| Cancer is a serious disease that threatens human health. With the changes in the bio-psycho-social medical modality, the focus of cancer treatment outcome gradually shifts from local tumor size to the patient’s general condition and their quality of lives. A variety of treatment (such as surgery, radiotherapy, chemotherapy, targeted therapy, Traditional Chinese Medicine(TCM), immunotherapy, etc.) forms the integrative cancer treatment modality, but efficacy evaluation is the key that defines any kind of new treatment. Evaluation of efficacy determines whether a treatment or a research project should continue.TCM is an important part of the integrative cancer treatment modality. But the following questions have long plagued TCM scholars:Is the treatment to cancer with TCM valid? How to evaluate? Although many scholars have carried out long-term researches, the lack of unified standard, the variability of therapeutic interventions and poor reproduction in TCM syndrome differentiation and treatment have increased the difficulty of TCM clinical efficacy evaluation.In western medicine, for over the past50years, solid tumor response evaluation criteria has changed from the WHO criteria to RECIST (1.0) and then to RECIST (1.1). All the evaluation is based on the measurement of tumor size, with eradication of tumor as the theoretical basis, mainly targeting to evaluate the efficacy of chemotherapy drugs. Although the RECIST (1.1) seeks to be objective and accurate, it still cannot express the state of tumor cell metabolism. Currently, cancer is considered as a chronic disease, to evaluate the efficacy of changes in tumor size and to pursue the outcome of "zero tumor" may lead to over-treatment and damage of the body’s own regulation to tumor. For targeted drugs, immunotherapy, TCM,etc, the changes in tumor size cannot fully represent the treatment benefit.Evaluation of the clinical efficacy of treating cancer with TCM should be directed by the theory of TCM as a whole concept, reflecting the characteristics of TCM efficacy, with mutual tumor-patient survival and good quality of life. TCM tumor efficacy evaluation should draw on the methods of modern epidemiology and evidence-based medicine, supported by high quality clinical research data, combined with the expertise of experienced TCM scholars, focusing on the survival time and quality of life as endpoint evaluation while at the same time, selectively including TCM syndromes, tumor size, TTP (Time to Progression) and CBR (Clinical Benefit Response) into the efficacy evaluation system, and determining the weights of all indicators in the evaluation system. This is a complex systematic task and a dynamic process of continuous improvement.In the clinical evaluation of cancer treatment, overall survival (OS) is still the gold standard. However, the survival time tells only what happen after the end of a treatment, the study of response evaluation criteria is to find the short-term effect indicators related to prognosis, predicting the possibility of long-term survival, in order to adjust the current treatment options. The quality of response evaluation criteria is determined by:①Ability to represent the response to therapeutic purposes;②Consistency with prognosis. Our department, since1996, under the guidance of both TCM and Western Medicine cancer experts, has carried out long-term study of comprehensive TCM response criteria, and has gained the "nursery project funding" by the China Academy of Traditional Chinese Medicine. As a part of the above funding research, the Cox multivariate regression method is used in this article, to analyze the clinical factors that affect the prognosis of advanced gastric cancer, and then a survival prediction model as well as a Comprehensive TCM Response(CTCMR) criteria model for advanced gastric cancer are built up to be compared with the standard WHO criteria.ObjectiveUsing the Cox multivariate regression method to analyze the clinical factors that affect the prognosis of advanced gastric cancer, a survival prediction model and a CTCMR criteria model for advanced gastric cancer were built up. Kaplan-Meier method was used to determine the concordance of survival time with CTCMR criteria model and WHO criteria respectively, so as to compare the two criteria’s values in evaluating the efficacy of TCM treatment in advanced gastric cancer. Materials and Methods (omitted) ResultsAccording to Cox multivariate regression analysis result, changes in tumor size, Karnofsky performance score, weight and main symptoms are the four factors that were included in the CTCMR criteria model.CTCMR criteria:Effective: Changes in tumor size belong to disease controlled (CR+PR+SD), Karnofsky score, weight change and changes in the main symptoms are all stable or on this basis,1and≥1of the above3items turn better.Progressive: Changes in tumor size, Karnofsky score, weight change and changes in the main symptoms,≥1of the above4items deteriorate.In the104cases of advanced gastric cancer of this research, according to CTCMR criteria,38cases and66cases are defined as effective and progressive respectively; while according to WHO criteria: CR:1case, PR:18cases, SD:46cases, PD:39cases. Both two criteria results are statistically significant (X2=72.103, P=2.04E-017)For the104cases of advanced gastric cancer patients evaluated by the WHO criteria, the CR, PR and SD curves in the survival curves crossed over each other, suggesting that in TCM treatment and Integrative treatment of western medicine and TCM, the pursuit of CR and PR cannot improve the prognosis better than SD does. Using the CTCMR criteria, the survival curve of effective result was significantly different from that of progressive result (X2=72.103, P=2.04E-017).Comparing the65cases evaluated as disease controlled(CR+PR+SD) by the WHO criteria with the38patients evaluated as effective in the CTCMR criteria, their median survival times were13.0±0.953(95%confidence interval11.13,14.87) and16.0±0.849(95%confidence interval14.34,17.66) respectively, their difference was statistically significant (X2=5.050, P=0.025)ConclusionThe CTCMR criteria, built in this research, reflects the two aspects of TCM, vital qi and pathogenic qi,①tumor factors (pathogenic qi):Tumor size stability is an important factor for the long survival of advanced gastric cancer; the changes of main symptoms associated with tumors are in the complement of evaluation for tumor size changes.②host factors (vital qi): Karnofsky score and weight can approximately summarize the general state of the hosts, as well as their quality of lives.Comparing the CTCMR criteria with the WHO criteria, the former gives better concordance with survival time, indicating that the CTCMR criteria can better reflect the prognosis of advanced gastric cancer. |
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