Abstract
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)
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Chen Y wrote the manuscript and was involved in the extraction of data, the statistical analysis of data and the follow-up of the patients. This project was initiated and developed by Yang YF, Xu YY and Jiang HJ. Yang YF was involved in the design of the study and manuscript revision and review. Xu YY and Jiang HJ were involved in the design of the study, literature research and the follow-up of the patients. Wang L was responsible for the follow-up of the patients. Zhai JW was responsible for the follow-up of the patients and data checking. Zhang T was involved in manuscript revision and review. All authors read and approved the final manuscripts.
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The authors declare that there are no conflicts of interest regarding the publication of this paper.
Supported by National Administration of Traditional Chinese Medicine: Qihuang Scholar (No. 02045004) and Collaborative Pilot Project of Clinical Traditional Chinese and Western Medicine for Major and Difficult Diseases in 2019 (No. 070030003)
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Patients with Metastatic Colorectal Cancer after Failure of Second-Line Treatment May Benefit from Low-Dose Apatinib and S-1 Combined with Jianpi Bushen Jiedu Decoction
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Chen, Y., Xu, Yy., Jiang, Hj. et al. Patients with Metastatic Colorectal Cancer after Failure of Second-Line Treatment May Benefit from Low-Dose Apatinib and S-1 Combined with Jianpi Bushen Jiedu Decoction. Chin. J. Integr. Med. 28, 924–929 (2022). https://doi.org/10.1007/s11655-022-3676-7
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DOI: https://doi.org/10.1007/s11655-022-3676-7