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- Title
Chemoradiotherapy with extended nodal irradiation and/or erlotinib in locally advanced oesophageal squamous cell cancer: long-term update of a randomised phase 3 trial.
- Authors
Xie, Congying; Jing, Zhao; Luo, Honglei; Jiang, Wei; Ma, Li; Hu, Wei; Zheng, Anping; Li, Duojie; Ding, Lingyu; Zhang, Hongyan; Xie, Conghua; Lian, Xilong; Du, Dexi; Chen, Ming; Bian, Xiuhua; Tan, Bangxian; Xia, Bing; Xie, Ruifei; Liu, Qing; Wang, Lvhua
- Abstract
<bold>Background: </bold>To report the long-term outcomes of a phase III trial designed to test two hypotheses: (1) elective nodal irradiation (ENI) is superior to conventional field irradiation (CFI), and (2) chemoradiotherapy plus erlotinib is superior to chemoradiotherapy in locally advanced oesophageal squamous cell cancer (ESCC).<bold>Methods: </bold>Patients with locally advanced ESCC were randomly assigned (1:1:1:1 ratio) to one of the four groups: A: radiotherapy adoption of ENI with two cycles of concurrent TP chemotherapy (paclitaxel and cisplatin) plus erlotinib; B: radiotherapy adoption of ENI with two cycles of concurrent TP; C: radiotherapy adoption of CFI with two cycles of concurrent TP plus erlotinib and D: radiotherapy adoption of CFI with two cycles of concurrent TP. A total of 60 Gy of radiation doses was delivered over 30 fractions. We explored the impact of epidermal growth factor receptor (EGFR) expression on the efficacy of erlotinib plus chemoradiotherapy.<bold>Results: </bold>A total of 352 patients (88 assigned to each treatment group) were enrolled. The 5-year survival rates were 44.9%, 34.8%, 33.8% and 19.6% in groups A, B, C and D, respectively (P = 0.013). ENI significantly improved OS compared with standard CFI (median, 38.5 vs 22.6 months; HR, 0.74; P = 0.018). The addition of erlotinib significantly improved OS (median, 39.4 vs 27.4 months; HR, 0.75; P = 0.025). Patients with overexpressing EGFR treated with erlotinib had a better OS and PFS than those without erlotinib.<bold>Conclusions: </bold>Concurrent chemoradiotherapy with ENI and/or erlotinib improved long-term survival in locally advanced ESCC.<bold>Clinical Trial Registration: </bold>Trial registration: NCT00686114.
- Subjects
CLINICAL trials; ANTINEOPLASTIC agents; LYMPH nodes; COMPARATIVE studies; RANDOMIZED controlled trials; CISPLATIN; PACLITAXEL; STATISTICAL sampling; ESOPHAGEAL tumors
- Publication
British Journal of Cancer, 2020, Vol 123, Issue 11, p1616
- ISSN
0007-0920
- Publication type
journal article
- DOI
10.1038/s41416-020-01054-6