PDF(Pubmed)
Abstract：
(1) Background: Following the results of RAINBOW and REGARD trials, ramucirumab was approved as the standard second-line treatment for patients with advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer, alone or in combination with paclitaxel. The present study aimed to evaluate the efficacy and safety of ramucirumab in the Romanian population during every-day clinical practice. (2) Methods: A two-center, retrospective, observational study evaluated patients with metastatic gastric and GEJ cancer treated with ramucirumab monotherapy or associated with paclitaxel. The patients were treated between 2018 and 2022 in two Romanian centers as follows: 18 patients underwent treatment with ramucirumab monotherapy, while 51 received the combined treatment regimen. Study endpoints included median progression-free survival (PFS), median overall survival (OS), and the evaluation of treatment-induced adverse events (AEs). (3) Results: In the study cohort (n = 69), the most frequent treatment-induced AE in the ramucirumab plus paclitaxel arm was hematological toxicity; the most common AE for patients treated with ramucirumab monotherapy was fatigue and headache. Overall, the median PFS was 4.7 months (95% CI: 3.4-5.9 months) and median OS was 18.23 months (95% CI: 15.6-20.7 months). PFS was correlated with the number of treatment cycle administrations, Eastern Cooperative Oncology Group performance status at treatment initiation, and metastatic site (visceral vs. peritoneal). OS was correlated with the number of treatment cycles administered and human epidermal growth factor receptor-2 status. (4) Conclusions: The results support the previously described toxicity profile for ramucirumab monotherapy or associated with paclitaxel and demonstrated a relatively superior median PFS.
摘要：
（1）背景：根据RAINBOW和REGARD试验的结果，ramucirumab被批准为晚期或转移性胃癌或胃食管交界癌（GEJ）患者的标准二线治疗方法，单独或与紫杉醇联合使用。本研究旨在评估雷莫西单抗在罗马尼亚人群中的日常临床实践中的疗效和安全性。(2)方法:双中心,回顾性,观察性研究评估了接受雷莫西单抗单药治疗或联合紫杉醇治疗的转移性胃癌和GEJ癌患者.这些患者于2018年至2022年在罗马尼亚的两个中心接受治疗，具体如下：18例患者接受了雷莫西单抗单药治疗，而51人接受了联合治疗方案。研究终点包括中位无进展生存期（PFS），中位总生存期（OS），并评估治疗引起的不良事件（AE）。(3)结果：在研究队列中(n=69)，雷莫西单抗联合紫杉醇治疗组最常见的AE是血液学毒性;雷莫西单抗单药治疗组最常见的AE是疲劳和头痛.总的来说,中位PFS为4.7个月(95%CI:3.4-5.9个月),中位OS为18.23个月(95%CI:15.6-20.7个月).PFS与治疗周期给药次数相关，东部肿瘤协作组在治疗开始时的表现状况，和转移部位(内脏与腹膜）。OS与施用的治疗周期数和人表皮生长因子受体2状态相关。(4)结论:结果支持先前描述的雷莫西单抗单一疗法或与紫杉醇相关的毒性谱,并显示相对较高的中值PFS。
