دورية أكاديمية

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

التفاصيل البيبلوغرافية
العنوان: External validity of clinical trials with diverse trastuzumab-based chemotherapy regimens in advanced gastroesophageal adenocarcinoma : data from the AGAMENON-SEOM registry
المؤلفون: Jimenez-Fonseca, Paula, Carmona-Bayonas, Alberto, Martinez-Torron, Alba, Alsina, Maria, Custodio, Ana, Serra, Olbia, Cacho Lavin, Diego, Limón, María Luisa, Sauri, Tamara, López, Flora, Visa, Laura, Granja, Mónica, Martínez Lago, Nieves, Arrazubi, Virginia, Vidal Tocino, Rosario, Hernandez, Raquel, Aguado, Gema, Cano, Juana María, Martín Carnicero, Alfonso, Mangas, Montserrat, Pimentel, Paola, Fernández Montes, Ana, Macias Declara, Ismael, Longo, Federico, Ramchandani, Avinash, Martín-Richard, Marta, Hurtado, Alicia, Azkárate, Aitor, Hernández Pérez, Carolina, Serrano, Raquel, Gallego, Javier
سنة النشر: 2021
المجموعة: Universitat Autònoma de Barcelona: Dipòsit Digital de Documents de la UAB
مصطلحات موضوعية: Chemotherapy, External validity, Gastric cancer, HER2, Oxaliplatin, Trastuzumab
الوصف: 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.
نوع الوثيقة: article in journal/newspaper
وصف الملف: application/pdf
اللغة: English
تدمد: 17588359
العلاقة: Therapeutic Advances in Medical Oncology; Vol. 13 (2021); https://ddd.uab.cat/record/271898Test; urn:10.1177/17588359211019672; urn:oai:ddd.uab.cat:271898; urn:scopus_id:85108079911; urn:pmid:34211587; urn:pmc-uid:8216357; urn:pmcid:PMC8216357; urn:oai:pubmedcentral.nih.gov:8216357
الإتاحة: https://ddd.uab.cat/record/271898Test
حقوق: open access ; Aquest 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/4.0Test/
رقم الانضمام: edsbas.1B22004F
قاعدة البيانات: BASE