PMID- 29179134 OWN - NLM STAT- MEDLINE DCOM- 20180813 LR - 20180813 IS - 1879-0852 (Electronic) IS - 0959-8049 (Linking) VI - 88 DP - 2018 Jan TI - A randomised phase II study of chemoradiotherapy with or without nimotuzumab in locally advanced oesophageal cancer: NICE trial. PG - 21-30 LID - S0959-8049(17)31345-X [pii] LID - 10.1016/j.ejca.2017.10.005 [doi] AB - 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. CI - Copyright (c) 2017 Elsevier Ltd. All rights reserved. FAU - de Castro Junior, Gilberto AU - de Castro Junior G AD - Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, Brazil. Electronic address: gilberto.castro@usp.br. FAU - Segalla, Jose Getulio AU - Segalla JG AD - Hospital Amaral Carvalho, Jau, Brazil. Electronic address: segalla@amaralcarvalho.org.br. FAU - de Azevedo, Sergio Jobim AU - de Azevedo SJ AD - Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil. Electronic address: sazevedo@hcpa.ufrgs.br. FAU - Andrade, Carlos Jose AU - Andrade CJ AD - Instituto Nacional de Cancer, Rio de Janeiro, Brazil. Electronic address: carlosj@inca.gov.br. FAU - Grabarz, Daniel AU - Grabarz D AD - Hospital de Mogi das Cruzes, Mogi das Cruzes, Brazil. Electronic address: dgrabarz@bol.com.br. FAU - de Araujo Lima Franca, Bruno AU - de Araujo Lima Franca B AD - Hospital Geral de Bonsucesso, Rio de Janeiro, Brazil. Electronic address: balf.dr@gmail.com. FAU - Del Giglio, Auro AU - Del Giglio A AD - Faculdade de Medicina do ABC, Santo Andre, Brazil. Electronic address: auro@cepho.org.br. FAU - Lazaretti, Nicolas Silva AU - Lazaretti NS AD - Hospital da Cidade de Passo Fundo, Passo Fundo, Brazil. Electronic address: nicolaslazaretti@yahoo.com.br. FAU - Alvares, Maria Nunes AU - Alvares MN AD - Santa Casa de Belo Horizonte, Belo Horizonte, Brazil. Electronic address: mnalvares@terra.com.br. FAU - Pedrini, Jose Luiz AU - Pedrini JL AD - Hospital Nossa Senhora Conceicao, Porto Alegre, Brazil. Electronic address: jose.pedrini@hotmail.com. FAU - Kussumoto, Celio AU - Kussumoto C AD - Hospital Municipal Sao Jose, Joinville, Brazil. Electronic address: celio@cho-joi.com.br. FAU - de Matos Neto, Joao Nunes AU - de Matos Neto JN AD - Hospital Universitario de Brasilia, Brasilia, Brazil. Electronic address: jnunes@cettro.com.br. FAU - Forones, Nora Manoukian AU - Forones NM AD - Universida de Federal de Sao Paulo, Sao Paulo, Brazil. Electronic address: noraforones@gmail.com. FAU - Fernandes Junior, Hezio Jadir AU - Fernandes Junior HJ AD - Consultoria em Estudos de Investigacao, Sao Caetano do Sul, Brazil; Instituto do Cancer Arnaldo Vieira de Carvalho, Sao Paulo, Brazil. Electronic address: hezio@uol.com.br. FAU - Borges, Giuliano AU - Borges G AD - Centro de Itajai, Itajai, Brazil. Electronic address: giuliano_borges@yahoo.com.br. FAU - Girotto, Gustavo AU - Girotto G AD - Hospital de Base, Sao Jose do Rio Preto, Brazil. Electronic address: oncofamerp@yahoo.com.br. FAU - da Silva, Ismael Dale Cotrim Guerreiro AU - da Silva IDCG AD - Universida de Federal de Sao Paulo, Sao Paulo, Brazil. Electronic address: ismael.dale@gmail.com. FAU - Maluf-Filho, Fauze AU - Maluf-Filho F AD - Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, Brazil. Electronic address: fauze.maluf@terra.com.br. FAU - Skare, Nils Gunnar AU - Skare NG AD - Hospital Erasto Gaertner, Curitiba, Brazil. Electronic address: ngskare@onda.com.br. LA - eng SI - ClinicalTrials.gov/NCT01249352 PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20171124 PL - England TA - Eur J Cancer JT - European journal of cancer (Oxford, England : 1990) JID - 9005373 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 6NS400BXKH (nimotuzumab) RN - Q20Q21Q62J (Cisplatin) RN - U3P01618RT (Fluorouracil) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Anemia/etiology MH - Antibodies, Monoclonal, Humanized/administration & dosage/adverse effects MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use MH - Chemoradiotherapy/adverse effects/methods MH - Cisplatin/administration & dosage/adverse effects MH - Esophageal Neoplasms/*drug therapy/pathology MH - Fatigue/etiology MH - Female MH - Fluorouracil/administration & dosage/adverse effects MH - Humans MH - Male MH - Middle Aged MH - Quality of Life MH - Survival Analysis OTO - NOTNLM OT - Chemoradiotherapy OT - Locally advanced oesophageal cancer OT - Nimotuzumab EDAT- 2017/11/28 06:00 MHDA- 2018/08/14 06:00 CRDT- 2017/11/28 06:00 PHST- 2017/04/19 00:00 [received] PHST- 2017/09/25 00:00 [revised] PHST- 2017/10/02 00:00 [accepted] PHST- 2017/11/28 06:00 [pubmed] PHST- 2018/08/14 06:00 [medline] PHST- 2017/11/28 06:00 [entrez] AID - S0959-8049(17)31345-X [pii] AID - 10.1016/j.ejca.2017.10.005 [doi] PST - ppublish SO - Eur J Cancer. 2018 Jan;88:21-30. doi: 10.1016/j.ejca.2017.10.005. Epub 2017 Nov 24.