A randomised phase II study of chemoradiotherapy with or without nimotuzumab in locally advanced oesophageal cancer: NICE trial.

Autor: de Castro Junior G; Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil. Electronic address: gilberto.castro@usp.br., Segalla JG; Hospital Amaral Carvalho, Jaú, Brazil. Electronic address: segalla@amaralcarvalho.org.br., de Azevedo SJ; Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil. Electronic address: sazevedo@hcpa.ufrgs.br., Andrade CJ; Instituto Nacional de Câncer, Rio de Janeiro, Brazil. Electronic address: carlosj@inca.gov.br., Grabarz D; Hospital de Mogi das Cruzes, Mogi das Cruzes, Brazil. Electronic address: dgrabarz@bol.com.br., de Araújo Lima França B; Hospital Geral de Bonsucesso, Rio de Janeiro, Brazil. Electronic address: balf.dr@gmail.com., Del Giglio A; Faculdade de Medicina do ABC, Santo André, Brazil. Electronic address: auro@cepho.org.br., Lazaretti NS; Hospital da Cidade de Passo Fundo, Passo Fundo, Brazil. Electronic address: nicolaslazaretti@yahoo.com.br., Álvares MN; Santa Casa de Belo Horizonte, Belo Horizonte, Brazil. Electronic address: mnalvares@terra.com.br., Pedrini JL; Hospital Nossa Senhora Conceição, Porto Alegre, Brazil. Electronic address: jose.pedrini@hotmail.com., Kussumoto C; Hospital Municipal São José, Joinville, Brazil. Electronic address: celio@cho-joi.com.br., de Matos Neto JN; Hospital Universitário de Brasília, Brasília, Brazil. Electronic address: jnunes@cettro.com.br., Forones NM; Universida de Federal de São Paulo, São Paulo, Brazil. Electronic address: noraforones@gmail.com., Fernandes Júnior HJ; Consultoria em Estudos de Investigação, São Caetano do Sul, Brazil; Instituto do Câncer Arnaldo Vieira de Carvalho, São Paulo, Brazil. Electronic address: hezio@uol.com.br., Borges G; Centro de Itajaí, Itajaí, Brazil. Electronic address: giuliano_borges@yahoo.com.br., Girotto G; Hospital de Base, São José do Rio Preto, Brazil. Electronic address: oncofamerp@yahoo.com.br., da Silva IDCG; Universida de Federal de São Paulo, São Paulo, Brazil. Electronic address: ismael.dale@gmail.com., Maluf-Filho F; Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil. Electronic address: fauze.maluf@terra.com.br., Skare NG; Hospital Erasto Gaertner, Curitiba, Brazil. Electronic address: ngskare@onda.com.br.
Jazyk: angličtina
Zdroj: European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2018 Jan; Vol. 88, pp. 21-30. Date of Electronic Publication: 2017 Nov 24.
DOI: 10.1016/j.ejca.2017.10.005
Abstrakt: Purpose: Chemoradiotherapy is the standard treatment for patients with inoperable locally advanced oesophageal cancer. We sought to assess the safety and efficacy of chemoradiation combined with nimotuzumab, a humanised antibody directed against epidermal growth factor receptor (EGFR).
Patients and Methods: Untreated patients with inoperable locally advanced oesophageal cancer and no distant metastases were randomised to chemoradiotherapy (cisplatin and fluorouracil combined with external beam radiation) alone or in combination with nimotuzumab. The primary end-point was the endoscopic complete response (eCR) rate, and secondary end-points comprised quality of life (QoL) and safety. The combined eCR and pathologic complete response (cEPCR) and overall survival (OS) were also evaluated.
Results: We enrolled 107 patients with a mean age of 59 years, and 93% had squamous cell carcinoma. Toxicity was manageable in both arms with no important differences in adverse events (AEs). We performed post-treatment endoscopies in 67 patients, including 60 who had a biopsy. In the intent-to-treat population, the eCR rates with and without nimotuzumab were 47.2% and 33.3% (P = 0.17), respectively, and the cEPCR rates were 62.3% and 37.0% (P = 0.02), respectively. With a median follow-up of 14.7 months, the hazard ratio (HR) for OS was 0.68 (95% confidence interval (CI): 0.44-1.07; P = 0.09) with a median OS of 15.9 months for the nimotuzumab arm and 11.5 months for the control arm. Regarding QoL, a significant difference was observed for the physical subscale score (P = 0.03) with lower values for the control arm.
Conclusion: Combined chemoradiotherapy plus nimotuzumab is safe for patients with locally advanced oesophageal cancer, it appears to increase the cEPCR rate, and without compromising QoL.
Clinical Trials: Identification number: EF024-201; Trial registry: NCT01249352.
(Copyright © 2017 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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