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The aims of this randomized, controlled study were to investigate the efficacy and safety of long-term monotherapy with the luteinizing hormone-releasing hormone agonist goserelin acetate compared with both short- and long-term combined androgen blockade.

The clinical efficacy and safety of 3.75 or 7.5 mg leuprorelin acetate depot given subcutaneously once every 4 weeks was evaluated in a collaborative study of 81 patients with untreated prostatic cancer. Efficacy of treatment was assessed using criteria based on a meeting of the Prostatic Cancer Study Group funded by the Japanese Ministry of Health and Welfare and using National Prostatic Cancer Project criteria. Japanese criteria enabled evaluation of individual parameters, unlike the National Prostatic Cancer Project System which classified a patient as unevaluable if one evaluation parameter was unavailable. Leuprorelin acetate depot suppressed serum luteinizing hormone, follicle stimulating hormone and testosterone concentrations. Objective response rates of the prostate, bone mtastases, serum prostatic acid phosphatase and soft tissue metastases, and subjective dysuria and pain responses were comparable to those found with conventional hormone therapy. Leuprorelin acetate depot was well tolerated, with no significant differences in response to the two doses.L'efficacité clinique de l'acétate de leuproréline sous forme retard à la dose de 3,75 ou 7,5 mg administré par voie sous-cutanée une fois toutes les 4 semaines a été évaluée dans le cadre d'une étude, portant sur 81 malades souffrant d'un cancer prostatique. L'efficacité du traitement a été évaluée en faisant appel à des critères déterminés par le Prostatic Cancer Study Group (Groupe d'Etudes sur le Cancer Prostatique) fondé par le Ministère de la Santé du Japon et le National Prostatic Cancer Project (Projet National sur le Cancer Prostatique). Les critères janonais ont rendus possibles l'évaluation de paramètres individuels à l'encontre du système adopté par le Projet National sur le Cancer Prostatique qui a classé un malade comme étant non évaluable dès que l'obtention d'un paramètre d'évaluation n'était pas possible. L'acétate de leuproréline retard induit la réduction des concentrations plasmatiques en hormones lutéinisantes, en hormones de stimulation des follicules (FSH) et en testérone. Les taux objectifs d'amélioration de la prostate, des métastases des tissus mous et des taux plasmatiques de phosphatase acide prostatique, de la dysurie subjective et des degrés de douleurs étaient comparables aux hormonothérapies conventionnelles. L'acétate de leuproréline retard a été bien toléré, et n'a pas induit de différences significatives dans la réponse obtenue aux deux doses administrées.L'efficacia clínica di 3,75 o 7,5 mg di leuprorelin acetato, in preparazione “ritardo”, somministrato per via sottocutanea ogni 4 settimane è stata valutata nel corso di uno studio collaborativo condotto su 81 pazienti ammalati di cancro alla prostata. L'efficacia del trattamento è stata valutata adottando dei criteri scaturiti da una riunione del Gruppo di Studio sul Cancro della Prostata, fondato dal Ministero della Sanit à giapponese, nonchè dei criteri stabiliti dal “National Prostatic Cancer Project”. I criteri elaborad in Giappone hanno consentito la valutazione dei singoli paramtri a differenza del sistema del “National Prostatic Cancer Project”, nell'ambito del quale un paziente veniva classificato corne non valutabile nel caso che uno dei parametri necessari alla valutazione non fosse disponibile. Il leuprorelin acetato, in preparazione “ritardo”, ha soppresso le concentrazioni seriche di ormone luteinizzante, ormone follicolostimolante e testosterone. I tassi di risposta oggettivi, relativi alle metastasi prostatiche, ossee, alla concentrazione serica di fosfatasi acida prostatica ed alle metastasi dei tessuti molli, nonchè le risposte soggettive relative alla disuria ed al dolore, sono risultati comparabili a quelli ottenuti con una convenzionale terapia ormonale. Il leuprorelin acetato, in preparazione “ritardo”, è stato ben tollerato, senza significative differenze nella risposta alle due dosi.

Purpose: Evaluation of prognostic significance of nucleolar organizer regions (NORs) in renal cell carcinoma (RCC). Materials and Methods: Nuclear organizer regions were quantified in a series of 59 cases of RCC by the silver colloid method, and the NOR index was obtained from the ratio between mean NOR counts in each neoplastic nucleus and in normal nucleus. The patients were staged pathologically and divided into 2 groups by average NOR index of all cases, which was 0.76. Correlations between the NOR index and other parameters were statistically analyzed, and the prognostic value of the NOR index was also examined. Results: The NOR indices from each group were correlated with the survival curve. In low stage tumors (pT1 or 2 N0M0), the low NOR index group had a survival rate of almost 100 per cent while in those patients with higher NOR indices, there was a significantly increased mortality (p less than 0.01). In patients presenting with high stage tumors (excluding pT1 and 2 NOMO), the survival rate was significantly improved in those patients with a low NOR index (p less than 0.01). On the other hand, the patients with a low NOR index have a better prognosis than those with a high NOR index within each tumor grade (p less than 0.01). Statistical analysis by the log rank test indicated NORs to be a significant predictor of survival over the whole series within low and high pathological stages and within each tumor grade. Analysis of the data with Cox's proportional hazard model showed that NOR index had a stronger hazard ratio than grade or stage of tumor (p = 0.0005). Conclusions: Our study has demonstrated that NOR index is a new prognostic indicator for patients with RCC (p = 0.0005).