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BACKGROUND@#Colorectal cancer (CRC) is the second most common cause of cancer-related deaths and has the third highest incidence in the world. Almost half of the patients with CRC have metastases at the time of diagnosis. However, the treatment for patients with metastatic CRC that progresses after approved conventional chemotherapy is still controversial. Chinese medicine (CM) has unique characteristics and advantages in treating metastatic CRC.@*OBJECTIVE@#To assess the effectiveness and safety of CM in patients with metastatic CRC after failure of conventional chemotherapy.@*METHODS@#The study is a multicenter prospective cohort study. A total of 384 patients with documented metastatic CRC after failure of conventional chemotherapy will be included from 9 hospitals among Beijing, Shanghai, Nanjing, and Guizhou, and assigned to three groups according to paitents' wishes: (1) integrated Chinese and Western medicine (ICM) group receiving CM herbal treatment combined with Western medicine (WM) anti-tumor therapy, (2) Chinese medicine (CM) group receiving only CM herbal treatment, and (3) WM group receiving only WM anti-tumor therapy. The primary endpoint is the overall survival (OS). Secondary endpoints include the progression free survival (PFS), quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaire, tumor control, and CM symptom score.@*DISCUSSION@#This prospective study will assess the effectiveness and safety of CM in treating metastatic CRC after conventional chemotherapy failure. Patients in the ICM group will be compared with those in the WM group and CM group. If certified to be effective, national provision of CM treatment in metastatic CRC will probably be advised. (Registration No. NCT02923622 on ClinicalTrials.gov).
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OBJECTIVE： To systematically evaluate the effects of Shenqi fuzheng injection combined with conventional chemotherapy on the immune function of patients with advanced non-small cell lung cancer （NSCLC）， and provide evidence-based reference for clinical medication. METHODS： Retrieved from Cochrane Library， PubMed， Medline， Embase， CNKI， Wanfang database， VIP and CBM， Shenqi fuzheng injection combined with conventional chemotherapy （trial group） versus conventional therapy （control group） for advanced NSCLC were collected. After literature screening， data extraction and quality evaluation with Cochrane system evaluator manual 5.1.0 risk evaluation tool， Meta-analysis was performed by using Rev Man 5.3 statistical software. RESULTS： A total of 16 literatures were included， involving 1 324 cases. Results of Meta-analysis showed that there were no statistical significance in the difference of objective remission rate （ORR） [RR＝1.14， 95％CI（0.91，1.43）， P＝0.25] and the level of CD8+ [MD＝－1.26，95％CI（－4.10， 1.59），P＝0.39] between 2 groups. The levels of CD3+ [MD＝17.48， 95％CI（13.40， 21.56）， P＜0.000 01 ]， CD4+[MD＝12.26， 95％CI（8.39 16.13）， P＜0.000 01]， CD4+/CD8+ [MD＝0.33，95％CI（0.27， 0.39），P＜0.000 01] and the percentage of NK cells [MD＝9.33， 95％CI（5.72， 12.94）， P＜0.000 01] in trial group were significantly higher than control group. Results of subgroup analysis for medication duration of Shenqi fuzheng injection showed that after 1-14 d treatment of Shenqi fuzheng injection， the levels of CD3+ [MD＝17.11， 95％CI（12.37 ，23.17），P＜0.000 01]， CD4+[MD＝13.28，95％CI（8.33， 18.23），P＜0.000 01]， CD4+/CD8+[MD＝0.36，95％CI（0.28，0.43），P＜0.000 01] and the percentage of NK cells [MD＝12.06，95％CI（7.52，16.61），P＜0.000 1] in trial group were significantly higher than control group. After 21 d treatment of Shenqi fuzheng injection， the levels of CD3+[MD＝14.88， 95％CI（7.51，22.26），P＜0.000 01]， CD4+[MD＝10.56，95％CI（5.57，15.56），P＜0.000 01]， CD8+[MD＝3.02， 95％CI（1.80， 4.23），P＜0.000 01]， CD4+/CD8+[MD＝0.29，95％CI（0.23， 0.35），P＜0.000 01] and the percentage of NK cells [MD＝5.58，95％CI（2.49， 8.67），P＝0.000 4] in trial group were significantly higher than control group. There was no statistical significance in the level of CD8+ between 2 groups after 7-14 d treatment of Shenqi fuzheng injection [MD＝－4.26，95％CI（－12.60， 4.09），P＝0.32]. The incidence of leukopenia， nausea and vomiting， and renal dysfunction in trial group were significantly lower than control group. There was no statistical significance in the incidence of hemoglobin decreased and thrombocytopenia between 2 groups. The results of publication bias showed that there was a greater possibility of publication bias in this study. CONCLUSIONS： Shenqi fuzheng injection combined with conventional chemotherapy may improve the immune function of patients with advanced NSCLC and improve the safety after chemotherapy. But more large-scale， milltiple-center and high-quality RCT are needed to validate this conclusion.
