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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Other: This item is not applicable to our observational study.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low TGR group<br>Patients with low level of TGR determined by X-tile program | Other: This item is not applicable to our observational study.<br>* This item is not applicable to our observational study.<br>|
| High TGR group<br>Patients with high level of TGR determined by X-tile program | Other: This item is not applicable to our observational study.<br>* This item is not applicable to our observational study.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival of patients undergoing ICI monotherapy. | Progression-free survival was calculated from ICI initiation to radiologically-defined progression or death from any causes. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tumor Growth Rate, NSCLC, immunotherapy