Department of Medical Oncology, Klinikum Grosshadern and Comprehensive Cancer Center, University of Munich, Munich.
Ann Oncol. 2013 Dec;24(12):3051-5. doi: 10.1093/annonc/mdt402. Epub 2013 Oct 14.
The 60 day mortality is an established parameter for chemotherapy-related safety in randomised trials for metastatic colorectal cancer (mCRC). Prognostic factors associated with 60-day mortality would be helpful to identify high-risk patients in advance.
Individual baseline patient data from four randomised, controlled trials from the Arbeitsgemeinschaft Internistische Onkologie (AIO) study group were retrospectively analysed. Chemotherapy consisted of fluoropyrimidine (5-FU/capecitabine), irinotecan, oxaliplatin with or without bevacizumab or cetuximab. Prognostic factors were identified by univariate and multivariate logistic regression models in two cohorts: one limited to ECOG PS 0 and 1 and one including ECOG PS 2 patients.
A total of 1377 patients were evaluated. The analysis of ECOG PS 0, 1 and 2 patients consisted of 898 patients where a total of 33 deaths within the first 60 days of treatment (3.7%) occurred. In multivariate analysis, 60-day mortality was significantly associated with ECOG PS 2 and high leucocyte count (white blood cell, WBC). Odds ratio was 6.28 for WBC and 12.92 for ECOG PS 2. Exclusion of ECOG PS 2 patients but inclusion of one trial limited to ECOG PS 0 and 1 patients resulted in 1302 assessable patients and 44 early deaths (3.4%). In both cohorts, around 50% of deaths were disease related. WBC was confirmed as a significant risk factor for early death (OR 7.60). A combined score using ECOG PS 2 and WBC ≥8.000/µl is able to identify high-risk patients with a sensitivity of 18% and specificity of 98%.
In this large retrospective analysis of individual patient data, around 50% of early deaths were disease related. Elevated WBC was found strongly associated with increased 60-day mortality in first-line treatment of mCRC. The proposed AIO-60-Day-Mortality score serves as an additional trial exclusion criterion.
60 天死亡率是转移性结直肠癌（mCRC）随机试验中化疗相关安全性的既定参数。与 60 天死亡率相关的预后因素有助于提前识别高危患者。
回顾性分析了 Arbeitsgemeinschaft Internistische Onkologie（AIO）研究组四项随机对照试验的个体基线患者数据。化疗包括氟嘧啶（5-FU/卡培他滨）、伊立替康、奥沙利铂联合或不联合贝伐珠单抗或西妥昔单抗。采用单变量和多变量逻辑回归模型在两个队列中确定预后因素：一个仅限于 ECOG PS 0 和 1，另一个包括 ECOG PS 2 患者。
共评估了 1377 名患者。ECOG PS 0、1 和 2 患者的分析包括 898 名患者，其中共有 33 名患者在治疗的前 60 天内死亡（3.7%）。多变量分析显示，60 天死亡率与 ECOG PS 2 和白细胞计数（白细胞）高显著相关。白细胞的优势比为 6.28，ECOG PS 2 的优势比为 12.92。排除 ECOG PS 2 患者，但纳入一项仅限于 ECOG PS 0 和 1 患者的试验，结果为 1302 名可评估患者和 44 例早期死亡（3.4%）。在两个队列中，约 50%的死亡与疾病有关。白细胞被确认为早期死亡的显著危险因素（OR 7.60）。使用 ECOG PS 2 和白细胞≥8.000/µl 的联合评分能够识别高风险患者，其敏感性为 18%，特异性为 98%。
在这项对个体患者数据的大型回顾性分析中，约 50%的早期死亡与疾病有关。在 mCRC 的一线治疗中，白细胞升高与 60 天死亡率增加密切相关。提出的 AIO-60 天死亡率评分可作为额外的试验排除标准。
