Department of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, Japan.
Department of Respiratory Internal Medicine, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, Japan.
BMC Cancer. 2018 Dec 10;18(1):1231. doi: 10.1186/s12885-018-5146-3.
We evaluated the safety and efficacy of induction chemotherapy with bevacizumab followed by maintenance chemotherapy with bevacizumab for advanced non-small cell lung cancer (NSCLC) in this multicenter phase II study.
Chemotherapy-naïve patient with stage IIIB-IV or recurrent nonsquamous NSCLC were eligible. We planned approximately four cycles of induction cisplatin (75 mg/m), pemetrexed (500 mg/m), and bevacizumab (15 mg/kg) followed by maintenance with pemetrexed (500 mg/m) and bevacizumab (15 mg/kg) until disease progression. Progression-free survival (PFS) was the primary endpoint.
Forty patients received a median of four induction chemotherapy cycles. Of them, 35 (87.5%) patients received a median of nine maintenance chemotherapy cycles. The objective response was 70.6%, and the disease control rate was 97.1%. The median PFS was 10.8 (95% CI, 9.0-12.6), and overall survival was 48.0 (95% CI, 32.9-63.1) months. Median PFS of 23 patients with epidermal growth factor receptor (EGFR) mutations and of 16 patients without EGFR mutations were 12.9 (95% CI, 9.4-16.3) and 7.9 (95% CI, 1.1-14.7) months, respectively. Toxicities graded ≥3 included neutropenia (15%), anemia (15%), hypertension (7.5%), anorexia (7.5%), fatigue (7.5%), thromboembolic events (5%), jaw osteonecrosis (5%), nausea (2.5%), oral mucositis (2.5%), tumor pain (2.5%), hyponatremia (2.5%), and gastrointestinal perforation (2.5%). Treatment-related deaths were not found.
In patients with advanced or recurrent nonsquamous NSCLC, induction chemotherapy with cisplatin, pemetrexed, and bevacizumab followed by maintenance chemotherapy with pemetrexed and bevacizumab is safe and effective regardless of their EGFR mutation status.
UMIN Clinical Trial Registry: UMIN000005569 . Registered date: May 8, 2011.
我们在这项多中心 II 期研究中评估了贝伐珠单抗诱导化疗联合贝伐珠单抗维持化疗治疗晚期非小细胞肺癌（NSCLC）的安全性和有效性。
入组标准为未经化疗的 IIIB-IV 期或复发性非鳞状 NSCLC 患者。我们计划进行约 4 个周期的诱导化疗（顺铂 75mg/m2）、培美曲塞（500mg/m2）和贝伐珠单抗（15mg/kg），随后进行培美曲塞（500mg/m2）和贝伐珠单抗（15mg/kg）维持治疗，直至疾病进展。无进展生存期（PFS）是主要终点。
40 例患者接受了中位数为 4 个周期的诱导化疗。其中，35 例（87.5%）患者接受了中位数为 9 个周期的维持化疗。客观缓解率为 70.6%，疾病控制率为 97.1%。中位 PFS 为 10.8 个月（95%CI，9.0-12.6），总生存期为 48.0 个月（95%CI，32.9-63.1）。23 例表皮生长因子受体（EGFR）突变患者和 16 例无 EGFR 突变患者的中位 PFS 分别为 12.9 个月（95%CI，9.4-16.3）和 7.9 个月（95%CI，1.1-14.7）。≥3 级毒性包括中性粒细胞减少（15%）、贫血（15%）、高血压（7.5%）、厌食（7.5%）、疲劳（7.5%）、血栓栓塞事件（5%）、颌骨坏死（5%）、恶心（2.5%）、口腔黏膜炎（2.5%）、肿瘤疼痛（2.5%）、低钠血症（2.5%）和胃肠道穿孔（2.5%）。未发现与治疗相关的死亡。
对于晚期或复发性非鳞状 NSCLC 患者，顺铂、培美曲塞和贝伐珠单抗诱导化疗联合培美曲塞和贝伐珠单抗维持化疗是安全有效的，与 EGFR 突变状态无关。
UMIN 临床研究注册：UMIN000005569。注册日期：2011 年 5 月 8 日。
