Efficacy and safety of Jianpi Bushen Jiedu formula combined with apatinib and S-1 in the treatment of metastatic colorectal cancer.

Objective To evaluate the efficacy and safety of the Jianpi Bushen Jiedu formula combined with apatinib and tegafur/gimeracil/oteracil (S-1) for patients with metastatic colorectal cancer (mCRC). Methods A single-arm, open-label clinical study was conducted. The patients were treated with the Jianpi Bushen Jiedu formula combined with a low dose of apatinib (250 mg, once per day) and S-l (20 mg, twice per day). The primary outcome was progression-free survival (PFS), and secondary outcomes included the objective remission rate (ORR), the disease control rate (DCR), overall survival (OS), and the MD Anderson Symptom Inventory for Traditional Chinese Medicine (MDASI-TCM) score. Results The median PFS and median OS of the treatment of the Jianpi Bushen Jiedu formula combined with apatinib and S-l were 4. 80 months and 12.73 months, respectively. The ORR was 7.32% (3/41) while the DCR was 68.29% (28/41). The score of the MDASI-TCM did not fall. The common adverse events were hypertension, proteinuria, thrombocytopenia, and bleeding, with incidences of 51.22%, 41.46%, 26.83%, and 19.51%, respectively. Conclusion Patients with mCRC, especially after the failure of the second or above lines of treatment or without treatment with previous bevacizumab may potentially benefit from the treatment with the Jianpi Bushen Jiedu formula combined with low dose apatinib and S-l. [ABSTRACT FROM AUTHOR]