First-line cisplatin, docetaxel, and cetuximab for patients with recurrent or metastatic head and neck cancer: A multicenter cohort study

Autores
Falco, Agustín; Leiva, Marcelo; Blanco, Albano; Cefarelli, Guido; Rodríguez, Andrés; Melo, Juan; Cayol, Federico; Rizzo, Manglio Miguel; Sola, Alejandro; Rodríguez Montani, Hernán; Chacón, Matías; Enrico, Diego Hernán; Wasiberg, Federico
Año de publicación
2022
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Background: The targeted therapy cetuximab [directed at the epidermal growth factor receptor (EGFR)] in combination with 5-fluorouracil and platinum-based chemotherapy (the EXTREME regimen) has shown substantial efficacy for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). Thus, this scheme has been established as the preferred first-line option for these patients. However, more recently, a new strategy combining platinum, taxanes, and cetuximab (the TPEx regimen) has demonstrated similar efficacy with a more favorable toxicity profile in clinical trials.Aim: To evaluate the safety and efficacy of the TPEx scheme as first-line therapy in advanced SCCHN in a multicenter cohort study.Methods: This retrospective multicenter cohort study included patients with histologically confirmed recurrent or metastatic SCCHN treated with first-line TPEx at five medical centers in Argentina between January 1, 2017 and April 31, 2020. Chemotherapy consisted of four cycles of docetaxel, cisplatin, and cetuximab followed by cetuximab maintenance therapy. Clinical outcomes and toxicity profiles were collected from medical charts. Treatment response was assessed by the investigator in accordance with Response Evaluation Criteria in Solid Tumors (version 1.1). Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).Results: Twenty-four patients were included. The median age at diagnosis was 58 years (range: 36-77 years). The majority of patients (83.3%) received at least four chemotherapy cycles in the initial phase. In the included group, the overall response rate was 62.5%, and 3 patients achieved a complete response (12.5%). The median time to response was 2.4 mo [95% confidence interval (CI): 1.3-3.5]. With a median follow-up of 12.7 mo (95%CI: 8.8-16.6), the median progression-free survival (PFS) was 6.9 mo (95%CI: 6.5-7.3), and the overall survival rate at 12 mo was 82.4%. Patients with documented tumor response showed a better PFS than those with disease stabilization or progression [8.5 mo (95%CI: 5.5-11.5) and 4.5 mo (95%CI: 2.5-6.6), respectively; P = 0.042]. Regarding the safety analysis, two-thirds of patients reported at least one treatment-related adverse event, and 25% presented grade 3 toxicities. Of note, no patient experienced grade 4 adverse events.Conclusion: TPEx was an adequately tolerated regimen in our population, with low incidence of grade 3-4 adverse events. The median PFS were consistent with those in recent reports of clinical trials evaluating this treatment combination. This regimen may be considered an attractive therapeutic strategy due to its simplified administration, decreased total number of chemotherapy cycles, and treatment tolerability.Keywords: Cetuximab; Cisplatin; Docetaxel; First-line; Recurrent and/or metastatic head and neck cancer; TPEx schema.
