A multicenter phase II study of induction chemotherapy with FOLFOX-4 and cetuximab followed by radiation and cetuximab in locally advanced oesophageal cancer
| Autor: | A. Farella, R Innocenti, A. Del Genio, Gennaro Galizia, Alberto Ruol, Erika Martinelli, Vanna Chiarion Sileni, Vincenzo Napolitano, Carmine Pinto, Loredana Vecchione, M. Di Maio, Ermanno Ancona, F. De Vita, N. Di Martino, Michele Orditura, Teresa Troiani, Floriana Morgillo, Fortunato Ciardiello |
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| Přispěvatelé: | DE VITA, Ferdinando, Orditura, Michele, Martinelli, Erika, Vecchione, L, Innocenti, R, Sileni, Vc, Pinto, C, Di Maio, M, Farella, A, Troiani, Teresa, Morgillo, Floriana, Napolitano, Vincenzo, Ancona, E, Di Martino, N, Ruol, A, Galizia, Gennaro, Del Genio, A, Ciardiello, Fortunato |
| Jazyk: | angličtina |
| Rok vydání: | 2011 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty oesophageal cancer Esophageal Neoplasms Organoplatinum Compounds medicine.medical_treatment Leucovorin Phases of clinical research Cetuximab Antibodies Monoclonal Humanized Gastroenterology FOLFOX Predictive Value of Tests Internal medicine Multicenter trial Antineoplastic Combined Chemotherapy Protocols medicine Biomarkers Tumor Humans Aged FOLFOX-4 business.industry Induction chemotherapy Antibodies Monoclonal Middle Aged Combined Modality Therapy Neoadjuvant Therapy Surgery Radiation therapy Esophagectomy Regimen Oncology Positron-Emission Tomography preoperative chemoradiotherapy Clinical Study Cytokines Intercellular Signaling Peptides and Proteins Female Radiotherapy Adjuvant Fluorouracil business Chemoradiotherapy medicine.drug |
| Zdroj: | British Journal of Cancer |
| ISSN: | 1532-1827 0007-0920 |
| Popis: | "Background: Preoperative chemoradiotherapy (CRT) improves the survival of patients with oesophageal cancer when compared with surgery alone.. . Methods: We conducted a phase II, multicenter trial of FOLFOX-4 and cetuximab in patients with locally advanced oesophageal cancer (LAEC) followed by daily radiotherapy (180 cGy fractions to 5040 cGy) with concurrent weekly cetuximab. Cytokines levels potentially related to cetuximab efficacy were assessed using multiplex-bead assays and enzyme-linked immunosorbent assay at baseline, at week 8 and at week 17. Primary end point was complete pathological response rate (pCR).. . Results: In all, 41 patients were enroled. Among 30 patients who underwent surgery, a pCR was observed in 8 patients corresponding to a rate of 27%. The most frequent grade 3\/4 toxicity was skin (30%) and neutropenia (30%). The 36-month survival rates were 85 and 52% in patients with pathological CR or PR vs 38 and 33% in patients with SD or PD.. . Conclusions: Incorporating cetuximab into a preoperative regimen for LAEC is feasible; no correlation between cytokines changes and patient outcome was observed. Positron emission tomography\/computed tomography study even if influenced by the small number of patients appears to be able to predict patients outcome both as early and late metabolic response.. . " Background: Preoperative chemoradiotherapy (CRT) improves the survival of patients with oesophageal cancer when compared with surgery alone. Methods: We conducted a phase II, multicenter trial of FOLFOX-4 and cetuximab in patients with locally advanced oesophageal cancer (LAEC) followed by daily radiotherapy (180 cGy fractions to 5040 cGy) with concurrent weekly cetuximab. Cytokines levels potentially related to cetuximab efficacy were assessed using multiplex-bead assays and enzyme-linked immunosorbent assay at baseline, at week 8 and at week 17. Primary end point was complete pathological response rate (pCR). Results: In all, 41 patients were enroled. Among 30 patients who underwent surgery, a pCR was observed in 8 patients corresponding to a rate of 27%. The most frequent grade 3/4 toxicity was skin (30%) and neutropenia (30%). The 36-month survival rates were 85 and 52% in patients with pathological CR or PR vs 38 and 33% in patients with SD or PD. Conclusions: Incorporating cetuximab into a preoperative regimen for LAEC is feasible; no correlation between cytokines changes and patient outcome was observed. Positron emission tomography/computed tomography study even if influenced by the small number of patients appears to be able to predict patients outcome both as early and late metabolic response. © 2011 Cancer Research UK All rights reserved. |
| Databáze: | OpenAIRE |
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