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Background: Little is known whether sublingual immunotherapy using Japanese cedar pollen extract (cedar SLIT) is effective for not only Japanese cedar pollinosis but also Japanese cypress pollinosis. We investigated the prevalence rate of Japanese cypress pollinosis, efficacy of cedar SLIT on cypress pollinosis and patients' wish to receive cypress SLIT., Methods: We investigated a multi-center (31 institutions), cross-sectional survey using a self-administrated questionnaire with four questions for patients received cedar SLIT aged from 5 to 69 years old., Results: 2523 subjects were enrolled for analysis. 83.4% of them had pollinosis symptoms during cypress season before cedar SLIT. In such patients, 37.4% experienced lessened efficacy of cedar SLIT during cypress season. Both the prevalence of cypress pollinosis and the lessened efficacy of cedar SLIT on cypress pollinosis were significantly seen in western Japan as compared to eastern Japan. 76.1% of the subject having cypress pollinosis before SLIT wished to receive cypress SLIT if it is available., Conclusion: A lessened efficacy of cedar SLIT during cypress season was broadly seen in Japan, and further showed a regional difference. Together with the finding of high wish by patients, these results suggest a development of cypress SLIT is desirable.

Case 1: 83 years old man. For left upper lobe lungs squamous cell carcinoma infiltrating left main pulmonary artery. After 2 courses went of carboplatin(CBDCA)(AUC: 6)+weekly nab-paclitaxel(nab-PTX)(AUC: 6)+, left upper lobectomy and ND2 lymph nodes dissection. Tumor disappeared in pathology and diagnosed of Ef. 3. Case 2: 81 years old man. Right upper lobe lungs squamous cell carcinoma in #4R lymph node metastasis with the superior vena cava invasion. After 2 courses went of CBDCA(AUC: 6)+weekly nab-PTX(100mg/m2), left upper lobectomy and ND2 lymph nodes dissection. Tumor disappeared in pathology and diagnosed of Ef. 3. Nab-PTX may be considered a preoperative chemotherapeutic agent of choice for squamous cell carcinoma.

A 25-year-old man with a left testicular tumor underwent a high inguinal orchiectomy. Histopathological examination of the resected specimen revealed tumors of more than one histological type, mixed forms (seminoma, immature teratoma). Further evaluation revealed no metastasis (pT1N0M0S1 Stage IS).Four months after orchiectomy, alpha-fetoprotein (AFP) was elevated.CT scan revealed retroperitoneal masses of recurrent tumor. Although the AFP returned to normal level after four courses of BEP (bleomycin, etoposide and cisplatin), the retroperitoneal lymph nodes continued to grow. He underwent excision of the retroperitoneal lymph node dissection. Histopathological examination of the resected specimen revealed mature teratoma.Few reports examined about the development mechanism of growing teratoma syndrome (GTS). We considered that the development mechanism of GTS in this case is induction of differentiation. In this case report, we discuss the development mechanism of GTS based on bibliographical consideration.

Objectives: Facial palsy may cause excessive stress due to the obviousness of its manifestations. We evaluated psychological stress in patients with facial palsy., Subjects and Methods: Subjects were 57 patients with Bell's palsy, 12 with Ramsay Hunt syndrome, and 11 with zoster sine herpete. Eighteen of 50 questions from the Psychological Stress Response Scale (PSRS) were selected and used to in a questionnaire completed by each patient on 2 separate occasions the first hospital visit and after recovery from facial palsy. They also completed a second bodily condition questionnaire before and after treatment., Results: The psychological stress response score of patients with facial palsy was high on the first visit. Intermediate and high psychological stress were observed in 35% on the first visit. These psychological stress response score decreased after recovery from facial palsy. The psychological stress response of patients under 65 years of age in those over 65 years. No gender difference was seen in psychological stress response. Those with herpes zoster showed a higher psychological stress response than others and this decreased after recovery from facial palsy., Conclusions: Psychological stress response score of patients with facial palsy was high on the first hospital visit, suggesting that we must treat the psychological aspects of this manifestation by adequately explaining prognosis and pathology, in addition to physical therapy.

