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Efficacy and Safety of Ceritinib 450 mg/day with Food and 750 mg/day in Fasted State in Treatment-Naïve Patients with ALK+ Non–Small Cell Lung Cancer: Results from the ASCEND-8 Asian Subgroup Analysis

PURPOSE: Previous report from the ASCEND-8 trial showed consistent efficacy with less gastrointestinal (GI) toxicity in patients with anaplastic lymphoma kinase-rearranged (ALK+) advanced/metastatic non–small cell lung cancer (NSCLC) treated with ceritinib 450-mg with food compared with 750-mg faste...

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Autores principales: Cho, Byoung Chul, Kim, Dong-Wan, Batra, Ullas, Park, Keunchil, Kim, Sang-We, Yang, Cheng-Ta, Voon, Pei-Jye, Sriuranpong, Virote, Babu, K. Govind, Amin, Khalid, Wang, Yingbo, Sen, Paramita, Slimane, Khemaies, Geater, Sarayut
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Korean Cancer Association 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9873336/
https://www.ncbi.nlm.nih.gov/pubmed/35344649
http://dx.doi.org/10.4143/crt.2021.1571
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author Cho, Byoung Chul
Kim, Dong-Wan
Batra, Ullas
Park, Keunchil
Kim, Sang-We
Yang, Cheng-Ta
Voon, Pei-Jye
Sriuranpong, Virote
Babu, K. Govind
Amin, Khalid
Wang, Yingbo
Sen, Paramita
Slimane, Khemaies
Geater, Sarayut
author_facet Cho, Byoung Chul
Kim, Dong-Wan
Batra, Ullas
Park, Keunchil
Kim, Sang-We
Yang, Cheng-Ta
Voon, Pei-Jye
Sriuranpong, Virote
Babu, K. Govind
Amin, Khalid
Wang, Yingbo
Sen, Paramita
Slimane, Khemaies
Geater, Sarayut
author_sort Cho, Byoung Chul
collection PubMed
description PURPOSE: Previous report from the ASCEND-8 trial showed consistent efficacy with less gastrointestinal (GI) toxicity in patients with anaplastic lymphoma kinase-rearranged (ALK+) advanced/metastatic non–small cell lung cancer (NSCLC) treated with ceritinib 450-mg with food compared with 750-mg fasted. In this subgroup analysis, we report outcomes in Asian patients of the ASCEND-8 trial. MATERIALS AND METHODS: Key efficacy endpoints were blinded independent review committee (BIRC)–assessed overall response rate (ORR) and duration of response (DOR) evaluated per Response Evaluation Criteria in Solid Tumors v1.1. Other efficacy endpoints were investigator-assessed ORR and DOR; BIRC- and investigator-assessed progression-free survival (PFS) and disease control rate; overall survival (OS). Safety was evaluated by frequency and severity of adverse events. RESULTS: At final data cutoff (6 March 2020), 198 treatment-naïve patients were included in efficacy analysis, of which 74 (37%) comprised the Asian subset; 450-mg fed (n=29), 600-mg fed (n=19), and 750-mg fasted (n=26). Baseline characteristics were mostly comparable across study arms. At baseline, more patients in 450-mg fed arm (44.8%) had brain metastases than in 750-mg fasted arm (26.9%). Per BIRC, patients in the 450-mg fed arm had a numerically higher ORR, 24-month DOR rate and 24-month PFS rate than the 750-mg fasted arm. The 36-month OS rate was 93.1% in 450-mg fed arm and 70.9% in 750-mg fasted arm. Any-grade GI toxicity occurred in 82.8% and 96.2% of patients in the 450-mg fed and 750-mg fasted arms, respectively. CONCLUSION: Asian patients with ALK+ advanced/metastatic NSCLC treated with ceritinib 450-mg fed showed numerically higher efficacy and lower GI toxicity than 750-mg fasted patients.
