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1 maart 2018: zie ook dit artikel: 

https://kanker-actueel.nl/champignons-bewerkt-met-speciale-belichting-hebben-daarmee-veel-extra-vitamine-d-en-kunnen-vitamine-d-supplementen-vervangen.html

30 maart 2015: lees ook deze reviewstudie van PSK - polysaccharide, extracten van medicinale paddenstoelen bij longkanker

polysaccharide-k-psk-verbetert-immuunfunctie-vermindert-bijwerkingen-van-chemo-en-verlengt-levensduur-van-longkankerpatienten-blijkt-uit-grote-overzichtstudie.html

10 juni 2011 Ik heb de informatie over PSK en PSP nog maar eens naar voren gehaald. Onderstaande abstracten heb ik wat beter zichtbaar gemaakt gedeeltelijk door het doel van de studie en de resultaten uit elkaar te halen en vet te maken. Raadpleeg aub altijd een goed gekwalificeerd orthomoleculair arts voor u aan de slag gaat met medicinale paddenstoelen en extracten daarvan. 

Januari 2005:

Een paar belangrijke studies van effect van PSK geactualiseerd. Zie abstracten hieronder die duidelijk aangeven dat PSK significant beter werkt dan chemo bij darmkanker.  Raadpleeg wel altijd een deskundig arts voor gebruik van medicinale paddestoelen

5 januari 2005: bron: M. Andersson Ziekenhuis

Hier een aantal studies op een rijtje gezet die gedaan zijn met PSK en PSP - stofjes uit medicinale paddestoelen - bij kankerpatiënten met verschillende soorten tumoren en al of niet in combinatie met andere behandelingen zoals chemo enz. Wat opvalt is dat zover wij kunnen nagaan bijna alle studies een beter resultaat en veelal zelfs statistisch significant verschil  geven voor de PSK en - of PSP groep. O.i. zijn PSK en PSP zeer interessante en al meerdere malen bewezen aanvullingen in een behandeling van vele kankersoorten.

Human Studies Only Survival And Disease Response

Toi M, Hattori T, Akagi M, Inokuchi K, Orita K, Sugimachi K, et al. Randomized adjuvant trial to evaluate the addition of Tamoxifen and PSK to chemotherapy in patients with primary breast cancer. Five-year results from the Nishi-Nippon Group of the Adjuvant Chemoendocrine Therapy for Breast Cancer Organization. Cancer 1992;70(10):2475-83.

Purpose
: Disease response and survival Type of Study: RCT Methods: (Breast) (n=967, 914 evaluable) Women younger than 76 years of age with Stage IIA, IIB, and IIIA primary breast cancer who received extended, standard, or modified radical mastectomy were entered in the study. Patients were stratified and randomized to receive one of four treatments: Patients with ER-positive tumors received A) mitomycin-C (MMC) + ftorafur (FT) + tamoxifen (TMX) or B) MMC + FT only; patients with ER-negative tumors received C) MMC + FT with PSK D) MMC + FT only.
Results: For patients with ER-negative tumors, no significant difference in relapse free or overall survival for MMC + FT with PSK was observed. However, subset analyses demonstrated a longer overall survival with MMC + FT with PSK for patients who were node negative stage IIA TxN1 (95.7% versus 80.8% at five years; p< 0.0017 by log-rank test). (Disease free and overall survival advantage was also observed for postmenopausal patients with TMX and ER-positive, Stage IIIA T2N0 cancer (p<.0098).)

Go P, Chung C-H. Adjuvant PSK immunotherapy in patients with carcinoma of the nasopharynx. The Journal of International Medical Research 1989;17:141-9.

Purpose: Disease response and survival. Type of Study: RCT. Methods: (Nasopharynx) (n=38, 34 evaluable) A total of 17 patients in the PSK group and 17 in the control group were evaluated. Immunotherapy with PSK was initiated within one month after completion of primary treatment (radiotherapy plus chemotherapy). Monthly blood chemistry and counts were analyzed to detect PSK toxicity.
Results: In the PSK group, eight developed local recurrences, and three died due to distant metastasis; whereas in the control group, three developed local recurrence and six patients died due to distant metastasis. Estimated median survival time was significantly (p<0.04) longer for the PSK group (35 mos) versus controls (25 mos). The five-year survival was significantly (p<.04) higher for the PSK (28%) versus control (15%) also.

