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Observational Study
. 2024 Jul;15(20):1541-1552.
doi: 10.1111/1759-7714.15305. Epub 2024 May 29.

Treatment patterns and clinical outcomes of resectable clinical stage III non-small cell lung cancer in a Japanese real-world setting: Surgery cohort analysis of the SOLUTION study

Masahiro Tsuboi  1 , Haruyasu Murakami  2 , Hideyuki Harada  3 , Tomotaka Sobue  4 , Tomohiro Kato  5 , Shinji Atagi  6 , Takaaki Tokito  7 , Tadashi Mio  8 , Hirofumi Adachi  9 , Toshiyuki Kozuki  10 , Takashi Sone  11 , Masahiro Seike  12 , Shinichi Toyooka  13 , Hiroshi Kitagawa  14 , Ryo Koto  14 , Satoshi Yamazaki  14 , Hidehito Horinouchi  15
Affiliations
Observational Study

Treatment patterns and clinical outcomes of resectable clinical stage III non-small cell lung cancer in a Japanese real-world setting: Surgery cohort analysis of the SOLUTION study

Masahiro Tsuboi et al. Thorac Cancer. 2024 Jul.

Abstract

Background: To elucidate the treatment and surgery outcomes with or without perioperative therapies in Japanese patients with clinical stage III non-small cell lung cancer (NSCLC) in real-world settings.

Methods: We performed subset analyses of the SOLUTION study, a multicenter, noninterventional, observational study of Japanese patients diagnosed with clinical stage III NSCLC, for those who started first-line treatment (surgery±perioperative therapy) between January 2013 and December 2014 (study registration: UMIN000031385). Follow-up data were obtained using medical records from diagnosis to March 1, 2018.

Results: Of 149 eligible patients, 67 underwent surgery alone (median age 71 years) and 82 underwent surgery+perioperative therapy (median age 63 years). Lung resection was performed in 137 patients and the others underwent exploratory thoracotomy or other procedures. Perioperative therapies included adjuvant therapy only (n = 41), neoadjuvant therapy only (n = 24), and neoadjuvant+adjuvant therapy (n = 17). The median overall survival (OS) and 3-year OS rate were 29.3 months and 44.0%, respectively, in patients who underwent surgery alone, and not reached and 61.1%, respectively, in patients who underwent surgery+perioperative therapy. The 3-year progression-free survival (PFS) and disease-free survival (DFS) rates were 42.4% and 47.1%, respectively, in patients who underwent surgery+perioperative therapy and 28.5% and 28.9%, respectively, in patients who underwent surgery alone. In multivariable Cox regression, perioperative therapy was associated with improved OS (hazard ratio [95% confidence interval] 0.49 [0.29-0.81]), PFS (0.62 [0.39-0.96]), and DFS (0.62 [0.39-0.97]) versus surgery alone.

Conclusions: Our study suggested that perioperative therapy may be associated with better survival among patients undergoing surgical treatment of clinical stage III NSCLC.

Keywords: disease‐free survival; perioperative therapy; resectability; stage III non‐small cell lung cancer; surgery.

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Conflict of interest statement