Fil: Falco, Agustín. Instituto Alexander Fleming; Argentina
Fil: Leiva, Marcelo. Instituto Alexander Fleming; Argentina
Fil: Blanco, Albano. Instituto Alexander Fleming; Argentina
Fil: Cefarelli, Guido. Instituto Alexander Fleming; Argentina
Fil: Rodríguez, Andrés. Instituto Alexander Fleming; Argentina
Fil: Melo, Juan. Hospital Italiano; Argentina
Fil: Cayol, Federico. Hospital Italiano; Argentina
Fil: Rizzo, Manglio Miguel. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Austral; Argentina
Fil: Sola, Alejandro. Fundación Centro Oncológico de Integración Regional; Argentina
Fil: Rodríguez Montani, Hernán. Hospital Italiano; Argentina
Fil: Chacón, Matías. Instituto Alexander Fleming; Argentina
Fil: Enrico, Diego Hernán. Instituto Alexander Fleming; Argentina
Fil: Wasiberg, Federico. Instituto Alexander Fleming; Argentina
Materia
HEAD AND NECK CANCER
TARGET THERAPY
CHEMOTHERAPY
METASTASIC CANCER
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/267483
Acceder
id CONICETDig_dff59ea1aa0783d69cddcd011604c62e
oai_identifier_str oai:ri.conicet.gov.ar:11336/267483
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling First-line cisplatin, docetaxel, and cetuximab for patients with recurrent or metastatic head and neck cancer: A multicenter cohort studyFalco, AgustínLeiva, MarceloBlanco, AlbanoCefarelli, GuidoRodríguez, AndrésMelo, JuanCayol, FedericoRizzo, Manglio MiguelSola, AlejandroRodríguez Montani, HernánChacón, MatíasEnrico, Diego HernánWasiberg, FedericoHEAD AND NECK CANCERTARGET THERAPYCHEMOTHERAPYMETASTASIC CANCERhttps://purl.org/becyt/ford/3.1https://purl.org/becyt/ford/3Background: The targeted therapy cetuximab [directed at the epidermal growth factor receptor (EGFR)] in combination with 5-fluorouracil and platinum-based chemotherapy (the EXTREME regimen) has shown substantial efficacy for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). Thus, this scheme has been established as the preferred first-line option for these patients. However, more recently, a new strategy combining platinum, taxanes, and cetuximab (the TPEx regimen) has demonstrated similar efficacy with a more favorable toxicity profile in clinical trials.Aim: To evaluate the safety and efficacy of the TPEx scheme as first-line therapy in advanced SCCHN in a multicenter cohort study.Methods: This retrospective multicenter cohort study included patients with histologically confirmed recurrent or metastatic SCCHN treated with first-line TPEx at five medical centers in Argentina between January 1, 2017 and April 31, 2020. Chemotherapy consisted of four cycles of docetaxel, cisplatin, and cetuximab followed by cetuximab maintenance therapy. Clinical outcomes and toxicity profiles were collected from medical charts. Treatment response was assessed by the investigator in accordance with Response Evaluation Criteria in Solid Tumors (version 1.1). Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).Results: Twenty-four patients were included. The median age at diagnosis was 58 years (range: 36-77 years). The majority of patients (83.3%) received at least four chemotherapy cycles in the initial phase. In the included group, the overall response rate was 62.5%, and 3 patients achieved a complete response (12.5%). The median time to response was 2.4 mo [95% confidence interval (CI): 1.3-3.5]. With a median follow-up of 12.7 mo (95%CI: 8.8-16.6), the median progression-free survival (PFS) was 6.9 mo (95%CI: 6.5-7.3), and the overall survival rate at 12 mo was 82.4%. Patients with documented tumor response showed a better PFS than those with disease stabilization or progression [8.5 mo (95%CI: 5.5-11.5) and 4.5 mo (95%CI: 2.5-6.6), respectively; P = 0.042]. Regarding the safety analysis, two-thirds of patients