Ohno R, Yamada K, Masaoka T, Ohshima T, Amaki I, Hirota Y, et al. A randomized trial of chemoimmunotherapy of acute nonlymphocytic leukemia in adults using a protein-bound polysaccharide preparation. Cancer Immunology, Immunotherapy 1984;18:149-54.

Purpose: Disease response and survival. Type of Study: RCT Methods: (Leukemia) (n=73) Patients with ANLL who achieved complete remission were randomized to maintenance chemotherapy only (n=38, 36 evaluable) or chemotherapy plus immunotherapy plus PSK (n=35, 31 evaluable). No significant differences between the two groups were observed by age, sex, or type of ANLL. All patients were followed by outpatient clinics at one- to two-week intervals until relapse. After chemotherapy was terminated two years later, patients were assessed at two- to four-week intervals. PSK was continued as long as the patients were in remission.
Results: Treatment with PSK for six months tended to extend remission (p<0.09) and survival (p<0.06) time; however, at 12, 18, and 24 months, no significant differences improvement was found for remission and survival. A subset analysis by length of remission before starting the PSK and chemo showed that patients who had achieved a remission of more than 270 days tended (not significant) to have longer survival with PSK (p<0.11).

Mitomi T, Tsuchiya S, Iijima N, Aso K, Suzuki K, Nishiyama K, et al. Randomized, controlled study on adjuvant immunochemotherapy with PSK in curatively resected colorectal cancer. Diseases of the Colon and Rectum 1992;35(2):123-30.

Purpose: To study the effect of immunochemotherapy with PSK on prolonged survival. Type of Study: RCT Methods: (Colorectal) (n=462, 448 evaluable) The control group (n=227) received mitomycin C on the day of and the day after surgery, followed by oral 5-fluorouracil (5-FU) for over six months. The PSK group (n=221) received PSK orally for over three years, in addition to mitomycin C and 5-FU. Median follow-up time was four years (range three to five years).
Results: The disease-free overall survival curves of the PSK group were better than those of the control group; these differences were statistically significant for disease-free survival (p<0.01 and survival (p<0.01).

Nagao T, Komatsuda M, Yamauchi K, Nozaki H, Watanabe K, Arimori S. Chemoimmunotherapy with Krestin in acute leukemia. Tokai Journal of Experimental & Clinical Medicine 1981;6(2):141-6.

Purpose: Disease response and survival. Type of Study: RCT. Methods: (Leukemia) (n=28) Patients were placed at random in the chemotherapy and chemo-immunotherapy groups with 14 patients each. Remission had been induced by combination therapy (neocarzinostatin, cytosine arabinoside, prednisolone or vinicristine, daunorubicin, prednisolone). After complete remission, two to three courses of consolidation therapy consisting of mercaptopurine chemotherapy with or without Krestin (PSK) daily until relapse.
Results: The median duration for complete remission and survival were longer in the chemoimmunotherapy (PSK) than the chemotherapy group. The complete remission rate was higher in the chemoimmunotherapy group (36 weeks; range 17 - 128) than the chemotherapy group (25 weeks; range nine to 66+). The average survival time of the PSK group was 21 months (range eight to 37+) while that of the control group was 12 months (range four to 26). The cell-mediated immunity was somewhat enhanced in the chemoimmunotherapy group, while it was not enhanced in the chemotherapy group. No subjective or objective side effects due to PSK were observed for over one year.

Nakazato H, Koike A, Saji S, Ogawa N, Sakamoto J. Efficacy of immunochemotherapy as adjuvant treatment after curative resection of gastric cancer. The Lancet 1994;343:1122-6.

Purpose: Disease response and survival Type of Study: RCT Methods: (Gastrointestinal) (n=262, 253 evaluable) Patients who had a gastrectomy were randomly assigned to standard treatment with mitomycin and fluorouracil or standard treatment plus PSK. The minimum follow-up time was five years.
Results: Compared with the standard care group, PSK treatment increased five-year disease-free period (70.7% vs. 59.4%, p<0.05) and five-year survival (73.0% vs. 60.0%, p=0.04). The two regimens had slight toxic effects, consisting of nausea, leucopenia, and liver function impairment, with no significant differences between the two groups. No characteristic toxic effects could be identified for PSK. The treatments were clinically well tolerated and compliance was good.