The Yanagihara method and the House-Brackmann (H-B) method are widely used in Japan to evaluate facial paralysis. The present study focuses on the relationship between the evaluation of facial paralysis using these methods and self-evaluation by patients. One-hundred and thirty-one patients with facial paralysis were included in the study, consisting of 68 males and 63 females between the ages of 17 and 84 years (mean age: 41 +/- 18 years). In addition to the Yanagihara and H-B methods, two methods of self-evaluation were used by the patients. In the first self-evaluation method, the patient was asked to rate the degree of paralysis as a grade of one to six. In the second method, the patient was asked to rate the severity of the paralysis on a scale of 0-100. The paralysis scores and grades determined using the Yanagihara and H-B methods were correlated with the self-evaluations. However, the strength of the correlation varied among the patients, indicating that the evaluation of subjective symptoms differed among individuals. Even patients who were evaluated as either "completely paralyzed" or "cured" according to the Yanagihara and H-B methods did not always rate their subjective symptoms as being consistent with these scores. In particular, 20 to 30% of patients who were evaluated as "cured" complained of minor dyskinesia.

Purpose and Methods: We investigated the influence of flutamide on plasma adrenal androgens in advanced prostate cancer patients treated with dietylstilbestrol diphosphate (DES-DP) followed by luteinizing hormone-releasing hormone agonist (LH-RH agonist). Nine patients were enrolled in this study and they were divided into the following two treatment groups; group A: LHRH agonist mono-therapy (n = 4) and group B: LHRH agonist with flutamide (n = 5). For prevention of flare up, all patients were treated with DES-DP., Results: Two-week DES-DP administration led to reduction of plasma adrenal androgen levels. These levels were kept lower for 16 weeks in group B in contrast with group A in which the levels returned to the pretreatment levels. Basal ACTH levels in group B were significantly lower than those in group A., Conclusion: From our observations, we found that flutamide reduced adrenal androgen levels in prostate cancer patients treated with LH-RH agonist. ACTH suppression might be related to this phenomenon.

A nationwide questionnaire survey was carried out on low-dose cisplatin-5-FU therapy for solid malignant tumors (mostly stomach and colon cancer) regarding its antitumor as well as adverse effects. The regimen was defined as 4 weeks administration of cisplatin 2-5 mg/body, 5 days a week, which was used in 47% of 82 institutions studied. Cases were classified into an Ab regimen (86 cases) with cisplatin 3-5 mg/body, and a Bb regimen (122 cases) with cisplatin 6-30 mg (mostly 10 mg)/body, both of which were given 5-FU 300-500 mg/body daily. The antitumor effect (CR + PR) was shown to be slightly higher in the Bb regimen than in the Ab regimen, and was 35% overall. Very few adverse effects appeared with either regimen for mostly major digestive, hepatic and renal functions, except for myelodepressions (leucopenia and thrombocytopenia), which were more than grade 3 in only a few percent with the Ab regimen, and a little more than 10% with the Bb regimen. The advantages and disadvantages of the A/Bb regimens appeared to be counter-balanced in terms of their antitumor and adverse effects. Most institutions using the Ab regimen favored repeating the regimen cycle as much as possible. Those using more than 6 cycles accounted for about 20% of hospitals.

