Clinical Oncology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Department of Oncology, University of Calgary and Tom Baker Cancer Center, Calgary, Alberta, T2N 4N2, Canada.
Future Oncol. 2018 Oct;14(23):2335-2341. doi: 10.2217/fon-2018-0069. Epub 2018 Aug 24.
To evaluate the incidence and predictors of mortality in the first year following randomization among breast cancer patients recruited in five adjuvant chemotherapy clinical trials.
This is a pooled analysis of 9236 patients from five clinical trials. Univariate and multivariate logistic regression analyses were conducted to evaluate the impact of relevant clinicopathological factors on early mortality.
Early death rates were 0.1% (11 patients) at 6 months and 0.8% (70 patients) at 1 year. Patients with a documented relapse within 1 year have a higher risk of death within the first year (HR: 74.20, 95% CI: 42.28-130.22) in a multivariate Cox regression model. The following factors were predictive of 1-year mortality in multivariate logistic regression analysis: higher T-stage (p = 0.001), higher N-stage (p = 0.004) and negative hormone receptor status (p < 0.0001).
Six-month and 1-year mortality rates are low among breast cancer patients referred for adjuvant chemotherapy within a clinical trial.
评估在五项辅助化疗临床试验中随机分组后第一年乳腺癌患者的死亡率及其预测因素。
这是对五项临床试验中的 9236 例患者进行的汇总分析。采用单因素和多因素逻辑回归分析评估相关临床病理因素对早期死亡率的影响。
6 个月时早期死亡率为 0.1%（11 例），1 年时为 0.8%（70 例）。在多因素 Cox 回归模型中，1 年内有记录复发的患者在第 1 年内死亡的风险更高（HR：74.20，95%CI：42.28-130.22）。多因素逻辑回归分析表明，以下因素与 1 年死亡率相关：较高的 T 分期（p=0.001）、较高的 N 分期（p=0.004）和阴性激素受体状态（p<0.0001）。
在临床试验中接受辅助化疗的乳腺癌患者，6 个月和 1 年的死亡率较低。
