Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia.
Biostatistics & Clinical Trial Center, Fondazione IRCCS Policlinico San Matteo, Pavia.
ESMO Open. 2024 Aug;9(8):103666. doi: 10.1016/j.esmoop.2024.103666. Epub 2024 Aug 12.
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).
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.
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).
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.
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)。
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)。
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)。
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。