Purpose: Screening by only prostate specific antigen (PSA) for prostate cancer was started since PSA had been added to mass screening as one of check lists in 1997 in Isesaki city, Gunma pref. We expected PSA screening to be introduced into other areas. We therefore studied how to perform a screening procedure for prostate cancer as well as discussed our result of the screening conducted lately., Materials and Methods: 1,382 out of 1,423 Isesaki citizens who took mass screening aged 40 to 64 were chosen. Regardless of age, men with a serum PSA level equal or larger than 4.1 ng/ml (Tandem R) were selected for second screening since we determined it was a cut-off level for further check-up. Of those men, 38 were requested for second screening and actually only 24 took it. All these men took PSA check-up again, furthermore 23 took transrectal examination (TRE) and/or transrectal ultra sonography (TRUS) except for one of them. The next screening was requested for sixteen of them. Prostate biopsy was conducted for all of them., Results: More old men took screening and were diagnosed prostate cancer. The findings derived from such diagnosis showed one of them aged 50 to 59 and six of them aged 60 to 64 had the cancer. Moreover, four out of twenty with PSA level ranging 4.1 to 10.0 ng/ml and all of three with PSA level over 20.0 ng/ml had the cancer. Five out of sixteen with a positive sign for further PSA check-ups had the cancer. All the three suspect of the cancer by TURS and DRE had prostate cancer. Two of seven with PSA negative showed suspicion of prostate cancer and had the cancer. No neo-adjuvant and total prostatectomy was conducted for four with 4.0 to 10.0ng/ml diagnosed T2N0 M0. One of them with PSA equal or over 20.0 ng/ml was diagnosed T3N0M0. After hormone therapy its PSA decreased to that equal or under 0.5 ng/ml. Total prostatectomy was conducted for it., Conclusion: It is not proved that only PSA mass screening for prostatic cancer contributes to detect early cancer and better prognosis cure case. For the proof, it will be nessary that PSA mass screening is examined more people in the wide area. We conclude men aged 65 to 69 also should take PSA check-up based on epidemiological feature of prostatic cancer.

Purpose: Pyrimidine nucleoside phosphorylase (PyNPase), among which thymidine phosphorylase (dThdPase) exists mainly in human tumor tissues, is an enzyme to convert 5'-deoxy-5-fluorouridine (5'-DFUR) to 5-fluorouracil. Recently, it was reported that dThdPase was identical to platelet-derived endothelial cell growth factor, angiogenetic factor. Therefore, we expect that there is possibility of dThdPase being a prognostic factor., Methods: We investigated for a possible correlation between PyNPase activities in tumor tissues and prognostic factors of histological findings, examined the influences of preoperative oral 5'-DFUR administration to PyNPase levels and investigated for a correlation between HPLC methods and ELISA methods in patients with gastric cancer., Results: Higher levels of PyNPase were observed in patients with advanced t,n,v, and ly factors. PyNPase levels decreased by 5'-DFUR in patients with differentiated cases. A high correlation was found between HPLC and ELISA methods., Conclusion: This study suggests that we must investigate possibility of PyNPase being a prognostic factor in more detail.

We conducted a randomized controlled study to evaluate the clinical usefulness of (2"R) -4'-O-Tetrahydropyranyladriamycin (THP)-based combination therapy subsequent to induction therapy which was consisted with THP, 5'-DFUR, and CPA in the treatment of advanced or recurrent breast cancer. In maintenance therapy, Arm C received CPA and TAM, and Arm T received these two drugs plus THP. Survival time of 50% for all cases in which maintenance therapy was conducted was 26.9 months in Arm T and 20.9 months in Arm C, showing no significant difference by the log-rank test (p = 0.64). Survival time in all cases in which therapy had been completed was 54.6 months in Arm T and 28.1 months in Arm C, showing a significant difference by the log-rank test (p = 0.03) although the number of cases was few. A few cases showed a decrease in total leukocyte count to below 2,000/mm3 at the time of induction therapy, but this was transient in all cases. No significant difference in count was noted between two arms at the time of maintenance therapy. However, many cases in Arm T showed decreased total leukocyte count and hemoglobin content, and thrombocytopenia. These results suggest that combination therapy including THP conducted as maintenance therapy after induction is useful in the prolongation of survival time in patients with advanced or recurrent breast cancer.

Unlabelled: In a prospective randomized controlled trial (PRCT) of adjuvant chemotherapy for gastric cancer patients participated by 6 cancer center hospitals, inter-institutional and inter-individual differences about several factors related to the surgery and remote survivals were analyzed. From 1988 to 1992, 1,049 evaluable patients were enrolled and stratified to 6 groups according to the grade of the serosal invasion and curability, and analyzed statistically., Results: 1) There were no inter-institutional differences about postoperative survival rate, but there were slight differences about patient's background factors and entry policy of each institution. 2) There were no inter-institutional differences about several factors related to the surgery such as operative time, bleeding volume during operation, and the length of the administration periods. 3) There were no inter-individual differences about the length of the administration periods, but there were a little differences about operative time and the volume of hemorrhage. When the PRCT of adjuvant chemotherapy of which the end point is survival would be designed, no inter-institutional differences about remote survival and surgical operation in each institution should be confirmed before starting the trial.

