Quality of life evaluation by the EORTC QLQ-C30 questionnaire in patients treated with hormonal treatment in Italy. A QuABIOS group study.

OBJECTIVES: An observational study was planned by the QuABIOS group, to survey the hormonal treatment administered to prostate cancer patients in Italy within a time window of 12 months. We report here a prospective quality of life (QOL) evaluation over time and by hormonal treatment modalities. METHODS: Patients with diagnosis of prostate cancer and treated with hormonal therapy were eligible for this study. The EORTC QLQ-C30 v.3 questionnaire was administered at enrolment, after 6 months and after 12 months from enrolment. RESULTS: 587 patients were enrolled by 33 urological centers. When 1518 visits were considered together independently of time, antiandrogen monotherapy was associated with a significantly better QOL than LHRH-analogue containing treatment modalities in almost all functional scales; cyproterone acetate demonstrated a better physical function and general health status than bicalutamide. When QOL was analyzed in a prospective 12-month window, a worsening of physical function and general health status was observed, notwithstanding, antiandrogens remained significantly associated to a better QOL than LHRH-analogue therapies also over time: a favourable physical function and general health status appeared again to be related to cyproterone acetate than bicalutamide. CONCLUSIONS: Androgen deprivation therapy is associated with decline in QOL, particularly in the domains of physical function, energy, and general health status. This survey demonstrated that antiandrogens had a better QOL profile than LHRH-analogue containing therapies;furthermore, a more favourable tolerability for cyproterone acetate as compared to bicalutamide is suggested.

The start of pharmacological activity after sublingual administration of sildenafil citrate in 30 patients affected by erectile dysfunction.

INTRODUCTION AND OBJECTIVES: Sildnenafil citrate is a powerful phosphodiesterase type 5 isoenzyme; it is the first oral treatment to have had a significant success in treatment of erectile dysfunction (ED). After oral dosing on an empty stomach the pharmacological activity starts within 30 to 120 minutes (average 60 minutes) whereas the effect of this medication after a meal could be notably delayed. We evaluated the start of pharmacological activity in 30 patients affected by non-psychogenic ED after sublingual administration of Sildenafil citrate. METHODS: Patients participating in our study were all affected by ED whose etiology was assessed as vasculogenetic or diabetic. The study lasted 6 months. For the first 3 months patients were asked to take Sildenafil (50-100 mg) for oral administration, under normal everyday conditions, 30 minutes before planned sexual relations. During the second 3 months the patients were asked to take Sildenafil for sublingual administration (crushing the pill in the mouth and dissolving the drug under the tongue) 15 minutes before planned sexual relations. The patients did not know the purpose of the study. RESULTS: An appreciable reduction in the start of pharmacological activity was reported during the time of sublingual administration. In fact, while throughout the first 3 months the average pharmacological onset was 62.8 minutes (DS +/- 16.8), during the second 3 months it was 29.3 minutes (DS +/- 8.1), the mean difference in the start of pharmacological activity was 35.3 (DS +/- 12.4). The results of T-student test for paired observation were T (29) = 15.629; p-value 0.00001. During the two modalities of administration no differences were noted in the efficacy or in the frequency of adverse events. All the patients declared they preferred the sublingual way because of faster onset. CONCLUSIONS: Even though ours is a limited study, our clinical data points out that the sublingual administration of Sildenafil is useful because of the rapid onset unrelated to meals. All the patients were reported to appreciate this method of administration, particularly in the case of unplanned sexual relations.

[Conservative treatment of persistent calyceal fistula after tumor excision. Case report and clinical remarks]. / Trattamento conservativo di fistola caliceale persistente secondaria ad enucleoresezione renale. Descrizione di un caso e considerazioni cliniche.

BACKGROUND: Nowadays, ultrasounds allow to discover accidentally a large number of renal small tumors. So, radical nephrectomy, which years ago was considered as the gold standard, is rarely required. Today, nephron sparing surgery is often prescribed for renal masses smaller than 4 cm. Its most frequent complication is calyceal fistula. It can be prevented exploring carefully the surgical surface, and suturing any opening. It can heal over within a few days or some weeks, so it can be a trouble for both the patient and the surgeon. A complete urinary drainage, obtained with an ureteral stent and an open bladder catheter, helps heal. Recently, it has become common practice to spread synthetic or biological tissue sealants over the surgical surface, to improve hemostasis. These surgical glues have also been used to repair calyceal openings, with conflicting results. METHODS: We performed left renal tumor excision (3.5 x 3 cm) in a 72-years-old man, during temporary renal artery occlusion with surface hypothermia. We placed intraoperatively an ureteral stent. The visual examination of the surgical cavity did not reveal any calyceal opening. We electrocauterized it and stuffed it with FloSeal. Surgical edges were free from illness. After 5 days urinary leakage from the drainage tube increased. Pyelography showed a calyceal fistula. A further stent was placed, with no results. Bladder catheter was kept open for about 2 months. Urinary leakage stopped 34 days after surgery. RESULTS: Urinary leakage increased when the catheter was removed, and stopped only after many days of complete urinary drainage. CONCLUSIONS: The conservative treatment of a calyceal fistula must be considered a still effective therapy, also in difficult cases, provided that a complete and long-lasting urinary drainage is carried out.

[High alpha-fetoprotein persistence after orchiectomy. On a case of uncommon etiology]. / Persistenza di alfa-fetoproteina elevata dopo orchiectomia. Su di un caso ad etiologia inusuale.

BACKGROUND: The following report describes a case of inherited elevation of alpha-fetoprotein (AFP) in a young male suspected for testicular cancer. AFP shows very high values during fetal life. After birth the synthesis of AFP decreases dramatically, and only trace amounts are detected in the adult. From this age on, serum AFP can rise above normal in some diseases, e.g. liver disorders, and in some kind of tumors. A condition in which persistent high levels of AFP are found, named Hereditary Persistence of AFP (HPAFP), was first reported in 1983 by Ferguson-Smith, and then recorded in the literature only on eleven occasions till 2004. The occurrence of HPAFP may be underestimated. HPAFP can be easily confirmed by testing AFP levels in blood-related family members. METHODS: An elevated serum AFP (about 20 µg/mL) was found in a 27-year-old white man with an unremarkable medical history, who was concerned to have left testicular cancer. By our examination, his left testis was markedly reduced in size. ß-HCG, LDH, and liver function were normal. Surgical inguinal exploration with testis and spermatic cord excision was carried out. Postoperative repeated AFP levels remained persistently elevated, in the range from 20 to 30 µg/mL. Careful evaluation for occult cancer showed no abnormality. Histology showed necrotic tissue and could not make a reliable diagnosis. A literature search was done using PubMed by key word "alpha-fetoprotein" and "elevation". Thinking of a hereditary trait, we decided to screen patient's blood-related family members. RESULTS: AFP was found to be elevated in another four out of six relatives within three generations, unrelated to any disease. This pedigree was consistent with an autosomal dominant inheritance pattern. CONCLUSIONS: HPAFP could mislead the physician. Failure to recognize HPAFP can lead to unsuitable treatments. The existence of this clinically benign condition needs to be considered in both children and adults with unexplained and persistent elevation of AFP, e.g. those diagnosed or suspected for germ cell tumor.