Quality of life assessment in bladder cancer clinical trials: conceptual, methodological and practical issues.
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Biomedical subjects
Publications and source records attributed to O Yoshida.
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The recurrence preventing effect of Etretinate on 174 superficial bladder tumors was examined by a randomized study using the envelope method. After transurethral resection of the bladder tumor, the tumor-free patients were divided into two groups, one administered one 10 mg capsule of Etretinate once a day, and the other group untreated (control group). As a rule, the patients were examined for recurrence every 3 months. There were 9 drop outs (9.6%) in the Etretinate group, and 8 (10%) in the control group. Therefore, 85 subjects in the Etretinate group and 72 patients in the control group were analyzed for statistics. The recurrence rate during the observation period of over 2 years was 38% in the control group and 18% in the Etretinate group, the number of relapsing cases in the latter group tending to be decreased (P less than 0.1). The cumulative recurrence inhibition rate for cases observed over one year tested by the Kaplan Meier method tended to be higher in the Etretinate group compared to the control group (P less than 0.1). Etretinate administration had a high recurrence inhibitory effect (P less than 0.05) in the cases of relapse, multiple tumors, and tumors less than 1 cm. Side effects of Etretinate administration were seen in 21 cases (22.3%). The major symptoms were dry lips, cheilitis, stomatitis, dermal desquamation, etc., and drug use was discontinued in 7 cases (7.4%). The symptoms all disappeared after drug administration was discontinued.
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Various risk factors and inhibitors of the stone formation of the upper urinary tract have been pointed out in urine. We examined the amount of daily excretion of several important risk factors (calcium, phosphorus, urate and oxalate) and inhibitors (magnesium and citrate) in the urine of 21 healthy males, 13 male single stone formeks and recurrent and/or multiple stone formers before and after taking the regular diet which contains 500 mg of calcium and 1,000 mg of phosphorus a day. The daily excretion of calcium, phosphorus and magnesium indicated no significant differences among the 3 groups. The excretion of oxalate in urine for 24 hours was significantly decreased in the stone formers after taking the regular diet. The urinary excretion of the urate per body surface area in the stone formers was significantly higher than that in the healthy control. The amount of the excretion of the citrate in urine in the recurrent and/or multiple stone formers was significantly lower than that in the other 2 groups. Many patients of the recurrent and/or multiple urinary stones had more than two abnormal values of above-mentioned risk factors and inhibitors. These results suggest that the causes of the formation of the upper urinary stone were not single but multiple and that the dietary advice to these patients was important against the recurrence of the urolithiasis.
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The incidence rate of prostatic cancer in Japan is gradually increasing and the factor of its increase can be due to the environmental change "europeanization", especially of the dietary life. A Japanese-dutch case-control study for prostate cancer has been carried out in order to elucidate the environmental risk factors of prostatic cancer. Of Japan side, as far as dietary part of the result is concerned, vitamin A might be risk reducing factor for prostatic cancer when prostatic cancer is compared to benign prostatic hyperplasia or general control.
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Here, we report 2 cases of epididymovasostomy operation in which good results were obtained. These operations were done for patients whose complaints were male sterility due to obstructive azospermia after bilateral epididymitis. The method of this operation was reported by Silber in 1978 as "specific tubule technique", and excellent results have been reported. Herein, we introduce this technique perhaps for the first time in Japan, and the characteristics of this method are considered. The important factors and characteristics of this method are that it is very reasonable with a high success rate, it is more difficult than microsurgical vasovasostomy, it is a time-consuming operation. Epididymovasography should not be done preoperatively but intraoperatively, if possible and chronic epididymitis should be ruled out by serological study and culture study.
Statistical observations on inpatients and operations in our department from 1982 to 1985 were reviewed in comparison with the statistics for the preceeding three years. More elderly persons comprised the inpatients at our hospital than at other facilities. Urogenital tumors and urolithiasis were the predominant disease of the inpatients, as they were in the preceeding three years. Number of prostatic cancer has remarkably increased. Transurethral operations, TUR-P and TUR-Bt, were the most representative. Operations for the malignant disease, especially for prostatic cancer, were more frequent in this period than in the preceeding three years. As to urinary diversion, ileal conduit was the main procedure used during this four years. Kock continent ileal reservoir was adopted in 1985. In July 1985, open operations for urolithiasis were dramatically replaced by percutaneous and transurethral procedures.
