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Mobocertinib (TAK-788) in EGFR Exon 20 Insertion+ Metastatic NSCLC: Patient-Reported Outcomes from EXCLAIM Extension Cohort
Mobocertinib, an oral, first-in-class epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor selective for EGFR exon 20 insertions (ex20ins), achieved durable responses in adults with previously treated EGFR ex20ins+ metastatic non-small cell lung cancer (mNSCLC) in the EXCLAIM extension...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9821270/ https://www.ncbi.nlm.nih.gov/pubmed/36614913 http://dx.doi.org/10.3390/jcm12010112 |
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author | Garcia Campelo, Maria Rosario Zhou, Caicun Ramalingam, Suresh S. Lin, Huamao M. Kim, Tae Min Riely, Gregory J. Mekhail, Tarek Nguyen, Danny Goodman, Erin Mehta, Minal Popat, Sanjay Jänne, Pasi A. |
author_facet | Garcia Campelo, Maria Rosario Zhou, Caicun Ramalingam, Suresh S. Lin, Huamao M. Kim, Tae Min Riely, Gregory J. Mekhail, Tarek Nguyen, Danny Goodman, Erin Mehta, Minal Popat, Sanjay Jänne, Pasi A. |
author_sort | Garcia Campelo, Maria Rosario |
collection | PubMed |
description | Mobocertinib, an oral, first-in-class epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor selective for EGFR exon 20 insertions (ex20ins), achieved durable responses in adults with previously treated EGFR ex20ins+ metastatic non-small cell lung cancer (mNSCLC) in the EXCLAIM extension cohort of a phase 1/2 study (N = 96; NCT02716116). We assessed patient-reported outcomes (PROs) with mobocertinib 160 mg once daily (28-day cycles) in EXCLAIM (N = 90) with the European Organisation for Research and Treatment of Cancer Core Quality-of-Life Questionnaire (EORTC QLQ-C30) v3.0, lung cancer module (QLQ-LC13), EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire, and selected PRO Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire. Median treatment duration was 6.8 (range, 0.0–18.8) months (median follow-up: 13.0 [0.7–18.8] months; data cutoff: 1 November 2020). Clinically meaningful improvements in lung cancer symptoms measured by EORTC QLQ-LC13 were observed for dyspnea (54.4% of patients), cough (46.7%), and chest pain (38.9%), evident at cycle 2 and throughout treatment (least-squares mean [LSM] changes from baseline: dyspnea, −3.2 [p = 0.019]; cough, −9.3 [p < 0.001]; chest pain, −8.2 [p < 0.001]). EORTC QLQ-C30 results indicated no statistically significant changes in global health status/quality of life (LSM change from baseline: −1.8 [p = 0.235]). On symptom scores, significant worsening from baseline was observed for diarrhea (LSM change from baseline: +34.1; p < 0.001) and appetite loss (+6.6; p = 0.004), while improvements were observed for dyspnea (LSM change from baseline: −5.1 [p = 0.002]), insomnia (−6.5 [p = 0.001]), and constipation (−5.7 [p < 0.001]). EQ-5D-5L health status was maintained. Common PRO-CTCAE symptoms were diarrhea, dry skin, rash, and decreased appetite (mostly low grade); in the first 24 weeks of treatment, 64.4% of patients had worsening diarrhea frequency and 67.8% had worsening dry skin severity. Overall, PROs with mobocertinib showed clinically meaningful improvement in lung cancer–related symptoms, with health-related quality of life maintained despite changes in some adverse event symptom scales. |
format | Online Article Text |
