IASLC Grading System as a Predictor for EGFR-TKI Therapy

NCT06131645 | Completed

• 1 other identifier: GRADS-TKI
• Study Type: observational
• Target: 2,160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Disease-free survival

  DFS was defined as time from initiation of surgery to date of first event (recurrence or death)

  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)

  5 years

Secondary Outcomes (1)

• Overall survival

  5 years

Interventions

IASLC grading system DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• invasive lung adenocarcinoma patients who underwent complete resection with positive EGFR mutations in exons 18-21.

You may not qualify if:

• adenocarcinoma in situ (AIS), minimally invasive adenocarcinoma (MIA), invasive mucinous adenocarcinoma and other variants of adenocarcinoma
• patients with pathologic slides unavailable for re-evaluation

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Chaoqiang Deng

Shanghai, Please Select, 200032, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director in the Department of Thoracic Surgery, FUSCC

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: July 1, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

CN (1)