Tumor Growth Rate (TGR) Predicts Clinical Outcomes for Advanced Non-small Cell Lung Cancer Undergoing Immunotherapy.

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Other: This item is not applicable to our observational study.

• Registration Number: NCT04722406
• Lead Sponsor: Sun Yat-sen University

Brief Summary

We hypothesized that TGR could serve as an early predictor of outcomes for aNSCLC patients undergoing immune checkpoint inhibitors (ICIs). A retrospective analysis was conducted to investigate the association of TGR with response and long-term survival of aNSCLC patients undergoing ICI therapy.

Detailed Description

Tumor growth rate (TGR) signifies percentage change in tumor size per month (%/m). Electronic medical records were retrospectively reviewed for all histologically confirmed aNSCLC patients undergoing anti-PD-1/PD-L1 therapy at Sun Yat-Sen University Cancer Center (SYSUCC) between August 2016 and June 2018.

All response and outcome evaluation were determined as per RECIST 1.1 by two senior radiologists blinded to patients'information. Discrepancy was solved by consensus.

X-tile software was used to determine cut-off values that maximumly differentiate overall survival (OS). Log-rank tests and Cox regression models were performed for survival analysis. The predictive value of TGR for clinical outcomes in ICI-treated aNSCLC patients was validated in two external cohorts, recruited form Guangdong Province Traditional Chinese Medical Hospital and Shanghai Chest Hospital.

Study Timeline

• Study Start: 2019-08-15
• Study First Submitted: 2021-01-18
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-25
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17
• Primary Completion: 2021-07-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Histologically confirmed aNSCLC patients
• Having received anti-PD-1/PD-L1 therapy
• Must have two consecutive computed tomography (CT) scans upon early treatment (from baseline to the first imaging evaluation)

Exclusion Criteria

• Lacking available computed tomography (CT) evaluation at any of two time points-baseline and the first evaluation
• Without measurable lesions at baseline CT scan
• Having received local anticancer therapy during ICI treatment, for example, radiotherapy and radiofrequency ablation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low TGR group	This item is not applicable to our observational study.	Patients with low level of TGR determined by X-tile program
High TGR group	This item is not applicable to our observational study.	Patients with high level of TGR determined by X-tile program

Primary Outcome Measures

Name	Time	Method
Overall survival of patients undergoing ICI monotherapy	From date of ICI treatment initiation until the date of death from any causes, assessed up to 100 months.	Overall survival (OS) was defined as the time from immunotherapy initiation to death from any causes.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival of patients undergoing ICI monotherapy.	From date of ICI treatment initiation until the date of first documented progression or date of death from any causes, whichever came first, assessed up to 100 months.	Progression-free survival was calculated from ICI initiation to radiologically-defined progression or death from any causes.

Trial Locations

Locations (3)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Guangdong Provincial Hospital of Traditional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

Shaihai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China