Background: Maintenance chemotherapeutic regimen with low toxicity is needed for
metastatic colorectal cancer. A recent patent has been issued on the spleen-strengthening and detoxification
prescription (JPJDF), a traditional Chinese herbal medicinal formula with anti-angiogenesis
effect. The clinical effect of JPJDF on the maintenance treatment of advanced colorectal cancer
has not been evaluated.
Objective: This study aims to evaluate the effectiveness and safety of JPJDF in combination with
fluoropyrimidine compared to fluoropyrimidine alone as maintenance therapy for metastatic colorectal
Methods: We applied a prospective, randomized, double-blinded, single center clinical study design.
A total of 137 patients with advanced colorectal cancer were recruited. Patients received either
Fluoropyrimidine (Flu-treated group, n = 68), or Fluoropyrimidine plus JPJDF (Flu-F-treated
group, n = 69) as maintenance treatment after 6-cycle of FOLFOX4 or FOLFORI induction treatment.
The primary endpoints were Progression-Free Survival (PFS) and Overall Survival (OS).
The secondary endpoints were safety, Performance Status (PS) score and other symptoms.
Results: The endpoint of disease progression was observed in 91.7% of patients. The PFS was 5.0
months and 3.0 months in the Flu-F-treated and Flu-treated groups, respectively. The OS was 15.0
months and 9.0 months in the Flu-F-treated and Flu-treated groups, respectively. Some common
symptoms, such as hypodynamia, anepithymia, dizziness and tinnitus and shortness of breath, were
improved in the Flu-F-treated group. There was no significant difference in the common adverse reactions
between the two groups.
Conclusion: JPJDF and fluoropyrimidine have synergistic effect in the maintenance treatment of