Verlato Giuseppe, Marrelli Daniele, Accordini Simone, Bencivenga Maria, Di Leo Alberto, Marchet Alberto, Petrioli Roberto, Zoppini Giacomo, Muggeo Michele, Roviello Franco, de Manzoni Giovanni
Giuseppe Verlato, Simone Accordini, Unit of Epidemiology and Medical Statistics, Department of Public Health and Community Medicine, University of Verona, 37134 Verona, Italy.
World J Gastroenterol. 2015 Jun 7;21(21):6434-43. doi: 10.3748/wjg.v21.i21.6434.
While in chronic diseases, such as diabetes, mortality rates slowly increases with age, in oncological series mortality usually changes dramatically during the follow-up, often in an unpredictable pattern. For instance, in gastric cancer mortality peaks in the first two years of follow-up and declines thereafter. Also several risk factors, such as TNM stage, largely affect mortality in the first years after surgery, while afterward their effect tends to fade. Temporal trends in mortality were compared between a gastric cancer series and a cohort of type 2 diabetic patients. For this purpose, 937 patients, undergoing curative gastrectomy with D1/D2/D3 lymphadenectomy for gastric cancer in three GIRCG (Gruppo Italiano Ricerca Cancro Gastrico = Italian Research Group for Gastric Cancer) centers, were compared with 7148 type 2 diabetic patients from the Verona Diabetes Study. In the early/advanced gastric cancer series, mortality from recurrence peaked to 200 deaths per 1000 person-years 1 year after gastrectomy and then declined, becoming lower than 40 deaths per 1000 person-years after 5 years and lower than 20 deaths after 8 years. Mortality peak occurred earlier in more advanced T and N tiers. At variance, in the Verona diabetic cohort overall mortality slowly increased during a 10-year follow-up, with ageing of the type 2 diabetic patients. Seasonal oscillations were also recorded, mortality being higher during winter than during summer. Also the most important prognostic factors presented a different temporal pattern in the two diseases: while the prognostic significance of T and N stage markedly decrease over time, differences in survival among patients treated with diet, oral hypoglycemic drugs or insulin were consistent throughout the follow-up. Time variations in prognostic significance of main risk factors, their impact on survival analysis and possible solutions were evaluated in another GIRCG series of 568 patients with advanced gastric cancer, undergoing curative gastrectomy with D2/D3 lymphadenectomy. Survival curves in the two different histotypes (intestinal and mixed/diffuse) were superimposed in the first three years of follow-up and diverged thereafter. Likewise, survival curves as a function of site (fundus vs body/antrum) started to diverge after the first year. On the contrary, survival curves differed among age classes from the very beginning, due to different post-operative mortality, which increased from 0.5% in patients aged 65-74 years to 9.9% in patients aged 75-91 years; this discrepancy later disappeared. Accordingly, the proportional hazards assumption of the Cox model was violated, as regards age, site and histology. To cope with this problem, multivariable survival analysis was performed by separately considering either the first two years of follow-up or subsequent years. Histology and site were significant predictors only after two years, while T and N, although significant both in the short-term and in the long-term, became less important in the second part of follow-up. Increasing age was associated with higher mortality in the first two years, but not thereafter. Splitting survival time when performing survival analysis allows to distinguish between short-term and long-term risk factors. Alternative statistical solutions could be to exclude post-operative mortality, to introduce in the model time-dependent covariates or to stratify on variables violating proportionality assumption.
在诸如糖尿病等慢性疾病中,死亡率会随着年龄的增长而缓慢上升,而在肿瘤学系列研究中,死亡率在随访期间通常会发生显著变化,且往往呈现出不可预测的模式。例如,胃癌的死亡率在随访的头两年达到峰值,之后便开始下降。此外,诸如TNM分期等几个风险因素,在很大程度上会影响术后头几年的死亡率,而在那之后其影响趋于减弱。对一个胃癌系列和一组2型糖尿病患者的死亡率随时间变化的趋势进行了比较。为此,将在三个意大利胃癌研究组(Gruppo Italiano Ricerca Cancro Gastrico = Italian Research Group for Gastric Cancer)中心接受D1/D2/D3淋巴结清扫的根治性胃切除术的937例胃癌患者,与来自维罗纳糖尿病研究的7148例2型糖尿病患者进行了比较。在早期/进展期胃癌系列中,复发导致的死亡率在胃切除术后1年达到每1000人年200例死亡的峰值,随后下降,5年后降至每1000人年低于40例死亡,8年后低于20例死亡。在T和N分期更晚的患者中,死亡峰值出现得更早。与之不同的是,在维罗纳糖尿病队列中,在为期10年的随访期间,随着2型糖尿病患者的老龄化,总体死亡率缓慢上升。还记录到了季节性波动,冬季的死亡率高于夏季。此外,两种疾病中最重要的预后因素呈现出不同的随时间变化的模式:虽然T和N分期的预后意义会随着时间显著降低,但在整个随访期间,接受饮食、口服降糖药或胰岛素治疗的患者之间的生存差异是一致的。在另一个由568例接受D2/D3淋巴结清扫的根治性胃切除术的进展期胃癌患者组成的意大利胃癌研究组系列中,评估了主要风险因素的预后意义随时间的变化、它们对生存分析的影响以及可能的解决方法。在随访的前三年,两种不同组织学类型(肠型和混合型/弥漫型)的生存曲线相互重叠,之后开始出现分歧。同样,作为部位(胃底与胃体/胃窦)函数的生存曲线在第一年之后开始出现分歧。相反,由于不同的术后死亡率,不同年龄组的生存曲线从一开始就不同,术后死亡率从65 - 74岁患者的0.5%增加到75 - 91岁患者的9.9%;这种差异后来消失了。因此,就年龄、部位和组织学而言,Cox模型的比例风险假设被违反了。为了解决这个问题,通过分别考虑随访的前两年或后续年份进行多变量生存分析。组织学和部位仅在两年后才成为显著的预测因素,而T和N分期虽然在短期和长期都具有显著性,但在随访的后半段变得不那么重要了。年龄增长在头两年与较高的死亡率相关,但在那之后则不然。在进行生存分析时划分生存时间,能够区分短期和长期风险因素。其他统计解决方案可以是排除术后死亡率、在模型中引入时间依赖性协变量或对违反比例假设的变量进行分层。