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Real‐world outcomes of chemoradiotherapy for unresectable Stage III non‐small cell lung cancer: The SOLUTION study
There are limited real‐world data on the treatment practices, outcomes, and safety of chemoradiotherapy (CRT) alone in potential candidates for immune checkpoint inhibitors (ICI) for unresectable non‐small cell lung cancer (NSCLC). In this study, we analyzed the safety and efficacy of CRT in patient...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7520333/ https://www.ncbi.nlm.nih.gov/pubmed/32730697 http://dx.doi.org/10.1002/cam4.3306 |
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author | Horinouchi, Hidehito Atagi, Shinji Oizumi, Satoshi Ohashi, Kadoaki Kato, Tomohiro Kozuki, Toshiyuki Seike, Masahiro Sone, Takashi Sobue, Tomotaka Tokito, Takaaki Harada, Hideyuki Maeda, Tadashi Mio, Tadashi Shirosaka, Ikue Hattori, Kana Shin, Eisei Murakami, Haruyasu |
author_facet | Horinouchi, Hidehito Atagi, Shinji Oizumi, Satoshi Ohashi, Kadoaki Kato, Tomohiro Kozuki, Toshiyuki Seike, Masahiro Sone, Takashi Sobue, Tomotaka Tokito, Takaaki Harada, Hideyuki Maeda, Tadashi Mio, Tadashi Shirosaka, Ikue Hattori, Kana Shin, Eisei Murakami, Haruyasu |
author_sort | Horinouchi, Hidehito |
collection | PubMed |
description | There are limited real‐world data on the treatment practices, outcomes, and safety of chemoradiotherapy (CRT) alone in potential candidates for immune checkpoint inhibitors (ICI) for unresectable non‐small cell lung cancer (NSCLC). In this study, we analyzed the safety and efficacy of CRT in patients who underwent CRT and would satisfy the key eligibility criteria for maintenance therapy with durvalumab (eg, no progression after CRT) in real‐world settings (m‐sub) for unresectable Stage III NSCLC between 1 January 2013 and 31 December 2015 at 12 sites in Japan. The m‐sub comprised 214 patients with a median follow‐up of 31.6 months (range 1.9‐65.8 months). Median overall survival (OS) and progression‐free survival (PFS) from completing CRT were 36.4 months (95% confidence interval [CI] 28.1 months to not reached) and 9.5 months (95% CI 7.7‐11.7 months), respectively. Consolidation chemotherapy did not influence OS or PFS. Median PFS was 16.9 vs 9.1 months in patients with vs without epidermal growth factor receptor (EGFR) mutations, with PFS rates of ~20% at 3‐4 years. Pneumonitis was the most common adverse event (according to MedDRA version 21.0J), and about half of events were grade 1. Pneumonitis mostly occurred 10‐24 weeks after starting CRT, peaking at 18‐20 weeks. Esophagitis and dermatitis generally occurred from 0 to 4 weeks, peaking at 2‐4 weeks after starting CRT. Pericarditis was rare and occurred sporadically. In conclusion, the results of the m‐sub provide real‐world insight into the outcomes of CRT, and will be useful for future evaluations of ICI maintenance therapy after CRT. |
format | Online Article Text |
id | pubmed-7520333 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-75203332020-09-30 Real‐world outcomes of chemoradiotherapy for unresectable Stage III non‐small cell lung cancer: The SOLUTION study Horinouchi, Hidehito Atagi, Shinji Oizumi, Satoshi Ohashi, Kadoaki Kato, Tomohiro Kozuki, Toshiyuki Seike, Masahiro Sone, Takashi Sobue, Tomotaka Tokito, Takaaki Harada, Hideyuki Maeda, Tadashi Mio, Tadashi Shirosaka, Ikue Hattori, Kana Shin, Eisei Murakami, Haruyasu Cancer Med Clinical Cancer Research There are limited real‐world data on the treatment practices, outcomes, and safety of chemoradiotherapy (CRT) alone in potential candidates for immune checkpoint inhibitors (ICI) for unresectable non‐small cell lung cancer (NSCLC). In this study, we analyzed the safety and efficacy of CRT in patients who underwent CRT and would satisfy the key eligibility criteria for maintenance therapy with durvalumab (eg, no progression after CRT) in real‐world settings (m‐sub) for unresectable Stage III NSCLC between 1 January 2013 and 31 December 2015 at 12 sites in Japan. The m‐sub comprised 214 patients with a median follow‐up of 31.6 months (range 1.9‐65.8 months). Median overall survival (OS) and progression‐free survival (PFS) from completing CRT were 36.4 months (95% confidence interval [CI] 28.1 months to not reached) and 9.5 months (95% CI 7.7‐11.7 months), respectively. Consolidation chemotherapy did not influence OS or PFS. Median PFS was 16.9 vs 9.1 months in patients with vs without epidermal growth factor receptor (EGFR) mutations, with PFS rates of ~20% at 3‐4 years. Pneumonitis was the most common adverse event (according to MedDRA version 21.0J), and about half of events were grade 1. Pneumonitis mostly occurred 10‐24 weeks after starting CRT, peaking at 18‐20 weeks. Esophagitis and dermatitis generally occurred from 0 to 4 weeks, peaking at 2‐4 weeks after starting CRT. Pericarditis was rare and occurred sporadically. In conclusion, the results of the m‐sub provide real‐world insight into the outcomes of CRT, and will be useful for future evaluations of ICI maintenance therapy after CRT. John Wiley and Sons Inc. 2020-07-30 /pmc/articles/PMC7520333/ /pubmed/32730697 http://dx.doi.org/10.1002/cam4.3306 Text en © 2020 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Clinical Cancer Research Horinouchi, Hidehito Atagi, Shinji Oizumi, Satoshi Ohashi, Kadoaki Kato, Tomohiro Kozuki, Toshiyuki Seike, Masahiro Sone, Takashi Sobue, Tomotaka Tokito, Takaaki Harada, Hideyuki Maeda, Tadashi Mio, Tadashi Shirosaka, Ikue Hattori, Kana Shin, Eisei Murakami, Haruyasu Real‐world outcomes of chemoradiotherapy for unresectable Stage III non‐small cell lung cancer: The SOLUTION study |
title | Real‐world outcomes of chemoradiotherapy for unresectable Stage III non‐small cell lung cancer: The SOLUTION study |
title_full | Real‐world outcomes of chemoradiotherapy for unresectable Stage III non‐small cell lung cancer: The SOLUTION study |
title_fullStr | Real‐world outcomes of chemoradiotherapy for unresectable Stage III non‐small cell lung cancer: The SOLUTION study |
title_full_unstemmed | Real‐world outcomes of chemoradiotherapy for unresectable Stage III non‐small cell lung cancer: The SOLUTION study |
title_short | Real‐world outcomes of chemoradiotherapy for unresectable Stage III non‐small cell lung cancer: The SOLUTION study |
title_sort | real‐world outcomes of chemoradiotherapy for unresectable stage iii non‐small cell lung cancer: the solution study |
topic | Clinical Cancer Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7520333/ https://www.ncbi.nlm.nih.gov/pubmed/32730697 http://dx.doi.org/10.1002/cam4.3306 |
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