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ABSTRACT: Background
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.Methods
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/m2 plus docetaxel 75 mg/m2 (DC75) or 60 mg/m2 (DC60) for up to 4 cycles. Patients without progression were further randomized (R2, 1:2) to best supportive care (BSC) or DCM (60 mg/m2) 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.Results
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 vs. 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 vs. 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% vs. 3.2%, P=0.029). Other toxicities were comparable between the 2 docetaxel dose groups.Conclusions
Continuation maintenance treatment with docetaxel is well tolerated and improves PFS in patients with NSCLC. The docetaxel dose of 60 mg/m2 may be preferred due to similar efficacy and less diarrhea.Trial registration
NCT01038661.
SUBMITTER: Zhang L
PROVIDER: S-EPMC7944306 | biostudies-literature | 2021 Feb
REPOSITORIES: biostudies-literature
Zhang Li L Lu Shun S Cheng Ying Y Hu Zhihuang Z Wu Yi-Long YL Chen Zhiwei Z Chen Gongyan G Liu Xiaoqing X Yang Jinji J Zhang Li L Chen Jia J Huang Meijuan M Tao Min M Cheng Gang G Huang Cheng C Zhou Caicun C Zhang Weimin W Zhao Hong H Sun Yuping Y
Annals of translational medicine 20210201 4
<h4>Background</h4>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.<h4>Methods</h4>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 m ...[more]