Anlotinib plus docetaxel vs. docetaxel alone for advanced non-small-cell lung cancer patients who failed first-line treatment : A multicenter, randomized phase II trial
Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved..
OBJECTIVES: Given the modest efficacy of docetaxel in advanced non-small cell lung cancer (NSCLC), this study assesses the therapeutic potential and safety profile of anlotinib in combination with docetaxel compared to docetaxel monotherapy as a second-line therapy for patients with advanced NSCLC.
MATERIALS AND METHODS: In this phase II study, patients with advanced NSCLC experiencing failure with first-line platinum-based regimens were randomized in a 1:1 ratio to receive either anlotinib plus docetaxel or docetaxel alone. Primary endpoint was progression-free survival (PFS), with overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety as secondary endpoints.
RESULTS: A total of 83 patients were randomized. The combination of anlotinib and docetaxel significantly extended median PFS to 4.4 months compared to 1.6 months for docetaxel alone (hazard ratio [HR] = 0.38, 95 % confidence interval [CI]: 0.23-0.63, P = 0.0002), and also demonstrated superior ORR (32.5 % vs. 9.3 %, P = 0.0089) and DCR (87.5 % vs. 53.5 %, P = 0.0007). Median OS was observed at 12.0 months in the combination group vs. 10.9 months in the monotherapy group (HR = 0.82, 95 % CI: 0.47-1.43, P = 0.4803). For patients previously treated with immunotherapy, the median PFS was notably longer at 7.8 vs. 1.7 months (HR = 0.22, 95 % CI: 0.09-0.51, P = 0.0290). The incidence of grade ≥ 3 treatment-related adverse events, predominantly leukopenia (15.0 % vs. 7.0 %) and neutropenia (10.0 % vs. 5.0 %), was manageable across both groups.
CONCLUSION: Anlotinib plus docetaxel offers a viable therapeutic alternative for patients with advanced NSCLC who failed first-line platinum-based treatments.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:191 |
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| Enthalten in: |
Lung cancer (Amsterdam, Netherlands) - 191(2024) vom: 18. März, Seite 107538 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Pu, Xingxiang [VerfasserIn] |
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| Links: |
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| Themen: |
Anlotinib |
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| Anmerkungen: |
Date Revised 29.03.2024 published: Print-Electronic Citation Status Publisher |
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| doi: |
10.1016/j.lungcan.2024.107538 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM370420713 |
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| 245 | 1 | 0 | |a Anlotinib plus docetaxel vs. docetaxel alone for advanced non-small-cell lung cancer patients who failed first-line treatment |b A multicenter, randomized phase II trial |
| 264 | 1 | |c 2024 | |
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| 500 | |a Date Revised 29.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved. | ||
| 520 | |a OBJECTIVES: Given the modest efficacy of docetaxel in advanced non-small cell lung cancer (NSCLC), this study assesses the therapeutic potential and safety profile of anlotinib in combination with docetaxel compared to docetaxel monotherapy as a second-line therapy for patients with advanced NSCLC | ||
| 520 | |a MATERIALS AND METHODS: In this phase II study, patients with advanced NSCLC experiencing failure with first-line platinum-based regimens were randomized in a 1:1 ratio to receive either anlotinib plus docetaxel or docetaxel alone. Primary endpoint was progression-free survival (PFS), with overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety as secondary endpoints | ||
| 520 | |a RESULTS: A total of 83 patients were randomized. The combination of anlotinib and docetaxel significantly extended median PFS to 4.4 months compared to 1.6 months for docetaxel alone (hazard ratio [HR] = 0.38, 95 % confidence interval [CI]: 0.23-0.63, P = 0.0002), and also demonstrated superior ORR (32.5 % vs. 9.3 %, P = 0.0089) and DCR (87.5 % vs. 53.5 %, P = 0.0007). Median OS was observed at 12.0 months in the combination group vs. 10.9 months in the monotherapy group (HR = 0.82, 95 % CI: 0.47-1.43, P = 0.4803). For patients previously treated with immunotherapy, the median PFS was notably longer at 7.8 vs. 1.7 months (HR = 0.22, 95 % CI: 0.09-0.51, P = 0.0290). The incidence of grade ≥ 3 treatment-related adverse events, predominantly leukopenia (15.0 % vs. 7.0 %) and neutropenia (10.0 % vs. 5.0 %), was manageable across both groups | ||
| 520 | |a CONCLUSION: Anlotinib plus docetaxel offers a viable therapeutic alternative for patients with advanced NSCLC who failed first-line platinum-based treatments | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Anlotinib | |
| 650 | 4 | |a Docetaxel | |
| 650 | 4 | |a Immunotherapy-Pretreated | |
| 650 | 4 | |a Non-Small-Cell Lung Cancer | |
| 650 | 4 | |a Second-Line Therapy | |
| 700 | 1 | |a Xiao, Zemin |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Jia |e verfasserin |4 aut | |
| 700 | 1 | |a Wu, Zhijun |e verfasserin |4 aut | |
| 700 | 1 | |a Ma, Zhongxia |e verfasserin |4 aut | |
| 700 | 1 | |a Weng, Jie |e verfasserin |4 aut | |
| 700 | 1 | |a Xiao, Maoliang |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Yanhua |e verfasserin |4 aut | |
| 700 | 1 | |a Cao, Yongqing |e verfasserin |4 aut | |
| 700 | 1 | |a Cao, Peiguo |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Qianzhi |e verfasserin |4 aut | |
| 700 | 1 | |a Xu, Yan |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Kang |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Bolin |e verfasserin |4 aut | |
| 700 | 1 | |a Xu, Fang |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Liyu |e verfasserin |4 aut | |
| 700 | 1 | |a Kong, Yi |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Hui |e verfasserin |4 aut | |
| 700 | 1 | |a Duan, Huaxin |e verfasserin |4 aut | |
| 700 | 1 | |a Wu, Lin |e verfasserin |4 aut | |
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