Jimenez-Fonseca Paula, Foy Victoria, Raby Sophie, Carmona-Bayonas Alberto, Macía-Rivas Lola, Arrazubi Virginia, Cacho Lavin Diego, Hernandez San Gil Raquel, Custodio Ana, Cano Juana María, Fernández Montes Ana, Mirallas Oriol, Macias Declara Ismael, Vidal Tocino Rosario, Visa Laura, Limón María Luisa, Pimentel Paola, Martínez Lago Nieves, Sauri Tamara, Martín Richard Marta, Mangas Monserrat, Gil Raga Mireia, Calvo Aitana, Reguera Pablo, Granja Mónica, Martín Carnicero Alfonso, Hernández Pérez Carolina, Cerdá Paula, Gomez Gonzalez Lucía, Garcia Navalon Francisco, Pacheco Barcia Vilma, Gutierrez Abad David, Ruiz Martín Maribel, Weaver Jamie, Mansoor Wasat, Gallego Javier
Medical Oncology Department, Hospital Universitario Central de Asturias, ISPA, Oviedo, Spain.
Department of Medical Oncology, Christie Hospital, Manchester, UK.
Ther Adv Med Oncol. 2023 Mar 4;15:17588359231157641. doi: 10.1177/17588359231157641. eCollection 2023.
Trastuzumab and chemotherapy is the standard first-line treatment in human epidermal growth factor receptor 2 (HER2)-positive advanced gastro-oesophageal cancer. The objective was to develop a predictive model for overall survival (OS) and progression-free survival (PFS) in patients treated with trastuzumab.
Patients with HER2-positive advanced gastro-oesophageal adenocarcinoma (AGA) from the Spanish Society of Medical Oncology (SEOM)-AGAMENON registry and treated first line with trastuzumab and chemotherapy between 2008 and 2021 were included. The model was externally validated in an independent series (The Christie NHS Foundation Trust, Manchester, UK).
In all, 737 patients were recruited (AGAMENON-SEOM, = 654; Manchester, = 83). Median PFS and OS in the training cohort were 7.76 [95% confidence interval (CI), 7.13-8.25] and 14.0 months (95% CI, 13.0-14.9), respectively. Six covariates were significantly associated with OS: neutrophil-to-lymphocyte ratio, Eastern Cooperative Oncology Group performance status, Lauren subtype, HER2 expression, histological grade and tumour burden. The AGAMENON-HER2 model demonstrated adequate calibration and fair discriminatory ability with a c-index for corrected PFS/OS of 0.606 (95% CI, 0.578-0.636) and 0.623 (95% CI, 0.594-0.655), respectively. In the validation cohort, the model is well calibrated, with a c-index of 0.650 and 0.683 for PFS and OS, respectively.
The AGAMENON-HER2 prognostic tool stratifies HER2-positive AGA patients receiving trastuzumab and chemotherapy according to their estimated survival endpoints.
曲妥珠单抗联合化疗是人类表皮生长因子受体2（HER2）阳性晚期胃食管癌的标准一线治疗方案。目的是建立一个预测模型，用于预测接受曲妥珠单抗治疗患者的总生存期（OS）和无进展生存期（PFS）。
纳入西班牙医学肿瘤学会（SEOM）-AGAMENON注册研究中HER2阳性晚期胃食管腺癌（AGA）患者，这些患者在2008年至2021年间接受曲妥珠单抗联合化疗作为一线治疗。该模型在一个独立队列（英国曼彻斯特克里斯蒂国民保健服务基金会信托医院）中进行外部验证。
共招募737例患者（AGAMENON-SEOM队列654例；曼彻斯特队列83例）。训练队列的中位PFS和OS分别为7.76个月[95%置信区间（CI），7.13 - 8.25]和14.0个月（95% CI，13.0 - 14.9）。六个协变量与OS显著相关：中性粒细胞与淋巴细胞比值、东部肿瘤协作组体能状态、劳伦分型、HER2表达、组织学分级和肿瘤负荷。AGAMENON-HER2模型显示出良好的校准和适度的区分能力，校正后PFS/OS的c指数分别为0.606（95% CI，0.578 - 0.636）和0.623（95% CI，0.594 - 0.655）。在验证队列中，该模型校准良好，PFS和OS的c指数分别为0.650和0.683。
AGAMENON-HER2预后工具可根据HER2阳性AGA患者的估计生存终点，对接受曲妥珠单抗联合化疗的患者进行分层。
