A multicenter phase II study of induction chemotherapy with FOLFOX-4 and cetuximab followed by radiation and cetuximab in locally advanced oesophageal cancer

F. De Vita, M. Orditura, E. Martinelli, L. Vecchione, R. Innocenti, V. C. Sileni, C. Pinto, M. Di Maio, A. Farella, T. Troiani, F. Morgillo, V. Napolitano, E. Ancona, N. Di Martino, A. Ruol, G. Galizia, A. Del Genio, F. Ciardiello

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)427-432
Number of pages6
JournalBritish Journal of Cancer
Volume104
Issue number3
DOIs
Publication statusPublished - Feb 1 2011

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Induction Chemotherapy
Esophageal Neoplasms
Radiation
Cetuximab
Cytokines
Chemoradiotherapy
Neutropenia
Multicenter Studies
Radiotherapy
Survival Rate
Enzyme-Linked Immunosorbent Assay
Skin

Keywords

  • cetuximab
  • FOLFOX-4
  • oesophageal cancer
  • preoperative chemoradiotherapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

A multicenter phase II study of induction chemotherapy with FOLFOX-4 and cetuximab followed by radiation and cetuximab in locally advanced oesophageal cancer. / De Vita, F.; Orditura, M.; Martinelli, E.; Vecchione, L.; Innocenti, R.; Sileni, V. C.; Pinto, C.; Di Maio, M.; Farella, A.; Troiani, T.; Morgillo, F.; Napolitano, V.; Ancona, E.; Di Martino, N.; Ruol, A.; Galizia, G.; Del Genio, A.; Ciardiello, F.

In: British Journal of Cancer, Vol. 104, No. 3, 01.02.2011, p. 427-432.

Research output: Contribution to journalArticle

De Vita, F, Orditura, M, Martinelli, E, Vecchione, L, Innocenti, R, Sileni, VC, Pinto, C, Di Maio, M, Farella, A, Troiani, T, Morgillo, F, Napolitano, V, Ancona, E, Di Martino, N, Ruol, A, Galizia, G, Del Genio, A & Ciardiello, F 2011, 'A multicenter phase II study of induction chemotherapy with FOLFOX-4 and cetuximab followed by radiation and cetuximab in locally advanced oesophageal cancer', British Journal of Cancer, vol. 104, no. 3, pp. 427-432. https://doi.org/10.1038/sj.bjc.6606093
De Vita, F. ; Orditura, M. ; Martinelli, E. ; Vecchione, L. ; Innocenti, R. ; Sileni, V. C. ; Pinto, C. ; Di Maio, M. ; Farella, A. ; Troiani, T. ; Morgillo, F. ; Napolitano, V. ; Ancona, E. ; Di Martino, N. ; Ruol, A. ; Galizia, G. ; Del Genio, A. ; Ciardiello, F. / A multicenter phase II study of induction chemotherapy with FOLFOX-4 and cetuximab followed by radiation and cetuximab in locally advanced oesophageal cancer. In: British Journal of Cancer. 2011 ; Vol. 104, No. 3. pp. 427-432.
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abstract = "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.",
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T1 - A multicenter phase II study of induction chemotherapy with FOLFOX-4 and cetuximab followed by radiation and cetuximab in locally advanced oesophageal cancer

AU - De Vita, F.

AU - Orditura, M.

AU - Martinelli, E.

AU - Vecchione, L.

AU - Innocenti, R.

AU - Sileni, V. C.

AU - Pinto, C.

AU - Di Maio, M.

AU - Farella, A.

AU - Troiani, T.

AU - Morgillo, F.

AU - Napolitano, V.

AU - Ancona, E.

AU - Di Martino, N.

AU - Ruol, A.

AU - Galizia, G.

AU - Del Genio, A.

AU - Ciardiello, F.

PY - 2011/2/1

Y1 - 2011/2/1

N2 - 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.

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