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Comparation Of RECIST1.1 And EORTC Criteria For Evaluating The Efficacy Of Advanced NSCLC Treated With EGFR-TKIS

Posted on:2017-07-03Degree:MasterType:Thesis
Country:ChinaCandidate:J XieFull Text:PDF
GTID:2334330485473907Subject:Internal Medicine
Abstract/Summary:PDF Full Text Request
Objective: Lung cancer is one of the largest threat for the human's health and life currently,and the incidence and mortality rates tend to increase year by year.The 5-years survival rate is very low.Non-small cell lung cancer include squamous cell carcinoma,adenocarcinoma,large cell carcinoma and so on,and accounts for 80% of the lung cancer.Because there are few early symptoms,about 75% of patients have been found advanced at the first time of diagnosis,who have lost the chance of operation Chemotherapy,radiotherapy and molecular targeted therapy become the main treatment for the advanced NSCLC.Platinum-based chemotherapy is currently the first-line treatment for the lung cancer.With the development of science and technology,there have been some new drugs in the market,such as Pemetrexed and EGFR-TKIs.The efficacy and safety have been confirmed by a large number of clinical trials.The new drugs improve the quality of life and prolong the survival time of patients.After the patients accepting treatment,an accurate evaluation is essential to comfirm whether the treatment modalities are effective,and whether need Change treatment.RECIST1.0 in 2000 and RECIST 1.1 criteria in 2009 are the most popular criteria.However,RECIST criteria does not adopt the PET/CT into the criteria content,which represent the most advanced medical imaging molecular image.With the application of some new drugs such as pemetrexed,EGFR-TKIs and other treatment modalities,a new evaluation criteria is needed to evaluate changes in the lesion becomes an concern issue to many people.EORTC evaluation criteria use the tumor lesions of 18F-FDG uptake(Standardized utake value,SUV)as a tumor efficacy evaluation.This study was designed by comparing PET / CT and CT to evaluate treatment efficacy,and select a better evaluation criteria to decide the next treatment.Methods: The datas were collected from 26 cases of advanced NSCLC patients confirmed by histopathology since February 2014 to January 2016,in the Fourth Hospital of Hebei Medical Universityof eastern district.Enhanced chest CT and PET / CT examination were done for each patient in the treatment before and after 42 ± 7 days for the evaluation of drug efficacy.The disease control rate and objective response rate were compared using chi-square test,and the Fisher exact test for the theoretical frequency less than 5.We applied Kappa values for the consistency analysis.Using the Wilcoxon Signed-Rank Test to compare the RECIST1.1 and EORTC criteria at evaluating the results.P<0.05 were considered statistically significant.Results: 1 Compare the RECIST 1.1 and EORTC criteria for the evaluation analysisIn the 26 patients,The patients who were evaluated by RECIST criteria as CR,PR,SD and PD were 0,4,18 and 4 cases.The objective response rate was 15.3%,and the disease control rate was 84.6%.When the patients were evaluated by EORTC criteria as CMR,PMR,SMD and PMD were 1,18,2 and 5 cases.The objective response rate was 69.2%,and the disease control rate was 76.9%.Wilcoxon rank sum test results Z for the two methods of evaluating results was-3.441,and P value was 0.001.The difference was statistically significant.There were 18 patients who took EGFR-TKIs.In the 18 patients,The patients who were evaluated by RECIST 1.1 criteria as CR were 0 cases,While PR were 4 cases,SD were 10 cases,and PD were 4 cases.The objective response rate was 22.2%,and the disease control rate was 77.8%.The patients who were evaluated by EORTC criteria as CMR were 0 cases,While PMR were 14 cases,SMD were 0 cases,and PMD were 4 cases.The objective response rate was 77.8%,and the disease control rate was 77.8%.The Wilcoxon rank sum test results Z for the two methods of evaluating results was-3.162,and P value was 0.002.The difference was statitically significant.The objective response rate was 15.3% using the RECIST 1.1 criteria for evaluating the efficacy,while 69.2% using the EORTC criteria.The Fisher's exact test results was P<0.001.The difference was statistically significant.The Kappa value was 0.126 for the objective response rate,and the Kappa value less than 0.4.The consistency was poor between the two criterias.The disease control rate was 84.6% using the RECIST 1.1 criteria for evaluating the efficacy,while 76.9% using the EORTC criteria.The Fisher's exact test results was P =1.0.The difference was not statistically significant.The Kappa values was 0.866 for the disease control rate,and the Kappa values more than 0.75.The consistency was good between the two criterias.2 The influence of baseline SUV values on Prognostic Factors 2.1 The influence of baseline SUV values on PFSIn the 26 patients,the baseline SUV values were measured between 3.1-13.8 before treatment.The median baseline SUV values 6.95.We intercepted 7 as a cut-off point.There were 13 patients which baseline SUV value less than 7,and the median PFS was 6 months.While