Interferons are produced in response to viral infection and play an important part in defense by their antiviral effects. An interferon-induced enzyme, 2'-5' oligoadenylate synthetase (2-5AS) also takes an important part of the system of defense against viral infections, and its activity elevates in nonspecific viral infections. This study was designed to evaluate the usefulness of examining serum 2-5AS activity and peripheral blood WBC 2-5AS (WBC 2-5AS) as diagnostic aids of viral infections that cause facial paralysis. Samples were obtained from 83 patients with Bell's palsy, 20 with Ramsay Hunt syndrome, 74 healthy individuals, and a total of 177 subjects. In 177, we measured serum 2-5AS level in 123 subjects, WBC 2-5AS level in 57, and both in 25. Serum 2-5AS levels in Bell's palsy (60 cases) ranged from 20 to 146 pmol/dl (average: 38.5). The range in Ramsay Hunt syndrome (13) was 20-333 (average: 59.0), and in healthy controls (50), it was 20-128 (average: 41.4). WBC 2-5AS level ranged from 20 to 5900 pmol/dl (average: 733.2) in Bell's palsy (23 cases), from 20-4540 (average: 1371.4) in Ramsay Hunt syndrome (7), and from 20-903 (average: 294.5) in healthy individuals (24). There were no statistically significant differences in serum 2-5AS activities. Otherwise, there was significant difference (p < 0.01) between healthy individuals and Patients with Ramsay Hunt syndrome in WBC 2-5AS activity. In Bell's palsy, 3 cases (13.0%) with markedly high WBC 2-5AS levels existed.(ABSTRACT TRUNCATED AT 250 WORDS)

Seventy eight patients with testicular tumor were treated in our hospital between 1982 and 1992. Of 78 patients, 74 had germinal cell tumor (seminoma in 47 patients and non-seminoma in 27), and the other 4 had 3 malignant lymphoma and 1 rhabdomyosarcoma. Ages ranged from 1 to 67 years with the average of 36.1. The age of the patients with seminoma was significantly higher than that of patients with non-seminoma. Most patients complained of painless swelling of the scrotal content, but some patients complained of testicular pain, fever, and so on. Those who complained of such symptoms had significantly worse prognosis than those who had only painless scrotal swelling. Patients with non-seminoma visited us about 4.9 months after the onset of their symptoms and 12.1 months in seminoma. Clinical stages were more progressive in non-seminoma than in seminoma. Inguinal orchiectomy was performed followed by irradiation, chemotherapy, retroperitoneal lymph node dissection or thoracotomy. Recurrence developed in 6 patients and the other 7 patients died of progressive disease within 2 years from the first attendance. The 2-year survival rate calculated by the Kaplan-Meier method was 81 and 70% in seminoma and non-seminoma, respectively, and 100, 88, 63, 75, and 22% in stage I, IIA, IIB, IIIO and IIIA, B, C, respectively.

In order to study preliminary the safety of 5'-DFUR treatment as postoperative adjuvant therapy, intermittent and continuous treatment regimens were administered to patients undergoing curative resection of carcinomas of the stomach and the colorectum. Two treatment schedules were employed: 5'-DFUR was either given continuously in a daily oral dose of 600 mg/patient (continuous group) or for 2 weeks in a daily oral dose of 1,200 mg/patient followed by 2 weeks of no treatment (intermittent group). Twenty-one stomach cancer patients and 34 colorectal cancer patients were registered in the study. The rates of adverse drug reactions in the patients who completed treatment were 20.0% (2/10) in the continuous group and 50.0% (4/8) in the intermittent group of gastric cancer patients, and 16.6% (2/12) in the continuous group and 17.6% (3/17) in the intermittent group of colorectal cancer patients. The main adverse drug reactions were gastrointestinal symptoms. The incidence of diarrhea, a problematic side effect of 5'-DFUR, was 4.5% (1/22) in the continuous group and 12.0% (3/25) in the intermittent group. There were no statistically significant differences between the continuous group and the intermittent group in regard to the incidence of adverse drug reactions and survival rate. In addition, as there were no serious adverse drug reactions, both treatment regimens were demonstrated to be highly safe when administered as postoperative adjuvant therapy.

