Al-Husseini Muneer J, Saad Anas M, El-Shewy Kholoud M, Nissan Ninos E, Gad Mohamed M, Alzuabi Muayad A, Samir Alfaar Ahmad
a Faculty of Medicine , Ain Shams University , Cairo , Egypt.
b Heart and Vascular Institute, Cleveland Clinic Foundation , Cleveland , Ohio , USA.
Int J Neurosci. 2019 May;129(5):447-454. doi: 10.1080/00207454.2018.1538989. Epub 2018 Dec 4.
Glioblastoma multiforme (GBM) patients with a prior malignancy are usually excluded from clinical trials on GBM based on the assumption that this history will affect their survival outcomes. This practice may affect clinical trial accrual and limit the gathering of knowledge essential to the formulation of therapeutic options for this patient population. However, not much is known about the real impact of these prior malignancies on the survival of patients with subsequent GBM. We aimed to investigate the degree of such an impact.
We used the Surveillance, Epidemiology, and End Results (SEER) Program to analyze data of GBM patients diagnosed between 1973 and 2014. We calculated the overall and GBM-specific survival of these patients using the unadjusted Kaplan-Meier test and the multivariable covariate-adjusted Cox models.
Of 51,158 GBM patients, 3,076 had a prior malignancy. The unadjusted Kaplan-Meier test showed worse overall and GBM-specific survivals for patients who had a prior history of cancer. However, after adjusting for age at diagnosis of GBM, sex, race, marital status, and conduction of surgery, multivariable covariate-adjusted Cox models showed that having a prior malignancy did not significantly affect neither overall survival (HR = 1.025, 95%CI = .986 - 1.066, p = .213) nor GBM-specific survival (HR = 1.005, 95%CI = .963 - 1.049, p = .810).
Our findings suggest that the broad practice of excluding patients with a prior history of cancer should be reconsidered as it may adversely affect accrual, trial completion rates, and generalizability of the results.
多形性胶质母细胞瘤(GBM)患者若有既往恶性肿瘤病史,通常会被排除在GBM临床试验之外,原因是认为该病史会影响其生存结果。这种做法可能会影响临床试验的入组率,并限制为该患者群体制定治疗方案所需关键知识的收集。然而,对于这些既往恶性肿瘤对后续GBM患者生存的实际影响,人们了解得并不多。我们旨在研究这种影响的程度。
我们利用监测、流行病学和最终结果(SEER)计划分析了1973年至2014年间诊断的GBM患者的数据。我们使用未调整的Kaplan-Meier检验和多变量协变量调整的Cox模型计算了这些患者的总生存率和GBM特异性生存率。
在51158例GBM患者中,3076例有既往恶性肿瘤病史。未调整的Kaplan-Meier检验显示,有癌症病史的患者总生存率和GBM特异性生存率较差。然而,在对GBM诊断时的年龄、性别、种族、婚姻状况和手术实施情况进行调整后,多变量协变量调整的Cox模型显示,既往有恶性肿瘤病史对总生存率(HR = 1.025,95%CI = 0.986 - 1.066,p = 0.213)和GBM特异性生存率(HR = 1.005,95%CI = 0.963 - 1.049,p = 0.810)均无显著影响。
我们的研究结果表明,广泛排除有癌症病史患者的做法应重新考虑,因为这可能会对入组率、试验完成率和结果的普遍性产生不利影响。