinical and Experimental Medicine and 5-HT2 Receptor Agonist Gene ID surgery `F Magrassi e A Lanzara’, Second University of Naples, Through Pansini 5, STAT3 Purity & Documentation Naples 80131, Italy; 2Division of Radiotherapy, CRO, By way of Franco Gallini two, Aviano (PN) 33081, Italy; 3Division of Health-related Oncology, Azienda ` Ospedaliera di Padova, Via Nicolo Giustiniani 1, Padova 35128, Italy; 4Division of Oncology, Azienda Ospedaliera di Bologna, By way of Albertoni 15, Bologna 40138, Italy; 5National Cancer Institute, Clinical Trials Unit, Via Mariano Semmola, 80131 Naples, Italy; 6Division of Radiotherapy, Federico II University of Naples, By means of Pansini 5, Naples 80131, Italy; 7Division of Surgical Oncology, Division of Clinical and Experimental Medicine and Surgery `F Magrassi e A Lanzara’, Second University of Naples, Naples, Italy; 8Division of Surgery, University of Padova, By means of 8 Febbraio 2, Padova 35122, ItalyBACKGROUND: Preoperative chemoradiotherapy (CRT) improves the survival of individuals with oesophageal cancer when compared with surgery alone. Methods: We conducted a phase II, multicenter trial of FOLFOX-4 and cetuximab in individuals with locally advanced oesophageal cancer (LAEC) followed by every day radiotherapy (180 cGy fractions to 5040 cGy) with concurrent weekly cetuximab. Cytokines levels potentially related to cetuximab efficacy had been assessed employing multiplex-bead assays and enzyme-linked immunosorbent assay at baseline, at week 8 and at week 17. Major finish point was full pathological response price (pCR). Benefits: In all, 41 patients had been enroled. Amongst 30 sufferers who underwent surgery, a pCR was observed in eight patients corresponding to a rate of 27 . One of the most frequent grade 3/4 toxicity was skin (30) and neutropenia (30). The 36-month survival prices had been 85 and 52 in sufferers with pathological CR or PR vs 38 and 33 in sufferers with SD or PD. CONCLUSIONS: Incorporating cetuximab into a preoperative regimen for LAEC is feasible; no correlation between cytokines alterations and patient outcome was observed. Positron emission tomography/computed tomography study even when influenced by the smaller quantity of individuals seems to be able to predict individuals outcome both as early and late metabolic response. British Journal of Cancer (2011) 104, 427 432. doi:10.1038/sj.bjc.6606093 www.bjcancer.com Published on-line 18 January 2011 2011 Cancer Analysis UKKeywords: oesophageal cancer; preoperative chemoradiotherapy; cetuximab; FOLFOX-Oesophageal cancer outcome remains poor. Surgery continues to be the initial selection of treatment for fit patients with resectable illness, however the 5-year survival is only 20 25 due to the fact lymphatic and haematogenous dissemination happens early (Rice et al, 2009). Many research recommend that preoperative chemoradiation may well boost long-term outcome of resected sufferers when compared with surgery alone. A recent meta-analysis examined 10 randomised research comparing trimodality therapy with surgery alone. All round results showed a statistically considerable relative reduction in mortality for patients getting trimodality therapy with a hazard ratio of 0.81.