Iino Y, Yokoe T, Maemura M, Horiguchi J, Takei H, Ohwada S, et al. Immunochemotherapies versus chemotherapy as adjuvant treatment after curative resection of operable breast cancer. Anticancer Research 1995;15:2907-12.

Purpose: Disease response and survival Type of Study: RCT Methods: (Breast) (n=227) Patients with operable breast cancer with vascular invasion in the tumor and/or in the metastatic lymph node were entered in the study. The patients were randomized into three groups: 5-fluorouracil, cyclophosphamide, mitomycin C and predonisolone (FEMP) FEMP+ levamisole (LMS) FEMP+PSK. Each treatment was carried out at six-month intervals for five years.
Results: Risk ratio lower for the PSK group (1.00) than the FEMP (1.64) and FEMP+LMS (1.19) groups. Disease free survival rates at 10 years were 64.6% for the FEMP; 70.7% for the FEMP+LMS; and 74.1% for the FEMP+PSK (not statistically significant). Overall survival rates were 64.6% Femp, 76.9% Femp+LMS, and 81.1% FEMP+PSK (p=0.07). Side effects of leukopenia and nausea observed in five patients were mild and tolerable.

Hayakawa K, Mitsuhashi N, Saito Y, Takahashi M, Katano S, Shiojima K, et al. Effect of Krestin (PSK) as adjuvant treatment on the prognosis after radical radiotherapy in patients with non-small cell lung cancer. Anticancer Research 1993;13:1815-20.

Purpose: Disease response and survival Type of Study: Prospective cohort with external controls. Methods: (Lung) (n=185) Among patients with little residual tumor and considered to be highly curable, PSK was administered after radical radiotherapy.
Results: Five year survival of PSK patients with stages I or II disease, as well as stage III was 39% and 22% respectively, compared with the control group of 16% and 5%. These differences are statistically significant. Note: The PSK group was compared with a group that was not doing as well at start of study. Thus, statistical significance, in this situation, is not clinically meaningful.

Torisu M, Hayashi Y, Ishimitsu T, Fujimura T, Iwasaki K, Katano M, et al. Significant prolongation of disease-free period gained by oral polysaccharide K (PSK) administration after curative surgical operation of colorectal cancer. Cancer Immunology, Immunotherapy 1990;31:261-8.

Purpose: Disease response and survival Type of Study: RCT. Methods: (Colorectal) (n=120) Patients were randomized to receive PSK (n=56) or placebo (n=55) at 10-15 days post surgery in decreasing doses over three years.
Results: The number of patients in remission and surviving at 10 years were significantly higher (p<.05) in the PSK group than in the placebo group. Survival Studies Without Disease Response

Niimoto M, Hattori T, Tamada R, Sugimachi K, Inokuchi K, Ogawa N. Postoperative adjuvant immunochemotherapy with mitomycin C, futraful and PSK for gastric cancer. An analysis of data on 579 patients followed for five years. Japanese Journal of Surgery 1988;18(6):681-6.

Purpose: Survival Type of Study: Randomized clinical trial. Methods: (Gastric cancer) (n=579) Patients under 75 years of age with gastric cancer, no previous cancer therapy, and successful surgery were entered into the study. MMC 20 mg IV was administered on the day after gastrectomy, followed by an additional 10 mg the next day for patients who were less than 70 years of age, 40 kg or more, and no total gastrectomy with combined resection of the colon or pancreas. PSK was administered orally at a daily dose of 3 g for one year, commencing from one to two weeks after the operation in the patients of Group A. FT was administered as a daily dose to the patients in Group B in the same manner, and a combination of PSK plus FT was administered to the patients in Group C.
Results: The MMC+FT+PSK group showed a significant increase in five-year survival compared with the other groups (p<0.05) as was survival compared the MMC+FT group (p<0.01). According to subset analyses, the MMC+FT+PSK group had significantly improved survival among cases with positive lymph node metastases, positive serosal invasion, or both (p<.01) and undifferentiated carcinoma by histological type and in those with a preoperative positive PPD reaction (p<0.05).

Ogoshi K, Satou H, Isono K, Mitomi T, Endoh M, Sugita M, et al. Immunotherapy for esophageal cancer: A randomized trial in combination with radiotherapy and radiochemotherapy. American Journal of Clinical Oncology 1995;18(3):216-22.

