Hata Akito, Harada Daijiro, Okuda Chiyuki, Kaji Reiko, Masuda Yoshio, Takechi Yoshika, Kozuki Toshiyuki, Nogami Naoyuki, Katakami Nobuyuki
Department of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan.
Department of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Oncotarget. 2018 Jun 12;9(45):27789-27796. doi: 10.18632/oncotarget.25578.
The aim of our study was to evaluate the efficacy and safety of docetaxel plus ramucirumab with primary prophylactic pegylated (PEG)-granulocyte-colony stimulating factor (G-CSF) for pretreated non-small cell lung cancer (NSCLC).
Sixty-one pretreated NSCLC patients underwent docetaxel plus ramucirumab. Primary prophylactic PEG-G-CSF was performed in 52 (85%) patients (prophylactic group). No febrile neutropenia (FN) (0%) was confirmed in 52 prophylactic group patients, whereas FN was observed in 3 (33%) of 9 non-prophylactic group patients. Among prophylactic group, median lines of prior therapy was 2 (range, 1-9). Median cycles of docetaxel plus ramucirumab was 3 (range, 1-25) (9 and 3 cases moved to ramucirumab and docetaxel monotherapies, respectively). Response rate and disease control rate were 30.8% and 73.1%, respectively. Median progression-free survival was 4.5 (95% confidence interval [CI], 3.0-6.6) months. Median overall survival was 11.4 (95% CI, 8.0-13.9) months. Six (11.5%) patients had grade 3/4 neutropenia. Observed grade 3 (incidence ≥10%) adverse event (AE) was oral mucositis (13.5%). There were no grade 4/5 non-hematological AEs.
Our study demonstrated the efficacy and safety of docetaxel plus ramucirumab with PEG-G-CSF in clinical practice. Primary prophylactic PEG-G-CSF could markedly reduce incidence of FN.
We retrospectively reviewed medical records of pretreated NSCLC cases who had received docetaxel plus ramucirumab in our departments.
我们研究的目的是评估多西他赛联合雷莫西尤单抗加用聚乙二醇化（PEG）-粒细胞集落刺激因子（G-CSF）进行一级预防用于预处理过的非小细胞肺癌（NSCLC）的疗效和安全性。
61例预处理过的NSCLC患者接受了多西他赛联合雷莫西尤单抗治疗。52例（85%）患者进行了一级预防PEG-G-CSF治疗（预防组）。52例预防组患者中未确认有发热性中性粒细胞减少（FN）（0%），而9例非预防组患者中有3例（33%）观察到FN。在预防组中，既往治疗的中位疗程数为2（范围1-9）。多西他赛联合雷莫西尤单抗的中位周期数为3（范围1-25）（分别有9例和3例患者转为雷莫西尤单抗和多西他赛单药治疗）。缓解率和疾病控制率分别为30.8%和73.1%。中位无进展生存期为4.5（95%置信区间[CI]，3.0-6.6）个月。中位总生存期为11.4（95%CI，8.0-13.9）个月。6例（11.5%）患者出现3/4级中性粒细胞减少。观察到的3级（发生率≥10%）不良事件（AE）为口腔黏膜炎（13.5%）。没有4/5级非血液学AE。
我们的研究证明了多西他赛联合雷莫西尤单抗加用PEG-G-CSF在临床实践中的疗效和安全性。一级预防PEG-G-CSF可显著降低FN的发生率。
我们回顾性分析了在我们科室接受多西他赛联合雷莫西尤单抗治疗的预处理过的NSCLC病例的病历。