id | pubmed-9821270 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-98212702023-01-07 Mobocertinib (TAK-788) in EGFR Exon 20 Insertion+ Metastatic NSCLC: Patient-Reported Outcomes from EXCLAIM Extension Cohort Garcia Campelo, Maria Rosario Zhou, Caicun Ramalingam, Suresh S. Lin, Huamao M. Kim, Tae Min Riely, Gregory J. Mekhail, Tarek Nguyen, Danny Goodman, Erin Mehta, Minal Popat, Sanjay Jänne, Pasi A. J Clin Med Article Mobocertinib, an oral, first-in-class epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor selective for EGFR exon 20 insertions (ex20ins), achieved durable responses in adults with previously treated EGFR ex20ins+ metastatic non-small cell lung cancer (mNSCLC) in the EXCLAIM extension cohort of a phase 1/2 study (N = 96; NCT02716116). We assessed patient-reported outcomes (PROs) with mobocertinib 160 mg once daily (28-day cycles) in EXCLAIM (N = 90) with the European Organisation for Research and Treatment of Cancer Core Quality-of-Life Questionnaire (EORTC QLQ-C30) v3.0, lung cancer module (QLQ-LC13), EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire, and selected PRO Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire. Median treatment duration was 6.8 (range, 0.0–18.8) months (median follow-up: 13.0 [0.7–18.8] months; data cutoff: 1 November 2020). Clinically meaningful improvements in lung cancer symptoms measured by EORTC QLQ-LC13 were observed for dyspnea (54.4% of patients), cough (46.7%), and chest pain (38.9%), evident at cycle 2 and throughout treatment (least-squares mean [LSM] changes from baseline: dyspnea, −3.2 [p = 0.019]; cough, −9.3 [p < 0.001]; chest pain, −8.2 [p < 0.001]). EORTC QLQ-C30 results indicated no statistically significant changes in global health status/quality of life (LSM change from baseline: −1.8 [p = 0.235]). On symptom scores, significant worsening from baseline was observed for diarrhea (LSM change from baseline: +34.1; p < 0.001) and appetite loss (+6.6; p = 0.004), while improvements were observed for dyspnea (LSM change from baseline: −5.1 [p = 0.002]), insomnia (−6.5 [p = 0.001]), and constipation (−5.7 [p < 0.001]). EQ-5D-5L health status was maintained. Common PRO-CTCAE symptoms were diarrhea, dry skin, rash, and decreased appetite (mostly low grade); in the first 24 weeks of treatment, 64.4% of patients had worsening diarrhea frequency and 67.8% had worsening dry skin severity. Overall, PROs with mobocertinib showed clinically meaningful improvement in lung cancer–related symptoms, with health-related quality of life maintained despite changes in some adverse event symptom scales. MDPI 2022-12-23 /pmc/articles/PMC9821270/ /pubmed/36614913 http://dx.doi.org/10.3390/jcm12010112 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Garcia Campelo, Maria Rosario Zhou, Caicun Ramalingam, Suresh S. Lin, Huamao M. Kim, Tae Min Riely, Gregory J. Mekhail, Tarek Nguyen, Danny Goodman, Erin Mehta, Minal Popat, Sanjay Jänne, Pasi A. Mobocertinib (TAK-788) in EGFR Exon 20 Insertion+ Metastatic NSCLC: Patient-Reported Outcomes from EXCLAIM Extension Cohort |
title | Mobocertinib (TAK-788) in EGFR Exon 20 Insertion+ Metastatic NSCLC: Patient-Reported Outcomes from EXCLAIM Extension Cohort |
title_full | Mobocertinib (TAK-788) in EGFR Exon 20 Insertion+ Metastatic NSCLC: Patient-Reported Outcomes from EXCLAIM Extension Cohort |
title_fullStr | Mobocertinib (TAK-788) in EGFR Exon 20 Insertion+ Metastatic NSCLC: Patient-Reported Outcomes from EXCLAIM Extension Cohort |
title_full_unstemmed | Mobocertinib (TAK-788) in EGFR Exon 20 Insertion+ Metastatic NSCLC: Patient-Reported Outcomes from EXCLAIM Extension Cohort |
title_short | Mobocertinib (TAK-788) in EGFR Exon 20 Insertion+ Metastatic NSCLC: Patient-Reported Outcomes from EXCLAIM Extension Cohort |
title_sort | mobocertinib (tak-788) in egfr exon 20 insertion+ metastatic nsclc: patient-reported outcomes from exclaim extension cohort |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9821270/ https://www.ncbi.nlm.nih.gov/pubmed/36614913 http://dx.doi.org/10.3390/jcm12010112 |
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