Purpose: Survival Type of Study: Randomized clinical trial. Methods: (Esophagus) (n=174) Among 187 patients, 174 (93.1%) eligible patients with biopsy-proven esophageal squamous cell carcinoma underwent esophagectomy and were randomly assigned to receive radiotherapy (RT) with or without protein-bound polysaccharide (PSK), or RT plus chemotherapy (CT) with or without PSK. The immunotherapy group received oral PSK for three months, commencing as soon as possible after esophagectomy. PSK or Futraful were then given for as long as possible after surgery.
Results: The five-year survival rates for each group are as follows: RT (40.0%), RT+PSK (42.3%), RT+CT (29.1%) and RT+CT+PSK (37.2%). The survival difference between the RT + CT group and the RT + CT+PSK group was significant (log-rank and generalized Wilcoxon tests, p=0.1370, p=0.0404).

Ogoshi K, Satou H, Isono K, Mitomi T, Endoh M, Sugita M. Possible predictive markers of immunotherapy in esophageal cancer: Retrospective analysis of a randomized study. Cancer Investigation 1995;13(4):363-9. Note: This is a stratified re-analysis of the Ogoshi, et al. RCT study31.

Purpose: Survival Type of Study: Randomized clinical trial. Methods: (Esophagus) (n=158) Initially, 187 esophageal cancer patients entered in the study, 174 were eligible, and 158 actually completed therapy. Pre-treatment blood samples were collected for examination of the levels of two markers with immunosuppressive activity, 1-antichymotrypsin (ACT) and sialic acid (SA).
Results: Stage IV patients had significantly higher serum levels of ACT. In addition to the significant differences in survival between the patients with and without PSK therapy reported in the previous study31. For 43 patients with normal levels of ACT, no significant differences occurred in five-year survival rates. However, for the 68 patients with abnormal levels of ACT, higher better survival rates occurred for those who received PSK (54.8% and 25.9%; log-rank and generalized Wilcoxon tests, p=0.0077, p=0.0057). Among patients with normal levels of SA, no significant survival differences occurred with or without PSK. However, patients with abnormal levels of SA had significantly better survival with PSK (58.3% and 30.8%; log-rank and generalized Wilcoxon tests, p = 0.0671, p=0.0333).
Chung C-H, Go P, Chang K-H. PSK immunotherapy in cancer patients - a preliminary report. Chinese Journal of Microbiology and Immunology 1987;20:210-6.

Purpose: Survival Type of Study: Prospective cohort with historical controls. Methods: (Various) (n=67, 43 evaluable) PSK (1 g/daily) was administered for at least a month upon completion of primary treatment for the tumor, with a maximum use of one to two years. All patients received radiotherapy prior to the start of PSK, and 23 (34.3%) of the patients underwent chemotherapy and surgery in addition to radiotherapy.
Results: Only four sites, nasopharynx, uterine cervix, breast, and gastrointestinal carcinoma, had sufficient numbers for analysis. Nasopharyngeal patients with PSK had significantly improved (p<.05) survival compared with controls. The cervical carcinoma patients had no significant differences in survival; however, the authors state that "there seems to be an increase in the survival period among patients with carcinoma of the uterine cervix who are maintained on a longer period of PSK immunotherapy".

Toge T, Yamaguchi Y. Protein-bound polysaccharide increases survival in resected gastric cancer cases stratified with a preoperative granulocyte and lymphocyte count. Oncology Reports. 2000 Sep-2000 Oct;7(5):1157-61.

Purpose: Survival Type of Study: Stratified re-analysis of the Mitomi et al. RCT study6 Methods: (Gastric) The previous study evaluated treatment of 751 patients with gastric cancer by comparing treatment with surgery plus chemotherapy with surgery plus chemotherapy plus PSK. This study re-analyzed the data according to pre-operative granulocyte/lymphocyte (G/L) ratios.
Results: Five-year survival for patients with G/L ratios less than 2.0 differ not differ significantly with or without PSK. However, patients with G/L equal to or above 2.0 had significant differences in five-year survival with and without PSK. For patients with PSK, 68.7% survived five years versus 55.4% for those without (Log rank p-0.007; generalized Wilcoxen p=0.006, Cox regression p=0.002 as adjusted for sex, age, primary tumor, and regional lymph nodes.)

