培拉罗瑞普与多西他赛联合或多西他赛单药治疗转移性去势抵抗性前列腺癌男性患者的随机II期研究：加拿大癌症试验组研究IND 209

A randomized phase II study of pelareorep and docetaxel or docetaxel alone in men with metastatic castration resistant prostate cancer: CCTG study IND 209.

作者信息

Eigl Bernhard Josef, Chi Kim, Tu Dongsheng, Hotte Sebastien J, Winquist Eric, Booth Christopher M, Canil Christina, Potvin Kylea, Gregg Richard, North Scott, Zulfiqar Muhammad, Ellard Susan, Ruether Joseph Dean, Le Lyly, Kakumanu A Saranya, Salim Mohammad, Allan Alison L, Feilotter Harriet, Theis Ashley, Seymour Lesley

机构信息

BC Cancer Agency, Vancouver, BC, Canada.

Canadian Cancer Trials Group, Kingston, ON, Canada.

出版信息

Oncotarget. 2018 Jan 17;9(8):8155-8164. doi: 10.18632/oncotarget.24263. eCollection 2018 Jan 30.

DOI:10.18632/oncotarget.24263

PMID:29487723

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5814290/

Abstract

BACKGROUND

Pelareorep is an oncolytic virus with activity in many cancers including prostate. It has synergism with microtubule-targeted agents. We undertook a clinical trial evaluating pelareorep in mCRPC patients receiving docetaxel.

PATIENTS AND METHODS

In this randomized, open-label phase II study, patients received docetaxel 75mg/m on day 1 of a 21-day cycle and prednisone 5mg twice daily, in combination with pelareorep (arm A) or alone (arm B). The primary endpoint was 12 weeks lack of disease progression rate (LPD).

RESULTS

Eighty-five pts were randomized. Median age was 69, ECOG performance status was 0/1/2 in 31%/66%/3% of patients. Bone/regional lymph node/liver metastases were present in 98%/24%/6%. The median prognostic score was slightly higher in Arm A (144 vs. 129 p= 0.005). Adverse events were as expected but more prevalent in arm A. The 12-week LPD rate was 61% and 52.4% in arms A/B (p=0.51). Median survival was 19.1 on Arm A and 21.1 months on Arm B (HR 1.83; 95% CI 0.96 to 3.52; p=0.06). No survival benefit of pelareorep was found.

CONCLUSION

Pelareorep with docetaxel was tolerable with comparable LPD in both arms but response and survival were inferior and so this combination does not merit further study.

摘要

背景

培拉罗替是一种溶瘤病毒，对包括前列腺癌在内的多种癌症具有活性。它与微管靶向药物具有协同作用。我们开展了一项临床试验，评估培拉罗替在接受多西他赛治疗的转移性去势抵抗性前列腺癌（mCRPC）患者中的疗效。

患者和方法

在这项随机、开放标签的II期研究中，患者在21天周期的第1天接受75mg/m²的多西他赛和每日两次5mg的泼尼松，联合培拉罗替（A组）或单独使用（B组）。主要终点是12周无疾病进展率（LPD）。

结果

85例患者被随机分组。中位年龄为69岁，31%/66%/3%的患者东部肿瘤协作组（ECOG）体能状态为0/1/2。98%/24%/6%的患者存在骨/区域淋巴结/肝转移。A组的中位预后评分略高（144对129，p = 0.005）。不良事件如预期，但在A组中更常见。A/B组的12周LPD率分别为61%和52.4%（p = 0.51）。A组的中位生存期为19.1个月，B组为21.1个月（风险比1.83；95%置信区间0.96至3.52；p = 0.06）。未发现培拉罗替有生存获益。