Evaluation of adjuvant immunochemotherapy using Polysaccharide K (PSK) for advanced gastric cancers was performed by meta-analysis of 6 clinical trials in which 5-year survival has been reported in distinguished journals of Japan. The odds ratio of 0.75 (95% confidence interval 0.62-0.93, p < 0.01) favored immunochemotherapy compared to chemotherapy. In the Chubu district, 3 consecutive trials using PSK were performed beginning in 1977. From meta-analysis of the 2 preceding trials, immunochemotherapy was suggested to be effective in a subgroup of T2 and T3 primary tumor, and PPD skin test positive cases. The third trial was performed in this group of patients and a statistically significant difference (p = 0.044) was observed from the 5-year results.

To clarify the clinico-pathological characteristic of poorly differentiated adenocarcinoma of gastric cancer with medullary growth pattern, the immunohistochemical study was performed using antibodies against blood group related antigens (Lewis(a), Lewis(b), Lewis(x), Lewis(y)) and gastrointestinal tissue related antigens (CEA, AFP and NSE). The following results were obtained. 1. Foveolar epithelium of normal gastric mucosa has type 1 blood group associated antigen (Lewis(a), Lewis(b)) and deep gland has type 2 antigen (Lewis(x), Lewis(y)) respectively, as the differentiation antigens. 2. Expression of Lewis(a) and Lewis(b) are more often observed in poorly differentiated adenocarcinoma with medullary and scirrhous growth pattern than in well and moderately differentiated adenocarcinoma. Poorly differentiated adenocarcinomas postulated to have closer relation with normal gastric deep gland in terms of antigen expression. 3. Poorly differentiated adenocarcinoma with medullary growth pattern is characterized as more differentiated type cancer than scirrhous type with respect to expression of blood group related antigen. 4. Poorly differentiated adenocarcinoma with medullary growth pattern may be divided into 3 subgroups by each antigen expression of CEA, NSE, and AFP.

Importance of histopathological type of tumor for the prediction of recurrence and prognosis of gastric cancers was analysed in 4419 patients who underwent surgery in Aichi Cancer Center during the 23 years from 1965 to 1987. Correlation of initial recurrence site and the histology of the tumor was examined by the categorical discriminant analysis in 617 patients. Among these patients, 62% of liver metastasis was caused by well differentiated type cancers whereas 71% of peritoneal recurrence was poorly differentiated type cancers. Cox's regression tree type analysis was performed for 2893 cases with curative gastrectomy and the maximum difference in risk ratio was observed whether the tumor microscopically penetrated the serosal layer of the stomach. Difference of the prognosis due to histopathological type of the tumor appeared after correction of the s and n factors and in the early stages poorly differentiated type had better prognosis than well differentiated type cancers. On the contrary, in more advanced cases well differentiated type tumors had much better prognosis than poorly differentiated type cancers. From these results, we suggest that the consideration of histopathological type of the tumor should be implemented as an important parameter for the evaluation of prognosis of the gastric cancers.

Issues in the statistical evaluation for therapeutic efficacy of surgical adjuvant modality therapy on the patients suffering from gastrointestinal cancers were mentioned as follows: 1) When a therapeutic effect is evaluated, it is important that a well-controlled, randomized trial should be requested under the statistical consideration. 2) On a series of systematized process such as protocol planning, coordination and administration, analysis and its interpretation, such a trial should be enough to complete several conditions which are mutually understood and coordinated between doctors and statisticians, and which are rich in knowledge and skill for the trial in each institutions. 3) Method of overview and its application for clinical data has been mentioned as an method of exploratory trials.

