Tcm Efficacy Evaluation Criteria And The Western Response Evaluation Criteria (recist) In Advanced Colorectal Cancer In Comparison

Background:With a long history of using Chinese Medicine (CM) for cancer, it has been made a great progress recently. With seeking a variety of ways in CM, as well as exploring the indicators of curative effect in CM, especially for advanced cancer, although TMN staging in Western Medicine has been accepted and used with no reserve in the criteria of CM diagnosis and treatment of cancer, some differences still exist between CM and WM in the evaluation criterion. At present, based on CM regime processed to cancer, aim is to restore quality of life(QOL) after radical operation as soon as possible, to improve the sensitivity of radio-chemotherapy, to reduce side effect with recurrence and metastasis, to improve cure rates, to prolong survival (namely, to control tumor growth)etc[1]. Therefore, it is a serious problem, in which how to evaluate the criteria of CM in the treatment of cancer, and has been recognized and accepted by scholars coming from at home and abroad.For Advanced Cancer Clinical evaluation of treatment decisions for clinicians treating patients with the next step the researchers decided to study the program or project (such as drug trials) whether it is worthwhile to continue the important basis[2].At present the efficacy of TCM treatment of cancer has basically adopted the western standard evaluation criteria, although the efficacy of Chinese medicine in recent years, there are many standards, but most lack the system of mathematical statistics, not yet comprehensive,objective tumor response to treatment efficacy of Chinese medicine and advantages,it is necessary clinical development of a unified Chinese medicine treatment of cancer efficacy evaluation criteria, and that the standard should be precise and objective outcome measures and outcome indicators.RECIST criteria for solid tumor effects of objective changes in tumor size as a basis for evaluation and can not reflect the Chinese medicine treatment with tumor survival and efficacy of a high quality of life features, but how to make the clinical efficacy evaluation to objectivity, quantification, standardization, "there will be help solve long-standing intractable problems of TCM therapy "[3]3]. U.S. Office of Alternative Medicine Advisory Committee in 1995, "Alternative Medicine Research Methodology," pointed out:traditional/alternative medicine therapies, "the effectiveness of evaluation is a critical and core issues", "its effect must be the endpoint of the people to be recognized confirmed that "[4]4].This study in a number of Chinese and Western academic experts under the guidance of advanced colorectal cancer will affect more than one factors Cox regression analysis to explore the Chinese medicine treatment of advanced colorectal cancer prognostic factors, screening out the effects of integrated TCM with advanced colorectal cancer evaluation, the establishment of advanced colorectal cancer survival prediction model in an attempt to establish the basis of efficacy of the standard model of integrated TCM [5]5]and objective response with RECIST criteria for solid tumors were compared.Objective:1. TCM Comprehensive Treatment of advanced colorectal cancer prognostic factors.2.TCM Comprehensive Treatment with advanced colorectal cancer screening efficacy evaluation.3.To establish and verify the efficacy of TCM Comprehensive Treatment with advanced colorectal cancer the standard model.4.Solid Tumors criteria and RECIST Chinese medicine and integrative medicine in the treatment of advanced colorectal cancer compared value.Methods:Based on the literature review of January 2002-2009 years in December Xiyuan Hospital of China Academy of Traditional Chinese Medicine Oncology consecutive patients hospitalized with advanced clinical data of 177 cases of colorectal cancer, including less than two months for 56 cases treated by TCM Comprehensive Treatment,while excluded 32 cases because of tumor-free Changes at the exclusion of information, of which 89 patients complete data included in the study.Contents:1.Retrospective analysis of the continuity of cases, will affect the 14 advanced colorectal cancer factors Kaplan-Meier survival curve (log-rank test) analysis, weed out the integrated traditional Chinese medicine treatment of advanced colorectal cancer prognostic factors.2.The selection of integrated traditional Chinese medicine treatment of advanced colorectal cancer prognostic factors in Cox multivariate regression analysis