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

Show simple item record

dc.contributor.author Jimenez-Fonseca, Paula
dc.contributor.author Carmona-Bayonas, Alberto
dc.contributor.author Martinez-Torron, Alba
dc.contributor.author Alsina, Maria
dc.contributor.author Custodio, Ana
dc.contributor.author Serra, Olbia
dc.contributor.author Cacho Lavin, Diego
dc.contributor.author Limón, María Luisa
dc.contributor.author Sauri, Tamara
dc.contributor.author López, Flora
dc.contributor.author Visa, Laura
dc.contributor.author Granja, Mónica
dc.contributor.author Martínez Lago, Nieves
dc.contributor.author Arrazubi, Virginia
dc.contributor.author Vidal Tocino, Rosario
dc.contributor.author Hernandez, Raquel
dc.contributor.author Aguado, Gema
dc.contributor.author Cano, Juana María
dc.contributor.author Martín Carnicero, Alfonso
dc.contributor.author Mangas, Monserrat
dc.contributor.author Pimentel, Paola
dc.contributor.author Fernández Montes, Ana
dc.contributor.author Macias Declara, Ismael
dc.contributor.author Longo, Federico
dc.contributor.author Ramchandani, Avinash
dc.contributor.author Martín Richard, Marta
dc.contributor.author Hurtado, Alicia
dc.contributor.author Azkarate, Aitor
dc.contributor.author Hernández Pérez, Carolina
dc.contributor.author Serrano, Raquel
dc.contributor.author Gallego, Javier
dc.date.accessioned 2021-07-08T07:56:53Z
dc.identifier.uri http://hdl.handle.net/11201/155645
dc.description.abstract [eng] 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.
dc.format application/pdf
dc.relation.isformatof https://doi.org/10.1177/17588359211019672
dc.relation.ispartof Therapeutic Advances In Medical Oncology, 2021, vol. 13, p. 1-13
dc.rights , 2021
dc.subject.classification 61 - Medicina
dc.subject.classification 616 - Patologia. Medicina clínica. Oncologia
dc.subject.other 61 - Medical sciences
dc.subject.other 616 - Pathology. Clinical medicine
dc.title External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma: data from the AGAMENON-SEOM registry
dc.type info:eu-repo/semantics/article
dc.date.updated 2021-07-08T07:56:55Z
dc.date.embargoEndDate info:eu-repo/date/embargoEnd/2026-12-31
dc.embargo 2026-12-31
dc.rights.accessRights info:eu-repo/semantics/embargoedAccess
dc.identifier.doi https://doi.org/10.1177/17588359211019672


Files in this item

This item appears in the following Collection(s)

Show simple item record