TY - JOUR
T1 - Efficacy of Adjuvant Chemotherapy With Tegafur-Uracil in Patients With Completely Resected, Node-Negative NSCLC—Real-World Data in the Era of Molecularly Targeted Agents and Immunotherapy
AU - Shukuya, Takehito
AU - Takamochi, Kazuya
AU - Sakurai, Hiroyuki
AU - Yoh, Kiyotaka
AU - Hishida, Tomoyuki
AU - Tsuboi, Masahiro
AU - Goto, Yasushi
AU - Kudo, Yujin
AU - Ohde, Yasuhisa
AU - Okumura, Sakae
AU - Taguri, Masataka
AU - Kunitoh, Hideo
N1 - Funding Information:
Disclosure: Dr. Shukuya received grants from AstraZeneca, Chugai Pharmaceutical, Boehringer Ingelheim, Novartis, and Merck Sharp & Dohme and honoraria from AstraZeneca, Chugai Pharmaceutical, Boehringer Ingelheim, Novartis, Merck Sharp & Dohme, Taiho Pharma, Daiichi Sankyo, Ono Pharmaceutical, Bristol-Myers Squibb, Nippon Kayaku, and Pfizer outside of the submitted work. Yoh received grants from AstraZeneca, Lilly, Pfizer, Daiichi Sankyo, AbbVie, Taiho, Merck Sharp & Dohme, and Takeda and honoraria from AstraZeneca, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Janssen, Eli Lilly, Taiho, Novartis, Kyowa Kirin, and Boehringer Ingelheim outside of the submitted work. Hishida received support for the present work from Taiho Pharmaceutical Company; grants from Covidien Japan, Johnson and Johnson Medical Company, Taiho Pharmaceutical Company, Eli Lilly and Company, and Astellas; and honoraria from Johnson and Johnson Medical Company and AstraZeneca outside of the submitted work. Dr. Tsuboi received grants from Boehringer Ingelheim Japan, Merck Sharp & Dohme, AstraZeneca KK, Ono Pharmaceutical Co., Ltd., Bristol-Myers Squibb KK, Eli Lilly Japan, and Novartis, and honoraria from AstraZeneca, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Janssen, Lilly, Taiho, Novartis, Kyowa Kirin, and Boehringer Ingelheim outside of the submitted work. Goto received grants from AZK, Pfizer, AbbVie, Eli Lilly, Pfizer, Bristol-Myers Squibb, Ono, Novartis, Kyorin, Daiichi Sankyo, Novartis, and Preferred Networks and fees for speaker's bureaus or advisory board from Eli Lilly, Chugai, Taiho, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Merck Sharp & Dohme, Novartis, Merck, Thermo Fisher, AstraZeneca, Taiho, Guardant Health Inc., Illumina, Daiichi Sankyo, and Ono Pharmaceutical outside of the submitted work. Kunitoh received honoraria from Taiho, Covidien Japan, Merck Sharp & Dohme, EA Pharma, Daiichi Sankyo, Johnson and Johnson, Boehringer Ingelheim, Eisai, AstraZeneca, and Chugai Pharma outside of the submitted work. The remaining authors declare no conflict of interest.
Funding Information:
This work was supported by funding from Taiho Pharmaceutical under a study contract. The Comprehensive Support Project for Oncology Research of the Public Health Research Foundation in Japan conducted this study. Taiho Pharmaceutical had no role in the design of the study. The company did not participate in the collection, management, analysis, or interpretation of the data; the preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication. The authors thank all 34 institutions that participated in this multicenter study conducted in Japan.