Saji S, Sakamoto J, Teramukai S, Kunieda K, Sugiyama Y, Ohashi Y, et al. Impact of splenectomy and immunochemotherapy on survival following gastrectomy for carcinoma: covariate interaction with immunosuppressive acidic protein, a serum marker for the host immune system. Tumor Marker Committee for the Study Group of Immunochemotherapy with PSK for Gastric Cancer. Surgery Today. 1999;29(6):504-10.

Purpose: Survival Type of Study: This is a stratified re-analysis of the Nakazoto et al. RCT study24. Methods: (Gastric) The previous RCT evaluated the impact of splenectomy on the survival of 253 patients gastric cancer patients by comparing immunochemotherapy (PSK) versus standard chemotherapy. This study analyzes these groups according to sub-groups with and without splenectomy and preoperative levels of the immune defense parameter, immunosuppressive acidic protein (IAP) for 228 patients in whom these levels were measured. Note that patients with splenectomies generally had more advanced pathological stage of tumors (p<0.001, Wilcoxen).
Results: (This description is limited to the effect of PSK upon survival in relation to splenectomy and IAP levels.) In the group with low IAP levels, survival was better with PSK with and without splenectomy, but only the low level group without splenectomy was significantly better (p=0.024). Some differences in the hazard ratios also occurred in the high IAP group between those with and without splenectomy, but these differences were not significant.

Ogoshi K, Miyaji M, Nakamura K, Kondoh Y, Makuuchi H, Tajima T. Immunotherapy and combined assay of serum levels of carcinoembryonic antigen and acute-phase reactants. Cancer Immunology, Immunotherapy. 1998 Mar;46(1):14-20.

Purpose: Survival Type of Study: Retrospective review of tumor markers, treatment, and other characteristics Methods: (Gastric) Demographic and disease factors including pre-operative serum levels of tumor/immune markers were analyzed in reference to treatment with PSK for 872 resected gastric cancer patients with histologically confirmed adenocarcinoma. Tumor/immune markers included: Carcioembryonic antigen (CEA), and the following acute phase reactants (APR): immunosuppressive acidic protein, acid-soluble glycoproteins, 1-antichymotrypsin, sialic acid.
Results: 1) Patients with abnormal levels of CEA had significantly longer survival with PSK (log-rank test, p=0.0136; Breslow test, p=0.0125). 2) Patients with abnormal levels of CEA and one or more APR levels (Group D, n=73) had significantly longer survival with PSK. (log-rank test, P=0.0015; Breslow test, P=0.0042). 3) Cox multivariate regression analysis of four factors significantly related to survival in Group D (PSK, pathological stage, age, and differentiated type) indicated that "PSK was the most significant factor", but this statistic was not reported. 4) PSK was not significantly related to survival in Group A (normal CEA & APR) or Group B (abnormal CEA, normal APR) or Group C (normal CEA, abnormal APR).

Ogoshi K, Tajima T, Mitomi T, Makuuchi H, Tsuji K. HLA-A2 antigen status predicts metastasis and response to immunotherapy in gastric cancer. Cancer Immunology, Immunotherapy. 1997 Oct;45(1):53-9.

Purpose
: Survival (related to PSK & HLA-A2 status) Type of Study: Prospective Controlled study with internal controls for PSK Methods: (Gastric) Among 847 patients with gastric cancer, 739 patients were followed from two to twenty years to investigate the outcome of gastrectomy with or without adjuvant treatment consisting of chemotherapy with or without PSK. Chemotherapy and PSK were continued for at least three months or until tumor progression. Survival interval was defined as from operation until death. Risk of metastasis and survival was analyzed by multiple variable logistic regression.
Results: For the entire group of 847 patients, multiple logistic regression analysis showed that HLA-A2 and HLA-B52 antigens were significantly related to low and high risk of lymph node metastasis (p=0.0372 and 0.0271). For the 739 patients followed for at least two years, PSK was significantly related to better survival in HLA-A2 positive patients (RR for no PSK = 1.8081, P=0.0405). No significant differences in survival occurred within the HLA-A2 negative patients treated with or without PSK (RR =1.0037 for no PSK, P=0.9880). Immune Effects

Nio Y, Tsubono M, Tseng C-C, Morimoto H, Kawabata K, Masai Y, et al. Immunomodulation by orally administered protein-bound polysaccharide PSK in patients with gastrointestinal cancer. Biotherapy 1992;4:117-28.

