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Efficacy and safety of concurrent chemoradiotherapy with or without Nimotuzumab in unresectable locally advanced squamous cell carcinoma of head and neck: Prospective comparative study - ESCORT-N study

BACKGROUND: Nimotuzumab is an anti-epidermal growth factor receptor monoclonal antibody which can be added to chemoradiotherapy (CRT) to improve efficacy for management of locally advanced squamous cell carcinoma of the head and neck (LASCCHN). We prospectively evaluated the efficacy and safety of n...

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Autores principales: Kumar, Ashok, Chakravarty, Nilotpal, Bhatnagar, Sharad, Chowdhary, G. S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer - Medknow 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6498712/
https://www.ncbi.nlm.nih.gov/pubmed/31069191
http://dx.doi.org/10.4103/sajc.sajc_38_18
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author Kumar, Ashok
Chakravarty, Nilotpal
Bhatnagar, Sharad
Chowdhary, G. S.
author_facet Kumar, Ashok
Chakravarty, Nilotpal
Bhatnagar, Sharad
Chowdhary, G. S.
author_sort Kumar, Ashok
collection PubMed
description BACKGROUND: Nimotuzumab is an anti-epidermal growth factor receptor monoclonal antibody which can be added to chemoradiotherapy (CRT) to improve efficacy for management of locally advanced squamous cell carcinoma of the head and neck (LASCCHN). We prospectively evaluated the efficacy and safety of nimotuzumab with CRT for LASCCHN and compared with CRT alone. MATERIALS AND METHODS: In this prospective study, 29 LASCCHN (Stage III–IVb) patients received Nimotuzumab plus CRT or CRT alone. Treatment included six cycles of cisplatin (40–50 mg/week) or carboplatin (area under the curve-based), nimotuzumab (200 mg/week), and radiotherapy (60–70 Gy). Tumor response was evaluated as per response evaluation criteria in solid tumors criteria. MoS was estimated using the Kaplan–Meier method. Toxicity and adverse events (AE's) were assessed as per CTCAE v 4.0. RESULTS: At 24 weeks after completion of treatment, the tumor response rate (complete response, partial response, stable disease) was 53.3% and 35.7% favoring nimotuzumab arm while progression of disease was 40% and 35.7% in Nimotuzumab plus CRT and CRT groups, respectively. However, the objective response rate was 57% and 30% in favor of nimotuzumab arm. At median follow-up of 45.5 months, MoS was 33 months in Nimotuzumab plus CRT and 27 months in CRT group. The 5-year survival rate was 33.3% in Nimotuzumab plus CRT versus 7.1% in CRT group. Nimotuzumab was observed to be safe with no additional AE's such as hypersensitivity, hypomagnesemia, and allergic reaction was reported. CONCLUSION: Addition of Nimotuzumab to standard CRT showed improved survival rate in unresectable, LASCCHN patients without producing additional toxicity.
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spelling pubmed-64987122019-05-08 Efficacy and safety of concurrent chemoradiotherapy with or without Nimotuzumab in unresectable locally advanced squamous cell carcinoma of head and neck: Prospective comparative study - ESCORT-N study Kumar, Ashok Chakravarty, Nilotpal Bhatnagar, Sharad Chowdhary, G. S. South Asian J Cancer ORIGINAL ARTICLE: Head and Neck Cancers BACKGROUND: Nimotuzumab is an anti-epidermal growth factor receptor monoclonal antibody which can be added to chemoradiotherapy (CRT) to improve efficacy for management of locally advanced squamous cell carcinoma of the head and neck (LASCCHN). We prospectively evaluated the efficacy and safety of nimotuzumab with CRT for LASCCHN and compared with CRT alone. MATERIALS AND METHODS: In this prospective study, 29 LASCCHN (Stage III–IVb) patients received Nimotuzumab plus CRT or CRT alone. Treatment included six cycles of cisplatin (40–50 mg/week) or carboplatin (area under the curve-based), nimotuzumab (200 mg/week), and radiotherapy (60–70 Gy). Tumor response was evaluated as per response evaluation criteria in solid tumors criteria. MoS was estimated using the Kaplan–Meier method. Toxicity and adverse events (AE's) were assessed as per CTCAE v 4.0. RESULTS: At 24 weeks after completion of treatment, the tumor response rate (complete response, partial response, stable disease) was 53.3% and 35.7% favoring nimotuzumab arm while progression of disease was 40% and 35.7% in Nimotuzumab plus CRT and CRT groups, respectively. However, the objective response rate was 57% and 30% in favor of nimotuzumab arm. At median follow-up of 45.5 months, MoS was 33 months in Nimotuzumab plus CRT and 27 months in CRT group. The 5-year survival rate was 33.3% in Nimotuzumab plus CRT versus 7.1% in CRT group. Nimotuzumab was observed to be safe with no additional AE's such as hypersensitivity, hypomagnesemia, and allergic reaction was reported. CONCLUSION: Addition of Nimotuzumab to standard CRT showed improved survival rate in unresectable, LASCCHN patients without producing additional toxicity. Wolters Kluwer - Medknow 2019 /pmc/articles/PMC6498712/ /pubmed/31069191 http://dx.doi.org/10.4103/sajc.sajc_38_18 Text en Copyright: © 2019 The South Asian Journal of Cancer http://creativecommons.org/licenses/by-nc-sa/4.0 This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.
spellingShingle ORIGINAL ARTICLE: Head and Neck Cancers
Kumar, Ashok
Chakravarty, Nilotpal
Bhatnagar, Sharad
Chowdhary, G. S.
Efficacy and safety of concurrent chemoradiotherapy with or without Nimotuzumab in unresectable locally advanced squamous cell carcinoma of head and neck: Prospective comparative study - ESCORT-N study
title Efficacy and safety of concurrent chemoradiotherapy with or without Nimotuzumab in unresectable locally advanced squamous cell carcinoma of head and neck: Prospective comparative study - ESCORT-N study
title_full Efficacy and safety of concurrent chemoradiotherapy with or without Nimotuzumab in unresectable locally advanced squamous cell carcinoma of head and neck: Prospective comparative study - ESCORT-N study
title_fullStr Efficacy and safety of concurrent chemoradiotherapy with or without Nimotuzumab in unresectable locally advanced squamous cell carcinoma of head and neck: Prospective comparative study - ESCORT-N study
title_full_unstemmed Efficacy and safety of concurrent chemoradiotherapy with or without Nimotuzumab in unresectable locally advanced squamous cell carcinoma of head and neck: Prospective comparative study - ESCORT-N study
title_short Efficacy and safety of concurrent chemoradiotherapy with or without Nimotuzumab in unresectable locally advanced squamous cell carcinoma of head and neck: Prospective comparative study - ESCORT-N study
title_sort efficacy and safety of concurrent chemoradiotherapy with or without nimotuzumab in unresectable locally advanced squamous cell carcinoma of head and neck: prospective comparative study - escort-n study
topic ORIGINAL ARTICLE: Head and Neck Cancers
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6498712/
https://www.ncbi.nlm.nih.gov/pubmed/31069191
http://dx.doi.org/10.4103/sajc.sajc_38_18
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