Kitagawa Chiyoe, Mori Masahide, Ichiki Masao, Sukoh Noriaki, Kada Akiko, Saito Akiko M, Ichinose Yukito
Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan
Department of Thoracic Oncology, National Hospital Organization Toneyama National Hospital, Toyonaka, Japan.
In Vivo. 2019 Mar-Apr;33(2):477-482. doi: 10.21873/invivo.11498.
BACKGROUND/AIM: A phase II trial was conducted to assess the efficacy and safety of gefitinib plus bevacizumab for EGFR mutation-positive non-small cell lung cancer (NSCLC).
Patients were randomly assigned to receive either gefitinib at 250 mg/day alone or with bevacizumab at 15 mg/kg every 3 weeks.
Ten patients were allocated to the gefitinib group (group A) and 6 to the gefitinib plus bevacizumab group (group B). Median survival time (80%CI) for progression-free survival (PFS) was 15.1 months for group A, and 5.4 months for group B. Overall survival probability at 1 year (95%CI) was 0.750 for group A, and 0.667 for group B. The response rate was 44 % for group A and 50 % for group B. Adverse events occurred at a similar frequency in both groups.
PFS was shorter in group B than group A, and therefore there was no basis to proceed to a phase III trial.
背景/目的：开展一项II期试验，以评估吉非替尼联合贝伐单抗治疗表皮生长因子受体（EGFR）突变阳性的非小细胞肺癌（NSCLC）的疗效和安全性。
患者被随机分配，分别接受每日250毫克吉非替尼单药治疗，或每3周接受吉非替尼联合15毫克/千克贝伐单抗治疗。
10例患者被分配至吉非替尼组（A组），6例患者被分配至吉非替尼联合贝伐单抗组（B组）。A组无进展生存期（PFS）的中位生存时间（80%CI）为15.1个月，B组为5.4个月。A组1年总生存概率（95%CI）为0.750，B组为0.667。A组缓解率为44%，B组为50%。两组不良事件发生频率相似。
B组PFS短于A组，因此没有依据开展III期试验。
