IASLC Grading System as a Predictor for EGFR-TKI Therapy

The IASLC Grading System as a Predictor for EGFR-TKI Therapy in EGFR-mutant Lung Adenocarcinoma

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Diagnostic test: IASLC grading system

• Study Type: Observational
• Enrollment (Actual): 2160

Contacts and Locations

Study Locations

• China
  • Please Select
    • Shanghai, Please Select, China, 200032
      • Chaoqiang Deng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: GRADS-TKI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No