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Biomedical subjects

K Isurugi

Publications and source records attributed to K Isurugi.

At least 55 records · Page 3Linked to original sources

LH-RH agonist, Zoladex (Goserelin), depot formulation in the treatment of prostatic cancer. Randomized dose-finding trial in Japan.

Ninety patients with advanced prostatic cancer (15 with stage B, 23 with stage C, and 52 with stage D) were randomized to receive 0.9, 1.8, or 3.6 mg, respectively, of Zoladex depot subcutaneous injection every 28 days for 12 weeks. The serum levels of LH, FSH, and testosterone were elevated after the first injection, and followed by a significant decrease. The suppression of testosterone levels in the blood to castrate levels was observed in all patients except two treated with 0.9 mg. Objective response (CR and PR) was seen in 63.6% (0.9 mg), 47.8% (1.8 mg), and 68% (3.6 mg) of patients according to the Japanese Prostatic Group Criteria. Subjective improvement (performance status, analgesic consumption) was also observed in 75-88% of patients but without a statistically significant difference between each dose group. Only minor adverse effects were found during the treatments. The drug was detected dose dependently in the blood by radioimmunoassay. These results suggest that endocrine therapy with Zoladex depot in doses of 3.6 mg subcutaneously every 4 weeks is a useful alternative to surgical castration in patients with prostatic cancer.

Aged↗

[Clinical experience with single and multiple subcutaneous administration of LHRH analog Buserelin (Hoe 766) in prostatic carcinoma: endocrinological study of optimum subcutaneous doses].

Seventy three patients with prostatic carcinoma (PC) and 7 patients with benign prostatic hypertrophy (BPH) in 12 institutes subcutaneously received single and multiple doses of Hoe 766, and clinical efficacy, safety and endocrine effects of drug were examined. In a single doses study, six doses were subcutaneously administered to 7 BPH and 3 with PC. Gonadotropin and testosterone levels in the blood were increased following all these doses. In a multiple study, 7 kinds of doses were given to 40 patients with PC. The optimum doses of subcutaneous injection was decided to be 500 x 3 micrograms/day based on gonadotropin and testosterone suppression. Objective response by NPCP's criteria was observed in 35.3% (complete response 5.9%, partial response 29.4%) following 3 months of Hoe 766 treatment. Adverse reactions were observed in 9 cases (12.8%): Treatment was discontinued in 3 cases (eruption in 2, nausea and vomiting in 1), and continued in 6 cases (8.6%) without any treatment required. Buserelin was thus considered to be an effective, safe drug to treat prostatic carcinoma.

Aged↗

A prospective, randomized controlled study on the treatment of stage C and stage D prostatic cancer with estracyt in combination with other chemotherapeutic agents.

The present study was designed to investigate the efficacy of various combinations of chemotherapeutic agents in the treatment of prostatic cancer in a group refractory to antiandrogenic therapy (Group 1) and in a previous untreated group (Group 2). Therapeutic combinations of Estracyt (E) + Peplomycin (P) + Doxorubicin (Do) and P + Do + 5 FU (F) in Group 1 and E + P, Honvan (Ds) + P and E in Group 2 were carried out. The main objectives of this study were estimations of the efficacy of E and P in relation to the refractory cases of Group 1 and the efficacy of the combination E + P, in Group 2. This is the first such prospective, randomized, controlled study to be carried out in Japan in relation to prostatic cancer. The results obtained in the present study indicated that chemotherapeutic regimens including E provide some enhanced efficacy, but that the efficacy with regard to refractory cases is poor (23.1-27.3%), as has been reported of studies conducted in the USA and Europe. With regard to previously untreated cases, the E + P regimen achieved a relatively higher response rate than the other treatments (72.7 vs 44.5 or 50.0%). In the comparison of survival times and survival curves, there were no statistically significant differences among the various treatment subgroups. A comparison of survival curves revealed the interesting finding that the PAP-related response showed a clear correlation to the survival curves of Group 2 patients.

Aged↗

[Endocrine therapy of prostatic carcinoma with slow release (depot) formulation of the LH-RH analog ICI 118630 (Zoladex)].

