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

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Institut Català de la Salut
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[Jimenez-Fonseca P] Medical Oncology Department, Hospital Universitario Central de Asturias, ISPA, Oviedo, Spain. [Carmona-Bayonas A] Medical Oncology Department, Hospital Universitario Morales Meseguer, 30007 Murcia, Spain. [Martinez-Torron A] Pharmacy Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain. [Alsina M] Medical Oncology Department, Complejo Hospitalario de Navarra, Pamplona. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Custodio A] Medical Oncology Department, Hospital Universitario La Paz, CIBERONC CB16/12/00398, Madrid, Spain. [Serra O] Medical Oncology Department, Catalan Institute of Oncology, L’Hospitalet, Spain
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Vall d'Hebron Barcelona Hospital Campus
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Jimenez-Fonseca, Paula
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Martinez-Torron, Alba
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Alsina Maqueda, Maria
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Custodio, Ana
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Serra, Olbia
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Carmona-Bayonas, Alberto
dc.date.accessioned
2025-10-25T05:39:40Z
dc.date.available
2025-10-25T05:39:40Z
dc.date.issued
2022-02-22T11:44:39Z
dc.date.issued
2022-02-22T11:44:39Z
dc.date.issued
2021-01
dc.identifier
Jimenez-Fonseca P, Carmona-Bayonas A, Martinez-Torron A, Alsina M, Custodio A, Serra O, et al. External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma: data from the AGAMENON-SEOM registry. Ther Adv Med Oncol. 2021 Jan;13:1–13.
dc.identifier
1569-8041
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https://hdl.handle.net/11351/7066
dc.identifier
10.1177/17588359211019672
dc.identifier
34211587
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000688566300001
dc.identifier.uri
http://hdl.handle.net/11351/7066
dc.description.abstract
Quimioteràpia; Càncer gàstric; Trastuzumab
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Quimioterapia; Cáncer gástrico; Trastuzumab
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Chemotherapy; Gastric cancer; Trastuzumab
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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.description.abstract
The authors received no financial support for the research, authorship, and/or publication of this article.
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dc.language
eng
dc.publisher
SAGE Publications
dc.relation
Therapeutic Advances in Medical Oncology;13
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https://doi.org/10.1177/17588359211019672
dc.rights
Attribution-NonCommercial 4.0 International
dc.rights
http://creativecommons.org/licenses/by-nc/4.0/
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info:eu-repo/semantics/openAccess
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Scientia
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Esòfag - Càncer - Tractament
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Estómac - Càncer - Tractament
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Quimioteràpia combinada
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DISEASES::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Esophageal Neoplasms
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Other subheadings::Other subheadings::Other subheadings::/drug therapy
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ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols
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Other subheadings::Other subheadings::/therapeutic use
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ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias gastrointestinales::neoplasias del esófago
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Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
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TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada
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Otros calificadores::Otros calificadores::/uso terapéutico
dc.title
External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma: data from the AGAMENON-SEOM registry
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info:eu-repo/semantics/article
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info:eu-repo/semantics/publishedVersion


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