@article{b77e2c495bc14ed299121520001eb801,
title = "Real-world outcomes of chemoradiotherapy for unresectable Stage III non-small cell lung cancer: The SOLUTION study",
abstract = "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.",
keywords = "chemotherapy, clinical observations, lung cancer, radiation therapy",
author = "Hidehito Horinouchi and Shinji Atagi and Satoshi Oizumi and Kadoaki Ohashi and Tomohiro Kato and Toshiyuki Kozuki and Masahiro Seike and Takashi Sone and Tomotaka Sobue and Takaaki Tokito and Hideyuki Harada and Tadashi Maeda and Tadashi Mio and Ikue Shirosaka and Kana Hattori and Eisei Shin and Haruyasu Murakami",
note = "Funding Information: The authors thank all of the radiologists who participated in this study. This study was funded by AstraZeneca K.K. The authors thank Nicholas D. Smith (EMC K.K.) for medical writing support, which was funded by AstraZeneca K.K. Funding Information: Hidehito Horinouchi reports lecture fees, honoraria, or other fees from Eli Lilly, AstraZeneca, MSD, Ono, and Bristol‐Myers Squibb, and research grants from MSD, Chugai, Ono, Bristol‐Myers Squibb, AstraZeneca, Daiichi‐Sankyo, Novartis, and Genomic Health. Shinji Atagi reports research grants from AstraZeneca, MSD, Eli Lilly, Chugai, Ono, Taiho, Boehringer Ingelheim, Pfizer, and Bristol‐Myers Squibb. Satoshi Oizumi reports lecture fees, honoraria, or other fees from AstraZeneca and Eli Lilly, and research grants from AstraZeneca, Bristol‐Myers Squibb, Chugai, Kyowa Kirin, Ono, Merck Biopharma, Taiho, and Pfizer. Kadoaki Ohashi reports research grants from Boehringer Ingelheim, AstraZeneca, Eli Lilly, and Novartis. Toshiyuki Kozuki reports lecture fees, honoraria, or other fees from Chugai, AstraZeneca, and Eli Lilly. Hideyuki Harada reports lecture fees, honoraria, or other fees from AstraZeneca. Ikue Shirosaka, Kana Hattori, and Eisei Shin are employees of AstraZeneca. Haruyasu Murakami reports lecture fees, honoraria, or other fees from AstraZeneca and Chugai. Tomohiro Kato, Masahiro Seike, Takashi Sone, Tomotaka Sobue, Takaaki Tokito, Tadashi Maeda, and Tadashi Mio declare no conflict of interest. AstraZeneca was involved in the design and conduct of the study, statistical analyses, and in writing of the report. The authors had full access to the data. ",
year = "2020",
month = sep,
day = "1",
doi = "10.1002/cam4.3306",
language = "English",
volume = "9",
pages = "6597--6608",
journal = "Cancer Medicine",
issn = "2045-7634",
publisher = "John Wiley and Sons Ltd",
number = "18",
}