The monoclonal antibodies detecting blood group related antigens of the Lewis systems have been used to define the immunoanatomic distribution of these antigens within the normal gastric mucosa and in gastric cancer tissues. In this study we analysed the presence of these antigens in histologically intestinal metaplasia of the stomach by the immunoperoxidase method. In normal gastric mucosa, Lewisb was distinctly expressed in normal foveolar epithelia and Lewisa was present in foveolar epithelia in half of the cases. Lewisx and Lewisy were detected in deep gastric glands. In intestinal metaplasia, more pronounced expression of Lewisa and decreased expression of Lewisb were observed. Lewisx and Lewisy were absent in most specimens of intestinal metaplasia. These pattern of expression of Lewis antigens in intestinal metaplasia were very similar to those observed in well and moderately differentiated adenocarcinomas of the stomach. These results indicate that well and moderately differentiated adenocarcinomas of the stomach have very similar character with the intestinal metaplasia in terms of the Lewis blood group antigen expression.

Although sample size calculation is mandatory in clinical trials, the power of most of the published small size clinical studies, was only about 0.25 instead of 0.80 which is normally required in a standard randomized controlled trial. This phenomenon is probably due to the publication bias. In a cancer clinical study, the ideal sample size needed in a trial exceeds over a thousand, when significance level was fixed under 0.05 and treatment difference is estimated from 10 to 15%. In such cases, evaluation of a new treatment in less common cancers or in a specified strata become unfeasible. Although statistically plausible clinical trial is difficult, small trials of newly advocated treatment is likely to be performed elsewhere, and presentation of these haphazard results might propagate a wrong information about the new treatment. To prevent the dissemination of these biased results, 1) preregistration of all planned clinical trials to an authorized organization before the initiation of the trial, 2) randomization of the patients entered in the trial from the first case, and 3) registration of all available data of the patients and meta-analysis of preregistered multiple trials, should be the most effective counterplans. In order to achieve those functions, installation of a computer assisted coordinating center is considered to be the best solution for the proper evaluation of the clinical trial as well as for the evaluation of a new treatment. With the collaboration of regional affiliating hospitals, a pilot study have started to establish a computer network system.

Preoperative and postoperative carcinoembryonic antigen (CEA) levels were studied in 3,532 patients with Surgically treated gastric cancer in 52 institutions from 1980 to 1981. These patients had disease resectable with curative intent and were followed for a minimum of 5 years or until death. Among 2,749 Stage I cases, 33 had recurrence and proved to be histologically stage I. A pair matching case control study between these 33 cases and matched 33 stage I controls without recurrence proved that the preoperative CEA level was relatively higher in cases with recurrence (p = 0.079). In Stage II and III cases, an analysis of variance using a cut off level as a block factor was performed. Among 315 Stage II cases, preoperative CEA levels were significantly higher in cases with recurrence than in cases without recurrence. In 468 Stage III cases, no correlations between preoperative CEA levels and high risks of cancer recurrence were detected. In Stage I and Stage II cases, CEA levels significantly increased at the time of recurrence. In conclusion, preoperative high serum CEA levels might be considered one of the risk factors for recurrence of Stage I and II gastric cancers, and monitoring the postoperative CEA levels might be useful in early detection of recurrence.

The quality of life of patients who had undergone a primary radical resection of the rectum for cancer was restricted by colostomy, urinary incontinence or sexual disturbance. This paper describes the developments and surgical results of sphincter saving operation and nerve preserving operation for rectal cancer. 1) Sphincter saving operation: With the advent of modern sphincter saving techniques such as low anterior resection and stapling technique, abdomino-perineal resection of the rectum are no longer necessary for the treatment of nearly all tumors of rectosigmoid, three of four tumors of the upper rectum and one of five tumors of the lower rectum. At low anterior resection of the rectum, in general principle, the affected parts of the diseased rectum were resected with a macroscopically free margin of at least 3 cm on anal side of the cancer. Recurrence rates of anterior resection were fewer than those of abdomino-perineal resection, and five year survival rates after AR were better than those of after APR. 2) Autonomic nerve preserving operation: As it is impossible to remove the internal iliac lymph-nodes completely without disturbing the underlying pelvic plexus, an autonomic nerve preserving operation was done unless there was microscopic lymphatic gland involvement by frozen section. Urinary bladder function was impaired in 80% of patients after extended lateral dissection without nerve preservation whereas it was unaffected in 14 of 16 patients after nerve preserving operation. Six of seven male patients with nerve preserving operation retained potency, but only one was capable of ejaculation.

