Please use this identifier to cite or link to this item: https://observatorio.fm.usp.br/handle/OPI/24941
Title: A randomised phase II study of chemoradiotherapy with or without nimotuzumab in locally advanced oesophageal cancer: NICE trial
Authors: CASTRO JUNIOR, Gilberto deSEGALLA, Jose GetulioAZEVEDO, Sergio Jobim deANDRADE, Carlos JoseGRABARZ, DanielFRANCA, Bruno de Araujo LimaGIGLIO, Auro DelLAZARETTI, Nicolas SilvaALVARES, Maria NunesPEDRINI, Jose LuizKUSSUMOTO, CelioMATOS NETO, Joao Nunes deFORONES, Nora ManoukianFERNANDES JUNIOR, Hezio JadirBORGES, GiulianoGIROTTO, GustavoSILVA, Ismael Dale Cotrim Guerreiro daMALUF-FILHO, FauzeSKARE, Nils Gunnar
Citation: EUROPEAN JOURNAL OF CANCER, v.88, p.21-30, 2018
Abstract: 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.
Appears in Collections:

Artigos e Materiais de Revistas Científicas - HC/ICESP
Instituto do Câncer do Estado de São Paulo - HC/ICESP

Artigos e Materiais de Revistas Científicas - HC/ICHC
Instituto Central - HC/ICHC

Artigos e Materiais de Revistas Científicas - LIM/24
LIM/24 - Laboratório de Oncologia Experimental

Artigos e Materiais de Revistas Científicas - LIM/37
LIM/37 - Laboratório de Transplante e Cirurgia de Fígado

Artigos e Materiais de Revistas Científicas - ODS/03
ODS/03 - Saúde e bem-estar


Files in This Item:
File Description SizeFormat 
art_CASTRO JUNIOR_A_randomised_phase_II_study_of_chemoradiotherapy_with_2018.PDF
  Restricted Access
publishedVersion (English)678.69 kBAdobe PDFView/Open Request a copy

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.