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spelling pubmed-98733362023-02-02 Efficacy and Safety of Ceritinib 450 mg/day with Food and 750 mg/day in Fasted State in Treatment-Naïve Patients with ALK+ Non–Small Cell Lung Cancer: Results from the ASCEND-8 Asian Subgroup Analysis Cho, Byoung Chul Kim, Dong-Wan Batra, Ullas Park, Keunchil Kim, Sang-We Yang, Cheng-Ta Voon, Pei-Jye Sriuranpong, Virote Babu, K. Govind Amin, Khalid Wang, Yingbo Sen, Paramita Slimane, Khemaies Geater, Sarayut Cancer Res Treat Original Article PURPOSE: Previous report from the ASCEND-8 trial showed consistent efficacy with less gastrointestinal (GI) toxicity in patients with anaplastic lymphoma kinase-rearranged (ALK+) advanced/metastatic non–small cell lung cancer (NSCLC) treated with ceritinib 450-mg with food compared with 750-mg fasted. In this subgroup analysis, we report outcomes in Asian patients of the ASCEND-8 trial. MATERIALS AND METHODS: Key efficacy endpoints were blinded independent review committee (BIRC)–assessed overall response rate (ORR) and duration of response (DOR) evaluated per Response Evaluation Criteria in Solid Tumors v1.1. Other efficacy endpoints were investigator-assessed ORR and DOR; BIRC- and investigator-assessed progression-free survival (PFS) and disease control rate; overall survival (OS). Safety was evaluated by frequency and severity of adverse events. RESULTS: At final data cutoff (6 March 2020), 198 treatment-naïve patients were included in efficacy analysis, of which 74 (37%) comprised the Asian subset; 450-mg fed (n=29), 600-mg fed (n=19), and 750-mg fasted (n=26). Baseline characteristics were mostly comparable across study arms. At baseline, more patients in 450-mg fed arm (44.8%) had brain metastases than in 750-mg fasted arm (26.9%). Per BIRC, patients in the 450-mg fed arm had a numerically higher ORR, 24-month DOR rate and 24-month PFS rate than the 750-mg fasted arm. The 36-month OS rate was 93.1% in 450-mg fed arm and 70.9% in 750-mg fasted arm. Any-grade GI toxicity occurred in 82.8% and 96.2% of patients in the 450-mg fed and 750-mg fasted arms, respectively. CONCLUSION: Asian patients with ALK+ advanced/metastatic NSCLC treated with ceritinib 450-mg fed showed numerically higher efficacy and lower GI toxicity than 750-mg fasted patients. Korean Cancer Association 2023-01 2022-03-25 /pmc/articles/PMC9873336/ /pubmed/35344649 http://dx.doi.org/10.4143/crt.2021.1571 Text en Copyright © 2023 by the Korean Cancer Association https://creativecommons.org/licenses/by-nc/4.0/This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Cho, Byoung Chul
Kim, Dong-Wan
Batra, Ullas
Park, Keunchil
Kim, Sang-We
Yang, Cheng-Ta
Voon, Pei-Jye
Sriuranpong, Virote
Babu, K. Govind
Amin, Khalid
Wang, Yingbo
Sen, Paramita
Slimane, Khemaies
Geater, Sarayut
Efficacy and Safety of Ceritinib 450 mg/day with Food and 750 mg/day in Fasted State in Treatment-Naïve Patients with ALK+ Non–Small Cell Lung Cancer: Results from the ASCEND-8 Asian Subgroup Analysis
title Efficacy and Safety of Ceritinib 450 mg/day with Food and 750 mg/day in Fasted State in Treatment-Naïve Patients with ALK+ Non–Small Cell Lung Cancer: Results from the ASCEND-8 Asian Subgroup Analysis
title_full Efficacy and Safety of Ceritinib 450 mg/day with Food and 750 mg/day in Fasted State in Treatment-Naïve Patients with ALK+ Non–Small Cell Lung Cancer: Results from the ASCEND-8 Asian Subgroup Analysis
title_fullStr Efficacy and Safety of Ceritinib 450 mg/day with Food and 750 mg/day in Fasted State in Treatment-Naïve Patients with ALK+ Non–Small Cell Lung Cancer: Results from the ASCEND-8 Asian Subgroup Analysis
title_full_unstemmed Efficacy and Safety of Ceritinib 450 mg/day with Food and 750 mg/day in Fasted State in Treatment-Naïve Patients with ALK+ Non–Small Cell Lung Cancer: Results from the ASCEND-8 Asian Subgroup Analysis
title_short Efficacy and Safety of Ceritinib 450 mg/day with Food and 750 mg/day in Fasted State in Treatment-Naïve Patients with ALK+ Non–Small Cell Lung Cancer: Results from the ASCEND-8 Asian Subgroup Analysis
title_sort efficacy and safety of ceritinib 450 mg/day with food and 750 mg/day in fasted state in treatment-naïve patients with alk+ non–small cell lung cancer: results from the ascend-8 asian subgroup analysis
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9873336/
https://www.ncbi.nlm.nih.gov/pubmed/35344649
http://dx.doi.org/10.4143/crt.2021.1571
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