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生物阻抗法身体成分参数可预测死亡率和剂量限制毒性:多中心 ONCO-BIVA 研究。

Bioimpedance-derived body composition parameters predict mortality and dose-limiting toxicity: the multicenter ONCO-BIVA study.

机构信息

Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia.

Biostatistics & Clinical Trial Center, Fondazione IRCCS Policlinico San Matteo, Pavia.

出版信息

ESMO Open. 2024 Aug;9(8):103666. doi: 10.1016/j.esmoop.2024.103666. Epub 2024 Aug 12.

Abstract

BACKGROUND

In patients with cancer, lean body mass loss is frequent and associated with worse outcomes, including reduced treatment tolerance and survival. Bioelectrical impedance analysis (BIA) is a popular method for body composition assessment. We evaluated the value of BIA-derived body composition parameters in predicting mortality and, for the first time, dose-limiting toxicity (DLT).

PATIENTS AND METHODS

We conducted a prospective multicenter (n = 12) observational study in adult patients with solid neoplastic disease and receiving primary systemic treatment. We collected information on BIA-derived parameters: phase angle (PhA) <5th percentile of age and gender-specific normative values; standardized PhA (SPA) <-1.65; Nutrigram® <660 mg/24 h/m and <510 mg/24 h/m for males and females, respectively. The primary outcome and the key secondary were 1-year mortality and DLT (any-type severe toxicity requiring a delay in systemic treatment administration or a reduction of its dosage), respectively.

RESULTS

In total, 640 patients were included. At 12 months, death occurred in 286 patients (47.6%). All BIA-derived body composition parameters were independently associated with death: SPA, hazard ratio (HR) = 1.59 [95% confidence interval (CI) 1.30-1.95] (P < 0.001); PhA, HR = 1.38 (95% CI 1.13-1.69) (P = 0.002); Nutrigram®, HR = 1.71 (95% CI 1.42-2.04) (P < 0.001). DLT occurred in 208 patients (32.5%) and body composition parameters were associated with this outcome, particularly SPA: odds ratio = 6.37 (95% CI 2.33-17.44) (P < 0.001).

CONCLUSIONS

The study confirmed that BIA-derived body composition parameters are independently associated not only with survival but also with DLT. Although our findings were limited to patients receiving first-line systemic treatment, the evidence reported may have important practice implications for the improvement of the clinical work-up of cancer patients.

摘要

背景

在癌症患者中,瘦体重的损失很常见,且与预后较差相关,包括降低治疗耐受性和生存。生物电阻抗分析(BIA)是一种常用的身体成分评估方法。我们评估了 BIA 衍生的身体成分参数在预测死亡率方面的价值,并且首次评估了剂量限制毒性(DLT)。

患者和方法

我们进行了一项前瞻性的多中心(n=12)观察性研究,纳入了接受原发性系统治疗的成年实体瘤患者。我们收集了 BIA 衍生参数的信息:相位角(PhA)<第 5 百分位数的年龄和性别特异性正常值;标准化 PhA(SPA)<-1.65;Nutrigram®<660 mg/24 h/m 和<510 mg/24 h/m,分别用于男性和女性。主要结局和关键次要结局分别为 1 年死亡率和 DLT(任何类型的严重毒性,需要延迟系统治疗或减少其剂量)。

结果

总共纳入了 640 名患者。在 12 个月时,有 286 名患者(47.6%)死亡。所有 BIA 衍生的身体成分参数均与死亡独立相关:SPA,危险比(HR)=1.59 [95%置信区间(CI)1.30-1.95](P<0.001);PhA,HR=1.38(95% CI 1.13-1.69)(P=0.002);Nutrigram®,HR=1.71(95% CI 1.42-2.04)(P<0.001)。208 名患者(32.5%)发生 DLT,身体成分参数与该结局相关,特别是 SPA:比值比=6.37(95% CI 2.33-17.44)(P<0.001)。

结论

该研究证实,BIA 衍生的身体成分参数不仅与生存相关,而且与 DLT 相关。尽管我们的发现仅限于接受一线系统治疗的患者,但报告的证据可能对改善癌症患者的临床评估具有重要的实际意义。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ad7f/11369426/67c628dc945b/gr1.jpg

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