Cargando…
A phase II study of anlotinib combined with etoposide and platinum‐based regimens in the first‐line treatment of extensive‐stage small cell lung cancer
BACKGROUND: The aim of this prospective, pilot, single‐arm phase II trial was to evaluate the safety and efficacy of anlotinib combined with etoposide and platinum‐based regimens in the first‐line treatment of extensive‐stage small cell lung cancer (ES‐SCLC). METHODS: This phase II study was conduct...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley & Sons Australia, Ltd
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9108065/ https://www.ncbi.nlm.nih.gov/pubmed/35388976 http://dx.doi.org/10.1111/1759-7714.14414 |
_version_ | 1784708620145917952 |
---|---|
author | Liu, Chang Liao, Jiatao Wu, Xianghua Zhao, Xinmin Sun, Si Wang, Huijie Hu, Zhihuang Zhang, Yao Yu, Hui Wang, Jialei |
author_facet | Liu, Chang Liao, Jiatao Wu, Xianghua Zhao, Xinmin Sun, Si Wang, Huijie Hu, Zhihuang Zhang, Yao Yu, Hui Wang, Jialei |
author_sort | Liu, Chang |
collection | PubMed |
description | BACKGROUND: The aim of this prospective, pilot, single‐arm phase II trial was to evaluate the safety and efficacy of anlotinib combined with etoposide and platinum‐based regimens in the first‐line treatment of extensive‐stage small cell lung cancer (ES‐SCLC). METHODS: This phase II study was conducted at Fudan University Shanghai Cancer Center between December 2018 and December 2020. All patients received standard chemotherapy (etoposide plus cisplatin/carboplatin) consisting of four courses and anlotinib at 12 mg once per day for 2 weeks followed by a one‐week rest. Anlotinib administration was continued until disease progression, intolerable adverse events (AEs) or patient withdrawal from the study. The primary outcome measure was progression‐free survival (PFS). The secondary outcome measures were overall survival (OS), objective control rate (ORR), disease control rate (DCR) and AEs. RESULTS: Thirty‐seven patients were included in this study, and 30 patients were eligible for efficacy analysis. ORR and DCR were 90.0% and 96.7%, respectively. The estimated PFS and OS were 6.0 months (95% CI: 1.1–11.9 months) and 14.0 months (95% CI: 8.6–19.4 months), respectively. No unexpected adverse effects were reported. Hypertension (20/37, 54.1%), anemia (16/37, 43.2%), alopecia (15/37, 40.5%), elevated transaminases (9/37, 24.3%) and alkaline phosphatase (9/37, 24.3%) were the most commonly reported AEs. Thirteen patients (35.1%) reported grade 3–5 AEs. No treatment‐related deaths occurred during this study. CONCLUSION: The addition of anlotinib to standard etoposide/platinum chemotherapy achieved encouraging PFS and OS in previously untreated ES‐SCLC patients, with an acceptable tolerability profile and no new safety signals observed. |
format | Online Article Text |
id | pubmed-9108065 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley & Sons Australia, Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-91080652022-05-20 A phase II study of anlotinib combined with etoposide and platinum‐based regimens in the first‐line treatment of extensive‐stage small cell lung cancer Liu, Chang Liao, Jiatao Wu, Xianghua Zhao, Xinmin Sun, Si Wang, Huijie Hu, Zhihuang Zhang, Yao Yu, Hui Wang, Jialei Thorac Cancer Original Articles BACKGROUND: The aim of this prospective, pilot, single‐arm phase II trial was to evaluate the safety and efficacy of anlotinib combined with etoposide and platinum‐based regimens in the first‐line treatment of extensive‐stage small cell lung cancer (ES‐SCLC). METHODS: This phase II study was conducted at Fudan University Shanghai Cancer Center between December 2018 and December 2020. All patients received standard chemotherapy (etoposide plus cisplatin/carboplatin) consisting of four courses and anlotinib at 12 mg once per day for 2 weeks followed by a one‐week rest. Anlotinib administration was continued until disease progression, intolerable adverse events (AEs) or patient withdrawal from the study. The primary outcome measure was progression‐free survival (PFS). The secondary outcome measures were overall survival (OS), objective control rate (ORR), disease control rate (DCR) and AEs. RESULTS: Thirty‐seven patients were included in this study, and 30 patients were eligible for efficacy analysis. ORR and DCR were 90.0% and 96.7%, respectively. The estimated PFS and OS were 6.0 months (95% CI: 1.1–11.9 months) and 14.0 months (95% CI: 8.6–19.4 months), respectively. No unexpected adverse effects were reported. Hypertension (20/37, 54.1%), anemia (16/37, 43.2%), alopecia (15/37, 40.5%), elevated transaminases (9/37, 24.3%) and alkaline phosphatase (9/37, 24.3%) were the most commonly reported AEs. Thirteen patients (35.1%) reported