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. 2021 Feb;10(2):712-722.
doi: 10.21037/tlcr-20-721.

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: NJLCG1001

Kana Watanabe  1 , Yukihiro Toi  2 , Atsushi Nakamura  2 , Ryosuke Chiba  3 , Masachika Akiyama  3 , Jun Sakakibara-Konishi  4 , Hisashi Tanaka  5 , Naruo Yoshimura  6 , Eisaku Miyauchi  7 , Taku Nakagawa  8 , Ryotaro Igusa  9 , Hiroyuki Minemura  10 , Yoshiaki Mori  11 , Keisuke Fujimoto  12 , Haruo Matsushita  13 , Fumiaki Takahashi  14 , Tatsuro Fukuhara  1 , Akira Inoue  15 , Shunichi Sugawara  2 , Makoto Maemondo  3 ; North Japan Lung Cancer Study Group, Sendai, Japan
Affiliations

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: NJLCG1001

Kana Watanabe et al. Transl Lung Cancer Res. 2021 Feb.

Abstract

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.

Keywords: Concurrent chemoradiotherapy (CCRT); involved-field radiotherapy (IFRT); non-squamous non-small cell lung cancer (NSCLC); pemetrexed; uracil/tegafur (UFT).

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Conflict of interest statement

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/tlcr-20-721). YT reports personal fees from AstraZeneca, Bristol-Myers Squibb, MSD, Ono Pharmaceutical, outside the submitted work. Atsushi Nakamura reports personal fees from MSD, AstraZeneca, Boehringer Ingelheim Japan, outside the submitted work. EM reports grants and personal fees from Chugai pharmaceutical co ltd, Ono pharmaceutical co., ltd., Boehringer Ingelheim, Eli Lilly Japan, and personal fees from AstraZeneca, Taiho pharma, Kyowa kirin, Daiichi sankyo, MSD, Bristol-Meyers Squibb, Novartis, Merck Bio, outside the submitted work. HM reports personal fees from Ono Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Eli Lilly Japan, Chugai Pharmaceutical Co., Ltd., outside the submitted work. TF reports grants from Ono Pharmaceutical Co., Bristol Myers Squibb, AstraZeneca, MSD, outside the submitted work. AI reports personal fees from Eli Lilly Japan, outside the submitted work. Shunichi Sugawara reports personal fees from Eli Lilly Japan, Taiho Pharmaceutical, MSD, AstraZeneca, Bristol-Myers Squibb, Ono Pharmaceutical, Chugai Pharma, Nippon Boehringer Ingelheim, Pfizer, Novartis, Kyowa Kirin, Yakult Honsha, outside the submitted work. MM reports personal fees from Eli Lilly Japan, grants from Taiho, outside the submitted work. The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
CONSORT diagram. 86 patients were enrolled from11 institutions. Finally 85 patients were evaluable for efficacy and safety.
Figure 2
Figure 2
Kaplan–Meier curves. (A) Overall survival and (B) progression-free survival for the randomly assigned treatment arms.
Figure 3
Figure 3
Subgroup analysis. Overall survival (A) and progression-free survival (B) hazard ratio in subgroups according to baseline characteristics.
See this image and copyright information in PMC

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