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OBJECTIVE： To systematically evaluate the efficacy and safety of thalidomide combined with conventional chemotherapy in the treatment of advanced gastric cancer， and to provide evidence-based reference for clinical drug use. METHODS： Retrieved from PubMed， Embase， Cochrane library， CNKI， Wanfang database and VIP， RCTs about thalidomide combined with conventional chemotherapy （observation group） vs. conventional chemotherapy （control group） in the treatment of advanced gastric cancer were collected. After data extraction and quality evaluation of included literatures with Cochrane system evaluator manual 5.0 risk evaluation tool， Meta-analysis was conducted by using Rev Man 5.3 statistical software. The evidence qualities of outcome indexes were evaluated by using Grade evidence quality classification system. RESULTS： A total of 13 studies were included， involving 761 patients. Results of Meta-analysis showed that the total response rate [OR＝1.72， 95％CI（1.29，2.31），P＝0.000 2]， complete remission rate [OR＝1.90，95％CI（1.05，3.44），P＝0.03]， disease control rate [OR＝2.66， 95％CI（1.92，3.68），P＜0.001]， improvement rate of survival quality [OR＝3.09， 95％CI（1.82，5.24），P＜0.001] and the incidence of constipation [OR＝2.64， 95％CI（1.74，4.01），P＜0.001] of observation group were significantly higher than those of control group， while disease progression rate [OR＝0.39， 95％CI （0.28，0.54）， P＜0.001] and the incidence of nausea and vomiting [OR＝0.32， 95％CI（0.18，0.56）， P＜0.001] of observation group were significantly lower than those of control group. Results of quality evaluation of Grade evidence showed that total response rate， complete remission rate， the incidence of leucopenia， thrombocytopenia， hemoglobin reduction and liver dysfunction were recommended for advanced evidence. Disease control was recommended for moderate-level evidence. The incidence of disease progression， peripheral neuritis， nausea and vomiting， diarrhea， constipation and hand-foot syndrome were recommended for low-level evidence. Improvement rate of survival was recommended for very low-level evidence. CONCLUSIONS： Thalidomide combined with conventional chemotherapy show significant therapeutic efficacy for advanced gastric cancer， can improve the quality of life but increase the risk of constipation.
