Advanced digestive tract malignant tumors,represented by advanced colorectal cancer,advanced gastric cancer and advanced esophageal cancer,have insidious onsets and high mortality.Western medicine based on targeted th...Advanced digestive tract malignant tumors,represented by advanced colorectal cancer,advanced gastric cancer and advanced esophageal cancer,have insidious onsets and high mortality.Western medicine based on targeted therapy greatly can improves the benefit and efficacy for patients through population stratification,but its population is limited.Traditional Chinese medicine(TCM)has a long history in treatment of tumors,which is an important part of comprehensive treatment of tumors.Clinical observation has shown that different patients could get different efficacy from TCM treatment.Based on real world registration studies,patients with advanced colorectal cancer,advanced gastric cancer or advanced esophageal cancer who had received TCM treatment were observed and followed,and a TCM dominant population that achieved significant efficacy was screened out to carry out multivariate regression analysis,further explore key factors that affect survival in advanced digestive tract malignant tumors,and establish a prediction model of TCM dominant population.It will provide reference for the follow-up TCM treatment,and provide reference for development of individualized treatment plans,making the TCM treatment for advanced digestive tract malignant tumors more targeted,and helping to improve the benefit rate in TCM.展开更多
Objective: To evaluate the effect and safety of low-dose of apatinib and S-1 combined with Jianpi Bushen Jiedu Decoction(JBJD) in patients with metastatic colorectal cancer(mCRC) who have failed second or above lines ...Objective: To evaluate the effect and safety of low-dose of apatinib and S-1 combined with Jianpi Bushen Jiedu Decoction(JBJD) in patients with metastatic colorectal cancer(mCRC) who have failed second or above lines treatment, in order to provide more treatment option for mCRC patients by integrated medicine. Methods: Thirteen patients were selected from a single-arm, open-label clinical study from April 2019 to September 2020. The patients were treated with low-dose apatinib(250 mg, once a day) and S-1(20 mg, twice a day) combined with JBJD for at least one cycle and were followed up to August 2021. The primary endpoint was disease progression-free survival(PFS). Disease control rate(DCR), objective response rate(ORR), and overall survival(OS) of patients were observed as the secondary endpoints. Adverse events were recorded as well. Results: The average age of the 13 patients was 56.5±13.0 years and 76.9% were male. The median PFS and median OS were 4.6 and 8.3 months, respectively. The ORR was 7.7%(1/13) while the DCR was 61.5%(8/13). The common adverse events were hypertension, proteinuria, elevated transaminase, and thrombocytopenia. One patient experienced thrombocytopenia of grade 3. Conclusions: Patients with mCRC after failure of the second or above lines of treatment may potentially benefit from the treatment of low-dose apatinib and S-1 combined with JBJD because of its similar effect as the standard dose of target therapy and relatively better safety.(Registration No. ChiCTR1900022673)展开更多
基金Special Projects of Capital Scientific Research on Health Development(No.2016-1-4171)Projects on"Millions"of Talents for Inheritance and Innovation of Traditional Chinese Medicine of National Administration of Traditional Chinese Medicine(Qihuang Projects)。
文摘Advanced digestive tract malignant tumors,represented by advanced colorectal cancer,advanced gastric cancer and advanced esophageal cancer,have insidious onsets and high mortality.Western medicine based on targeted therapy greatly can improves the benefit and efficacy for patients through population stratification,but its population is limited.Traditional Chinese medicine(TCM)has a long history in treatment of tumors,which is an important part of comprehensive treatment of tumors.Clinical observation has shown that different patients could get different efficacy from TCM treatment.Based on real world registration studies,patients with advanced colorectal cancer,advanced gastric cancer or advanced esophageal cancer who had received TCM treatment were observed and followed,and a TCM dominant population that achieved significant efficacy was screened out to carry out multivariate regression analysis,further explore key factors that affect survival in advanced digestive tract malignant tumors,and establish a prediction model of TCM dominant population.It will provide reference for the follow-up TCM treatment,and provide reference for development of individualized treatment plans,making the TCM treatment for advanced digestive tract malignant tumors more targeted,and helping to improve the benefit rate in TCM.
基金Supported by National Administration of Traditional Chinese Medicine:Qihuang Scholar (No.02045004)Collaborative Pilot Project of Clinical Traditional Chinese and Western Medicine for Major and Difficult Diseases in 2019 (No.070030003)。
文摘Objective: To evaluate the effect and safety of low-dose of apatinib and S-1 combined with Jianpi Bushen Jiedu Decoction(JBJD) in patients with metastatic colorectal cancer(mCRC) who have failed second or above lines treatment, in order to provide more treatment option for mCRC patients by integrated medicine. Methods: Thirteen patients were selected from a single-arm, open-label clinical study from April 2019 to September 2020. The patients were treated with low-dose apatinib(250 mg, once a day) and S-1(20 mg, twice a day) combined with JBJD for at least one cycle and were followed up to August 2021. The primary endpoint was disease progression-free survival(PFS). Disease control rate(DCR), objective response rate(ORR), and overall survival(OS) of patients were observed as the secondary endpoints. Adverse events were recorded as well. Results: The average age of the 13 patients was 56.5±13.0 years and 76.9% were male. The median PFS and median OS were 4.6 and 8.3 months, respectively. The ORR was 7.7%(1/13) while the DCR was 61.5%(8/13). The common adverse events were hypertension, proteinuria, elevated transaminase, and thrombocytopenia. One patient experienced thrombocytopenia of grade 3. Conclusions: Patients with mCRC after failure of the second or above lines of treatment may potentially benefit from the treatment of low-dose apatinib and S-1 combined with JBJD because of its similar effect as the standard dose of target therapy and relatively better safety.(Registration No. ChiCTR1900022673)
