An observational study in Lung Cancer, sponsored by Fudan University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by Fudan University · Observational
The investigators previously validated the grading system proposed by International Association for the Study of Lung Cancer (IASLC) for invasive nonmucinous lung adenocarcinoma (LADC) for its reproducibility, prognostication function and predictive value of adjuvant chemotherapy (ACT). In this exploratory study, the investigators aimed to investigate the role of IASLC grading system in EGFR tyrosine kinase inhibitor (TKI) therapy selection either as adjuvant or palliative therapy.
Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
Counted across the registry records on this site, refreshed daily.
From January 2008 to April 2021, we consecutively collected lung adenocarcinoma patients who underwent complete resection at the Department of Thoracic Surgery, Fudan University Shanghai Cancer Center (FUSCC), Shanghai, China. The 8th TNM staging was used in this study. The study included three main subgroups: (1) patients with p-TNM stage Ib-III LADCs received adjuvant EGFR-TKI or chemotherapy (ADJUVANT subgroup, N=620), (2) patients developed post-operative recurrence and treated with either EGFR-TKI or chemotherapy (RECURRENCE subgroup, N=321), and (3) next-generation sequencing (NGS) was carried out which provided co-occurring mutation information (NGS subgroup, N=1158).
Exclusion Criteria:
A cohort of 2160 patients with invasive nonmucinous EGFR-mutant LADCs were retrospectively collected and classified according to the IASLC grading system. The role of IASLC grading system in EGFR tyrosine kinase inhibitor (TKI) therapy selection either as adjuvant or palliative therapy was investigated.
Disease-free survival
DFS was defined as time from initiation of surgery to date of first event (recurrence or death)
Time frame: 5 years
Progression-free survival
PFS was defined as time from initiation of systemic palliative treatment to date of disease progression or death for 1L treatment of each patient and the initiation time was re-assigned additionally for each drug applied during the treatment history of the patients regardless of line of therapy (all lines)
Time frame: 5 years
Overall survival
was defined as time from surgery to date of death resulting from any cause in ADJUVANT subgroup and from 1L systemic palliative treatment assignment to date of death resulting from any cause in RECURRENCE subgroup.
Time frame: 5 years
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Fudan University