Analysis of the Effects of Alleviating Adverse Events and Improving Completion in Colorectal Cancer Patients with Postoperative Adjuvant Chemotherapy with PSK

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  • SUGIMOTO KIICHI
    Department of Coloproctological Surgery, Juntendo University Faculty of Medicine
  • TAKAHASHI RINA
    Department of Coloproctological Surgery, Juntendo University Faculty of Medicine
  • ISHIYAMA SHUN
    Department of Coloproctological Surgery, Juntendo University Faculty of Medicine
  • HATA MASAKI
    Department of Coloproctological Surgery, Juntendo University Faculty of Medicine
  • KAMIYAMA HIROHIKO
    Department of Coloproctological Surgery, Juntendo University Faculty of Medicine
  • KOMIYAMA HIROMITSU
    Department of Coloproctological Surgery, Juntendo University Faculty of Medicine
  • TAKAHASHI MAKOTO
    Department of Coloproctological Surgery, Juntendo University Faculty of Medicine
  • KOJIMA YUTAKA
    Department of Coloproctological Surgery, Juntendo University Faculty of Medicine
  • GOTO MICHITOSHI
    Department of Coloproctological Surgery, Juntendo University Faculty of Medicine
  • SENGOKU HIRONOBU
    Department of Coloproctological Surgery, Juntendo University Faculty of Medicine
  • TOMIKI YUICHI
    Department of Coloproctological Surgery, Juntendo University Faculty of Medicine
  • SAKAMOTO KAZUHIRO
    Department of Coloproctological Surgery, Juntendo University Faculty of Medicine

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Objective: It is well known that anti-cancer drugs generate reactive oxygen species and lipoperoxides in cancer patients, and that these free radicals can give rise to adverse events. It has been reported that free radical effects might be attenuated by antioxidants. Recent reports have indicated that Protein-bound polysaccharide K (PSK) exhibits antioxidant effects in addition to its anti-tumor effects. However, there have been few reports investigating whether the antioxidant effects induced by PSK can actually alleviate the adverse events of anti-cancer drugs. In an attempt to alleviate the adverse events and improve completion of oral anti-cancer drugs, we performed a randomized, controlled trial of oral UFT/LV plus PSK as postoperative adjuvant chemotherapy for stage II and III colorectal cancer. Materials: Fifty patients who had undergone curative resection of high-risk stage II or stage III adenocarcinoma of the colon and rectum between May 2008 and May 2010 were enrolled in this study. Methods: Patients were randomly assigned to the UFT/LV treatment (PSK (-) ) and the UFT/LV plus PSK treatment (PSK (+) ) groups at a 1:1 ratio. The PSK (-) group received UFT (300 mg/m2/day) and LV (75 mg/day), starting 4-8 weeks after surgery and continuing for 6 months or until the diagnosis of tumor recurrence. The PSK (+) group received PSK (3.0g/day) every day in addition to the UFT/LV treatment. Patient backgrounds, adverse events, completion of oral administration, laboratory test, stress indices, such as Reactive Oxygen Metabolites Test (d-ROMs Test) and salivary chromogranin A, and NK cell population were analyzed. Results: Nine patients (36.0%) and 11 patients (44.0%) had overall adverse events in the PSK (-) and PSK (+) groups, respectively. There was no significant difference in the incidence of adverse events between the PSK (-) and PSK (+) groups. Twenty-two patients (88.0%) and 23 patients (92.0%) completed oral administration of anti-cancer drugs in the PSK (-) and PSK (+) groups, respectively. There was no significant difference in completion of oral administration between the two groups. In laboratory tests, no significant differences were observed between the two groups. There was no significant difference in the d-ROMs Test between the two groups. Similarly, no significant difference was observed in the salivary chromogranin A. The NK cell population in the PSK (+) group was significantly higher than that in the PSK (-) group (p = 0.03). Conclusions: There were no significant differences in the incidence of adverse events between the PSK (-) and PSK (+) groups. In addition, completion of oral administration was high in both groups, and therefore no effects of PSK to alleviate adverse events and improve completion of oral administration of anti-cancer drugs were recognized. In the future, it will be necessary to investigate whether or not PSK can reduce adverse events and improve the completion of oral administration of anticancer drugs when PSK is combined with other regimens with a higher incidence of adverse events or a lower completion rate.

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