TY - JOUR
T1 - Randomized phase II trial of uracil/tegafur and cisplatin versus pemetrexed and cisplatin with concurrent thoracic radiotherapy for locally advanced unresectable stage III non-squamous non-small cell lung cancer
T2 - NJLCG1001
AU - Watanabe, Kana
AU - Toi, Yukihiro
AU - Nakamura, Atsushi
AU - Chiba, Ryosuke
AU - Akiyama, Masachika
AU - Sakakibara-Konishi, Jun
AU - Tanaka, Hisashi
AU - Yoshimura, Naruo
AU - Miyauchi, Eisaku
AU - Nakagawa, Taku
AU - Igusa, Ryotaro
AU - Minemura, Hiroyuki
AU - Mori, Yoshiaki
AU - Fujimoto, Keisuke
AU - Matsushita, Haruo
AU - Takahashi, Fumiaki
AU - Fukuhara, Tatsuro
AU - Inoue, Akira
AU - Sugawara, Shunichi
AU - Maemondo, Makoto
N1 - Publisher Copyright:
© 2021 Translational Lung Cancer Research.
PY - 2021/2
Y1 - 2021/2
N2 - Background: The optimal regimen for concurrent chemoradiotherapy (CCRT) of locally advanced non-squamous non-small cell lung cancer (NSCLC) was not definitive. We conducted randomized phase II study, NJLCG0601, and chemoradiotherapy with uracil/tegafur (UFT) and cisplatin achieved promising efficacy without severe toxicities. Here, we evaluated between this regimen and pemetrexed plus cisplatin in chemoradiotherapy for stage III non-squamous NSCLC. Methods: Patients with inoperable stage III non-squamous NSCLC were randomly assigned in a 1:1 ratio to UFT 400 mg/m2 on days 1-14 and 29-42, and cisplatin 80 mg/m2 on days 8 and 36 (UP), or cisplatin 75 mg/m2 and pemetrexed 500 mg/m2 on days 1, 22, and 43 (PP). Involved-field radiotherapy (IFRT) underwent from day 1 to a total dose of 66 Gy in 33 fractions. Consolidation chemotherapy after CCRT was prohibited for this study. The primary endpoint was defined as 2-year overall survival (OS). This trial was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN000003948). Results: From November 2010 to June 2017, 86 patients were entered from 11 institutions. Median follow-up was 54 months. Of the 85 eligible patients, the 2-year OS rate was 78.6% (95% CI, 62.8-88.3%) in UP and 85.5% (95% CI, 70.5-93.2%) in PP. Median PFS and OS was 12.3 and 64.2 months in UP, 26.2 months and not reached in PP, respectively. Grade 3/4 febrile neutropenia was more frequent in the UP group (14.0% vs. 2.0%). Conclusions: Both UP and PP with IFRT achieved the expected 2-year OS. PP engendered more favorable OS and PFS compared to UP in terms.
AB - Background: The optimal regimen for concurrent chemoradiotherapy (CCRT) of locally advanced non-squamous non-small cell lung cancer (NSCLC) was not definitive. We conducted randomized phase II study, NJLCG0601, and chemoradiotherapy with uracil/tegafur (UFT) and cisplatin achieved promising efficacy without severe toxicities. Here, we evaluated between this regimen and pemetrexed plus cisplatin in chemoradiotherapy for stage III non-squamous NSCLC. Methods: Patients with inoperable stage III non-squamous NSCLC were randomly assigned in a 1:1 ratio to UFT 400 mg/m2 on days 1-14 and 29-42, and cisplatin 80 mg/m2 on days 8 and 36 (UP), or cisplatin 75 mg/m2 and pemetrexed 500 mg/m2 on days 1, 22, and 43 (PP). Involved-field radiotherapy (IFRT) underwent from day 1 to a total dose of 66 Gy in 33 fractions. Consolidation chemotherapy after CCRT was prohibited for this study. The primary endpoint was defined as 2-year overall survival (OS). This trial was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN000003948). Results: From November 2010 to June 2017, 86 patients were entered from 11 institutions. Median follow-up was 54 months. Of the 85 eligible patients, the 2-year OS rate was 78.6% (95% CI, 62.8-88.3%) in UP and 85.5% (95% CI, 70.5-93.2%) in PP. Median PFS and OS was 12.3 and 64.2 months in UP, 26.2 months and not reached in PP, respectively. Grade 3/4 febrile neutropenia was more frequent in the UP group (14.0% vs. 2.0%). Conclusions: Both UP and PP with IFRT achieved the expected 2-year OS. PP engendered more favorable OS and PFS compared to UP in terms.
KW - Concurrent chemoradiotherapy (CCRT)
KW - Involved-field radiotherapy (IFRT)
KW - Non-squamous non-small cell lung cancer (NSCLC)
KW - Pemetrexed
KW - Uracil/ tegafur (UFT)
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UR - http://www.scopus.com/inward/citedby.url?scp=85103124929&partnerID=8YFLogxK
U2 - 10.21037/tlcr-20-721
DO - 10.21037/tlcr-20-721
M3 - Article
AN - SCOPUS:85103124929
VL - 10
SP - 712
EP - 722
JO - Translational Lung Cancer Research
JF - Translational Lung Cancer Research
SN - 2226-4477
IS - 2
ER -