Masahiro Tsuboi received research grants from Nippon Boehringer Ingelheim, MSD, AstraZeneca, Ono Pharmaceutical, Bristol‐Myers Squibb, Eli Lilly Japan, and Novartis; personal and lecture fees from Johnson & Johnson Japan, AstraZeneca, Eli Lilly Japan, Chugai Pharmaceutical, MSD, Bristol‐Myers Squibb, Teijin Pharma, Taiho Pharmaceutical, and Ono Pharmaceutical; personal fees from Medtronic Japan; has participated in a data safety monitoring board for Chugai Pharmaceutical; and has participated in advisory boards for AstraZeneca, MSD, and Novartis. Haruyasu Murakami has received support in relation to this manuscript from AstraZeneca; research grants from AstraZeneca, Takeda Pharmaceutical, Daiichi Sankyo, AbbVie, and IQVIA; and honoraria from AstraZeneca, Chugai Pharmaceutical, Takeda Pharmaceutical, Daiichi Sankyo, Ono Pharmaceutical, Bristol‐Myers Squibb, MSD, Pfizer, Novartis, Eli Lilly Japan, and Taiho Pharmaceutical; and participated on an advisory board for Chugai Pharmaceutical. Hideyuki Harada received support for this manuscript from AstraZeneca, and has received lecture fees from Hitachi, AstraZeneca, Brainlab, Accuray, Chugai Pharmaceutical, Eisai, Taiho Pharmaceutical, Takeda Pharmaceutical, Pfizer, MSD, and Nihon Medi‐Physics. Tomohiro Kato has received honoraria from AstraZeneca, Chugai Pharmaceutical, Kyowa Kirin, Eli Lilly, MSD, Boehringer Ingelheim, Taiho Pharmaceutical, Ono Pharmaceutical, Nippon Kayaku, Takeda Pharmaceutical, and Novartis. Shinji Atagi received support for this manuscript from AstraZeneca, and research grants from AstraZeneca, Eli Lilly, Ono Pharmaceutical, Taiho Pharmaceutical, Boehringer Ingelheim, Pfizer, Bristol‐Myers Squibb, MSD, Chugai Pharmaceutical, Merck, and F. Hoffmann‐La Roche. Takaaki Tokito has received lecture fees from Chugai Pharmaceutical, AstraZeneca, MSD, Novartis, and Bristol‐Myers Squibb. Toshiyuki Kozuki has received research grants from Chugai Pharmaceutical, AstraZeneca, Eli Lilly Japan, Taiho Pharmaceutical, Bristol‐Myers Squibb, Ono Pharmaceutical, MSD, Kyowa Kirin, Merck Biopharma, Daiichi Sankyo, Abbvie, Amgen, Sanofi, Eisai, and Labcorp Development Japan, and personal fees from Chugai Pharmaceutical, AstraZeneca, Eli Lilly Japan, Taiho Pharmaceutical, Bristol‐Myers Squibb, Ono Pharmaceutical, MSD, Pfizer Japan, Kyowa Kirin, Merck Biopharma, Nippon Boehringer Ingelheim, Nippon Kayaku, Novartis, Daiichi Sankyo, Takeda Pharmaceutical, AbbVie, Bayer, and Sawai. Masahiro Seike has received lecture fees from AstraZeneca, MSD, Chugai Pharmaceutical, Taiho Pharmaceutical, Nippon Kayaku, Ono Pharmaceutical, Bristol‐Myers Squibb, Eli Lilly Japan, Takeda Pharmaceutical, Kyowa Kirin, and Novartis, and scholarship donations from Taiho Pharmaceutical, MSD, Chugai Pharmaceutical, Eli Lilly Japan, Nippon Kayaku, and Nippon Boehringer Ingelheim. Hiroshi Kitagawa and Ryo Koto are employees of AstraZeneca. Satoshi Yamazaki was an employee of AstraZeneca at the time of the study. Hidehito Horinouchi has received research funds from MSD, AbbVie, AstraZeneca, Bristol‐Myers Squibb, Ono Pharmaceutical, Merck Biopharma, Daiichi Sankyo, Janssen, Genomic Health, Chugai Pharmaceutical, Roche, and Novartis; honoraria from AstraZeneca, MSD, Eli Lilly, Ono Pharmaceutical, Bristol‐Myers Squibb, Chugai Pharmaceutical, Roche, Kyowa Kirin, and Novartis; and has participated on advisory boards for AstraZeneca, Eli Lilly, Chugai Pharmaceutical, Roche, Ono Pharmaceutical, Bristol‐Myers Squibb, and MSD. Tomotaka Sobue, Tadashi Mio, Hirofumi Adachi, Takashi Sone, and Shinichi Toyooka have no conflicts of interest to declare.

Figures

FIGURE 1
FIGURE 1
Overall survival in (a) the overall surgery cohort, (b) patients who underwent surgery alone or surgery+perioperative therapy, and (c) according to the type of perioperative therapy. adju, adjuvant therapy; CI, confidence interval; mo, month; neoadju, neoadjuvant therapy; NR, not reached; OS, overall survival; yr, year.
FIGURE 2
FIGURE 2
Progression‐free survival in (a) the overall surgery cohort, (b) patients who underwent surgery alone or surgery+perioperative therapy, and (c) according to the type of perioperative therapy. adju, adjuvant therapy; CI, confidence interval; mo, month; neoadju, neoadjuvant therapy; NR, not reached; PFS, progression‐free survival; yr, year.
FIGURE 3
FIGURE 3
Multivariable Cox proportional hazards regression analysis of (a) overall survival, (b) progression‐free survival, and (c) disease‐free survival. CI, confidence interval; COPD, chronic obstructive pulmonary disease; ECOG PS, Eastern Cooperative Oncology Group performance status; HR, hazard ratio; IP, interstitial pneumonia; SCC, squamous cell carcinoma.
See this image and copyright information in PMC

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