External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma: data from the AGAMENON-SEOM registry

Background: Trastuzumab combined with cisplatin and fluoropyrimidines, either capecitabine or 5-fluorouracile (XP/FP), is the standard first-line treatment for advanced, HER2-positive, gastric cancer patients based on the ToGA trial. Despite the lack of phase III trials, many clinicians administer t...

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Autores: Jimenez-Fonseca, P, Carmona-Bayonas, A, Martinez-Torron, A, Alsina, M, Custodio, A, Serra, O, Lavin, DC, Limon, ML, Sauri, T, Lopez, F, Visa, L, Granja, M, Lago, NM, Arrazubi, V, Tocino, RV, Hernandez, R, Aguado, G, Cano, JM, Carnicero, AM, Mangas, M, Pimentel, P, Montes, AF, Declara, IM, Longo, F, Ramchandani, A, Richard, MM, Hurtado, A, Azkarate, A, Perez, CH, Serrano, R, Gallego, J
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Institución:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositorio:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:fisabio.fundanetsuite.com:p11796
Acceso en línea:https://fisabio.portalinvestigacion.com/publicaciones/11796
Access Level:acceso abierto
Palabra clave:chemotherapy
external validity
gastric cancer
HER2
oxaliplatin
trastuzumab
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spelling External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma: data from the AGAMENON-SEOM registryJimenez-Fonseca, PCarmona-Bayonas, AMartinez-Torron, AAlsina, MCustodio, ASerra, OLavin, DCLimon, MLSauri, TLopez, FVisa, LGranja, MLago, NMArrazubi, VTocino, RVHernandez, RAguado, GCano, JMCarnicero, AMMangas, MPimentel, PMontes, AFDeclara, IMLongo, FRamchandani, ARichard, MMHurtado, AAzkarate, APerez, CHSerrano, RGallego, Jchemotherapyexternal validitygastric cancerHER2oxaliplatintrastuzumabBackground: Trastuzumab combined with cisplatin and fluoropyrimidines, either capecitabine or 5-fluorouracile (XP/FP), is the standard first-line treatment for advanced, HER2-positive, gastric cancer patients based on the ToGA trial. Despite the lack of phase III trials, many clinicians administer trastuzumab with alternative regimens. One meta-analysis suggests that substituting cisplatin for oxaliplatin might lead to greater efficacy and less toxicity. Methods: 594 patients with HER2-positive gastroesophageal adenocarcinoma were recruited from the AGAMENON-SEOM registry. The objective was to evaluate the external validity of clinical trials with chemotherapy and trastuzumab. Results: The regimens used in at least 5% of the patients were XP (27%), oxaliplatin and capecitabine (CAPOX) (26%), oxaliplatin and 5-fluorouracil (FOLFOX) (14%), FP (14%), triplet with anthracycline/docetaxel (7%), and carboplatin-FU (5%). Median exposure to trastuzumab was longer with FOLFOX (11.4 months, 95% CI, 9.1-21.0) versus ToGA regimens (7.5, 6.4-8.5), p < 0.001. Patients with HER2-IHC 3+ cancers had higher response rates than those with IHC 2+/FISH+, odds-ratio 1.97 (95% CI, 1.25-3.09). The results achieved with CAPOX-trastuzumab were comparable to those attained with ToGA regimens. FOLFOX-trastuzumab was superior to ToGA schemes in terms of overall survival (OS), with a greater magnitude of effect in IHC 2+/FISH+ tumors (HR 0.47, 0.24-0.92) compared with IHC 3+ (HR 0.69, 0.49-0.96), and in diffuse (HR 0.37, 0.20-0.69) versus intestinal-type tumors (HR 0.76, 0.54-1.06). Conclusion: We have updated the external validity of clinical trials with trastuzumab in first-line treatment of gastric cancer. Our data confirm the comparable outcomes of ToGA regimens and CAPOX-trastuzumab in clinical practice and point toward a possible benefit of FOLFOX-trastuzumab, contingent on the subtypes typically less sensitive to trastuzumab, to be confirmed in clinical trials.SAGE PUBLICATIONS LTD2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fisabio.portalinvestigacion.com/publicaciones/11796Therapeutic Advances in Medical OncologyISSN: 17588340ISSNe: 17588359reponame:r-FISABIO. Repositorio Institucional de Producción Científicainstname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)Inglésinfo:eu-repo/semantics/openAccessoai:fisabio.fundanetsuite.com:p117962026-06-11T12:45:17Z
dc.title.none.fl_str_mv External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma: data from the AGAMENON-SEOM registry
title External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma: data from the AGAMENON-SEOM registry
spellingShingle External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma: data from the AGAMENON-SEOM registry
Jimenez-Fonseca, P
chemotherapy
external validity
gastric cancer
HER2
oxaliplatin
trastuzumab
title_short External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma: data from the AGAMENON-SEOM registry