of effects of TCM Comprehensive Treatment with advanced colorectal cancer evaluation.3.According to Cox multivariate regression analysis, advanced colorectal cancer and the prognostic index of survival prediction model.4.Test model,the establishment of TCM Comprehensive Treatment effective evaluation model.5.Validate the model, the efficacy of the standard model of TCM Comprehensive Treatment Solid Tumors criteria and RECIST medicine and integrative medicine in the treatment of advanced colorectal cancer compared value.5.1 Comprehensive Therapy Chinese Solid Tumors criteria and RECIST compared constituent ratio.5.2 Integrated Traditional solid tumors criteria with RECIST criteria with the survival time of analysis.Results:1.According to Kaplan-Meier survival curve (log-rank test) analysis, weed out the integrated traditional Chinese medicine treatment of advanced colorectal cancer prognostic factors for the changes in tumor size, Karnofsky score, body weight changes, changes of main symptoms, pain changes, Pulse 6 items.2.To screen out the effects of integrated TCM standard evaluation for Cox multivariate regression analysis, screening out the effects of TCM Comprehensive Treatment evaluation changes as tumor size, Karnofsky score, weight change, changes in four main disease.3.According to Cox multivariate regression to predict survival in advanced colorectal cancer model:h (t, x)= h0 (t)×e (1.510×changes of tumor size+0.827 xchanges of body weight+0.826 xchanges of main symptoms+0.757×changes of KPS), derived prognostic index (Prognostic index, PI) calculation formula:PI= 1.510×changes of tumor size +0.827 xchanges of body weight+0.826 xchanges of main symptoms+0.757 xchanges of KPS.4.Advanced colorectal cancer survival prediction model by the overall X2 test, the level of a= 0.05, X2= 64.697, (?)= 4, P<0.001, the model can be considered statistically significant, indicating that a reasonable equation.5.The establishment of TCM Comprehensive Treatment efficacy of the standard model, including four factors, namely, changes in tumor size, Karnofsky score, weight change, the main bone. Traditional methods for the comprehensive effect: effect:changes in tumor size for the disease control (CR+PR+SD), Karnofsky score, weight change, changes in four main disease all the stable or the basis of one and a more improved. Deterioration:changes in tumor size, Karnofsky score, weight change, changes in four main disease,≥1 entry for worse.6.Retrospective analysis of 89 cases of advanced colorectal cancer, the efficacy of the standard evaluation of TCM Comprehensive Treatment effective in 28 cases, worsened in 61 cases; RECIST Solid Tumors criteria to evaluate the CR0例,PR:23例,SD:42例,PD:24例that disease control in 65 cases,24 cases of disease progression. Pearson Chi-square test results showed that in a= 0.05 level, X2 15.084, v= 1, P<0.001, shows in 89 patients with advanced colorectal evaluation of the efficacy of the two standards significantly. TCM Comprehensive Treatment more stringent requirements for effective,In fact, it is the standard RECIST Solid Tumors disease control (CR+PR+SD) basis, Karnofsky score, weight change, change in three main disorders are not worsened.7. Traditional comprehensive criteria with RECIST Solid Tumors criteria and survival time of analysis:7.1 For 89 cases of patients with advanced colorectal cancer,65 patients were evaluated as disease control (CR, PR, SD)as a valid criteria under RECIST criteria,while 28 patients were done under criteria of TCM Comprehensive Treatment, then, comparing with the listed above treatments, the result indicated that the median survival time was 16.0±3.45 (95% CI 9.24,22.76) and 25.0±7.04 (95% CI 11.20,38.80), in a= 0.05 level, X2= 5.508, P= 0.019, the difference was statistically significant.7.2 For 89 cases of patients with advanced colorectal cancer,24 patients were evaluated as disease progress (PD)as a valid criteria under RECIST criteria,while 61 patients were worsen under criteria of TCM Comprehensive Treatment,then,comparing with the listed above treatments, the result indicated that the median survival time was 5.0±0.95 (95% confidence interval 3.13,6.87) and 6.0±0.75 (95% confidence interval 4.52,7.48), the level of a= 0.05, X2= 4.581, P= 0.032, the difference was statistically significant.Conclusions:The standard used to evaluate the efficacy of Comprehensive Treatment of TCM with the treatment of advanced colorectal cancer prognosis better than RECIST Solid Tumors criteria, efficacy criteria better reflect the integrated TCM quality of life of patients.