There were 13 patients which baseline SUV values more than 7,and the median PFS was 8.4 months.The two groups applied the Kaplan-Meier survival curve analysis methods,and made survival Log-rank method for significant test calculating,P = 0.214.There was no statistically significant difference.There were 18 patients who took EGFR-TKIs.The median baseline SUV values 7.25.We intercepted 7 as a cut-off point.There were 8 patients which baseline SUV value less than 7,and the median PFS was 7.5 months.While there were 10 patients which initial SUV values more than 7,and the median PFS was 7.9 months.The two groups applied the Kaplan-Meier survival curve analysis methods,and made survival Log-rank method for significant test calculating,P = 0.492.There was no statistically significant difference.2.2 The influence of baseline SUV value on OSSeven patients had been dead at the end of the study in the 26 patients.The median initial SUV values 10.4 in the 7 patients.We intercepted 10 as a cut-off point.There were 3 patients which initial SUV values less than 10,and the median OS was 15 months.While there were 4 patients which baseline SUV values more than 10,and the median OS was 8.5 months.The two groups applied the Kaplan-Meier survival curve analysis methods,and made survival Log-rank method for significant test calculating,P = 0.377.There was no statistically significant difference.3 The influence of SUV change value on Prognostic Factors 3.1 The influence of SUV change value on PFSIn the 26 patients,the median SUV change value was decreasing 3.2 before and after treatment.We intercepted 3 as a cut-off point,There were 14 patients which SUV reduced value more than 3,and the median PFS was 9.4 months.While there were 12 patients which SUV reduced values less than 3 and increased,and the median PFS was 4 months.The two groups applied the Kaplan-Meier survival curve analysis methods,and made survival Log-rank method for significant test calculating,P<0.001.The difference was statistically significant.In the 18 patients who took EGFR-TKIs,the median SUV change value was 3.2 before and after treatment.We intercepted 3 as a cut-off point,There were 10 patients which SUV reduced value more than 3,and the median PFS was 9 months.While there were 8 patients which SUV reduced value less than 3 and increased,and the median PFS was 4 months.The two groups applied the Kaplan-Meier survival curve analysis methods,and made survival Logrank method for significant test calculating,P<0.001.The difference was statistically significant.3.2 The influence of SUV change value on OSSeven patients had been dead at the end of the study in the 26 patients.The median SUV change value was decreasing 2.4 in the 7 patients.We intercepted 0 as a cut-off point.There were 4 patients which SUV value reduced,and the median PFS 12 months.While there were 3 patients which SUV value increased,and the median OS was 11 months.The two groups applied the Kaplan-Meier survival curve analysis methods,and made survival Log-rank method for significant test calculating,P = 0.932.There was no statistically significant difference.4 The influence of SUV and SUV change value on Prognostic Factors in the patients evaluated SD with the RECIST 1.1 criteriaIn the 26 patients,there were 18 patients evaluated SD with the RECIST 1.1 criteria.The median baseline SUV valued 6.7.We intercepted 7 as a cut-off point.There were 9 patients which baseline SUV values less than 7,and the median PFS was 6 months.While there were 9 patients which baseline SUV valued more than 7,and the median PFS was 8.4 months.The two groups applied the Kaplan-Meier survival curve analysis methods,and made survival Log-rank method for significant test calculating,P = 0.359.There was no statistically significant difference.In the 18 patients evaluated SD with the RECIST 1.1 criteria,the median SUV change value was decreasing 3.2 before and after treatment.We intercepted 3 as a cut-off point,There were 11 patients which SUV reduced value more than 3,and the median PFS was 9 months.While there were 7 patients which SUV value reduced less than 3 and SUV value increased,and the median PFS was 4 months.The two groups applied the Kaplan-Meier survival curve analysis methods,and made survival Log-rank method for significant test calculating,P=0.001.The difference was statistically significant.Conclusions:1 This study show differences between the RECIST and EORTC criteria,especially for the patients who are evaluated SD applying the RECIST criteria.2 This study can show that baselinne SUV values are correlated with prognosis,the overall survival of the patients' baseline SUV value less than 10 is longer(8.4 month vs 15 month,P=0.377).3 This study can show that in the 18 patients evaluated SD with the RECIST 1.1 criteria,the PFS is longer in the patients that the SUV value decreased more than 3(9 month vs 4 month,P=0.377)4 This study can show that SUV change values are correlated with prognosis,especially for the patients who take the EGFR-TKIs.The more SUV value decreases,the longer PFS is.
Keywords/Search Tags:Non-small cell lung cancer, Pemetrexed, EGFR-TKIs, RECIST 1.1 criteria, EORTC criteria
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