W.C. Xue and T.F. Liu
Cancer Hospital, Shanghai Medical University
Abstract
There is no really effective treatment for moderate and advanced stages of esophageal
carcinoma. Although surgery for the earlier cases has been able to give a 5 years survival
rate of 28.7%, such operable cases are relatively few. By far the greater majority are
already in stage III to IV when first seen in the clinic, and radiotherapy alone in these cases
has given a 5 years survival rate of only 8-14%. In order to improve treatment results, a
variety of chemotherapeutic agents have been used in combination surgery, but so far no
really effective drug has been found.
The drug PSP (polysaccharide-peptide of Coriolus versicolor) has been discovered and
produced by Professor Qing-yao Yang of. It is a new anti-cancer and immuno-regulatory
drug, similar to PSK (Krestin) but the effective component has been found to be larger
than PSK. Experimental data has proved these properties of PSP, and in vitro as well as
in vivo studies have all proved that PSP is superior to PSK. Of course, as is the case with
all new drugs, the ultimate proof of its value will have to be shown by clinical application.
Data on Krestin suggest that this family of drugs when used in combination with
radiotherapy, there might be an increase of the biological effects of radiation. To do a
pilot study on such a possibility, the authors have treated 41 moderate to advanced cases of
esophageal carcinoma with a combination of PSP and radiotherapy.
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Ichihashi H, Kondo T, Nakazato H.
A randomized controlled study was carried out on curatively resected gastric cancer patients in a cooperative study involving 16 institutions in order to evaluate the effect of an alternative long-term adjuvant immunochemotherapy using Esquinon (CQ) and Krestin (PSK). One week after surgery, CQ was given at a dose of 2mg/m2 once a week for 3 weeks and this was repeated every 6 weeks. CQ was administered intravenously in the 1st course and thereafter orally up to 9 courses. Three postoperative week, immunotherapy was then started in which PSK was given orally in 3 divided doses of
2g/m2/day from the day when CQ therapy ended for 4 consecutive weeks, and this performed for every course. Estimated survival rate and cumulative survival curves were compared utilizing the data up to 7 years after surgery in the chemotherapy group given CQ alone and in the immunochemotherapy group given CQ + PSK. The survival curve in all cases showed a favorable form in the CQ + PSK group for up to 36 months, and thereafter it crossed with that of the CQ group for up to 68 months. Both curves twisted at 68 months and then deviated from each other, showing that the effect in the CQ + PSK group beneficial. The curve showed a twisting configuration throughout the treatment period. There was no statistically significant difference between the survival curves of the two groups. Retrospective survival analysis was then performed on separate subgroups classified into the category of S1, S2, N1, and N2. The CQ + PSK group was better than the CQ alone group in its survival rate for the S1 + S2 (N1-2) group, the percentage being 11.5%, and a statistically significant difference was observed between the two groups (p = 0.089).
W.C. Xue and T.F. Liu
There is no really effective treatment for moderate and advanced stages of esophageal carcinoma. Although surgery for the earlier cases has been able to give a 5 years survival rate of 28.7%, such operable cases are relatively few. By far the greater majority are already in stage III to IV when first seen in the clinic, and radiotherapy alone in these cases has given a 5 years survival rate of only 8-14%. In order to improve treatment results, a variety of chemotherapeutic agents have been used in combination surgery, but so far no really effective drug has been found.
The drug PSP (polysaccharide-peptide of Coriolus versicolor) has been discovered and produced by Professor Qing-yao Yang of. It is a new anti-cancer and immuno-regulatory drug, similar to PSK (Krestin) but the effective component has been found to be larger than PSK. Experimental data has proved these properties of PSP, and in vitro as well as in vivo studies have all proved that PSP is superior to PSK. Of course, as is the case with all new drugs, the ultimate proof of its value will have to be shown by clinical application.
Data on Krestin suggest that this family of drugs when used in combination with radiotherapy, there might be an increase of the biological effects of radiation. To do a pilot study on such a possibility, the authors have treated 41 moderate to advanced cases of esophageal carcinoma with a combination of PSP and radiotherapy.
