Randomized, controlled study on adjuvant immunochemotherapy with PSK® in curatively resected colorectal cancer

Mitomi, Toshio; Tsuchiya, Shuji; Iijima, Noboru; Asō, K.; Suzuki, K.; Nishiyama, Kiyoshi; Amano, Tetsuya; Takahashi, Toshitake; Murayama, Norihisa; Oka, Hisashi; Oya, Kazumitsu; Noto, Takashi; Ogawa, Norio

doi:10.1007/bf02050666

Cited by 107 publications

(40 citation statements)

References 13 publications

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“…The protocol called for a total of 240 patients to be accrued over 3 years in an allocation ratio of 2 : 1 of PSK-treated to control subjects (160 PSK and 80 control). This sample size would give an 80% probability of detecting a 15% difference in 5-year disease-free survival, with a two-sided a level of 0.05, which seemed both modest and reasonable with respect to the previous study (Mitomi et al, 1992).…”

Section: Patientsmentioning

confidence: 66%

“…Patients were allocated to PSK-treatment and control groups in the ratio of 2 : 1, because PSK plus chemotherapy (MMC plus 5-FU) had been shown to improve the disease-free and overall survival of patients with curative resection of colorectal or gastric cancers (Mitomi et al, 1992;Nakazato et al, 1994). The protocol called for a total of 240 patients to be accrued over 3 years in an allocation ratio of 2 : 1 of PSK-treated to control subjects (160 PSK and 80 control).…”

Section: Patientsmentioning

confidence: 99%

“…The beneficial effects of PSK have been attributed to the activation of leucocyte chemotactic locomotion and phagocytic activity (Torisu et al, 1990). Adjuvant chemotherapy with PSK for over 3 years, and oral 5-FU for 2 years, following intravenous mitomycin C (MMC s ), significantly increased the disease-free survival rate, as compared with 5-FU alone in patients with curatively resected colorectal cancer (Mitomi et al, 1992). These results were promising evidence of survival benefits, and encouraged us to use oral PSK together with UFT as an adjuvant immunochemotherapy.…”

mentioning

confidence: 99%

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Adjuvant immunochemotherapy with oral Tegafur/Uracil plus PSK in patients with stage II or III colorectal cancer: a randomised controlled study

et al. 2004

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Intravenous fluorouracil and leucovorin is the standard adjuvant treatment for stage III colon cancer. However, oral adjuvant chemotherapy is attractive because it has low toxicity and greater convenience. We investigated the benefits of oral protein-bound polysaccharide K (PSK) with tegafur/uracil (UFT) as an adjuvant in stage II and III colorectal cancer. Patients were assigned to groups that received either 3 g PSK plus 300 mg UFT, or 300 mg UFT alone orally each day for a 2-year period following intravenous mitomycin C. Of 207 registered patients, 205 with stage II (n ¼ 123) or III (n ¼ 82) were analysed. The 5-year disease-free survival was 73.0% (95% CI 65.6 -80.4%) with PSK (n ¼ 137) and 58.8% (95% CI 47.1 -70.5%) in the controls (n ¼ 68) (P ¼ 0.016). POLYSACCHARIDE K reduced the recurrence by 43.6% (95% CI 4.5 -66.7%) and mortality by 40.2% (95% CI À12.5 to 68.3%). The 5-year survival was 81.8% (95% CI 75.3 -88.2%) in the PSK group and 72.1% (95% CI 61.4 -82.7%) in the control group (P ¼ 0.056). In stage III patients, disease-free and overall survivals in patients receiving PSK were increased significantly: 60.0% (95% CI 47.1 -72.9%) and 74.6% (95% CI 63.0 -86.1%) in the PSK group as compared with 32.1% (95% CI 14.8 -49.4%) and 46.4% (95% CI 28.0 -64.9%) in the controls (P ¼ 0.002 and 0.003, respectively). Polysaccharide K prevented recurrence, particularly lung metastases (P ¼ 0.02; odds ratio 0.27; 95% CI 0.09 -0.77). In the models, the presence of regional metastases (relative risk, 2.973; 95% CI 1.712 -5.165; Po0.001), omission of PSK (relative risk, 2.106; 95% CI 1.221 -3.633; P ¼ 0.007), and higher primary tumour (relative risk, 4.398; 95% CI 1.017 -19.014; P ¼ 0.047) were each significant indicators of recurrence. Adverse effects were mild and compliance was good. Oral PSK with UFT reduced recurrence in stage II and III colorectal cancer, and increased survival in stage III.

