A multicenter phase II study of induction chemotherapy with FOLFOX-4 and cetuximab followed by radiation and cetuximab in locally advanced oesophageal cancer.
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.
Division of Medical Oncology, Department of Clinical and Experimental Medicine and Surgery F Magrassi e A Lanzara, Second University of Naples, Via Pansini 5, Naples 80131, Italy.
F
F
De Vita
M
M
Orditura
E
E
Martinelli
L
L
Vecchione
R
R
Innocenti
V C
VC
Sileni
C
C
Pinto
M
M
Di Maio
A
A
Farella
T
T
Troiani
F
F
Morgillo
V
V
Napolitano
E
E
Ancona
N
N
Di Martino
A
A
Ruol
G
G
Galizia
A
A
Del Genio
F
F
Ciardiello
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D014408:Biomarkers, Tumor / Q000097:blood; D000068818:Cetuximab; D003131:Combined Modality Therapy; D016207:Cytokines / Q000097:blood; D004938:Esophageal Neoplasms / Q000097:blood / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D016629:Esophagectomy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D036341:Intercellular Signaling Peptides and Proteins / Q000097:blood; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D049268:Positron-Emission Tomography; D011237:Predictive Value of Tests; D018714:Radiotherapy, Adjuvant
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D014408:Biomarkers, Tumor; D016207:Cytokines; D036341:Intercellular Signaling Peptides and Proteins; D009944:Organoplatinum Compounds; D000068818:Cetuximab; D002955:Leucovorin; D005472:Fluorouracil
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