Medical Oncology, St. Salvatore Hospital, University of L'Aquila, Via Vetoio, 67100, L'Aquila, Italy.
Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
J Cancer Res Clin Oncol. 2019 Sep;145(9):2365-2373. doi: 10.1007/s00432-019-02971-7. Epub 2019 Jul 6.
This multicenter retrospective study aims to evaluate the correlations between Body Weight Loss (BWL), Body Mass Index (BMI) and clinical outcomes (ORR, PFS, and OS) of advanced gastric cancer (aGC) patients treated with second-line ramucirumab-based therapy in a "real-life" setting.
From December 2014 to October 2018, 101 consecutive aGC patients progressed to a first-line chemotherapy were treated with ramucirumab alone (10.9%) or in combination with paclitaxel (89.1%). Median BMI was 21.2 kg/m and mBWL since first-line treatment commencement was 4.5%. Among 53 patients who underwent primary tumor resection (PTR), 73.6% experienced BWL, while 26.4% did not experience BWL (p = 0.0429). Patients who underwent PTR had a significantly higher probability of experiencing BWL (yes vs no) [OR = 2.35 (95% CI 1.02-5.42), p = 0.0439]. Among the 89 evaluable patients, ORR was 26.9% (95% CI 17.2-40.1). At a median follow-up of 17.3 months, mPFS was 5.4 months (95% CI 3.6-6.8) and mOS was 8.7 months (95% CI 7.3-11.9). In the multivariate analysis, only ECOG-PS and BMI were confirmed independent predictors for shorter PFS [HR = 1.69 (95% CI 1.01-2.82), p = 0.04] [HR = 1.97 (95% CI 1.12-3.46), p = 0.01] and OS [HR = 1.69 (95% CI 1.01-2.83), p = 0.04] [HR = 2.08 (95% CI 1.17-3.70), p = 0.01].
Efficacy of ramucirumab is confirmed in this "real-life" analysis. BWL seems not to have correlations with clinical outcomes in these patients, while BMI and ECOG-PS remain major prognostic factors. A possible explanation for the lack of prognostic effect of BWL might be the proportion of patients subjected to PTR in this series (52.5%).
本多中心回顾性研究旨在评估二线雷莫芦单抗治疗晚期胃癌（aGC）患者的体重减轻（BWL）、体重指数（BMI）与临床结局（ORR、PFS 和 OS）之间的相关性。
2014 年 12 月至 2018 年 10 月，101 例一线化疗进展的 aGC 患者接受雷莫芦单抗单药治疗（10.9%）或联合紫杉醇治疗（89.1%）。中位 BMI 为 21.2kg/m2，自一线治疗开始时的平均体重减轻（mBWL）为 4.5%。在 53 例行原发肿瘤切除术（PTR）的患者中，73.6%的患者出现 BWL，26.4%的患者未出现 BWL（p=0.0429）。行 PTR 的患者出现 BWL 的可能性显著更高（是 vs 否）[比值比（OR）=2.35（95%置信区间 1.02-5.42），p=0.0439]。在 89 例可评估患者中，ORR 为 26.9%（95%置信区间 17.2-40.1）。中位随访 17.3 个月时，mPFS 为 5.4 个月（95%置信区间 3.6-6.8），mOS 为 8.7 个月（95%置信区间 7.3-11.9）。多变量分析显示，ECOG-PS 和 BMI 是 PFS 较短的独立预测因素[风险比（HR）=1.69（95%置信区间 1.01-2.82），p=0.04][HR=1.97（95%置信区间 1.12-3.46），p=0.01]和 OS [HR=1.69（95%置信区间 1.01-2.83），p=0.04][HR=2.08（95%置信区间 1.17-3.70），p=0.01]。
本“真实世界”分析证实了雷莫芦单抗的疗效。BWL 似乎与这些患者的临床结局无相关性，而 BMI 和 ECOG-PS 仍是主要的预后因素。BWL 缺乏预后作用的可能解释是本研究中接受 PTR 的患者比例（52.5%）。
