A Retrospective Study of Radiotherapy Combined With EGFR-TKI for Stage III EGFR Mutant Lung Cancer

Objective: To investigate the efficacy and safety of radiotherapy combined with EGFR-KI in the treatment of stage III EGFR mutant lung cancer. Methods: Stage III EGFR mutant lung cancer cases who underwent radiotherapy combined with EGFR-TKI from December 2014 to December 2022 at the People's Hospital of Laibin, the First People's Hospital of Yulin, the Affiliated Hospital of Guilin Medical College, and the Park East Hospital of Guangxi Medical University Kaiyuan were collected, and the primary index of the study was progression-free survival (PFS), and the secondary indexes were objective remission rate, overall survival, recurrence pattern, and adverse events. Survival analysis was performed using the Kaplan-Meier method with Log rank test for univariate analysis and Cox proportional risk model for multifactorial analysis of prognosis.

Study Overview

• Status: Completed
• Conditions: The Primary Study Metric is Progression-free Survival (PFS)

• Study Type: Observational
• Enrollment (Actual): 48

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with lung cancer by pathology,genetic testing for EGFR mutation type

Description

Inclusion Criteria:

• ①patients diagnosed with lung cancer by pathology; ②genetic testing for EGFR mutation type; ③compliance with the international eighth edition of lung cancer TNM stage IIIA-IIIC; ④treatment modality of radiotherapy + targeted therapy. ⑤Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 2

Exclusion Criteria:

• (1) those who underwent surgery; (2) those who received chemotherapy. (3) Combination of other serious diseases that affect survival.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
an open-label, multiinstitutional, single-arm retrospective study; Three-dimensional conformal radiotherapy (3DCRT) or intensity-modulated conformal radiotherapy (IMRT) at a prescribed dose of 54-66 Gy/27-33 f. The combined TKI includes gefitinib, erlotinib, erlotinib, oseltinib, and ametinib. The specific uses are: gefitinib 250 mg orally once daily; erlotinib 125 mg orally three times daily; erlotinib 150 mg orally once daily; oseltinib 80 mg orally once daily; ametinib 110 mg orally once daily. TKI is taken until disease progression or intolerability.
RT+C; Three-dimensional conformal radiotherapy (3DCRT) or intensity-modulated conformal radiotherapy (IMRT) at a prescribed dose of 54-66 Gy/27-33 f. The combined TKI includes gefitinib, erlotinib, erlotinib, oseltinib, and ametinib. The specific uses are: gefitinib 250 mg orally once daily; erlotinib 125 mg orally three times daily; erlotinib 150 mg orally once daily; oseltinib 80 mg orally once daily; ametinib 110 mg orally once daily. TKI is taken until disease progression or intolerability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival (PFS)	the time from treatment initiation to first documented progressive disease (PD) or time to death.	2 years

Collaborators and Investigators

• Sponsor: Laibin People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression
• Other Study ID Numbers: Z-G20221781

Drug and device information, study documents

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