Osmani Freshteh, Hajizadeh Ebrahim, Akbari Mohammad Esmaeil
Infectious Diseases Research Center, Birjand University of Medical Sciences, Birjand, Iran.
Department of Biostatistics, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.
Int J Prev Med. 2021 Jan 19;12:9. doi: 10.4103/ijpvm.IJPVM_89_19. eCollection 2021.
Recurrent event data arise frequently in longitudinal medical studies. In many situations, there are a large portion of patients without any recurrences, manifesting the "zero-inflated" nature of the data. Moreover, there often exists a terminal event which may be correlated with the recurrent events. The goal of this study is to extend the application of joint frailty model to identify the prognostic factors associated with curing in patients with breast cancer.
As a prospective study, medical records of women who had been attended to Cancer Research Center, Shahid Beheshti University of Medical Sciences from January 1998 to February 2016 were reviewed. Finally, after an initial review of medical records, 711 patients were included in the study and analyzed. A checklist that included items drawn from the demographic background of patients was provided in the study. Two joint frailty models for zero-inflated recurrent events, combining a logistic model for "structural zero" status (Yes/No) and a joint frailty proportional hazards model for recurrent and terminal event times were performed to identify factors associated with BCS.
The mean age of patients was 38.2 years. The numbers of subjects with 1, 2, 3, and 4 recurrent events were 392, 207, 97, and 15, respectively. The median follow-up time was 6.87 years. There were 137 (19.2%) deaths from cancer during the follow-up. Among the 574 patients who were censored, 418 had no tumor recurrence. Thus, there may exist a large portion of "cured" subjects. We can see that the radiation (OR = 6.02, CI = (3.87, 8.61)) and tumor size interaction with radiation (OR = 1.065, CI = (1.002-1.26)) were significant in the cure model ( < 0.05) which means that patients with smaller tumor sizes were more likely to be cured by radiation therapy.
Our proposed models can help investigators to evaluate which treatment will result in a higher fraction of cured subjects. This is usually an important research question in biomedical studies.
复发事件数据在纵向医学研究中经常出现。在许多情况下,有很大一部分患者没有任何复发情况,这体现了数据的“零膨胀”性质。此外,通常还存在一个终末事件,它可能与复发事件相关。本研究的目的是扩展联合脆弱模型的应用,以识别与乳腺癌患者治愈相关的预后因素。
作为一项前瞻性研究,回顾了1998年1月至2016年2月在沙希德·贝赫什提医科大学癌症研究中心就诊的女性的病历。最后,在初步审查病历后,711名患者被纳入研究并进行分析。研究中提供了一份包含从患者人口统计学背景中提取项目的清单。对零膨胀复发事件采用两种联合脆弱模型,一种是针对“结构性零”状态(是/否)的逻辑模型,另一种是针对复发和终末事件时间的联合脆弱比例风险模型,以识别与保乳手术相关的因素。
患者的平均年龄为38.2岁。复发1次、2次、3次和4次的患者人数分别为392人、207人、97人和15人。中位随访时间为6.87年。随访期间有137例(19.2%)死于癌症。在574例被截尾的患者中,418例没有肿瘤复发。因此,可能存在很大一部分“治愈”的患者。我们可以看到,放疗(OR = 6.02,CI =(3.87,8.61))以及肿瘤大小与放疗的相互作用(OR = 1.065,CI =(1.002 - 1.26))在治愈模型中具有显著性(<0.05),这意味着肿瘤较小的患者更有可能通过放疗治愈。
我们提出的模型可以帮助研究人员评估哪种治疗方法能使更高比例的患者被治愈。这通常是生物医学研究中的一个重要研究问题。