Song Yong, Miao Liyun, Wang Zhaoxia, Shi Meiqi
Department of Respiratory Medicine, Jinling Hospital, Nanjing University School of Medicine, Nanjing 210002, China.
Department of Respiratory Medicine, Nanjing Drum Tower Hospital, Nanjing University School of Medicine, Nanjing 210008, China.
J Thorac Dis. 2020 May;12(5):2450-2458. doi: 10.21037/jtd.2020.03.54.
This trial aimed to investigate the treatment response, survival profiles and treatment-related adverse events (AEs) of apatinib plus docetaxel in advanced non-squamous non-small cell lung cancer (NSCLC) patients with wild-type epidermal growth factor receptor (EGFR).
Thirty advanced non-squamous NSCLC patients with wild-type EGFR were recruited in this multi-center, phase II trial. All patients received apatinib (orally 500 mg, once daily until disease progression, intolerable toxicity, or death) plus docetaxel (intravenously 60 mg/m at day 1 every 3 weeks for 4-6 cycles). The treatment response, progression-free survival (PFS), overall survival (OS) and treatment-related AEs were evaluated.
One patient lacked response and survival assessment due to early lost follow-up, therefore, 29 patients were included in response and survival analysis. There was no (0.0%) patient achieved complete remission, 8 (27.6%) patients achieved partial remission, 20 (69%) patients with stable disease, and 1 (3.4%) patient with progressive disease, resulting in objective response rate and disease control rate of 27.6% and 96.6%, respectively. According to the survival data, median PFS was 5.3 months (95% CI: 3.6-6.9 months) and median OS was 9.6 months (95% CI: 6.33-12.9 months). For safety, totally 30 patients were included in the analysis. Common non-hematologic AEs included hypertension (66.7%), hand-foot syndrome (40.0%), proteinuria (36.7%); common hematologic AEs included leukopenia (26.7%), thrombocytopenia (23.3%), neutropenia (16.7%). Notably, majority of AEs were at grade 1-2, and the overall AEs were tolerable.
Apatinib plus docetaxel is an effective and tolerable treatment option for advanced non-squamous NSCLC with wild-type EGFR.
本试验旨在研究阿帕替尼联合多西他赛治疗野生型表皮生长因子受体（EGFR）的晚期非鳞状非小细胞肺癌（NSCLC）患者的治疗反应、生存情况及治疗相关不良事件（AE）。
本多中心II期试验招募了30例野生型EGFR的晚期非鳞状NSCLC患者。所有患者接受阿帕替尼（口服500mg，每日一次，直至疾病进展、出现不可耐受的毒性或死亡）联合多西他赛（静脉注射60mg/m²，每3周一次，第1天给药，共4 - 6个周期）。评估治疗反应、无进展生存期（PFS）、总生存期（OS）及治疗相关AE。
1例患者因早期失访而缺乏反应和生存评估，因此，29例患者纳入反应和生存分析。无（0.0%）患者达到完全缓解，8例（27.6%）患者达到部分缓解，20例（69%）患者病情稳定，1例（3.4%）患者病情进展，客观缓解率和疾病控制率分别为27.6%和96.6%。根据生存数据，中位PFS为5.3个月（95%CI：3.6 - 6.9个月），中位OS为9.6个月（95%CI：6.33 - 12.9个月）。安全性方面，共30例患者纳入分析。常见的非血液学AE包括高血压（66.7%）、手足综合征（40.0%）、蛋白尿（36.7%）；常见的血液学AE包括白细胞减少（26.7%）、血小板减少（23.3%）、中性粒细胞减少（16.7%）。值得注意的是，大多数AE为1 - 2级，总体AE可耐受。
阿帕替尼联合多西他赛是治疗野生型EGFR的晚期非鳞状NSCLC的一种有效且可耐受的治疗选择。
