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

Tumor Growth Rate (TGR) as an Early Predictor of Clinical Outcomes in Advanced Non-small Cell Lung Cancer Treated With PD-1 Axis Inhibitors.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04722406

Enrollment

350

Registered

2021-01-25

Start date

2019-08-15

Completion date

2021-08-01

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Keywords

Tumor Growth Rate, NSCLC, immunotherapy

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.

Interventions

OTHERThis item is not applicable to our observational study.

This item is not applicable to our observational study.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactShaodong Hong, MD

hongshd@sysucc.org.cn+8615920527656

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026