Zhang Li, Lu Shun, Cheng Ying, Hu Zhihuang, Wu Yi-Long, Chen Zhiwei, Chen Gongyan, Liu Xiaoqing, Yang Jinji, Zhang Li, Chen Jia, Huang Meijuan, Tao Min, Cheng Gang, Huang Cheng, Zhou Caicun, Zhang Weimin, Zhao Hong, Sun Yuping
Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Jiao Tong University, Shanghai, China.
Ann Transl Med. 2021 Feb;9(4):338. doi: 10.21037/atm-20-8078.
Maintenance therapy is important in the management of advanced non-small cell lung cancer (NSCLC). The present TFINE study assessed the efficacy and safety of docetaxel continuation maintenance (DCM) therapy after first-line treatment with different doses of docetaxel plus cisplatin.
In this open-label, randomized, phase III study, newly diagnosed patients with advanced NSCLC were initially randomized (R1, 1:1) to receive first-line treatment with cisplatin 75 mg/m plus docetaxel 75 mg/m (DC75) or 60 mg/m (DC60) for up to 4 cycles. Patients without progression were further randomized (R2, 1:2) to best supportive care (BSC) or DCM (60 mg/m) for up to 6 cycles. The primary endpoint was progression-free survival (PFS) after R2, and the secondary endpoints included best response rate in first-line treatment, overall survival (OS), time to progression (TTP), and toxicities.
A total of 375 patients were enrolled in R1 and 184 of these patients continued in R2. DCM significantly prolonged PFS compared to BSC (HR =0.57, median PFS =5.8 . 3.0 months, P=0.002). The response rates were 30.2% and 23.9% in the DC75 and DC60 groups, respectively (P=0.17). There was no significant difference in OS (12.3 . 13.7 months, P=0.77). Additionally, 47.8% and 45.7% of patients reported AEs in the DC75 and DC60 groups, respectively. Diarrhea was more frequent with DC75 than with DC60 (8.6% . 3.2%, P=0.029). Other toxicities were comparable between the 2 docetaxel dose groups.
Continuation maintenance treatment with docetaxel is well tolerated and improves PFS in patients with NSCLC. The docetaxel dose of 60 mg/m may be preferred due to similar efficacy and less diarrhea.
NCT01038661.
维持治疗在晚期非小细胞肺癌（NSCLC）的管理中很重要。目前的TFINE研究评估了在一线使用不同剂量多西他赛加顺铂治疗后多西他赛持续维持（DCM）治疗的疗效和安全性。
在这项开放标签、随机、III期研究中，新诊断的晚期NSCLC患者最初被随机分组（R1，1:1）接受一线治疗，使用顺铂75mg/m加75mg/m多西他赛（DC75）或60mg/m多西他赛（DC60），最多4个周期。无进展的患者进一步被随机分组（R2，1:2）接受最佳支持治疗（BSC）或DCM（60mg/m），最多6个周期。主要终点是R2后的无进展生存期（PFS），次要终点包括一线治疗的最佳缓解率、总生存期（OS）、进展时间（TTP）和毒性。
共有375例患者进入R1，其中184例患者继续进入R2。与BSC相比，DCM显著延长了PFS（HR =0.57，中位PFS =5.8对3.0个月，P =0.002）。DC75组和DC60组的缓解率分别为30.2%和23.9%（P =0.17）。OS无显著差异（12.3对13.7个月，P =0.77）。此外，DC75组和DC60组分别有47.8%和45.7%的患者报告了不良事件。DC75组腹泻比DC60组更频繁（8.6%对3.2%，P =0.029）。其他毒性在两个多西他赛剂量组之间相当。
多西他赛持续维持治疗耐受性良好，可改善NSCLC患者的PFS。由于疗效相似且腹泻较少，60mg/m的多西他赛剂量可能更受青睐。
NCT01038661。