reported at least one treatment-related adverse event, and 25% presented grade 3 toxicities. Of note, no patient experienced grade 4 adverse events.Conclusion: TPEx was an adequately tolerated regimen in our population, with low incidence of grade 3-4 adverse events. The median PFS were consistent with those in recent reports of clinical trials evaluating this treatment combination. This regimen may be considered an attractive therapeutic strategy due to its simplified administration, decreased total number of chemotherapy cycles, and treatment tolerability.Keywords: Cetuximab; Cisplatin; Docetaxel; First-line; Recurrent and/or metastatic head and neck cancer; TPEx schema.Fil: Falco, Agustín. Instituto Alexander Fleming; ArgentinaFil: Leiva, Marcelo. Instituto Alexander Fleming; ArgentinaFil: Blanco, Albano. Instituto Alexander Fleming; ArgentinaFil: Cefarelli, Guido. Instituto Alexander Fleming; ArgentinaFil: Rodríguez, Andrés. Instituto Alexander Fleming; ArgentinaFil: Melo, Juan. Hospital Italiano; ArgentinaFil: Cayol, Federico. Hospital Italiano; ArgentinaFil: Rizzo, Manglio Miguel. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Austral; ArgentinaFil: Sola, Alejandro. Fundación Centro Oncológico de Integración Regional; ArgentinaFil: Rodríguez Montani, Hernán. Hospital Italiano; ArgentinaFil: Chacón, Matías. Instituto Alexander Fleming; ArgentinaFil: Enrico, Diego Hernán. Instituto Alexander Fleming; ArgentinaFil: Wasiberg, Federico. Instituto Alexander Fleming; ArgentinaBaishideng Publishing Group2022-02info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/267483Falco, Agustín; Leiva, Marcelo; Blanco, Albano; Cefarelli, Guido; Rodríguez, Andrés; et al.; First-line cisplatin, docetaxel, and cetuximab for patients with recurrent or metastatic head and neck cancer: A multicenter cohort study; Baishideng Publishing Group; World Journal of Clinical Oncology; 13; 2; 2-2022; 147-1582218-4333CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://www.wjgnet.com/2218-4333/full/v13/i2/147.htminfo:eu-repo/semantics/altIdentifier/doi/10.5306/wjco.v13.i2.147info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T09:59:51Zoai:ri.conicet.gov.ar:11336/267483instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-03 09:59:52.021CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv First-line cisplatin, docetaxel, and cetuximab for patients with recurrent or metastatic head and neck cancer: A multicenter cohort study
title First-line cisplatin, docetaxel, and cetuximab for patients with recurrent or metastatic head and neck cancer: A multicenter cohort study
spellingShingle First-line cisplatin, docetaxel, and cetuximab for patients with recurrent or metastatic head and neck cancer: A multicenter cohort study
Falco, Agustín
HEAD AND NECK CANCER
TARGET THERAPY
CHEMOTHERAPY
METASTASIC CANCER
title_short First-line cisplatin, docetaxel, and cetuximab for patients with recurrent or metastatic head and neck cancer: A multicenter cohort study
title_full First-line cisplatin, docetaxel, and cetuximab for patients with recurrent or metastatic head and neck cancer: A multicenter cohort study
title_fullStr First-line cisplatin, docetaxel, and cetuximab for patients with recurrent or metastatic head and neck cancer: A multicenter cohort study
title_full_unstemmed First-line cisplatin, docetaxel, and cetuximab for patients with recurrent or metastatic head and neck cancer: A multicenter cohort study
title_sort First-line cisplatin, docetaxel, and cetuximab for patients with recurrent or metastatic head and neck cancer: A multicenter cohort study
dc.creator.none.fl_str_mv Falco, Agustín
Leiva, Marcelo
Blanco, Albano
Cefarelli, Guido
Rodríguez, Andrés
Melo, Juan
Cayol, Federico
Rizzo, Manglio Miguel
