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

Sun Yat-sen University

Status: Unknown

Conditions: Non-Small Cell Lung Cancer

Treatments: Other: This item is not applicable to our observational study.

Study type: Observational

Funder types: Other

Identifiers

NCT04722406

SHong

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

350 participants in 2 patient groups

Low TGR group

Description:

Patients with low level of TGR determined by X-tile program

Treatment:

Other: This item is not applicable to our observational study.

High TGR group

Description:

Patients with high level of TGR determined by X-tile program

Treatment:

Other: This item is not applicable to our observational study.