RT Journal Article
T1 A Phase II Study Evaluating Combined Neoadjuvant Cetuximab and Chemotherapy Followed by Chemoradiotherapy and Concomitant Cetuximab in Locoregional Oesophageal Cancer Patients.
A1 Alsina, Maria
A1 Rivera, Fernando
A1 Ramos, Francisco Javier
A1 Galan, Maica
A1 Lopez, Rafael
A1 Garcia-Alfonso, Pilar
A1 Ales-Martinez, Jose Enrique
A1 Queralt, Bernardo
A1 Anton, Antonio
A1 Carrato, Alfredo
A1 Gravalos, Cristina
A1 Mendez-Vidal, Maria Jose
A1 Lopez, Carlos
A1 de Mena, Inmaculada Ruiz
A1 Tabernero, Josep
A1 Giralt, Jordi
A1 Aranda, Enrique
K1 Adult
K1 Aged
K1 Cetuximab / pharmacology
K1 Cetuximab / therapeutic use*
AB Background: Pre-operative chemoradiotherapy using a 5-fluorouracil (5-FU)/cisplatin backbone is widely used to improve surgical outcomes in locoregional oesophageal cancer patients, despite a non-negligible failure rate. Objective: We evaluated intensification of this approach to improve patient outcomes by adding cetuximab to induction 5-FU/cisplatin/docetaxel (TPF) and to chemoradiotherapy in a phase II study. Patients and methods: Between November 2006 and April 2009, 50 patients with stage II-IVa squamous cell carcinoma (SCC) or adenocarcinoma of the oesophagus or gastro-oesophageal junction initiated three TPF/cetuximab cycles. Six weeks later, patients with response or stabilisation initiated 6 weeks of cisplatin/cetuximab/radiotherapy, followed by surgery. The primary objective was the clinical complete response (cCR) rate after induction therapy plus chemoradiotherapy in intent-to-treat patients. Results: Thirty-eight patients were evaluable after chemoradiotherapy, 84% of whom showed disease control. Six patients (12%) achieved a cCR, with a 54% overall response rate. Twenty-seven patients underwent surgery, 11 of whom (22%; nine SCC, two adenocarcinoma) had a pathological CR (41%). Fifteen patients were alive after a median follow-up of 23.2 months. Median progression-free survival was 12.2 months (95% confidence interval [CI] 1.7-22.8). Median overall survival was 23.4 months (95% CI 12.2-36.6) and was significantly longer among the 22 patients with complete resection than in the five patients without (42.1 vs. 24.9 months; p = 0.02, hazard ratio: 3.6, 95% CI 1.1-11.6). The toxicity profile was acceptable. Conclusions: Neoadjuvant cetuximab/TPF followed by chemoradiotherapy in locoregional oesophageal carcinoma patients is feasible and offers a modest response rate in this trial. The results of combining trimodality neoadjuvant treatment with cetuximab are consistent with the literature.
PB Springer
YR 2018
FD 2018
LK http://hdl.handle.net/10668/11911
UL http://hdl.handle.net/10668/11911
LA en
NO Alsina M, Rivera F, Ramos FJ, Galán M, López R, García-Alfonso P, et al. Correction to: A Phase II Study Evaluating Combined Neoadjuvant Cetuximab and Chemotherapy Followed by Chemoradiotherapy and Concomitant Cetuximab in Locoregional Oesophageal Cancer Patients. Target Oncol. 2018 Feb;13(1):79
DS RISalud
RD Oct 15, 2025