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

Abstract

Background: The optimal regimen for concurrent chemoradiotherapy (CCRT) of locally advanced nonsquamous 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/m 2 on days 1-14 and 29-42, and cisplatin 80 mg/m 2 on days 8 and 36 (UP), or cisplatin 75 mg/m 2 and pemetrexed 500 mg/m 2 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 followup 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%).

Creation of an Integrated Clinical Trial Database and Data Sharing for Conducting New Research by the Japan Lung Cancer Society

“…All clinical trial groups have abundant experience and strong achievements, The JCOG Lung Cancer Study Group reported results of four phase 3 trials between 2014 and 2016, 15 , 16 , 17 , 18 and the WJOG also reported results of four phase 3 trials targeting lung cancer in the past 5 years. 19 , 20 , 21 , 22 The NJLCG and TORG have reported four 23 , 24 , 25 , 26 and three 12 , 27 , 28 randomized phase 2 trials, respectively, and several other single-arm trials in the past 5 years. The National Cancer Center Hospital EAST was the lead site of the SPECTRA trial, and the primary investigator, Niho Seiji, has abundant experience from many clinical trials, 29 , 30 , 31 , 32 , 33 which made it possible to constitute a reliable data set.…”

Comparison of post-chemoradiotherapy pneumonitis between Asian and non-Asian patients with locally advanced non-small cell lung cancer: a systematic review and meta-analysis

“…1 . Among the 248 studies, 174 studies (85 Asian and 89 non-Asian) with 20,999 patients examined definitive CRT without immunotherapy, 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 70 , 71 , 72 , 73 , 74 , 75 , 76 ,…”