External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma
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...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Tipo de recurso: | artículo |
| Fecha de publicación: | 2021 |
| País: | España |
| Institución: | Universitat Autònoma de Barcelona |
| Repositorio: | Dipòsit Digital de Documents de la UAB |
| Idioma: | inglés |
| OAI Identifier: | oai:ddd.uab.cat:271898 |
| Acceso en línea: | https://ddd.uab.cat/record/271898 https://dx.doi.org/urn:doi:10.1177/17588359211019672 |
| Access Level: | acceso abierto |
| Palabra clave: | Chemotherapy External validity Gastric cancer HER2 Oxaliplatin Trastuzumab |
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External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinomadata from the AGAMENON-SEOM registryJiménez Fonseca, Paula|||0000-0003-4592-3813Carmona-Bayonas, Alberto|||0000-0002-1930-9660Martinez-Torron, AlbaAlsina, Maria|||0000-0003-4835-7159Custodio, AnaSerra, OlbiaCacho Lavín, DiegoLimón, María Luisa|||0000-0003-4409-3029Saurí Nadal, Tamara|||0000-0002-7479-5120López, FloraVisa, Laura|||0000-0002-3409-8857Granja, MónicaMartínez Lago, Nieves|||0000-0002-0408-6871Arrazubi, VirginiaVidal Tocino, Rosario|||0000-0002-0588-2001Hernandez, RaquelAguado, GemaCano, Juana María|||0000-0002-2493-0988Martín Carnicero, Alfonso|||0000-0002-8564-2875Mangas, MontserratPimentel, Paola|||0000-0002-1676-5724Fernández Montes, Ana|||0000-0003-4630-5830Macias Declara, IsmaelLongo, Federico|||0000-0003-0902-2188Ramchandani, Avinash|||0000-0002-9754-3903Martín-Richard, Marta|||0000-0003-4933-2463Hurtado-Nuño, Alicia|||0000-0003-0082-8863Azkárate, Aitor|||0000-0002-6805-158XHernández Pérez, CarolinaSerrano, RaquelGallego Plazas, Javier|||0000-0002-0584-1242ChemotherapyExternal 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. 22021-01-0120212021-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/271898https://dx.doi.org/urn:doi:10.1177/17588359211019672reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2718982026-06-06T12:50:31Z |
| 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 |
| spellingShingle |
External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma Jiménez Fonseca, Paula|||0000-0003-4592-3813 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 |
| title_full |
External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma |
| title_fullStr |
External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma |
| title_full_unstemmed |
External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma |
| title_sort |
External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma |
| dc.creator.none.fl_str_mv |
Jiménez Fonseca, Paula|||0000-0003-4592-3813 Carmona-Bayonas, Alberto|||0000-0002-1930-9660 Martinez-Torron, Alba Alsina, Maria|||0000-0003-4835-7159 Custodio, Ana Serra, Olbia Cacho Lavín, Diego Limón, María Luisa|||0000-0003-4409-3029 Saurí Nadal, Tamara|||0000-0002-7479-5120 López, Flora Visa, Laura|||0000-0002-3409-8857 Granja, Mónica Martínez Lago, Nieves|||0000-0002-0408-6871 Arrazubi, Virginia Vidal Tocino, Rosario|||0000-0002-0588-2001 Hernandez, Raquel Aguado, Gema Cano, Juana María|||0000-0002-2493-0988 Martín Carnicero, Alfonso|||0000-0002-8564-2875 Mangas, Montserrat Pimentel, Paola|||0000-0002-1676-5724 Fernández Montes, Ana|||0000-0003-4630-5830 Macias Declara, Ismael Longo, Federico|||0000-0003-0902-2188 Ramchandani, Avinash|||0000-0002-9754-3903 Martín-Richard, Marta|||0000-0003-4933-2463 Hurtado-Nuño, Alicia|||0000-0003-0082-8863 Azkárate, Aitor|||0000-0002-6805-158X Hernández Pérez, Carolina Serrano, Raquel Gallego Plazas, Javier|||0000-0002-0584-1242 |