A prospective randomized trial of surgical adjuvant chemoimmunotherapy was conducted in patients who had undergone palliative gastrectomy for previously untreated advanced stomach cancer. Immediately after surgery, one hundred and forty-seven patients were randomized to receive either chemoimmunotherapy with FT-207 plus OK-432 (group A) or chemotherapy with only FT-207 (group B). The number of patients subjected to this analysis was 134 cases (group A: 70 cases, group B: 64 cases) because thirteen patients were excluded. FT-207 was administered orally and OK-432 was administered intracutaneously. There were no differences in the background factors influencing survival time between the two groups. While the survival rate of group A patients was higher than that of group B patients, the difference in the survival rate between the two study groups was not statistically significant. However, in patients with less differentiated cancer (poorly differentiated adenocarcinoma, signet-ring cell carcinoma) the survival rate of group A patients was significantly (p less than 0.05) higher than that of group B patients. The results of the present study show that OK-432 administered intracutaneously is effective in elevating the survival rate of patients receiving chemotherapy with FT-207 for advanced stomach cancer (especially for less differentiated cancer).

An endoscopic biopsy was performed on specimens taken from 374 patients with a large bowel cancer, who had received a colo-rectal resection between 1980 and 1984. An average of three to four biopsy specimens was taken from each patient. The pathological diagnosis of these specimens revealed a carcinoma with an identifiable pathological classification in 280 patients (74.9%), a carcinoma without an identifiable classification in 54 (14.4%), a suspect cancer in 7 (1.9%), and no sign of a cancer in 33 (8.8%). The diagnosis of the 33 cases in which no cancer was detected were adenoma in 11 patients, inflammation in 8, necrosis in 1, and no clear pathological determination in 11. The correspondence rates between a biopsy specimen and a tissue specimen diagnoses were 57.9% in a well differentiated adenocarcinoma; 77.4% in a moderately differentiated adenocarcinoma; 85.5% in a poorly differentiated adenocarcinoma; and 100% in a mucoid carcinoma.

Twenty mg of mitomycin C was administered to patients with colo-rectal cancer through various routes of administration. The values of pharmacokinetic parameters were as follows Intra-arterial administration (3 patients with rectal cancer): T1/2 alpha 8.4 min, T1/2 beta 63.8 min, maximum concentration (5 min after ia injection) 0.83 microgram/ml, AUC0-120 25.0 micrograms/ml/min. Intra-portal administration (7 patients with colon cancer): T1/2 alpha 6.1 min, T1/2 beta 61.0 min, maximum concentration (5 min after iv.) 0.75 microgram/ml, AUC0-120 25.3 micrograms/ml/min. Intra-peritoneal administration (14 patients with colon cancer): maximum concentration (20-30 min after i.p.) 0.23 microgram/ml, AUC0-120 21.1 micrograms/ml/min. Intra-pelvic administration (7 patients with rectal cancer): maximum concentration (20-30 min after i.p.) 0.06 micrograms/ml, AUC0-120 7.3 micrograms/ml/min. The reduction curve of intra-arterial administration closely resembles to that of intra-portal administration. Maximum blood level and AUC of intracavitary administration were relatively low compared with those of administration into blood vessels. Bone marrow suppression was seen in patients given mitomycin C into blood vessels and wound healing disturbance such as anastomotic leakage were noted in patients by intra-cavitary administration.

It is first mentioned that there is a method of evaluation for the effect on immunochemotherapy as an adjuvant and supporting therapy to surgery. The availability of clinical immunotherapy with surgical treatment was studied by using some prospectively randomized trials. The results were summarized as follows; A combined modality therapy of nonspecific and host mediate immunotherapy and chemotherapy as an adjuvant to surgery was effective on long survival, and the therapy had simultaneously a protective effect of toxicity based on some chemotherapeutic agents. The therapy was effective on the patients who had rather immunologically high response such as curatively or non-curatively resected case than those of nonresectable case. In some combination, combined modality therapy may have not effect, so it should be used under paying attention to the points that are type and dose of agents, timing and interval of administration, and combination method of surgical, chemical and immunological treatments.