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Section: Patientsmentioning

confidence: 66%

Section: Patientsmentioning

confidence: 99%

mentioning

confidence: 99%

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Adjuvant immunochemotherapy with oral Tegafur/Uracil plus PSK in patients with stage II or III colorectal cancer: a randomised controlled study

et al. 2004

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“…UFT has been shown to be more effective experimentally than FT and 5-FU 12) and is widely used as an oral antineoplastic agent in Japan. [13][14][15][16] …”

Section: )mentioning

confidence: 99%

Therapeutic Effect of 1 M Tegafur‐0.4 M 5‐Chloro‐2,4‐dihydroxypyridine‐1 M Potassium Oxonate (S‐1) on Liver Metastasis of Xenotransplanted Human Colon Carcinoma

Konno

Tanaka

Baba

et al. 1999

Japanese Journal of Cancer Research

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administered orally at an equitoxic dose (S-1, 7.5 mg/kg; UFT, 17.5 mg/kg as FT) for 37 consecutive days beginning 10 days after the transplantation. S-1 showed higher tumor growth inhibition than UFT (P< < < <0.05) and also showed a significant anti-metastatic effect on liver metastasis, while UFT did not. Liver metastasis developed in only 2 of the 17 mice (12%) in the S-1 group, whereas it developed in 9 of the 17 (53%) and 7 of the 18 (39%) in the control and UFT group, respectively. Analysis of AUC (area under the curve) revealed that S-1 yielded higher 5-FU levels in both tumor tissue (1.6 times) and plasma (2.5 times) than UFT. These results suggest that S-1 will show a higher clinical therapeutic effect against human colorectal cancer than UFT.

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“…Recent researches provide consistent approval for the development of ethnomedicine [3]. More evidence has been provided using bioactive materials extracted from mushrooms [4], as well as polysaccharides isolated from Ganoderma lucidum and Trametes versicolor [5], which showed great expression of tumor markers [4], increased natural killer cells activities, and higher survival rate [5]. Following the successful trials, polysaccharides isolated from T. versicolor had further been approved in Japan and marketed as an antitumor drug known as Krestin (PSK).…”

Section: Introductionmentioning

confidence: 99%

Between the Bioactive Extracts of Edible Mushrooms and Pharmacologically Important Nanoparticles: Need for the Investigation of a Synergistic Combination - A Mini Review

Ukaegbu

Jalal²,

Rashid³

et al. 2017

Asian J Pharm Clin Res

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The pharmacological potential of bioactive compounds extracted from mushrooms has been studied to a reasonable level. In the same vein, the bioactivity of nanoparticles has also been investigated and reported to be of potential pharmacological benefit. No doubt, there is a reasonable amount of claims regarding the vast activity of the mushroom extracts and nanoparticles on the tested cell lines and microorganisms. In this paper, a review of the recent application of bioactive compounds extracted from two edible mushrooms (Coprinus comatus and Lactarius deliciosus), as well as some of the recently reported studies on some nanoparticles of pharmacological potentials, was carried out. In order to check for synergy in the bioactivity of the mushroom extracts when co-administered with nanoparticles, an investigation on the synergistic application of the materials through the encapsulation of the bioactive extracts from the mushroom onto the nanoparticle was proposed. The supposed synergy in the activity of the extract-nanoparticle complex could hold the key to improved activity of nutraceuticals against resistant microorganisms and tumor cells.

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Randomized, controlled study on adjuvant immunochemotherapy with PSK® in curatively resected colorectal cancer

Cited by 107 publications

References 13 publications

Adjuvant immunochemotherapy with oral Tegafur/Uracil plus PSK in patients with stage II or III colorectal cancer: a randomised controlled study

Adjuvant immunochemotherapy with oral Tegafur/Uracil plus PSK in patients with stage II or III colorectal cancer: a randomised controlled study

Therapeutic Effect of 1 M Tegafur‐0.4 M 5‐Chloro‐2,4‐dihydroxypyridine‐1 M Potassium Oxonate (S‐1) on Liver Metastasis of Xenotransplanted Human Colon Carcinoma

Between the Bioactive Extracts of Edible Mushrooms and Pharmacologically Important Nanoparticles: Need for the Investigation of a Synergistic Combination - A Mini Review

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