Sola, Alejandro
Rodríguez Montani, Hernán
Chacón, Matías
Enrico, Diego Hernán
Wasiberg, Federico
author Falco, Agustín
author_facet Falco, Agustín
Leiva, Marcelo
Blanco, Albano
Cefarelli, Guido
Rodríguez, Andrés
Melo, Juan
Cayol, Federico
Rizzo, Manglio Miguel
Sola, Alejandro
Rodríguez Montani, Hernán
Chacón, Matías
Enrico, Diego Hernán
Wasiberg, Federico
author_role author
author2 Leiva, Marcelo
Blanco, Albano
Cefarelli, Guido
Rodríguez, Andrés
Melo, Juan
Cayol, Federico
Rizzo, Manglio Miguel
Sola, Alejandro
Rodríguez Montani, Hernán
Chacón, Matías
Enrico, Diego Hernán
Wasiberg, Federico
author2_role author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv HEAD AND NECK CANCER
TARGET THERAPY
CHEMOTHERAPY
METASTASIC CANCER
topic HEAD AND NECK CANCER
TARGET THERAPY
CHEMOTHERAPY
METASTASIC CANCER
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.1
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Background: The targeted therapy cetuximab [directed at the epidermal growth factor receptor (EGFR)] in combination with 5-fluorouracil and platinum-based chemotherapy (the EXTREME regimen) has shown substantial efficacy for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). Thus, this scheme has been established as the preferred first-line option for these patients. However, more recently, a new strategy combining platinum, taxanes, and cetuximab (the TPEx regimen) has demonstrated similar efficacy with a more favorable toxicity profile in clinical trials.Aim: To evaluate the safety and efficacy of the TPEx scheme as first-line therapy in advanced SCCHN in a multicenter cohort study.Methods: This retrospective multicenter cohort study included patients with histologically confirmed recurrent or metastatic SCCHN treated with first-line TPEx at five medical centers in Argentina between January 1, 2017 and April 31, 2020. Chemotherapy consisted of four cycles of docetaxel, cisplatin, and cetuximab followed by cetuximab maintenance therapy. Clinical outcomes and toxicity profiles were collected from medical charts. Treatment response was assessed by the investigator in accordance with Response Evaluation Criteria in Solid Tumors (version 1.1). Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).Results: Twenty-four patients were included. The median age at diagnosis was 58 years (range: 36-77 years). The majority of patients (83.3%) received at least four chemotherapy cycles in the initial phase. In the included group, the overall response rate was 62.5%, and 3 patients achieved a complete response (12.5%). The median time to response was 2.4 mo [95% confidence interval (CI): 1.3-3.5]. With a median follow-up of 12.7 mo (95%CI: 8.8-16.6), the median progression-free survival (PFS) was 6.9 mo (95%CI: 6.5-7.3), and the overall survival rate at 12 mo was 82.4%. Patients with documented tumor response showed a better PFS than those with disease stabilization or progression [8.5 mo (95%CI: 5.5-11.5) and 4.5 mo (95%CI: 2.5-6.6), respectively; P = 0.042]. Regarding the safety analysis, two-thirds of patients reported at least one treatment-related adverse event, and 25% presented grade 3 toxicities. Of note, no patient experienced grade 4 adverse events.Conclusion: TPEx was an adequately tolerated regimen in our population, with low incidence of grade 3-4 adverse events. The median PFS were consistent with those in recent reports of clinical trials evaluating this treatment combination. This regimen may be considered an attractive therapeutic strategy due to its simplified administration, decreased total number of chemotherapy cycles, and treatment tolerability.Keywords: Cetuximab; Cisplatin; Docetaxel; First-line; Recurrent and/or metastatic head and neck cancer; TPEx schema.
