Department of Investigational Cancer Therapeutics (A Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
PLoS One. 2012;7(1):e29330. doi: 10.1371/journal.pone.0029330. Epub 2012 Jan 3.
Body weight and body composition are relevant to the outcomes of cancer and antineoplastic therapy. However, their role in Phase I clinical trial patients is unknown.
We reviewed symptom burden, body composition, and survival in 104 patients with advanced cancer referred to a Phase I oncology service. Symptom burden was analyzed using the MD Anderson Symptom Assessment Inventory(MDASI); body composition was evaluated utilizing computerized tomography(CT) images. A body mass index (BMI)≥25 kg/m² was considered overweight. Sarcopenia, severe muscle depletion, was assessed using CT-based criteria.
Most patients were overweight (n = 65, 63%); 53 patients were sarcopenic (51%), including 79% of patients with a BMI<25 kg/m² and 34% of those with BMI≥25 kg/m². Sarcopenic patients were older and less frequently African-American. Symptom burden did not differ among patients classified according to BMI and presence of sarcopenia. Median (95% confidence interval) survival (days) varied according to body composition: 215 (71-358) (BMI<25 kg/m²; sarcopenic), 271 (99-443) (BMI<25 kg/m²; non-sarcopenic), 484 (286-681) (BMI≥25 kg/m²; sarcopenic); 501 d (309-693) (BMI≥25 kg/m²; non-sarcopenic). Higher muscle index and gastrointestinal cancer diagnosis predicted longer survival in multivariate analysis after controlling for age, gender, performance status, and fat index.
Patients referred to a Phase I clinic had a high frequency of sarcopenia and a BMI≥25 kg/m², independent of symptom burden. Body composition variables were predictive of clinically relevant survival differences, which is potentially important in developing Phase I studies.
体重和身体成分与癌症和抗肿瘤治疗的结果相关。然而,它们在 I 期临床试验患者中的作用尚不清楚。
我们回顾了 104 例晚期癌症患者的症状负担、身体成分和生存情况,这些患者被转介到 I 期肿瘤学服务机构。使用 MD 安德森症状评估量表(MDASI)分析症状负担;利用计算机断层扫描(CT)图像评估身体成分。体重指数(BMI)≥25 kg/m² 被认为是超重。使用基于 CT 的标准评估肌少症,即严重肌肉消耗。
大多数患者超重(n = 65,63%);53 例患者存在肌少症(51%),其中 BMI<25 kg/m² 的患者中 79%存在肌少症,BMI≥25 kg/m² 的患者中 34%存在肌少症。肌少症患者年龄较大,非裔美国人较少。根据 BMI 和肌少症的存在对患者进行分类,其症状负担没有差异。根据身体成分,中位(95%置信区间)生存(天)有所不同:215(71-358)(BMI<25 kg/m²;肌少症)、271(99-443)(BMI<25 kg/m²;非肌少症)、484(286-681)(BMI≥25 kg/m²;肌少症)、501 d(309-693)(BMI≥25 kg/m²;非肌少症)。多元分析后,在校正年龄、性别、表现状态和脂肪指数后,较高的肌肉指数和胃肠道癌症诊断预测生存时间更长。
转介到 I 期诊所的患者,无论症状负担如何,都存在肌少症和 BMI≥25 kg/m² 的高频率。身体成分变量与具有临床意义的生存差异相关,这在开展 I 期研究中可能很重要。