Purpose: Immune effects Type of Study: Randomized clinical trial. Methods: (Gastrointestinal) (n=47) A total of 29 gastric and 18 colorectal cancer patients were randomly assigned to either the control or PSK group. All patients had no prior treatment. Patients in the PSK group were given PSK orally before surgery, either daily or every other day, and were later divided into short and long duration groups. Peripheral blood lymphocytes (PBL) were compared before and after administration of PSK, and those of the regional node lymphocytes (RNL) were compared between groups.
Results: The results indicate that the effects of PSK were significantly influenced by the duration, not by frequency of administration. Among patients in the short duration group, the response of the PBL to PSK and Con A was significantly stronger compared to pre-test whereas the cytotoxicity against K562 and KATO-3, and the proportion of CD16+ cells increased significantly among patients in long duration group. In peripheral blood, natural killer cells were activated and increased in number. In the regional node lymphocytes, suppressor cells were suppressed so that helper cells increased in proportion.

Takahashi H, Okamoto M, Saito A, Suzuki T. Clinical experience of PSK to head and neck cancer; with special reference to combination with irradiation. Gan Kagakuryoho 1980;7(3):489-95. (Abstract only)

Purpose: Immune effects Type of Study: Prospective Cohort with Internal Controls. Methods: (Larynx and Hypopharynx) (n=26) PSK and radiation were administered to a 12 cases of laryngeal and two cases of hypopharyngeal cancer. This treatment group was compared with a control group of 12 cases (also with larygeal and hypopharyngeal cancer) receiving radiation alone.
Results: The inhibition of immune response from radiation (as demonstrated by PHA skin reaction and absolute number of T-lymphocytes in peripheral blood) "tended to be reduced" by PSK. However, there was no difference between the PSK administered group and the control group in the transformation rate of lymphocytes by PHA in vitro and PPD skin reaction. According to the authors, "These results suggest that PSK is capable of restoring non-specific immunoactivity in patients with head-and-neck cancer given irradiation therapy."

Kato M, Hirose K, Hakozaki M, Ohno M, Saito Y, Izutani R, et al. Induction of gene expression for immunomodulating cytokines in peripheral blood mononuclear cells in response to orally administered PSK, an immunomodulating protein-bound polysaccharide. Cancer Immunology, Immunotherapy 1995;40:152-6.

Purpose: Gene expression and immune effects - production of inflammatory and host-defensive cytokines, tumor necrosis factor (TNF) and interleukin-8 (IL-8). Type of Study: Prospective cohort Methods: (Gastric) (n=21) Healthy volunteers (n-12) and cancer patients with gastrectomy (n=9) were entered into the study; both groups received orally, once, PSK. Samples of whole blood were collected in heparinized tubes from volunteers before, and one, three, six, 12, 24 and 48 hour after PSK administration, and whole blood of patients was collected before and 24 hours after PSK administration in the same way as from the volunteers. The gene expression for cytokines in PBMC of each subject was assessed.
Results: The induction of gene expression for both TNF and IL-8 was detected in PBMC from five of the 12 healthy volunteers (42%) and four of the nine patients (44%). Furthermore, the concentration of serum IL-8 was elevated in five healthy volunteers given PSK who had shown induction of IL-8 gene expression. According to the authors, "These findings indicate that responsiveness of PBMC to PSK, in terms of gene expression and production of cytokines, varies among individuals."

Katoh R, Takenoshita S, Shimizu Y, Tanaka S, Yajima Y, Nagamachi Y. Changes in serum soluble IL-2 receptors (sIL-2R) and immunosuppressive acidic protein (IAP) associated with chemotherapy for lung cancer. Anticancer Research. 1997 Sep-1997 Oct;17(5B):3787-92.

