| Nowadays the total new cases and total deaths of non-small cell lung cancer(NSCLC)are continuesly increasing.Most patients with NSCLC present with advanced-stage disease and are not operable at the time of diagnosis.Due to delayed diagnosis,chemotherapy has become one of the main methods to treat advanced or metastatic NSCLC.Dispite the benefit of chemotherapy,side effects such as myelosuppression,gastrointestinal reaction,cancer-related fatigue etc.can not be ignored since they can greatly influence Quality of Life(QoL)and choice of treatment regimen.For now,the toxicity attenuation efficacy of related supportive care methods is not satisfying.The problem of how to improve efficacy and reduce toxicity of chemotherapy as well as enhance QoL remains to be solved.Therefor combinaiton regimen in which traditional Chinese medicine(TCM)is used during chemotherapy can be the answer as TCM plays an important role in improving chemotherapy's anti-tumor efficacy and minimizing its toxicity as well as guaranteing QoL of NSCLC pateints.Oncology Department of Guangan'men Hospital has carried many national technology R&D programs,brought together advantaged powers and made a comprehensive TCM treatment regimen called ClinicalGuidelinefor Traditiional Chinese Medicine in Lung Cancer.According to the Guideline,TCM combining chemotherapy is recommended to improve the completion rate of chemotherapy and its efficacy as well as patients' symptoms and QoL where TCM has an advantage,but related clinical researches are rare.Objectives:To prove the efficacy-enhancing and toxicity-reducing effect of comprehensive TCM treatment in advanced NSCLC and evaluate the safety of it combining chemotherapy.Methods:The study was a large-sampled,multi-centered and prospective randomized control led trial.We recruited360advanced NSCLC patients and randomized 182 of them into treatme nt group and 178 into contrast group.The treatment group used comprehensive TCM treatmen t regimen together with standard chemotherapy recommended in National Comprehensice Ca ncer Network(NCCN)Guidelines under the following TCM treatment strategies:1.strengthen the spleen and harmonize the stomach;2.tonify qi and nourish blood;3.nourish and tonify t he liver and kidney.The control group used standard chemotherapy recommended in National Comprehensice Cancer Network(NCCN)Guidelines only or in combination with Er Chen Ta ng.There were 21-28 days per cycle in the chemotherapy period.After 2 continuous cycles,w e evaluated the efficacy.Those who completed the whole treatment were taken as complete ca ses and those who didn't were only under safety evaluation.We used the following internatio nally recognized standards to evaluate completion rate of chemotherapy,change in tumor bur den and biomarkers,adverse effects,TCM clinical syndromes and QoL:1.Response Evaluatio n Criteria in Solid Tumor Version 1.1(RECIST 1.1);2.Common Terminology Criteria for Adv erse Events made by National Cancer Institute(NCI-CTCAE3.0);3.TCM Clinical Syndrom Int egral Cretiria for Lung Cancer in Clinical Guideline of New Drugs for Traditional Chinese M edicine;4.Functional Assessmentof Cancer Therapy-Lung Version 4.0(FACT-L4.0).All statistical analyses were conducted by using SPSS 20.0 statistics software.Results:360 patients were recruited and 315 completed the trial in which 163 were in the treat ment group and 150 in control group.There was no statistical difference in sex,age,histologi c subtype,neoplasm staging,performance score,vital signs,tumor burden before treatment,bi omarker level(CEA,SCC,CyFRA211),TCM symdrome and QoL between the two groups.Th e baselines were aligned and the two groups were comparable.Indicators for efficacy enhancement:1.Chemotherapy completion rate:The completion rates of chemotherapy were similar and wer of no significant difference(P>0.05);2.Response in solid tumor:Response rates(RR=CR+PR)were mot significantly different between the two groups which were 13.2%in the treatment group and 13.5%in the control group(P>0.05).Clinical benefit rates(CBR=CR+PR+SD)of the treatment group was 64.8 and was slightly higher than that of the control group of which CBR was 62.9%,but there was no statistical difference(P>0.05).3.Biomarkerlevel:CEA level after 2 cycles of treatment was lower in treatment group than that in control group and the difference was of statistical significant(P<0.05).No significant difference was shown in SCC and CyFRA211(P>0.05).The change in CEA?SCC?CyFRA211 compared with those in baseline showed inclination of decrease but was of no statistical difference between the two groups(P>0.05).These indicated that comprehensive TCM treatment can increase chemotherapy completion rate and CBRand decrease biomarker level,but the advantage are not significant.Indicators for toxicity reduction:1.Chemotherapy toxicity reaction:In the part of blood system,pateints showed higher white blood cell(WBC)level in treatment group than that in control group,and the difference was statistically significant(P<0.05);in the part of clinical symptoms,conditions of fatigue(drowsiness,discomfort,lack of strength),poor appetite,nausea and vomitingwere better in treatment group than in control group with significant difference(P<0.05);2.TCM syndrom evaluation:integrals after 2 cycles of treatment were similar in the two groupss,but the the change of integral compared with baseline was better in treatment group than in control group(P<0.05).According to RECIST,overall response rate was 45.1%in treatment group and was higher than that in control group(29.2%);conditions of fatigue and chest distresswere much better in treatment group than in control group with significant difference(P<0.05);3.QoL:Physical Well-being(PWB),score was better in treatment group with statistically difference(P<0.05);in the following items conditions were better in treatment group:I have a lack of energy,I have nausea,I am losing hope in the fight against my illness,I worry about dying,I worry that my condition will get worse,I have accepted my illness,I have a good appetite(P<0.05).These showed that TCM comprehensive treatment has an edge on reduing chemotherapy toxicity,changing TCM syndrome and improve QoL.Indicators for safety:Except for adverse events included in NCI-CTCAE,one adverse event occurred in both grouprespectively(0.5%in treatment group vs 0.6%in control group)and both were not related to the medicine used in the trial.No other adverse event was recorded.These suggested that TCM comprehensive treatment is safe and can be promoted.Conclusion:TCM comprehensive treatment can help increase chemotherapy completion rate and CBRand decrease biomarker level,but the advantage are not significant.TCM comprehensive treatment has an edge on reduing chemotherapy toxicity,changing TCM syndrome and improve QoL.TCM comprehensive treatment is safe and can be promoted. |
PDF Full Text Request