Paclitaxel/Ramucirumab vs. Paclitaxel in 2nd-line therapy of advanced esophageal squamous cell carcinoma: Randomized Phase II IKF-AIO-RAMOS Trial.

IF 2 4区医学 Q3 ONCOLOGY

Oncology Research and Treatment Pub Date : 2024-09-09 DOI:10.1159/000541174

Magdalena K Scheck,Thorsten O Goetze,Thomas J Ettrich,Harald Schmalenberg,Michael Clemens,Rolf Mahlberg,Steffen Heeg,Stephan Kanzler,Gunnar Hapke,Peter Thuss-Patience,Angelika Kestler,Anne Treschl,Stefan Heidel,Moritz Schiemer,Disorn Sookthai,Sabine Junge,Claudia Pauligk,Salah-Eddin Al-Batran,Sylvie Lorenzen

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引用次数: 0

Abstract

INTRODUCTION In squamous cell carcinoma of the esophagus (ESCC), therapeutical options in 2nd-line treatment are scarce with immune checkpoint inhibition being the only approved one. Ramucirumab/paclitaxel is an approved 2nd-line treatment in metastatic esophagogastric adenocarcinoma. We assessed safety and efficacy of ramucirumab/paclitaxel for ESCC. METHODS This prospective, randomized, open-label, multicenter, phase II trial evaluated paclitaxel (80 mg/m2 d1, 8, 15) plus ramucirumab (8 mg/kg d1, 15) (investigational arm A) vs. paclitaxel alone (80 mg/m2 d1, 8, 15) (standard arm B), both q4w, in advanced/metastatic ESCC refractory or intolerant to fluoropyrimidine and platinum-based drugs. Primary endpoint was overall survival (OS) rate at 6 months. RESULTS From 3/2019 to 4/2021, 21/186 planned patients were included (arm A 11 pts; arm B 10 pts) in 9 German centres. Due to slow accrual, the study was terminated prematurely. OS at 6 months was 72.7% for ramucirumab/paclitaxel and 50.0% for paclitaxel. The study design did not allow statistical comparison of the arms. PFS (3.8 vs. 3.5 months), OS (12.1 vs. 9.2 months), ORR (18.2% vs. 20.0%) and DCR (54.5% vs. 60.0%) were comparable in both arms. Most common treatment related adverse events (TRAEs) in arm A were leucopenia (54.5%), fatigue (27.3%) and peripheral sensory neuropathy (18.2%). 27.3% in arm A and 50.0% in arm B had TRAEs ≥ grade 3. CONCLUSION Ramucirumab/paclitaxel shows an acceptable tolerability and numerically improved OS at 6 months. Due to the small number of patients the current trial must be considered exploratory and more data are needed in this indication. REGISTRATION ClinicalTrials.gov, NCT03762564. IKF-s627 RAMOS Study.

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紫杉醇/Ramucirumab与紫杉醇在晚期食管鳞癌二线治疗中的对比：随机 II 期 IKF-AIO-RAMOS 试验。

简介：在食管鳞状细胞癌（ESCC）的二线治疗中，免疫检查点抑制剂是唯一获批的治疗方案。Ramucirumab/紫杉醇是已获批准的转移性食管胃腺癌二线治疗药物。我们评估了ramucirumab/紫杉醇治疗ESCC的安全性和有效性。方法这项前瞻性、随机、开放标签、多中心、II期试验评估了紫杉醇（80 mg/m2 d1, 8, 15）加ramucirumab（8 mg/kg d1, 15）（研究组A）与单用紫杉醇（80 mg/m2 d1, 8, 15）（研究组B）的比较。紫杉醇（80 毫克/平方米，每天 1、8、15 次）与拉穆单抗（8 毫克/公斤，每天 1、15 次）（标准研究组 B），均为每天 4 次，用于治疗对氟嘧啶类和铂类药物难治或不耐受的晚期/转移性 ESCC。结果2019年3月至2021年4月，9个德国中心共纳入21/186例计划患者（A组11例；B组10例）。由于进展缓慢，研究提前结束。6个月的OS率为：ramucirumab/紫杉醇72.7%，紫杉醇50.0%。研究设计不允许对两组患者进行统计比较。两组的PFS（3.8个月 vs. 3.5个月）、OS（12.1个月 vs. 9.2个月）、ORR（18.2% vs. 20.0%）和DCR（54.5% vs. 60.0%）相当。A组最常见的治疗相关不良事件（TRAEs）为白细胞减少（54.5%）、疲劳（27.3%）和周围感觉神经病变（18.2%）。A组和B组分别有27.3%和50.0%的患者出现≥3级的TRAE。由于患者人数较少，目前的试验必须被视为探索性试验，在这一适应症方面还需要更多数据。IKF-s627 RAMOS 研究。

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来源期刊

Oncology Research and Treatment ONCOLOGY-

CiteScore

3.20

自引率

0.00%

发文量

期刊介绍： With the first issue in 2014, the journal ''Onkologie'' has changed its title to ''Oncology Research and Treatment''. By this change, publisher and editor set the scene for the further development of this interdisciplinary journal. The English title makes it clear that the articles are published in English – a logical step for the journal, which is listed in all relevant international databases. For excellent manuscripts, a ''Fast Track'' was introduced: The review is carried out within 2 weeks; after acceptance the papers are published online within 14 days and immediately released as ''Editor’s Choice'' to provide the authors with maximum visibility of their results. Interesting case reports are published in the section ''Novel Insights from Clinical Practice'' which clearly highlights the scientific advances which the report presents.