To investigate the clinical efficacy, safety and endocrinology of ICI 118630 (Zoladex) depot formulation at 3 different dose levels (0.9, 1.8 and 3.6 mg), 90 patients were randomized to receive either one of the 3 doses from April, 1985 to March, 1986 in 28 centers. The depot preparation was injected subcutaneously every 4 weeks 3 times (for up to 12 weeks). Clinical efficacy was evaluated in terms of tumor response and overall subjective response. In 70 patients eligible for tumor response evaluation, 14 out of 22 (63.6%) in the 0.9 mg group, 11 out of 23 (47.8%) in the 1.8 mg group, and 17 out of 25 (68.0%) in the 3.6 mg group showed clinical improvement, that is, either complete response or partial response. In 72 eligible patients for overall subjective response evaluation, clinical subjective improvement was observed in 75.0, 81.8 and 88.0% of the patients in the 3 groups, respectively. There was no significant difference between the groups. As for endocrinology, there were 75 eligible patients. Endocrinological effect was observed in 23 out of 25 (92.0%) in the 0.9 mg group, 100% in both 1.8 mg and 3.6 mg groups. There was no significant difference between the groups. Castration was achieved by week 3.5 +/- 1.7 of therapy on average and by week 2 in the earliest case. There was no significant difference in incidence of side effects between the 3 groups: 5 out of 26 (19.2%) in the 0.9 mg group, 8 out of 29 (27.6%) in the 1.8 mg group, and 2 out of 30 (6.7%) in the 3.6 mg group. Flares presented as an increase in bone pain in 2 and as ureteric obstruction in 2 all in the 1.8 mg group but none in the other 2 dose groups. These flares disappeared on further treatment with Zoladex. These patients showed a clinical-response. The blood level of Zoladex was dose dependent, reaching its peak at week 2 of therapy in all 3 dose groups. There was no evidence of accumulation. Since these results demonstrate that 3.6 mg produces medical castration earlier, it may well be considered as an optimal dose in men.

Buserelin↗

[Collaborative study of UFT in far-advanced renal cell carcinoma. Urological Cooperative UFT Study Group].

A cooperative study of UFT was conducted in cases of far-advanced renal cell carcinoma. UFT was administered daily at a dose of 300-600 mg FT equivalent for at least 4 weeks. Forty-one patients were entered into the protocol from the 19 collaborating institutions in the group. The antitumor effects of the drug were clinically evaluable in 25 patients according to the response criteria proposed by the Koyama-Saito study group. Seven were not eligible and 9 were cases of protocol violation. Complete response (CR) and partial response (PR) were observed in 2 and 5 patients, respectively, showing a response rate of 28.0%. One patient showed minor response, 8 stable disease and 9 progressive disease. It took about 22 weeks and 16 weeks to attain CR and PR, respectively. Lung metastasis was the lesion showing most the favorable response to this treatment. Twenty-eight patients were used for evaluating the adverse effects of the drug. Gastrointestinal symptoms such as nausea, vomiting and anorexia, were observed most frequently, while bone marrow suppression was minimal. Only three patients had to be taken off the drug due to its adverse effects. In conclusion, UFT was considered to be one of the most effective drugs for the treatment of far-advanced renal cell carcinoma.

Adult↗

[Treatment of prostatic cancer with intranasal administration of LHRH analog, Buserelin (Hoe 766) study of the optimum dosage of intranasal application].

Patients with pathologically defined prostatic carcinoma (114 cases in 23 institutes) were subcutaneously administered 500 micrograms of Buserelin (Hoe 766) 3 times a day for 7 consecutive days, then randomized to intranasally administered 600 or 900 micrograms/day of Buserelin as maintenance treatment. We examined the clinical efficacy, safety and endocrinological effects of the drug by the intranasal dosage. Size of prostate decreased more than 25% in 21 cases (total 47 cases; measured at the start and 3 months treatment by ultrasonography. Complete response and partial response were observed in 13 cases (16.1%) by NPCP's criteria at 3 months Buserelin treatment. Grobal Improvement Rating (GIR) were respectively 64.3% (600 micrograms group) and 68.0% (900 micrograms group). Grobal Utility Rating (GUR) were respectively 85.7% (600 micrograms group) and 82.0% (900 micrograms group). No significance was observed in these two groups. Adverse reactions were observed in 21 cases (18.9%). Except in 1 case, they were slight and the Buserelin treatment could be continued. Objectively Safety Rating (OSR) was 92.8%. Five cases were treated for more than 2 years with Buserelin and these cases were well controlled. Buserelin was considered as an effective and safe drug to treat prostatic carcinoma.