title_full External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma: data from the AGAMENON-SEOM registry
title_fullStr External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma: data from the AGAMENON-SEOM registry
title_full_unstemmed External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma: data from the AGAMENON-SEOM registry
title_sort External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma: data from the AGAMENON-SEOM registry
dc.creator.none.fl_str_mv Jimenez-Fonseca, P
Carmona-Bayonas, A
Martinez-Torron, A
Alsina, M
Custodio, A
Serra, O
Lavin, DC
Limon, ML
Sauri, T
Lopez, F
Visa, L
Granja, M
Lago, NM
Arrazubi, V
Tocino, RV
Hernandez, R
Aguado, G
Cano, JM
Carnicero, AM
Mangas, M
Pimentel, P
Montes, AF
Declara, IM
Longo, F
Ramchandani, A
Richard, MM
Hurtado, A
Azkarate, A
Perez, CH
Serrano, R
Gallego, J
author Jimenez-Fonseca, P
author_facet Jimenez-Fonseca, P
Carmona-Bayonas, A
Martinez-Torron, A
Alsina, M
Custodio, A
Serra, O
Lavin, DC
Limon, ML
Sauri, T
Lopez, F
Visa, L
Granja, M
Lago, NM
Arrazubi, V
Tocino, RV
Hernandez, R
Aguado, G
Cano, JM
Carnicero, AM
Mangas, M
Pimentel, P
Montes, AF
Declara, IM
Longo, F
Ramchandani, A
Richard, MM
Hurtado, A
Azkarate, A
Perez, CH
Serrano, R
Gallego, J
author_role author
author2 Carmona-Bayonas, A
Martinez-Torron, A
Alsina, M
Custodio, A
Serra, O
Lavin, DC
Limon, ML
Sauri, T
Lopez, F
Visa, L
Granja, M
Lago, NM
Arrazubi, V
Tocino, RV
Hernandez, R
Aguado, G
Cano, JM
Carnicero, AM
Mangas, M
Pimentel, P
Montes, AF
Declara, IM
Longo, F
Ramchandani, A
Richard, MM
Hurtado, A
Azkarate, A
Perez, CH
Serrano, R
Gallego, J
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv chemotherapy
external validity
gastric cancer
HER2
oxaliplatin
trastuzumab
topic chemotherapy
external validity
gastric cancer
HER2
oxaliplatin
trastuzumab
description Background: Trastuzumab combined with cisplatin and fluoropyrimidines, either capecitabine or 5-fluorouracile (XP/FP), is the standard first-line treatment for advanced, HER2-positive, gastric cancer patients based on the ToGA trial. Despite the lack of phase III trials, many clinicians administer trastuzumab with alternative regimens. One meta-analysis suggests that substituting cisplatin for oxaliplatin might lead to greater efficacy and less toxicity. Methods: 594 patients with HER2-positive gastroesophageal adenocarcinoma were recruited from the AGAMENON-SEOM registry. The objective was to evaluate the external validity of clinical trials with chemotherapy and trastuzumab. Results: The regimens used in at least 5% of the patients were XP (27%), oxaliplatin and capecitabine (CAPOX) (26%), oxaliplatin and 5-fluorouracil (FOLFOX) (14%), FP (14%), triplet with anthracycline/docetaxel (7%), and carboplatin-FU (5%). Median exposure to trastuzumab was longer with FOLFOX (11.4 months, 95% CI, 9.1-21.0) versus ToGA regimens (7.5, 6.4-8.5), p < 0.001. Patients with HER2-IHC 3+ cancers had higher response rates than those with IHC 2+/FISH+, odds-ratio 1.97 (95% CI, 1.25-3.09). The results achieved with CAPOX-trastuzumab were comparable to those attained with ToGA regimens. FOLFOX-trastuzumab was superior to ToGA schemes in terms of overall survival (OS), with a greater magnitude of effect in IHC 2+/FISH+ tumors (HR 0.47, 0.24-0.92) compared with IHC 3+ (HR 0.69, 0.49-0.96), and in diffuse (HR 0.37, 0.20-0.69) versus intestinal-type tumors (HR 0.76, 0.54-1.06). Conclusion: We have updated the external validity of clinical trials with trastuzumab in first-line treatment of gastric cancer. Our data confirm the comparable outcomes of ToGA regimens and CAPOX-trastuzumab in clinical practice and point toward a possible benefit of FOLFOX-trastuzumab, contingent on the subtypes typically less sensitive to trastuzumab, to be confirmed in clinical trials.
publishDate 2021
dc.date.none.fl_str_mv 2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://fisabio.portalinvestigacion.com/publicaciones/11796
url https://fisabio.portalinvestigacion.com/publicaciones/11796
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv SAGE PUBLICATIONS LTD
publisher.none.fl_str_mv SAGE PUBLICATIONS LTD
dc.source.none.fl_str_mv Therapeutic Advances in Medical Oncology
ISSN: 17588340
ISSNe: 17588359
reponame:r-FISABIO. Repositorio Institucional de Producción Científica
instname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
instname_str Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
reponame_str r-FISABIO. Repositorio Institucional de Producción Científica
collection r-FISABIO. Repositorio Institucional de Producción Científica
repository.name.fl_str_mv
repository.mail.fl_str_mv
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