Pharmacy Clinical Programs, MD Anderson Cancer Center, University of Texas, Houston, Texas, USA.
Department of Biostatistics, MD Anderson Cancer Center, University of Texas, Houston, Texas, USA.
Oncology. 2019;96(5):252-258. doi: 10.1159/000496978. Epub 2019 Mar 20.
The RAINBOW trial established ramucirumab combined with paclitaxel as a second-line option in metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Ramucirumab was given on days 1 and 15 with paclitaxel on days 1, 8, and 15 of a 28-day cycle. The median overall survival (OS) was significantly longer with ramuciru-mab plus paclitaxel (p = 0.017), and it led to 41% grade 3 or higher neutropenia. We review our experience with both ramucirumab plus paclitaxel given biweekly (mRAINBOW) to assess efficacy and safety.
The primary objective was to assess OS. Secondary end points were progression-free survival (PFS), overall response, and safety.
We identified 129 patients retrospectively from our database between November 2014 and May 2017. Patients were included if they were followed up at our institution.
Median doses given were ramucirumab 8 mg/kg i.v. plus paclitaxel 110 mg/m2 i.v. given once every 2 weeks. The median performance status was 1, and ∼60% had poorly differentiated histology; 55.8% had progression in < 6 months on first-line therapy, and the majority had measurable cancer. Median overall OS and PFS for the entire cohort was 9.4 months (95% CI: 8.05-10.74) and 3.68 months (95% CI: 2.73-4.5), respectively. Median OS was 9.46 months (95% CI: 8.05-14.95) and median PFS was 4.14 months (95% CI: 2.96-5.29) in those patients that received ramucirumab plus paclitaxel in the second-line setting.
Biweekly administration of ramucirumab plus paclitaxel did not compromise efficacy. Delays, adjustments, or doses held were similar to the RAINBOW trial, with 31% requiring a dose or schedule modification.
RAINBOW 试验确立了雷莫芦单抗联合紫杉醇作为转移性胃和胃食管交界处（GEJ）腺癌的二线治疗选择。雷莫芦单抗在第 1 天和第 15 天使用，紫杉醇在第 1、8 和 15 天使用，每 28 天为一个周期。雷莫芦单抗联合紫杉醇组的中位总生存期（OS）显著延长（p=0.017），且导致 41%的患者出现 3 级或以上中性粒细胞减少症。我们回顾了本中心使用雷莫芦单抗联合紫杉醇每两周给药（mRAINBOW）的经验，以评估疗效和安全性。
主要目的是评估 OS。次要终点是无进展生存期（PFS）、总缓解率和安全性。
我们从 2014 年 11 月至 2017 年 5 月的数据库中回顾性地识别了 129 例患者。符合纳入标准的患者在本中心接受了随访。
中位剂量为雷莫芦单抗 8mg/kg 静脉注射联合紫杉醇 110mg/m2 静脉注射，每 2 周给药一次。中位体力状态为 1 级，约 60%的患者组织学分化差；55.8%的患者在一线治疗 6 个月内进展，大多数患者有可测量的癌症。整个队列的中位总 OS 和 PFS 分别为 9.4 个月（95%CI：8.05-10.74）和 3.68 个月（95%CI：2.73-4.5）。在二线治疗中接受雷莫芦单抗联合紫杉醇治疗的患者，中位 OS 为 9.46 个月（95%CI：8.05-14.95），中位 PFS 为 4.14 个月（95%CI：2.96-5.29）。
雷莫芦单抗联合紫杉醇每两周给药不会影响疗效。与 RAINBOW 试验一样，有 31%的患者需要调整剂量或治疗方案，延迟、调整或剂量暂停的比例相似。
