The JPJDF has Synergistic Effect with Fluoropyrimidine in the Maintenance Therapy for Metastatic Colorectal Cancer

Xiaoling       Fu; Yanbo       Zhang; Lisheng       Chang; Dengcheng       Hui; Ru       Jia; Ningning       Liu; Huayue       Zhang; Gang       Han; Zhifen      Han; Yuan       Li; Hui       Liu; Huirong       Zhu; Qi       Li

Abstract

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.

Keywords: Anti-angiogenesis, fluoropyrimidine, maintenance treatment, metastatic colorectal cancer, Progression-Free Survival (PFS), Overall Survival (OS).

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DOI https://dx.doi.org/10.2174/1574892815666200717141205	Print ISSN 1574-8928
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