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
cancer.
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
mCRC.
Clinical factors influencing outcome in metastatic colorectal cancer (mCRC) patients treated with fluoropyrimidine and bevacizumab (FP + Bev) maintenance treatment (Tx) vs observation: A pooled analysis of the phase 3 CAIRO3 and AIO 0207 trials
