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ADJUVANT-CTONG1104 is a randomized Phase III trial that shows that gyfroteni-assisted therapy can significantly improve the disease-free survival (DFS) of patients with non-small cell lung cancer (NSCLC) in stage II-IIIA (N1-N2) surgically removed with EGFR mutations compared to Changchun Ruibin joint cisplatin (VP).
the study's final overall survival (OS) results are reported in this paper.
the trial recruited 222 patients from 27 locations between September 2011 and April 2014, 1:1 randomly divided into two groups (111 patients each).
group: auxiliary treatment for 24 months, VP group: 3 Monday sessions, 4 courses in a row.
end point is DFS.
secondary endpoints include OS, 3/5 DFS and 5 OS.
80 months of follow-up in the prognosm of the two groups.
75.5 months and 62.8 months in the Gifeitini and VP groups (risk ratio of 0.92, 95% CI 0.62-1.36, p-0.674, 53.2% and 51.2%, respectively).
follow-up treatment in both groups was 68.4% of patients treated with gifeitinib and 73.6% of patients treated with VP received follow-up treatment during the progression period.
targeted treatment significantly affected OS (HR 0.23, 95% CI 0.14-0.38) compared to no follow-up treatment.
the latest three-year DFS rates for the two latest DFS groups and the VP group were 39.6% and 32.5%, respectively, and the five-year DFS rate was 22.6% and 23.2%, respectively.
, Gydfetinib-assisted therapy for early NSCLC patients with EGFR mutations improved patients' DFS compared to standard chemotherapy.
although this DFS advantage did not translate into significant OS differences, the OS of Gfeitinib-assisted therapy was one of the longest observed OSs in this class of patients compared to historical data.
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