| author |
Jiménez Fonseca, Paula|||0000-0003-4592-3813 |
| author_facet |
Jiménez Fonseca, Paula|||0000-0003-4592-3813 Carmona-Bayonas, Alberto|||0000-0002-1930-9660 Martinez-Torron, Alba Alsina, Maria|||0000-0003-4835-7159 Custodio, Ana Serra, Olbia Cacho Lavín, Diego Limón, María Luisa|||0000-0003-4409-3029 Saurí Nadal, Tamara|||0000-0002-7479-5120 López, Flora Visa, Laura|||0000-0002-3409-8857 Granja, Mónica Martínez Lago, Nieves|||0000-0002-0408-6871 Arrazubi, Virginia Vidal Tocino, Rosario|||0000-0002-0588-2001 Hernandez, Raquel Aguado, Gema Cano, Juana María|||0000-0002-2493-0988 Martín Carnicero, Alfonso|||0000-0002-8564-2875 Mangas, Montserrat Pimentel, Paola|||0000-0002-1676-5724 Fernández Montes, Ana|||0000-0003-4630-5830 Macias Declara, Ismael Longo, Federico|||0000-0003-0902-2188 Ramchandani, Avinash|||0000-0002-9754-3903 Martín-Richard, Marta|||0000-0003-4933-2463 Hurtado-Nuño, Alicia|||0000-0003-0082-8863 Azkárate, Aitor|||0000-0002-6805-158X Hernández Pérez, Carolina Serrano, Raquel Gallego Plazas, Javier|||0000-0002-0584-1242 |
| author_role |
author |
| author2 |
Carmona-Bayonas, Alberto|||0000-0002-1930-9660 Martinez-Torron, Alba Alsina, Maria|||0000-0003-4835-7159 Custodio, Ana Serra, Olbia Cacho Lavín, Diego Limón, María Luisa|||0000-0003-4409-3029 Saurí Nadal, Tamara|||0000-0002-7479-5120 López, Flora Visa, Laura|||0000-0002-3409-8857 Granja, Mónica Martínez Lago, Nieves|||0000-0002-0408-6871 Arrazubi, Virginia Vidal Tocino, Rosario|||0000-0002-0588-2001 Hernandez, Raquel Aguado, Gema Cano, Juana María|||0000-0002-2493-0988 Martín Carnicero, Alfonso|||0000-0002-8564-2875 Mangas, Montserrat Pimentel, Paola|||0000-0002-1676-5724 Fernández Montes, Ana|||0000-0003-4630-5830 Macias Declara, Ismael Longo, Federico|||0000-0003-0902-2188 Ramchandani, Avinash|||0000-0002-9754-3903 Martín-Richard, Marta|||0000-0003-4933-2463 Hurtado-Nuño, Alicia|||0000-0003-0082-8863 Azkárate, Aitor|||0000-0002-6805-158X Hernández Pérez, Carolina Serrano, Raquel Gallego Plazas, Javier|||0000-0002-0584-1242 |
| 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 |
2 2021-01-01 2021 2021-01-01 |
| dc.type.none.fl_str_mv |
Article http://purl.org/coar/resource_type/c_6501 VoR http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| dc.type.openaire.fl_str_mv |
info:eu-repo/semantics/article |
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article |
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https://ddd.uab.cat/record/271898 https://dx.doi.org/urn:doi:10.1177/17588359211019672 |
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https://ddd.uab.cat/record/271898 https://dx.doi.org/urn:doi:10.1177/17588359211019672 |
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Inglés eng |
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Inglés |
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eng |
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open access http://purl.org/coar/access_right/c_abf2 https://creativecommons.org/licenses/by-nc/4.0/ |
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info:eu-repo/semantics/openAccess |
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open access http://purl.org/coar/access_right/c_abf2 https://creativecommons.org/licenses/by-nc/4.0/ |
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openAccess |
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application/pdf |
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reponame:Dipòsit Digital de Documents de la UAB instname:Universitat Autònoma de Barcelona |
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