Diabetes and Clinical Outcome in Patients With Metastatic Colorectal Cancer: CALGB 80405 (Alliance)
Diabetes and Clinical Outcome in Patients With Metastatic Colorectal Cancer: CALGB 80405 (Alliance)
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DOI：
10.1093/jncics/pkz078
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发表时间：
2020-02-01
影响因子：
4.4
通讯作者：
Meyerhardt, Jeffrey A.
中科院分区：
文献类型：
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作者：
Brown, Justin C.;Zhang, Sui;Meyerhardt, Jeffrey A.
背景资料：糖尿病是一些恶性肿瘤的预后因素，但其与晚期或转移性结直肠癌（CRC）患者的预后关系尚不明确。方法：本队列研究嵌套在一项随机试验的一线化疗和贝伐单抗和/或西妥昔单抗晚期或转移性CRC。患者在全国临床试验网络的508个社区和学术中心登记。主要暴露是入组时医生记录的糖尿病。主要终点是总生存期（OS）;次要终点是无进展生存期（PFS）和不良事件。结果：在2326例患者中，378例（16.3%）患有糖尿病。中位随访时间为6.0年。我们观察到1973例OS事件和2173例PFS事件。糖尿病患者发生OS事件的中位时间为22.7个月，非糖尿病患者为27.1个月（HR = 1.27，95%CI = 1.13 - 1.44; P <0.001）。糖尿病患者至PFS事件的中位时间为9.7个月，非糖尿病患者为10.8个月（HR = 1.16，95% CI = 1.03 - 1.30; P = 0.02）。糖尿病患者更有可能经历不低于3级的高血压（8.1%比4.4%; P = 0.054），但并不更有可能经历其他不良事件，包括neuropathy.Conclusions：糖尿病与晚期或转移性结直肠癌患者死亡率和肿瘤进展风险增加相关。糖尿病患者耐受化疗和单克隆抗体的一线治疗，与非糖尿病患者相似。
Background: Diabetes is a prognostic factor for some malignancies, but its association with outcome in patients with advanced or metastatic colorectal cancer (CRC) is less clear.Methods: This cohort study was nested within a randomized trial of first-line chemotherapy and bevacizumab and/or cetuximab for advanced or metastatic CRC. Patients were enrolled at 508 community and academic centers throughout the National Clinical Trials Network. The primary exposure was physician-documented diabetes at the time of enrollment. The primary endpoint was overall survival (OS); secondary endpoints were progression-free survival (PFS) and adverse events. Tests of statistical significance were two-sided.Results: Among 2326 patients, 378 (16.3%) had diabetes. The median follow-up time was 6.0 years. We observed 1973 OS events and 2173 PFS events. The median time to an OS event was 22.7 months among those with diabetes and 27.1 months among those without diabetes (HR = 1.27, 95% CI = 1.13 to 1.44; P < .001). The median time to a PFS event was 9.7 months among those with diabetes and 10.8 months among those without diabetes (HR = 1.16, 95% CI = 1.03 to 1.30; P = .02). Patients with diabetes were more likely to experience no less than grade 3 hypertension (8.1% vs 4.4%; P = .054) but were not more likely to experience other adverse events, including neuropathy.Conclusions: Diabetes is associated with an increased risk of mortality and tumor progression in patients with advanced or metastatic CRC. Patients with diabetes tolerate first-line treatment with chemotherapy and monoclonal antibodies similarly to patients without diabetes.