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Optimal tumor shrinkage predicts long-term outcome in advanced nonsmall cell lung cancer (NSCLC) treated with target therapy: Result from 3 clinical trials of advanced NSCLC by 1 institution.

He X, Zhang Y, Ma Y, Zhou T, Zhang J, Hong S, Sheng J, Zhang Z, Yang Y, Huang Y, Zhang L, Zhao H - Medicine (Baltimore) (2016)

Bottom Line: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are used as standard therapies for advanced nonsmall cell lung cancer (NSCLC) patients with EGFR mutation positive.Univariate and multivariate Cox regression analyses were performed to compare the progression-free survival (PFS) and overall survival (OS) between responders and nonresponders stratified based on radiologic criteria.Among the 88 NSCLC patients, 26 were responders and 62 were nonresponders based on RECIST 1.0.Univariate and multivariate Cox regression analyses indicated that (1) the responders (≤8.32%) and nonresponders (≥ -8.32%) were significantly different in median PFS (13.40 vs 1.17 months, P < 0.001) and OS (19.80 vs 7.90 months, P < 0.001) and (2) -8.32% in SLD could be used as the optimal threshold for PFS (hazard ratio [HR], 8.11, 95% CI, 3.75 to 17.51, P < 0.001) and OS (HR, 2.36, 95% CI, 1.41 to 3.96, P = 0.001).However, 8.32% tumor diameter shrinkage is validated as a reliable outcome predictor of advanced NSCLC patients receiving EGFR-TKIs therapies and may provide a practical measure to guide therapeutic decisions.

View Article: PubMed Central - PubMed

Affiliation: aDepartment of Medical Oncology, Sun Yat-Sen University Cancer Center bState Key Laboratory of Oncology in South China, Guangzhou, China.

ABSTRACT
Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are used as standard therapies for advanced nonsmall cell lung cancer (NSCLC) patients with EGFR mutation positive. Because these targeted therapies could cause tumor necrosis and shrinkage, the purpose of the study is to search for a value of optimal tumor shrinkage as an appropriate indicator of outcome for advanced NSCLC.A total of 88 NSCLC enrollees of 3 clinical trials (IRESSA registration clinical trial, TRUST study and ZD6474 study), who received Gefitinib (250 mg, QD), Erlotinib (150 mg, QD), and ZD6474 (100 mg, QD), respectively, during December 2003 and October 2007, were retrospectively analyzed. The response evaluation criteria in solid tumors (RECIST) were used to identify responders, who had complete response (CR) or partial responses (PR) and nonresponders who had stable disease (SD) or progressive disease (PD). Receiver operating characteristics (ROC) analysis was used to find the optimal tumor shrinkage as an indicator for tumor therapeutic outcome. Univariate and multivariate Cox regression analyses were performed to compare the progression-free survival (PFS) and overall survival (OS) between responders and nonresponders stratified based on radiologic criteria.Among the 88 NSCLC patients, 26 were responders and 62 were nonresponders based on RECIST 1.0. ROC indicated that 8.32% tumor diameter shrinkage in the sum of the longest tumor diameter (SLD) was the cutoff point of tumor shrinkage outcomes, resulting in 46 responders (≤8.32%) and 42 nonresponders (≥8.32%). Univariate and multivariate Cox regression analyses indicated that (1) the responders (≤8.32%) and nonresponders (≥ -8.32%) were significantly different in median PFS (13.40 vs 1.17 months, P < 0.001) and OS (19.80 vs 7.90 months, P < 0.001) and (2) -8.32% in SLD could be used as the optimal threshold for PFS (hazard ratio [HR], 8.11, 95% CI, 3.75 to 17.51, P < 0.001) and OS (HR, 2.36, 95% CI, 1.41 to 3.96, P = 0.001).However, 8.32% tumor diameter shrinkage is validated as a reliable outcome predictor of advanced NSCLC patients receiving EGFR-TKIs therapies and may provide a practical measure to guide therapeutic decisions.

No MeSH data available.