grade 3–5 AEs. No treatment‐related deaths occurred during this study. CONCLUSION: The addition of anlotinib to standard etoposide/platinum chemotherapy achieved encouraging PFS and OS in previously untreated ES‐SCLC patients, with an acceptable tolerability profile and no new safety signals observed. John Wiley & Sons Australia, Ltd 2022-04-07 2022-05 /pmc/articles/PMC9108065/ /pubmed/35388976 http://dx.doi.org/10.1111/1759-7714.14414 Text en © 2022 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Original Articles Liu, Chang Liao, Jiatao Wu, Xianghua Zhao, Xinmin Sun, Si Wang, Huijie Hu, Zhihuang Zhang, Yao Yu, Hui Wang, Jialei A phase II study of anlotinib combined with etoposide and platinum‐based regimens in the first‐line treatment of extensive‐stage small cell lung cancer |
title | A phase II study of anlotinib combined with etoposide and platinum‐based regimens in the first‐line treatment of extensive‐stage small cell lung cancer |
title_full | A phase II study of anlotinib combined with etoposide and platinum‐based regimens in the first‐line treatment of extensive‐stage small cell lung cancer |
title_fullStr | A phase II study of anlotinib combined with etoposide and platinum‐based regimens in the first‐line treatment of extensive‐stage small cell lung cancer |
title_full_unstemmed | A phase II study of anlotinib combined with etoposide and platinum‐based regimens in the first‐line treatment of extensive‐stage small cell lung cancer |
title_short | A phase II study of anlotinib combined with etoposide and platinum‐based regimens in the first‐line treatment of extensive‐stage small cell lung cancer |
title_sort | phase ii study of anlotinib combined with etoposide and platinum‐based regimens in the first‐line treatment of extensive‐stage small cell lung cancer |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9108065/ https://www.ncbi.nlm.nih.gov/pubmed/35388976 http://dx.doi.org/10.1111/1759-7714.14414 |
work_keys_str_mv | AT liuchang aphaseiistudyofanlotinibcombinedwithetoposideandplatinumbasedregimensinthefirstlinetreatmentofextensivestagesmallcelllungcancer AT liaojiatao aphaseiistudyofanlotinibcombinedwithetoposideandplatinumbasedregimensinthefirstlinetreatmentofextensivestagesmallcelllungcancer AT wuxianghua aphaseiistudyofanlotinibcombinedwithetoposideandplatinumbasedregimensinthefirstlinetreatmentofextensivestagesmallcelllungcancer AT zhaoxinmin aphaseiistudyofanlotinibcombinedwithetoposideandplatinumbasedregimensinthefirstlinetreatmentofextensivestagesmallcelllungcancer AT sunsi aphaseiistudyofanlotinibcombinedwithetoposideandplatinumbasedregimensinthefirstlinetreatmentofextensivestagesmallcelllungcancer AT wanghuijie aphaseiistudyofanlotinibcombinedwithetoposideandplatinumbasedregimensinthefirstlinetreatmentofextensivestagesmallcelllungcancer AT huzhihuang aphaseiistudyofanlotinibcombinedwithetoposideandplatinumbasedregimensinthefirstlinetreatmentofextensivestagesmallcelllungcancer AT zhangyao aphaseiistudyofanlotinibcombinedwithetoposideandplatinumbasedregimensinthefirstlinetreatmentofextensivestagesmallcelllungcancer AT yuhui aphaseiistudyofanlotinibcombinedwithetoposideandplatinumbasedregimensinthefirstlinetreatmentofextensivestagesmallcelllungcancer AT wangjialei aphaseiistudyofanlotinibcombinedwithetoposideandplatinumbasedregimensinthefirstlinetreatmentofextensivestagesmallcelllungcancer AT liuchang phaseiistudyofanlotinibcombinedwithetoposideandplatinumbasedregimensinthefirstlinetreatmentofextensivestagesmallcelllungcancer AT liaojiatao phaseiistudyofanlotinibcombinedwithetoposideandplatinumbasedregimensinthefirstlinetreatmentofextensivestagesmallcelllungcancer AT wuxianghua phaseiistudyofanlotinibcombinedwithetoposideandplatinumbasedregimensinthefirstlinetreatmentofextensivestagesmallcelllungcancer AT zhaoxinmin phaseiistudyofanlotinibcombinedwithetoposideandplatinumbasedregimensinthefirstlinetreatmentofextensivestagesmallcelllungcancer AT sunsi phaseiistudyofanlotinibcombinedwithetoposideandplatinumbasedregimensinthefirstlinetreatmentofextensivestagesmallcelllungcancer AT wanghuijie phaseiistudyofanlotinibcombinedwithetoposideandplatinumbasedregimensinthefirstlinetreatmentofextensivestagesmallcelllungcancer AT huzhihuang phaseiistudyofanlotinibcombinedwithetoposideandplatinumbasedregimensinthefirstlinetreatmentofextensivestagesmallcelllungcancer AT zhangyao phaseiistudyofanlotinibcombinedwithetoposideandplatinumbasedregimensinthefirstlinetreatmentofextensivestagesmallcelllungcancer AT yuhui phaseiistudyofanlotinibcombinedwithetoposideandplatinumbasedregimensinthefirstlinetreatmentofextensivestagesmallcelllungcancer AT wangjialei phaseiistudyofanlotinibcombinedwithetoposideandplatinumbasedregimensinthefirstlinetreatmentofextensivestagesmallcelllungcancer |