Publisher Copyright:
© 2022 The Authors
PY - 2022/5
Y1 - 2022/5
N2 - Introduction: In Japan, adjuvant tegafur-uracil (UFT) chemotherapy is recommended for patients with completely resected, stage I NSCLC. This treatment requires real-world re-evaluation because of recent advances in target-based and immuno-oncological treatments and refinement of lung cancer staging. Methods: The Japan Clinical Oncology Group (JCOG) 0707, a phase 3 trial comparing the benefits of UFT and S-1 (tegafur-gimeracil-oteracil) in patients with completely resected stage I NSCLC (T1 >2 cm and T2 in the TNM sixth edition), was conducted in Japan. A multicenter observational cohort study (Comprehensive Support Project for Oncology Research [CSPOR]-LC03) was also conducted for those patients excluded from JCOG 0707 during the study enrollment period. Physicians from institutions that participated in JCOG 0707 retrospectively assessed the medical records of each patient. The efficacy of UFT was evaluated in the CSPOR-LC03 cohort. Results: In the entire study population (n = 5005), patients treated with UFT (n = 1549) had significantly longer overall survival (OS) than those without any adjuvant chemotherapy (n = 3338). There was no significant difference in OS between the patients treated with UFT (n = 1061) and those without adjuvant chemotherapy (n = 1484) in the JCOG 0707-eligible population (logrank p = 0.755). For tumors without ground-glass attenuation and size greater than 3 cm, patients treated with UFT had significantly longer survival than those without adjuvant chemotherapy, on univariate but not on multivariate analysis. Conclusions: There was no significant difference in OS between the patients treated with UFT and those without adjuvant chemotherapy in the clinical trial-eligible population. Adjuvant UFT for patients with completely resected NSCLC may be recommended only in patients with a tumor without ground-glass attenuation and size greater than 3 cm. In patients with node-negative early NSCLC, further study is needed to select patients who will benefit from adjuvant chemotherapy.
AB - Introduction: In Japan, adjuvant tegafur-uracil (UFT) chemotherapy is recommended for patients with completely resected, stage I NSCLC. This treatment requires real-world re-evaluation because of recent advances in target-based and immuno-oncological treatments and refinement of lung cancer staging. Methods: The Japan Clinical Oncology Group (JCOG) 0707, a phase 3 trial comparing the benefits of UFT and S-1 (tegafur-gimeracil-oteracil) in patients with completely resected stage I NSCLC (T1 >2 cm and T2 in the TNM sixth edition), was conducted in Japan. A multicenter observational cohort study (Comprehensive Support Project for Oncology Research [CSPOR]-LC03) was also conducted for those patients excluded from JCOG 0707 during the study enrollment period. Physicians from institutions that participated in JCOG 0707 retrospectively assessed the medical records of each patient. The efficacy of UFT was evaluated in the CSPOR-LC03 cohort. Results: In the entire study population (n = 5005), patients treated with UFT (n = 1549) had significantly longer overall survival (OS) than those without any adjuvant chemotherapy (n = 3338). There was no significant difference in OS between the patients treated with UFT (n = 1061) and those without adjuvant chemotherapy (n = 1484) in the JCOG 0707-eligible population (logrank p = 0.755). For tumors without ground-glass attenuation and size greater than 3 cm, patients treated with UFT had significantly longer survival than those without adjuvant chemotherapy, on univariate but not on multivariate analysis. Conclusions: There was no significant difference in OS between the patients treated with UFT and those without adjuvant chemotherapy in the clinical trial-eligible population. Adjuvant UFT for patients with completely resected NSCLC may be recommended only in patients with a tumor without ground-glass attenuation and size greater than 3 cm. In patients with node-negative early NSCLC, further study is needed to select patients who will benefit from adjuvant chemotherapy.
KW - Adjuvant chemotherapy
KW - Non–small cell lung cancer
KW - Randomized clinical trial
KW - Real-world study
KW - Tegafur-uracil
UR - http://www.scopus.com/inward/record.url?scp=85129917575&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85129917575&partnerID=8YFLogxK
U2 - 10.1016/j.jtocrr.2022.100320
DO - 10.1016/j.jtocrr.2022.100320
M3 - Article
AN - SCOPUS:85129917575
SN - 2666-3643
VL - 3
JO - JTO Clinical and Research Reports
JF - JTO Clinical and Research Reports
IS - 5
M1 - 100320
ER -