Fil: Falco, Agustín. Instituto Alexander Fleming; Argentina
Fil: Leiva, Marcelo. Instituto Alexander Fleming; Argentina
Fil: Blanco, Albano. Instituto Alexander Fleming; Argentina
Fil: Cefarelli, Guido. Instituto Alexander Fleming; Argentina
Fil: Rodríguez, Andrés. Instituto Alexander Fleming; Argentina
Fil: Melo, Juan. Hospital Italiano; Argentina
Fil: Cayol, Federico. Hospital Italiano; Argentina
Fil: Rizzo, Manglio Miguel. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Austral; Argentina
Fil: Sola, Alejandro. Fundación Centro Oncológico de Integración Regional; Argentina
Fil: Rodríguez Montani, Hernán. Hospital Italiano; Argentina
Fil: Chacón, Matías. Instituto Alexander Fleming; Argentina
Fil: Enrico, Diego Hernán. Instituto Alexander Fleming; Argentina
Fil: Wasiberg, Federico. Instituto Alexander Fleming; Argentina
description Background: The targeted therapy cetuximab [directed at the epidermal growth factor receptor (EGFR)] in combination with 5-fluorouracil and platinum-based chemotherapy (the EXTREME regimen) has shown substantial efficacy for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). Thus, this scheme has been established as the preferred first-line option for these patients. However, more recently, a new strategy combining platinum, taxanes, and cetuximab (the TPEx regimen) has demonstrated similar efficacy with a more favorable toxicity profile in clinical trials.Aim: To evaluate the safety and efficacy of the TPEx scheme as first-line therapy in advanced SCCHN in a multicenter cohort study.Methods: This retrospective multicenter cohort study included patients with histologically confirmed recurrent or metastatic SCCHN treated with first-line TPEx at five medical centers in Argentina between January 1, 2017 and April 31, 2020. Chemotherapy consisted of four cycles of docetaxel, cisplatin, and cetuximab followed by cetuximab maintenance therapy. Clinical outcomes and toxicity profiles were collected from medical charts. Treatment response was assessed by the investigator in accordance with Response Evaluation Criteria in Solid Tumors (version 1.1). Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).Results: Twenty-four patients were included. The median age at diagnosis was 58 years (range: 36-77 years). The majority of patients (83.3%) received at least four chemotherapy cycles in the initial phase. In the included group, the overall response rate was 62.5%, and 3 patients achieved a complete response (12.5%). The median time to response was 2.4 mo [95% confidence interval (CI): 1.3-3.5]. With a median follow-up of 12.7 mo (95%CI: 8.8-16.6), the median progression-free survival (PFS) was 6.9 mo (95%CI: 6.5-7.3), and the overall survival rate at 12 mo was 82.4%. Patients with documented tumor response showed a better PFS than those with disease stabilization or progression [8.5 mo (95%CI: 5.5-11.5) and 4.5 mo (95%CI: 2.5-6.6), respectively; P = 0.042]. Regarding the safety analysis, two-thirds of patients reported at least one treatment-related adverse event, and 25% presented grade 3 toxicities. Of note, no patient experienced grade 4 adverse events.Conclusion: TPEx was an adequately tolerated regimen in our population, with low incidence of grade 3-4 adverse events. The median PFS were consistent with those in recent reports of clinical trials evaluating this treatment combination. This regimen may be considered an attractive therapeutic strategy due to its simplified administration, decreased total number of chemotherapy cycles, and treatment tolerability.Keywords: Cetuximab; Cisplatin; Docetaxel; First-line; Recurrent and/or metastatic head and neck cancer; TPEx schema.
publishDate 2022
dc.date.none.fl_str_mv 2022-02
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/267483
Falco, Agustín; Leiva, Marcelo; Blanco, Albano; Cefarelli, Guido; Rodríguez, Andrés; et al.; First-line cisplatin, docetaxel, and cetuximab for patients with recurrent or metastatic head and neck cancer: A multicenter cohort study; Baishideng Publishing Group; World Journal of Clinical Oncology; 13; 2; 2-2022; 147-158
2218-4333
CONICET Digital
CONICET
url http://hdl.handle.net/11336/267483
identifier_str_mv Falco, Agustín; Leiva, Marcelo; Blanco, Albano; Cefarelli, Guido; Rodríguez, Andrés; et al.; First-line cisplatin, docetaxel, and cetuximab for patients with recurrent or metastatic head and neck cancer: A multicenter cohort study; Baishideng Publishing Group; World Journal of Clinical Oncology; 13; 2; 2-2022; 147-158
2218-4333
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/https://www.wjgnet.com/2218-4333/full/v13/i2/147.htm
info:eu-repo/semantics/altIdentifier/doi/10.5306/wjco.v13.i2.147
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Baishideng Publishing Group
publisher.none.fl_str_mv Baishideng Publishing Group
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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