Chinot Olivier L, Nishikawa Ryo, Mason Warren, Henriksson Roger, Saran Frank, Cloughesy Timothy, Garcia Josep, Revil Cedric, Abrey Lauren, Wick Wolfgang
Aix-Marseille University, AP-HM, Service de Neuro-Oncologie, CHU Timone, Marseille, France (O.L.C.); Saitama Medical University, Saitama, Japan (R.N.); Princess Margaret Hospital, Toronto, Canada (W.M.); Regional Cancer Center Stockholm Gotland, Stockholm, Sweden (R.H.); Department of Radiation Sciences and Oncology, Umeå University, Umeå, Sweden (R.H.); The Royal Marsden NHS Foundation Trust, Surrey, UK (F.S.); University of California, Los Angeles, California, USA (T.C.); F. Hoffmann-La Roche Ltd, Basel, Switzerland (J.G., C.R., L.A.); University Medical Center, Heidelberg, Germany (W.W.)
Aix-Marseille University, AP-HM, Service de Neuro-Oncologie, CHU Timone, Marseille, France (O.L.C.); Saitama Medical University, Saitama, Japan (R.N.); Princess Margaret Hospital, Toronto, Canada (W.M.); Regional Cancer Center Stockholm Gotland, Stockholm, Sweden (R.H.); Department of Radiation Sciences and Oncology, Umeå University, Umeå, Sweden (R.H.); The Royal Marsden NHS Foundation Trust, Surrey, UK (F.S.); University of California, Los Angeles, California, USA (T.C.); F. Hoffmann-La Roche Ltd, Basel, Switzerland (J.G., C.R., L.A.); University Medical Center, Heidelberg, Germany (W.W.).
Neuro Oncol. 2016 Sep;18(9):1313-8. doi: 10.1093/neuonc/now046. Epub 2016 Mar 22.
In this post-hoc, exploratory analysis, we examined outcomes for patients enrolled in the AVAglio trial of front-line bevacizumab or placebo plus radiotherapy/temozolomide who received only a single line of therapy.
Patients with newly diagnosed glioblastoma received protocol-defined treatment until progressive disease (PD). Co-primary endpoints were investigator-assessed progression-free survival (PFS) and overall survival (OS). After confirmed PD, patients were treated at the investigators' discretion. PFS/OS were assessed in patients with a PFS event who did not receive post-PD therapy (Group 1) and patients with a PFS event who received post-PD therapy plus patients who did not have a PFS event at the final data cutoff (Group 2). Kaplan-Meier methodology was used. A multivariate Cox proportional hazards model for known prognostic variables was generated.
Baseline characteristics were balanced. In patients with a PFS event who did not receive post-PD therapy (Group 1; n = 225 [24.4% of the intent-to-treat population]), the addition of bevacizumab to radiotherapy/temozolomide resulted in a 3.6-month extension in both median PFS (hazard ratio [HR]: 0.62, P = .0016) and median OS (HR: 0.67, P = .0102). Multivariate analyses supported this OS benefit (HR: 0.66). In the remaining patients (Group 2; n = 696), a 5.2-month PFS extension was observed in bevacizumab-treated patients (HR: 0.61, P < .0001); OS was comparable between the treatment arms (HR: 0.88, P = .1502). No significant differences in safety were observed between the 2 groups.
This exploratory analysis suggests that the addition of bevacizumab to standard glioblastoma treatment prolongs PFS and OS for patients with PD who receive only one line of therapy.
在这项事后探索性分析中，我们研究了仅接受一线治疗的、参加阿伐单抗一线治疗联合放疗/替莫唑胺或安慰剂对照试验的患者的预后情况。
新诊断的胶质母细胞瘤患者接受方案定义的治疗，直至疾病进展（PD）。共同主要终点为研究者评估的无进展生存期（PFS）和总生存期（OS）。确诊为PD后，患者由研究者酌情治疗。对发生PFS事件但未接受PD后治疗的患者（第1组）以及发生PFS事件且接受PD后治疗的患者加上在最终数据截止时未发生PFS事件的患者（第2组）进行PFS/OS评估。采用Kaplan-Meier方法。针对已知预后变量生成多变量Cox比例风险模型。
基线特征均衡。在发生PFS事件但未接受PD后治疗的患者（第1组；n = 225 [意向性治疗人群的24.4%]）中，放疗/替莫唑胺联合使用阿伐单抗使中位PFS延长3.6个月（风险比[HR]：0.62，P = 0.0016），中位OS延长3.6个月（HR：0.67，P = 0.0102）。多变量分析支持这一OS获益（HR：0.66）。在其余患者（第2组；n = 696）中，阿伐单抗治疗的患者PFS延长5.2个月（HR：0.61，P < 0.0001）；各治疗组之间OS相当（HR：0.88，P = 0.1502）。两组之间在安全性方面未观察到显著差异。
这项探索性分析表明，对于仅接受一线治疗的PD患者，在标准胶质母细胞瘤治疗中添加阿伐单抗可延长PFS和OS。