Purpose: Detection of changes in immune parameters during chemotherapy with/without PSK Type of Study: Prospective control Methods: (lung) Fifteen patients (11 males and 4 females) "excluding those in Stage I" were enrolled in this study. Chemotherapy consisting of VP therapy (CBDCA, CDDP, VP-16) was given in combination with Granulocyte Stimulating Colony Factor (G-SCF) or PSK. Surgery and/or radiotherapy was also received by all except two patients. Patients were followed for 5 to 21 months after 2 to 9 cycles of chemotherapy. Peripheral blood counts of leukocytes, lymphocytes, and platelets were serially measured. Serum soluble IL-2 receptor (sIL-2R) and immunosuppressive acidic protein (IAP) levels were quantified by (ELISA) and colorimetric methods respectively.
Results: Leucocyte and platelet counts fell during chemotherapy with all treatments to their lowest levels in week two; however, G-CSF was associated with reduced leukopenia and showed a similar but lesser effect upon platelet count. PSK was also associated with a reduced fall in these counts, but had a weaker effect than G-CSF. The combination of G-CSF and PSK was associated with the actual recovery of leucocyte and platelet counts in weeks two through four and this recovery was greater than that of patients who recovered without either treatment.
Results: SIL-2R and IAP levels: In all deaths due to early postoperative relapse, sIL-2R levels rapidly increased while there was no relapse or a slow course after relapse in patients showing gradual changes in sIL-2R and IAP levels. IAP levels remained low however in two patients with relapse who were continuously treated with PSK and this allowed their continual treatment with chemotherapy. Note: Acceptance of the findings of this study is limited by the lack of explanatory labeling of treatment groups in figures 1 and 2 and lack of assessment of statistical significance. Other Effects

Kariya K, Nakamura K, Nomoto K, Matama S, Saigenji K. Mimicking of superoxide dismutase activity by protein-bound polysaccharide of Coriolus versicolor QUEL, and oxidative stress relief for cancer patients. Molecular Biotherapy 1992 Mar;4(1):40-6.

Purpose: Relief of "oxidative stress" Type of Study: Clinical series. Methods: (Digestive tract) Patients with malignant neoplasms in the digestive tract were entered in the study. Blood superoxide and red blood cell levels were traced before and after the administration of PSK by the authors’ method. Heparinized peripheral blood was collected and centrifuged, and 10 l of plasma and RBCs were diluted by saline. Ten l of each were injected into a vial containing 1 M CLA in 990 l distilled water. Chemiluminescence was read by a chemiluminescent reader and peak values and total counts were recorded.
Results: Superoxide in plasma and then RBC-O2 decreased suddenly. Patients with digestive tract cancer who suffered from oxidative stress were relieved by a single intraperitoneal administration of PSK or a once per day oral prescription.

Anai H, Sakaguchi Y, Emi Y, Kohnoe S, Maehara Y, Sugimachi K. A protein-bound polysaccharide immunomodulator, PSK, does not suppress the conversion from 1-(2-tetrahydrofuryl)-5-fluorouracil to 5-fluorouracil in patients with gastric cancer. Anti-Cancer Drugs 1991 Jun;2(3):275-8.

Purpose: Effects on metabolism of 5FU chemotherapy Type of Study: Clinical series. Methods: (Gastric cancer) (n=10) Patients with gastric cancer were given PSK and tegafur for eight to 14 months from post-operative day 14. Blood samples were collected pre-operatively to determine the concentrations of tegafur and 5-FU. The same test was performed after tegafur administration was withdrawn for two weeks to eliminate 5-FU from the bloodstream.
Results: Following administration of PSK, there was no change in the plasma level of 5-FU, in any patient. Studies Not Designed to Evaluate the Specific Effects of PSK

Sugimachi K, Maehara Y, Ogawa M, Kakegawa T, Tomita M. Dose intensity of uracil and tegafur in postoperative chemotherapy for patients with poorly differentiated gastric cancer. Cancer Chemotherapy & Pharmacology 1997 Jul;40(3):233-8.

Purpose: Disease response and survival Type of Study: RCT (not evaluable for specific PSK effects) Treatment Groups: (Gastric cancer)(n=224) Surgery plus random assignment to either group A with Mitomycin C (MMC) and 5-fluorouracil and uracil (UFT)) plus PSK orally for 1 year or group B with UFT (higher dose) and MMC plus PSK.

Maehara Y, Inutsuka S, Takeuchi H, Baba H, Kusumoto H, Sugimachi K. Postoperative PSK and OK-432 immunochemotherapy for patients with gastric cancer. Cancer Chemotherapy & Pharmacology 1993;33(2):171-5.

Purpose: Survival Type of Study: Retrospective review. Methods: (n=963) A total of 627 patients received postoperative chemotherapy and 336 were also given the immunomodulators PSK or OK-432 and this postoperative immunochemotherapy was more often prescribed for patients with advanced disease.