The purpose of this study was to determine if immunotherapy with Krestin can prolong the durations of complete remission and survival. The patients were placed at random in the chemotherapy and chemoimmunotherapy groups. The median durations of complete remission and survival were longer in the chemoimmunotherapy group than in the chemotherapy group. The complete remission rate of the second induction was higher in the chemoimmunotherapy group than in the chemotherapy group. The cell-mediated immunity was somewhat enhanced in the chemoimmunotherapy group, while it was not enhanced in the chemotherapy group. These results suggested that Krestin administration for maintenance therapy was useful for prolongation of the durations of remission and survival time in patients with acute leukemia.
Masato Urano, Chihiro Tanaka, Yasuyuki Sugiyama, Kiichi Miya, and Shigetoyo Saji*
Cryoablation is a low-invasive surgical treatment for malignant tumors. It may induce an immunological response leading to the eradication of distant metastases or alternatively it might promote the growth of residual tumors. In this paper we confirm the occurrence of both phenomena and we describe the preventive effect of a protein-bound polysaccharide preparation. Metastatic liver tumors were produced in BALB/c mice by the intrasplenic inoculation of colon 26 cells and cryoablation was carried out usingliquid nitrogen ()170C) applied by a contact method. The value of combiningcryoablation with administration of the polysaccharide preparation in the prevention of growth of residual tumors was investigated. It was shown that the number of metastatic liver nodules and the size of the primary tumor at the site of inoculation in the spleen were significantly lower when the volume that was frozen was small. The production by splenocytes of the tumor necrosis factor TNF-a, interferon INF-c, and the interleukins IL-4 and IL-10 increased significantly after freezing and thawing of the tumor tissue. The polysaccharide treatment significantly reduced the production of IL-4 and IL-10 followingcryoablation; the production of TNF-a and INF-c was slightly promoted; the natural killer and cytotoxic T-cell activities of splenocytes were slightly enhanced. It was concluded that the polysaccharide preparation was beneficial by suppressing IL-4 and IL-10 production and might inhibit the growth of residual tumor that is sometimes induced by large-volume cryoablation.
To evaluate the efficacy of PSK for adjuvant immuno-chemotherapy in patients who had undergone radical gastrectomy, a randomized controlled trial has been in progress in collaboration with 46 institutions in the Chubu district of Japan. A total of 262 patients were registered for this trial during the two years from July 1985 to June 1987 with a centralized registration system, and were allocated into the 5-FU+PSK group (Group P) and 5-FU alone group (Group C) by the minimization method following the random permuted blocks method. Between the two groups, the parameters of sex, age, serosal invasion (S), lymph-node metastasis (N), and the combination of S . N factor levels were distributed without significant differences. An induction treatment with MMC 6 mg/m2 was given to all patients following curative mastectomy and on the 7th post-operative day. Two weeks after surgery, Group P received alternately PSK 3 g/day for 4 week and 5-FU 150 mg/day for 4 weeks as one course, and 10 courses were given. Group C received 5-FU alone for 4 weeks using alternate rest interval for 4 weeks. Since both experimental and clinical studies suggested that alternate treatments using PSK and anticancer agents were effective, treatment in this trial alternated PSK and 5-FU. A final follow-up study will be completed in June 1992, when all patients shall have survived more than 5 years after surgery. The administration of 5-FU was completed by January. 1989, but PSK has been administered to group P. The period from 18 to 42 months after surgery was reached in all eligible patients (253) at the end of December 1988. The disease-free survival curves and overall survival curves of group P were significantly (p = 0.018 and p = 0.045,) better than those of group C.
A total of 103 patients with advanced gastric carcinoma were randomized after curative surgery to receive an alternate administration of carabzilquinone (CQ) and PSK (Krestin) or carbazilquinone alone. Each course of therapies started 1 week after the surgical operation and therapy schedules consisted of 9 courses. In each course of 6 weeks, CQ was administered on day 0, 8, and 15. In combined immunochemotherapy group, PSK was given orally in 3-divided doses of 2g/m^2/day from the day of the third CQ administration for consecutive 4 weeks. Estimated survival rate and cumulative survival curve were compared untilizing the data up to 7 years after the operation. There was no overall significant difference in survival rates between the CQ plus PSK group and the CQ alone group, but a group of patients survived significantly longer when treated with the combination of CQ and PSK. Neither in more advanced cases nor in cancers of early stages, the addition of PSK provided an additive effect. The favorable result obtained in one subgroup treated with PSK, suggests that the use of this agent in treating gastric cancers should be carefully evaluated in terms of serosal infiltration and nodal metastasis.?
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