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Target Oncol. 2018 Feb;13(1):69-78. doi: 10.1007/s11523-017-0536-z.

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

Author information

1
Vall d'Hebron University Hospital, Department of Medical Oncology, and Vall d'Hebron Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Passeig de la Vall d'Hebron, 119-129, Barcelona, Spain. malsina@vhio.net.
2
Department of Medical Oncology, H.U. Marqués Valdecilla, Av. Valdecilla, 25, Santander, Spain.
3
Vall d'Hebron University Hospital, Department of Medical Oncology, and Vall d'Hebron Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Passeig de la Vall d'Hebron, 119-129, Barcelona, Spain.
4
Department of Medical Oncology, ICO Hospitalet, Avinguda de la Granvia, 199-203, Barcelona, Spain.
5
Medical Oncology Department and Translational Medical Oncology Group, University Clinical Hospital and Health Research Institute (IDIS); CIBERONC, Santiago de Compostela University School of Medicine, Santiago de Compostela, Spain.
6
Department of Medical Oncology, H. Gregorio Marañón, Calle del Dr. Esquerdo, 46, Madrid, Spain.
7
Department of Medical Oncology, H. Ruber Internacional, Calle de la Masó, 38, Madrid, Spain.
8
Spain and H Nuestra Sra Sonsoles, C/ Avda. Juan Carlos I, Avila, Spain.
9
Department of Medical Oncology, H. JosepTrueta (ICO), Avinguda de França, Girona, Spain.
10
Department of Medical Oncology, H. Miguel Servet, Paseo Isabel la Católica, 1-3, Zaragoza, Spain.
11
Department of Medical Oncology, H. Ramón y Cajal, Ctra. Colmenar Viejo, km. 9, 100, Madrid, Spain.
12
Department of Medical Oncology, H. 12 de Octubre, Avenida de Córdoba, Madrid, Spain.
13
Maimonides Institute of Biomedical Research (IMIBIC), Reina Sofía Hospital, Department of Medical Oncology, University of Córdoba, CIBERONC, Instituto de Salud Carlos III, Av. Menendez Pida, Cordoba, Spain.
14
TTD Group, Madrid, Spain.
15
Department of Radiation Oncology, Vall d'Hebron University Hospital, Passeig de la Vall d'Hebron, 119-129, Barcelona, Spain.

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).

PMID:
29128908
DOI:
10.1007/s11523-017-0536-z

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