Kodama Y, Kano T, Tamada R, Kumashiro R, Okamura T, Inokuchi K. Combined effect of prophylactic lymphadenectomy and long term combination chemotherapy for curatively resected carcinoma of the stomach. Japanese Journal of Surgery 1982;12(4):244-8.

Purpose: Survival Type of Study: Prospective cohorts with internal controls Treatment Groups: (Stomach) (n=487) Of the three patient groups who had curative gastric resection with prophylactic extensive lymph node dissection (PELD), controls received no anticancer drugs, a second group received Mitomycin-C (MMC), and a third received MMC, Tegafur, and PSK (PLCC).

Kano T, Kumashiro R, Masuda H, Tamada R, Inokuchi K. Late results of postoperative long-term cancer chemotherapy for the gastric cancer patients subjected to curative resection. Japanese Journal of Surgery 1983;13(2):112-6.

Purpose: Survival Type of Study: Randomized clinical trial. Treatment Groups: (Gastrointestinal) (n=528 evaluable) All patients underwent curative gastric resection and had PLCC as a main adjuvant chemotherapy. Mitomycin-C (MMC) injection was prescribed from 1964-1971, and Mitomycin-C, FT-207 and PSK was prescribed from 1971.

Kano T, Tamada R, Abe Y, Hiramoto Y, Notsuka T, Shiraishi M, et al. Postoperative long-term cancer chemotherapy (PLCC) extends life-span of non-curatively resected patients with stage IV gastric cancer. Japanese Journal of Surgery 1982;12(3):201-7.

Purpose: Survival Type of Study: Prospective cohort with controls. Treatment Groups: (Gastrointestinal) (n=324) Patients with stage IV gastric cancer underwent a non-curative resection, the 324 eligible patients were grouped treated with: 1) MMC, Tegafur, and PSK, 2) MMC (Mitomycin-C), and 3) no chemotherapy. 16Kano T, Kumashiro R, Tamada R, Kodama Y, Inokuchi K. Late results of postoperative long term cancer chemotherapy for advanced carcinoma of the stomach.

Japanese Journal of Surgery 1981;11(4):291-6. Purpose: Survival Type of Study: Prospective cohort with controls. Treatment Groups: (Stomach) (n=157) A total of 157 Japanese patients with advanced gastric cancer received gastrectomy and combined adjuvant chemotherapy. PLCC included intermittent iv administration of Mitomycin-C (MMC), and oral FT-207 and PSK. Controls were given MMC only during the surgery. All cases were divided into either the PLCC group or the control group.

Shibata M, Nezu T, Kanou H, Nagata Y, Kimura T, Takekawa M, et al. Immunomodulatory effects of low dose cis-Diaminedichloroplatinum (cisplatin) combined with UFT and PSK in patients with advanced colorectal cancer. Cancer Investigation. 2002;20(2):166-73.

Purpose: Immune effects Type of Study: Clinic series Treatment Groups: One group treated with Cisplatin and UFT, a form of uracil and tegafur, a prodrug of 5-FU, were administered with PSK to ten patients.

Munemoto Y, Iida Y, Abe J, Saito H, Fujisawa K, Kasahara Y, et al. Significance of postoperative adjuvant immunochemotherapy after curative resection of colorectal cancers: Association between host or tumor factors and survival. International Journal of Oncology. 2002 Feb;20(2):403-11.

Purpose: Survival Type of Study: Clinical Series with analysis of prognostic factors related to survival. Treatment Groups: One group treated with surgery plus mitomycin C, fluoroipyrimidine, and PSK.

Kawa K, Konishi S, Tsujiino G, Mabuchi S. Effects of biological response modifiers on childhood ALL being in remission after chemotherapy. Biomedicine & Pharmacotherapy 1991;45:113-6.

Purpose: Disease Response Type of Study: Prospective cohort with controls Treatment Groups: After termination of chemotherapy, patients were treated with biological response modifiers such as Nocardia rubra cell wall skeleton, PSK and Bestatin or no therapy. The twenty patients treated with PSK were included in the no therapy group because "no significant difference had been observed in a previous study" *. Note: The previous study referred to was not obtained for this review because it was in Japanese. An English abstract of that study reported that six of 20 patients treated with PSK relapsed compared with four of 17 with no treatment and eight out of 54 who received other biological response modifiers (N-CWS or OK-432)43.


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