Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
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
_version_ 1783587764777779200
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
work_keys_str_mv AT horinouchihidehito realworldoutcomesofchemoradiotherapyforunresectablestageiiinonsmallcelllungcancerthesolutionstudy
AT atagishinji realworldoutcomesofchemoradiotherapyforunresectablestageiiinonsmallcelllungcancerthesolutionstudy
AT oizumisatoshi realworldoutcomesofchemoradiotherapyforunresectablestageiiinonsmallcelllungcancerthesolutionstudy
AT ohashikadoaki realworldoutcomesofchemoradiotherapyforunresectablestageiiinonsmallcelllungcancerthesolutionstudy
AT katotomohiro realworldoutcomesofchemoradiotherapyforunresectablestageiiinonsmallcelllungcancerthesolutionstudy
AT kozukitoshiyuki realworldoutcomesofchemoradiotherapyforunresectablestageiiinonsmallcelllungcancerthesolutionstudy
AT seikemasahiro realworldoutcomesofchemoradiotherapyforunresectablestageiiinonsmallcelllungcancerthesolutionstudy
AT sonetakashi realworldoutcomesofchemoradiotherapyforunresectablestageiiinonsmallcelllungcancerthesolutionstudy
AT sobuetomotaka realworldoutcomesofchemoradiotherapyforunresectablestageiiinonsmallcelllungcancerthesolutionstudy
AT tokitotakaaki realworldoutcomesofchemoradiotherapyforunresectablestageiiinonsmallcelllungcancerthesolutionstudy
AT haradahideyuki realworldoutcomesofchemoradiotherapyforunresectablestageiiinonsmallcelllungcancerthesolutionstudy
AT maedatadashi realworldoutcomesofchemoradiotherapyforunresectablestageiiinonsmallcelllungcancerthesolutionstudy
AT miotadashi realworldoutcomesofchemoradiotherapyforunresectablestageiiinonsmallcelllungcancerthesolutionstudy
AT shirosakaikue realworldoutcomesofchemoradiotherapyforunresectablestageiiinonsmallcelllungcancerthesolutionstudy
AT hattorikana realworldoutcomesofchemoradiotherapyforunresectablestageiiinonsmallcelllungcancerthesolutionstudy
AT shineisei realworldoutcomesofchemoradiotherapyforunresectablestageiiinonsmallcelllungcancerthesolutionstudy
AT murakamiharuyasu realworldoutcomesofchemoradiotherapyforunresectablestageiiinonsmallcelllungcancerthesolutionstudy