Identifier to cite or link to this item: http://hdl.handle.net/20.500.13003/11510
External validity of docetaxel triplet trials in advanced gastric cancer: are there patients who still benefit?
StatisticsItem usage statistics
MetadataShow Dublin Core item record
AuthorJimenez-Fonseca, Paula; Carmona-Bayonas, Alberto; Martinez de Castro, Eva; Custodio, Ana; Pericay Pijaume, Carles; Hernandez, Raquel; Aguado, Gema; Castro Unanua, Natalia; Cano, Juana Maria; Lopez, Flora; Garrido, Marcelo; Fernandez Montes, Ana; Visa, Laura; Sanchez Canovas, Manuel; Limon, Maria Luisa; Martinez Lago, Nieves; Pimentel, Paola; Hurtado, Alicia; Azkarate, Aitor; Longo, Federico; Diez, Marc; Arias-Martinez, Aranzazu; Sauri, Tamara; Martin Carnicero, Alfonso; Mangas, Monserrat; Martin Richard, Marta; Granja, Monica; Ramchandani, Avinash; Hernandez Perez, Carolina; Cerda, Paula; Gil-Negrete, Aitziber; Calvo, Mariona; Vidal Tocino, Rosario; Gallego, Javier
Document typeresearch article
CitationJimenez-Fonseca P, Carmona-Bayonas A, Martinez De Castro E, Custodio A, Pericay Pijaume C, Hernandez R, et al. External validity of docetaxel triplet trials in advanced gastric cancer: are there patients who still benefit?. Gastric Cancer. 2021 Mar;24(2):445-56. Epub 2020 Sep 24.
Background The purpose of our study was to develop an online calculator to estimate the effect of docetaxel triplets (DPF) in first line of advanced gastric cancer (AGC), and to assess the external validity of docetaxel trials in individual patients. Methods The study includes patients with HER2(-) AGC treated with platin and fluoropyrimidine (PF) or with DPF in first line. Treatment effect and interactions were assessed using Bayesian accelerated failure time models. Result The series comprises 1376 patients; 238 treated with DPF and 1138 with PF between 2008 and 2019. DPF was associated with increased progression-free survival (PFS) and overall survival (OS) with time ratio (TR) 1.27 (95% credible interval [CrI], 1.15-1.40), and TR 1.19 (95% CrI, 1.09-1.27), respectively. Serious adverse events were more common with DPF, particularly hematological effects (32% vs 22%). Younger participants received greater DPF dose density without achieving greater disease control, while severe toxicity was likewise higher. DPF yielded superior OS in Lauren intestinal (TR 1.27, 95% CrI, 1.08-1.11) vs diffuse subtype (TR 1.17, 95% CrI, 1.09-1.24) and the probability of increasing OS > 15% was 90% vs 67% in each subtype, respectively. The effect dwindles over time, which can be attributed to pathological changes and clinical practice changes. Conclusion Our study confirms the effect of DPF is highly dependent on several clinical-pathological variables, with discreet and gradually declining benefit over platinum doublets in later years, at the expense of increased toxicity. These results may help to underpin the idea that external validity of AGC trials should be revised regularly.