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11.11.2017 | Original Research Article

A phase II Study Evaluating Combined Neoadjuvant Cetuximab and Chemotherapy Followed by Chemoradiotherapy and Concomitant Cetuximab in Locoregional Oesophageal Cancer Patients

verfasst von: Maria Alsina, Fernando Rivera, Francisco Javier Ramos, Maica Galán, Rafael López, Pilar García-Alfonso, José Enrique Alés-Martinez, Bernardo Queralt, Antonio Antón, Alfredo Carrato, Cristina Grávalos, Maria José Méndez-Vidal, Carlos López, Inmaculada Ruiz de Mena, Josep Tabernero, Jordi Giralt, Enrique Aranda, on behalf of the Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD) and Grupo de Investigación Clínica en Oncología Radioterápica (GICOR)

Erschienen in: Targeted Oncology | Ausgabe 1/2018

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Abstract

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.

Registration: The study is registered at ClinicalTrials.gov (NCT00733889).

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Titel: A phase II Study Evaluating Combined Neoadjuvant Cetuximab and Chemotherapy Followed by Chemoradiotherapy and Concomitant Cetuximab in Locoregional Oesophageal Cancer Patients
verfasst von: Maria Alsina
Fernando Rivera
Francisco Javier Ramos
Maica Galán
Rafael López
Pilar García-Alfonso
José Enrique Alés-Martinez
Bernardo Queralt
Antonio Antón
Alfredo Carrato
Cristina Grávalos
Maria José Méndez-Vidal
Carlos López
Inmaculada Ruiz de Mena
Josep Tabernero
Jordi Giralt
Enrique Aranda
on behalf of the Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD) and Grupo de Investigación Clínica en Oncología Radioterápica (GICOR)
Publikationsdatum: 11.11.2017
Verlag: Springer International Publishing
Erschienen in: Targeted Oncology / Ausgabe 1/2018
Print ISSN: 1776-2596
Elektronische ISSN: 1776-260X
DOI: https://doi.org/10.1007/s11523-017-0536-z

Springer Medizin

A phase II Study Evaluating Combined Neoadjuvant Cetuximab and Chemotherapy Followed by Chemoradiotherapy and Concomitant Cetuximab in Locoregional Oesophageal Cancer Patients