Administration, Intranasal↗

[Antiemetic effects of MS-5080 associated with cisplatin chemotherapy--an attempt in assessment based on the sample score system using multivariate analysis].

Effect of a new antiemetic drug, MS-5080 was evaluated against nausea and vomiting induced by chemotherapy including cisplatin. Fifty patients with various urological malignancies were registered into this study, which were distributed to the aliquot number with a respective dose schedule of 2, 3, 4 and 5 mg/kg body weight of MS-5080. Forty-seven patients with a total of 73 chemotherapeutic courses were eligible for evaluation of antiemetic efficacy, whereas the side effect of MS-5080 were evaluated in 48 patients with a total of 74 courses. Antiemetic efficacy was evaluated in terms of duration of nausea, duration of vomiting, duration of food intolerance, and the number of vomiting episodes. No statistically significant difference was observed in relation to the dose dependency of MS-5080. In assessment of the side effects, a relatively high incidence of diarrhea was observed compared to the other known antiemetic drugs. In the present study, we attempted an evaluation based on the sample score system using multivariate analysis. The results were correlated well with results of a grading system of efficacy that were determined by each physician who treated the patients.

Adult↗

[Surgery and adjuvant chemotherapy of disseminated testicular cancer].

The advent of combination chemotherapy regimens including Cis-Platinum (CDDP) in the 1970s brought about revolutionary improvement of short-term as well as long-term results of disseminated testicular cancer. PVB therapy (CDDP, Vinblastine and Bleomycin) introduced by L.H. Einhorn is reported to yield a 100% response rate but in Japan combination chemotherapy incorporating CDDP has not produced its maximal effects according to our results as well as analyses carried out by a multi-center cooperative study group. This is probably due to the toxicities and side effects of the drugs used. Facilities to deal with the high toxicities, i.e., severe myelosuppression, as well as enthusiasm on the part of the physician determined to arrive at a complete cure in each patient are prerequisite for the achievement of this final goal.

Antineoplastic Combined Chemotherapy Protocols↗

[Effects of etretinate on spermatogenesis and endocrine parameter function in man].

Nine adult men with psoriasis were treated orally with 50-75 mg/day aromatic retinoid, etretinate for more than 3 months. Semen analyses as well as measurement of serum levels of LH, FSH, prolactin, testosterone and estradiol were performed before and every month during the therapy for 3 months or more in order to study the effects of the drug on male reproductive function. Average sperm concentration at 2 months after the treatment by the drug was higher than the untreated value, although this was statistically not significant due to greater variations. Decrease in sperm count during the therapy was observed only in one patient. Sperm concentration of this case, however, was recovered and increased to higher levels after 6 months on the drug. No change was found in other semen parameters including sperm morphology. All hormone levels remained unchanged except for prolactin which increased. We conclude that etretinate did not cause suppression of spermatogenesis nor impairment of sperm motility or morphology as far as shown by the present observation periods.

Adolescent↗

[Randomized cross-over study on the effects of methylprednisolone, metoclopramide and droperidol on the control of nausea and vomiting associated with cis-platinum chemotherapy].

A randomized cross-over study on the effects of methylprednisolone (MP), metoclopramide (MT) and droperidol (DP) on the control of nausea and vomiting associated with cis-platinum chemotherapy was performed. Sixty-three patients were entered into the study; 60 patients (21 treated with MP, 18 with MT and 21 with DP) were eligible for evaluation of antiemetic efficacy, whereas the side effects of these drugs were evaluated in all of the 63 patients. Out of the above 60 patients, 36 were entered into the cross-over treatment. Antiemetic efficacy was evaluated in terms of duration of nausea, duration of vomiting, frequency of vomiting, duration of inability to take food and the amount of food first taken after cis-platinum treatment. Generally, the MP-treated group of patients showed favorable effects in these points, MP being especially more effective than other drugs with a statistically significant difference for the control of nausea and disturbed intake of food during the first 24 hours after the treatment with CDDP. Anticipatory nausea and vomiting were not observed in this study. Side-effects were minimal and all of the patients except one, who showed severe diarrhea following administration of MT and could not tolerate the treatment thereafter, were safely treated.

Adult↗