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Objective To study the significance of treating advanced primary hepatic carcinoma by using the different methods combined with chemotherapy. Methods One hundred and fifteen cases with advanced primary hepatic carcinoma were divided into 5 groups by accepting different chemotherapy: the groups of interventional-chemotherapy (group A, 40 cases), whole body hyperthermia combined with chemotherapy (group B, 16 cases), only chemotherapy (group C, 9 cases), local heat chemotherapy (group D, 26 cases), symptomatic supportive (group E, 24 cases) for comparing response rate (RR) and survival time between each other. Results The RR in group A,B,C were 30.5 % (12/40), 12.5 % (2/16), 11.1 % (1/9) respectively, and there was no significant difference among three groups (P>0.05). The mid-survival time of five groups were 7.7, 9.2, 7.9, 6.0, 4.7 months, and there was significant difference between group B and group E (P<0.05). The 0.5-, 1-, 2-year survival rate in group B were higher than those in group E with significant difference (81.2%vs. 29.1%, 37.5%vs. 12.5%, 12.5%vs. 0, all P<0.05). Conclusions The RR of only routine chemotherapy is low, while the RR of interventional-chemotherapy and local heat chemotherapy is high with non-prolonged survival time. Whole body hyperthermia combined with chemotherapy have active effects in helping to improve the efficacy and prolong the survival time in retreatment patients with advanced hepatic tumor.
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Objective To investigate the efficacy of low dose thalidomide combined with chemotherapy in treatment of multiple myeloma(MM)and the clinical curative effect of the treatment method.Methods From June 2010 to June 2012,80 patients were diagnosed with multiple myeloma as the research object in Traditional Chinese Medicine Hospital of Haining,randomly divided into control group and observation group,with 40 cases in each group.The control group adopted conventional chemotherapy,the observation group were given low dose thalidomide combined with conventional chemotherapy.The clinical effect and adverse drug reactions were compared. Results The total effective rate of observation group (87.5%)was significantly higher than that of control group(65.0%)(P<0.05).The adverse reactions were 87.5%(35/40)in observation group and 100.0%(40/40)in control group,there was no significant difference between the two groups.The mean progression-free survival(PFS)and overall survival(OS)in observation group(5.5 ±1.2 months;1 1.5 ±2.4 months)were higher than those in control group(3.7 ±0.8 months;8.5 ±1.3 months)(P<0.05 ). Conclusion Low dose thalidomide combined with conventional chemotherapy in the treatment of multiple myeloma can improve clinical effect and decrease recurrence rate,with high safety and less adverse reactions.
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This study aimed to analyze the overall survival period of adult lymphoblastic lymphoma patients treated with various therapeutic regimens, and to assess the determinants affecting survival outcome. Twenty-five adult patients with lymphoblastic lymphoma who had been treated at Severance Hospital, Yonsei University College of Medicine, Seoul, Korea from June 1996 to June 2005 were analyzed retrospectively. As an initial remission induction chemotherapy, the hyper-CVAD regimen was performed in eight patients, the Stanford/Northern California Oncology Group (NCOG) regimen in five, the CAVOP regimen in four, the m-BACOP regimen in three, and the CHOP regimen in one patient. Patients were divided into two groups according to their therapeutic modalities. Twenty patients received conventional chemotherapy alone and five received subsequent PBSCT after conventional chemotherapy. Four patients of the PBSCT group underwent autologous PBSCT and one underwent allogeneic PBSCT. The overall response rate was 80% (60% showing a complete response, 20% showing a partial response) and the relapse rate was 73.3%. The overall survival (OS) rate was 55.1% at 1 year, 31.5% at 5 years, and 23.6% at 9 years. The disease-free survival (DFS) rate was 46.7% at 1 year and 30.0% at 7 years. The 5-year OS rate in relation to the regimens was 60% with the Stanford/NCOG regimen, 50% with the CAVOP regimen, and 33.3% with the m-BACOP regimen. The patients treated with the hyper-CVAD regimen had an 18.2% 2-year OS rate, and other patients with CHOP or COPBLAM-V expired early in their course. The OS rate in patients treated with conventional chemotherapy alone was 19.8%, whereas patients treated with subsequent PBSCT after chemotherapy showed 50% overall survival (p=0.25). The age at presentation influenced the outcome of the patients (p=0.01). The Stanford/NCOG regimen is an effective initial choice of therapy for lymphoblastic lymphoma patients, and is superior to the hyper-CVAD regimen in complete response rate and overall survival rate (p=0.36). Addition of PBSCT after chemotherapy may be needed for achieving optimal outcomes.