We evaluated 113 patients with recurrent or multiple calcium urolithiasis at our outpatient stone clinic between 1980 and 1983. Diagnostic categories included hypercalciuria (36 patients), hyperoxaluria (35 patients), and hyperuricosuria (31 patients). Thiazides and/or allopurinol were administered to the hypercalciurics and hyperuricosurics, respectively for prevention of stone recurrence. Patients followed up for more than one year were 23 (male 16, female 7) in the thiazide group, and 15 (male 12, female 3) in the allopurinol group. The mean treatment interval was 2.49 years in the former, and 2.35 years in the latter. The remission rate (percentage of patients without formation of any new stones) was 82.6% in the thiazide group, and 73.3% in the allopurinol group. The group stone formation rate was reduced from 0.85 to 0.35/pt-yr in the thiazide group, and from 0.74 to 0.27/pt-yr in the allopurinol group. Efficacy of these two drugs for the prevention of calcium stone recurrence was observed in this selective therapy, but a careful double blind study should be carried out to draw a definite conclusion.
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Of the 843 patients with bladder cancer treated at Kyoto University between 1965 and 1984, 156 patients (18.6%) received total cystectomy. Between 1980 and 1984, 60 patients underwent multidisciplinary treatment with 4,000 or 2,400 rad adjuvant preoperative radiation therapy to the whole pelvis followed by radical cystectomy with or without postoperative adjuvant chemotherapy. The 5-year survival rate for the 65 patients with pelvic lymphadenectomy was 66% and that for the 40 patients without lymphadenectomy or only biopsy was 35%. The 5-year survival rate after radical cystectomy for 20 bladder cancer patients with regional lymph node metastasis was 11% and 73% for 59 patients without lymph node metastasis (p less than 0.001). The survival rate of multidisciplinary treatment protocol for muscle invasive bladder cancer was 55% a significantly (p less than 0.05) improved survival compared to the historical control. For analysis, the patients were divided into 2 categories according to histological criteria for evaluation of therapeutic effects for preoperative radiation by Ohoshi and Shimosato. The two groups were non-responder: grade I and IIa changes and responder: grade IIb, III and IV. Survival for responders and non-responders revealed significant differences (p less than 0.05), 87% for 28 responders and 48% for 24 non-responders.
The in vivo chemosensitivity test for bladder cancer, using the human bladder cancer xenografts (BT-8 and BT-11 strains) in nude mice (BALB/c) and the BBN-BT-1 bladder cancer strain in BALB/c hetero-mouse which was induced by peroral long-period administration of N-butyl-N-(4-hydroxybutyl) nitrosamine and transplantable into the subcutaneous of mouse, were examined especially in respect to the difference of chemosensitivity between young and old straining and the prospective propriety for clinical application. The subrenal capsule assay (SRC), was also compared with subcutaneous transplantation. Cis-diamminedichloroplatinum (II) and 5-FU were effective for all three strains and adriamycin and cyclophosphamide were effective for the BT-8 and BT-11 strains. Bleomycin, peplomycin and vinca alkaloids were more effective for the BT-11 strain than the BT-8 strain. The chemosensitivity of several anti-cancer drugs for the young BT-8 and BT-11 strains was almost equal to that of the old. A 68-year-old male with bladder cancer metastasized to lung and lymph nodes, whose primary tumor was transplanted to mice and established as the BT-11 strain in 1980, was treated with the VPM-CisCF combination chemotherapy which was evaluated as an effective therapy for this strain experimentally, and responded well to this therapy. As in this case, the results of nude mice experiments are valuable in clinical application. The chemosensitivity test in vivo for individual primary tumors should be done by SRC, and in SRC nude mice should be used instead of conventional mice until immunoreactive rejection can be prevented.
28 anticancer agents have been surveyed for Epstein-Barr virus (EBV) activating potency. Two vinca alkaloids with antitubulin activity, vinblastine (VLB) and vincristine (VCR), enhanced the expression of EBV early antigens (EA) in a latently infected human lymphoblastoid cell line (Raji), when used in combination with n-butyrate. Other antitubulin agents, colchicine, colcemid, and podophyllotoxin, had the same effect, although their effects were less than that of the potent tumor promoter, 12-O-tetradecanoyl phorbol-13-acetate (TPA).