Related in: MedlinePlus

Baseline and first follow-up computed tomography (CT) images of a 60-year-old man with metastatic lung adenocarcinoma treated with EGFR-TKIs. Axial CT images at baseline (A and B) demonstrate the target left lung and liver metastases (green measurement lines), measuring 71.06 mm and 10.06 mm in long axis, respectively. Axial contrast-enhanced CT at first follow-up after treatment initiation (C and D) demonstrated ∼9% decrease in the sum of the longest diameter of the targets (green measurement lines), measuring 64.20 mm and 10.11 mm, respectively. CT = computed tomography, EGFR = epidermal growth factor receptor, TKI = tyrosine kinase inhibitors.
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Figure 1: Baseline and first follow-up computed tomography (CT) images of a 60-year-old man with metastatic lung adenocarcinoma treated with EGFR-TKIs. Axial CT images at baseline (A and B) demonstrate the target left lung and liver metastases (green measurement lines), measuring 71.06 mm and 10.06 mm in long axis, respectively. Axial contrast-enhanced CT at first follow-up after treatment initiation (C and D) demonstrated ∼9% decrease in the sum of the longest diameter of the targets (green measurement lines), measuring 64.20 mm and 10.11 mm, respectively. CT = computed tomography, EGFR = epidermal growth factor receptor, TKI = tyrosine kinase inhibitors.

Mentions: A total of 88 patients were included in the retrospective analysis. Their median follow-up time was 12 months. Table 1 lists the baseline characteristics of all patients. Their median age was 55 years (range: 26–74 years). Among these patients, 37 patients (42.0%) were female and 46 (52.3%) were nonsmokers. In total, 73 patients (82.9%) were in Stage IV. Evaluation of all 88 patients by RECIST 1.0 and using 8.32% tumor diameter shrinkage as thresholds indicated that (1) the objective response rate (CR+PR) was 29.5%, (2) 46 (52.3%) patients were considered as responders (Fig. 1) whereas 42 (47.7%) were deemed as nonresponders. Changes of SLD of target lesions by referencing to baseline in all patients were in the range of 100% decrease to 110% increase in the SLD (Fig. 2). Table 2 shows the characteristics of patients in each subgroup.


Optimal tumor shrinkage predicts long-term outcome in advanced nonsmall cell lung cancer (NSCLC) treated with target therapy: Result from 3 clinical trials of advanced NSCLC by 1 institution.

He X, Zhang Y, Ma Y, Zhou T, Zhang J, Hong S, Sheng J, Zhang Z, Yang Y, Huang Y, Zhang L, Zhao H - Medicine (Baltimore) (2016)

Baseline and first follow-up computed tomography (CT) images of a 60-year-old man with metastatic lung adenocarcinoma treated with EGFR-TKIs. Axial CT images at baseline (A and B) demonstrate the target left lung and liver metastases (green measurement lines), measuring 71.06 mm and 10.06 mm in long axis, respectively. Axial contrast-enhanced CT at first follow-up after treatment initiation (C and D) demonstrated ∼9% decrease in the sum of the longest diameter of the targets (green measurement lines), measuring 64.20 mm and 10.11 mm, respectively. CT = computed tomography, EGFR = epidermal growth factor receptor, TKI = tyrosine kinase inhibitors.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4979775&req=5

Figure 1: Baseline and first follow-up computed tomography (CT) images of a 60-year-old man with metastatic lung adenocarcinoma treated with EGFR-TKIs. Axial CT images at baseline (A and B) demonstrate the target left lung and liver metastases (green measurement lines), measuring 71.06 mm and 10.06 mm in long axis, respectively. Axial contrast-enhanced CT at first follow-up after treatment initiation (C and D) demonstrated ∼9% decrease in the sum of the longest diameter of the targets (green measurement lines), measuring 64.20 mm and 10.11 mm, respectively. CT = computed tomography, EGFR = epidermal growth factor receptor, TKI = tyrosine kinase inhibitors.
Mentions: A total of 88 patients were included in the retrospective analysis. Their median follow-up time was 12 months. Table 1 lists the baseline characteristics of all patients. Their median age was 55 years (range: 26–74 years). Among these patients, 37 patients (42.0%) were female and 46 (52.3%) were nonsmokers. In total, 73 patients (82.9%) were in Stage IV. Evaluation of all 88 patients by RECIST 1.0 and using 8.32% tumor diameter shrinkage as thresholds indicated that (1) the objective response rate (CR+PR) was 29.5%, (2) 46 (52.3%) patients were considered as responders (Fig. 1) whereas 42 (47.7%) were deemed as nonresponders. Changes of SLD of target lesions by referencing to baseline in all patients were in the range of 100% decrease to 110% increase in the SLD (Fig. 2). Table 2 shows the characteristics of patients in each subgroup.

