RRx-001 followed by platinum plus etoposide in patients with previously treated small-cell lung cancer
RRx-001 followed by platinum plus etoposide in patients with previously treated small-cell lung cancer
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DOI：
10.1038/s41416-019-0504-8
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发表时间：
2019-07-30
影响因子：
8.8
通讯作者：
Padda, Sukhmani K.
中科院分区：
文献类型：
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作者：
Morgensztern, Daniel;Rose, Michal;Padda, Sukhmani K.
背景技术背景：这项探索性单臂II期研究评估了在既往接受过治疗的小细胞肺癌（SCLC）患者中重新引入铂类联合依托泊苷后使用RRx-001的疗效和安全性。患者在21天周期的每周第1天接受RRx-001 4 mg IV治疗，随后在进展时在第1天接受依托泊苷80-100 IV mg/m2再次激发，顺铂60-80 mg/m2，第1天静脉注射，或卡铂AUC 5-6，第1天静脉注射，每21天一次。主要终点为总生存期（OS）和铂类药物治疗的总反应率。结果：26例患者入组并接受至少一剂RRx-001。既往治疗线的中位数为2线（范围1-9），19例（73.1%）患者患有铂类耐药疾病。在意向治疗人群中，1例患者（3.8%）在铂类联合依托泊苷治疗后完全缓解，6例患者（23.1%）部分缓解。入组后的估计中位OS和12个月OS分别为8.6个月和44.1%。RRx-001最常见的治疗后出现的不良事件是输注部位的轻度不适（23%）。结论：RRx-001后再用铂加依托泊苷化疗是可行的，并与有希望的结果相关。
BACKGROUND: This exploratory single-arm phase II study evaluated the efficacy and safety of RRx-001 followed by reintroduction of platinum plus etoposide in patients with previously treated small-cell lung cancer (SCLC).METHODS: Patients were treated with RRx-001 4mg IV on day 1 of each week of a 21-day cycle followed at progression by re-challenge with etoposide 80-100 IV mg/m(2) on days 1, 2 and 3 and cisplatin 60-80 mg/m(2) IV on day 1 or carboplatin AUC 5-6 IV on day 1, every 21 days. The primary end points were overall survival (OS) and overall response rate to platinum regimen.RESULTS: Twenty-six patients were enroled and received at least one dose of RRx-001. The median number of prior lines of therapy was 2 (range 1-9) and 19 (73.1%) patients had platinum-resistant disease. In the intention-to-treat population, one patient (3.8%) had complete response and six (23.1%) had partial response on platinum plus etoposide. The estimated median and 12-month OS from enrolment were 8.6 months and 44.1%, respectively. The most common treatment-emergent adverse event from RRx-001 was mild discomfort at the infusion site (23%).CONCLUSIONS: RRx-001 followed by re-challenge with platinum plus etoposide chemotherapy is feasible and associated with promising results.