Bottom Line: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are used as standard therapies for advanced nonsmall cell lung cancer (NSCLC) patients with EGFR mutation positive.Univariate and multivariate Cox regression analyses were performed to compare the progression-free survival (PFS) and overall survival (OS) between responders and nonresponders stratified based on radiologic criteria.Among the 88 NSCLC patients, 26 were responders and 62 were nonresponders based on RECIST 1.0.Univariate and multivariate Cox regression analyses indicated that (1) the responders (≤8.32%) and nonresponders (≥ -8.32%) were significantly different in median PFS (13.40 vs 1.17 months, P < 0.001) and OS (19.80 vs 7.90 months, P < 0.001) and (2) -8.32% in SLD could be used as the optimal threshold for PFS (hazard ratio [HR], 8.11, 95% CI, 3.75 to 17.51, P < 0.001) and OS (HR, 2.36, 95% CI, 1.41 to 3.96, P = 0.001).However, 8.32% tumor diameter shrinkage is validated as a reliable outcome predictor of advanced NSCLC patients receiving EGFR-TKIs therapies and may provide a practical measure to guide therapeutic decisions.

View Article: PubMed Central - PubMed

Affiliation: aDepartment of Medical Oncology, Sun Yat-Sen University Cancer Center bState Key Laboratory of Oncology in South China, Guangzhou, China.

ABSTRACT
Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are used as standard therapies for advanced nonsmall cell lung cancer (NSCLC) patients with EGFR mutation positive. Because these targeted therapies could cause tumor necrosis and shrinkage, the purpose of the study is to search for a value of optimal tumor shrinkage as an appropriate indicator of outcome for advanced NSCLC.A total of 88 NSCLC enrollees of 3 clinical trials (IRESSA registration clinical trial, TRUST study and ZD6474 study), who received Gefitinib (250 mg, QD), Erlotinib (150 mg, QD), and ZD6474 (100 mg, QD), respectively, during December 2003 and October 2007, were retrospectively analyzed. The response evaluation criteria in solid tumors (RECIST) were used to identify responders, who had complete response (CR) or partial responses (PR) and nonresponders who had stable disease (SD) or progressive disease (PD). Receiver operating characteristics (ROC) analysis was used to find the optimal tumor shrinkage as an indicator for tumor therapeutic outcome. Univariate and multivariate Cox regression analyses were performed to compare the progression-free survival (PFS) and overall survival (OS) between responders and nonresponders stratified based on radiologic criteria.Among the 88 NSCLC patients, 26 were responders and 62 were nonresponders based on RECIST 1.0. ROC indicated that 8.32% tumor diameter shrinkage in the sum of the longest tumor diameter (SLD) was the cutoff point of tumor shrinkage outcomes, resulting in 46 responders (≤8.32%) and 42 nonresponders (≥8.32%). Univariate and multivariate Cox regression analyses indicated that (1) the responders (≤8.32%) and nonresponders (≥ -8.32%) were significantly different in median PFS (13.40 vs 1.17 months, P < 0.001) and OS (19.80 vs 7.90 months, P < 0.001) and (2) -8.32% in SLD could be used as the optimal threshold for PFS (hazard ratio [HR], 8.11, 95% CI, 3.75 to 17.51, P < 0.001) and OS (HR, 2.36, 95% CI, 1.41 to 3.96, P = 0.001).However, 8.32% tumor diameter shrinkage is validated as a reliable outcome predictor of advanced NSCLC patients receiving EGFR-TKIs therapies and may provide a practical measure to guide therapeutic decisions.

No MeSH data available.


Related in: MedlinePlus