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Biomedical subjects

M Pavone-Macaluso

Publications and source records attributed to M Pavone-Macaluso.

At least 91 records · Page 5Linked to original sources
PubMed1986

Intravesical bleomycin in bladder tumour prophylaxis.

The authors have evaluated the efficacy, tolerability and systemic absorption of bleomycin administered by intravesical route in the prophylaxis of recurrences of superficial vesical tumours after endoscopic resection (TUR). Thirty mg of bleomycin dissolved in 30 ml of saline solution were instilled in the bladder once a week for the first month and then once a month for 12 months. The instilled fluid was held in the bladder for 1 hour. The systemic absorption of the drug was evaluated by a microbiological assay of bleomycin in plasma and in the perfusion liquid recovered from the bladder. Fifteen patients were treated; most had a long history of multiple recurrent tumours despite previous intravesical treatments. Thirteen patients presented tumour recurrences during the treatment; 4 of them were given a second course of instillations following a second TUR and 3 of these presented further recurrences. The authors conclude that the drug, administered intravesically to high-risk patients with the modalities employed in the present study, was not effective in preventing recurrences. It was well tolerated locally and was free from systemic toxicity. The amount of bleomycin that was not recovered from the bladder after a contact time of one hour was relatively high but the drug did not reach measurable levels in the peripheral blood.

Aged↗
PubMed1986

Comparison of diethylstilbestrol, cyproterone acetate and medroxyprogesterone acetate in the treatment of advanced prostatic cancer: final analysis of a randomized phase III trial of the European Organization for Research on Treatment of Cancer Urological Group.

Patients with previously untreated category T3 to T4 Mo or Ml prostatic cancer were allocated randomly to receive 250 mg. cyproterone acetate per day, a loading dose of 500 mg. medroxyprogesterone acetate intramuscularly 3 times weekly for 8 weeks followed by 100 mg. orally twice daily, or 1 mg. diethylstilbestrol 3 times daily in a phase III trial (protocol 30761) performed by the genitourinary tract cooperative group of the European Organization for Research on the Treatment of Cancer. Of 236 patients entered 210 were eligible: 75 received cyproterone acetate, 71 medroxyprogesterone acetate and 64 diethylstilbestrol. Local and distant tumor response, time to progression, survival and toxicity were assessed. Patients treated with medroxyprogesterone acetate had a less favorable course with a shorter duration of survival and time to progression than those treated with the other 2 drugs. There was no significant difference between diethylstilbestrol and cyproterone acetate. Cardiovascular side effects were reported more often in patients treated with diethylstilbestrol than in those treated with cyproterone acetate but severe and lethal cardiovascular toxicity was relatively low in all groups. Other side effects were negligible. Further studies are required to establish the influence of effective hormonal treatment upon survival.

Aged↗
PubMed1986

Cardiovascular side effects of diethylstilbestrol, cyproterone acetate, medroxyprogesterone acetate and estramustine phosphate used for the treatment of advanced prostatic cancer: results from European Organization for Research on Treatment of Cancer trials 30761 and 30762.

Two randomized trials were started in 1976 by the European Organization for Research on Treatment of Cancer urological group. Trial 30761 compared 1 mg. diethylstilbestrol orally 3 times daily to 250 mg. oral cyproterone acetate daily and to 500 mg. medroxyprogesterone acetate intramuscularly 3 times weekly for 8 weeks, then 200 mg. orally daily. Trial 30762 compared 3 mg. diethylstilbestrol to 560 mg. estramustine phosphate orally for 8 weeks and then 280 mg. daily. The 239 patients in study 30761 and 226 in study 30762 were evaluated for cardiovascular toxicity during treatment. Various types of side effects (fluid retention, hypertension, electrocardiographic changes, myocardial infarction and thromboembolic disease) and their degrees of severity were analyzed. In both studies the most frequent type of cardiovascular toxicity was represented by fluid retention. Cardiovascular toxicity as a whole was higher with diethylstilbestrol than with estramustine phosphate or medroxyprogesterone acetate therapy, and was the lowest with cyproterone acetate therapy. The risk of severe cardiovascular complications developing was the highest during the first 6 months of treatment. Increasing age, body weight greater than 75 kg. and, especially, the presence of previous cardiovascular disease represented adverse factors in the development of cardiovascular toxicity.

Aged↗
PubMed1985

Randomized comparative trial with ceftizoxime and cefotaxime in urinary tract infections.

Ceftizoxime, a new, semisynthetic, beta-lactamase-resistant cephalosporin, is not metabolized in man and is excreted almost entirely as the original active compound in the urine. The efficacy and safety of ceftizoxime were assessed in 80 patients with acute and chronic urinary infections, with and without associated pathological conditions, in comparison with cefotaxime. Two dosage schedules, 1 g or 0.5 g every 12 h, i.v. or i.m. for 10 days, were adopted according to the severity of each case and to separate randomization tables for each schedule; causal agents were all sensitive to both drugs in vitro. The overall results were excellent. Safety was excellent in almost all cases. In this trial ceftizoxime proved at least as effective and well tolerated as the reference antibiotic.

Adolescent↗
PubMed1985

[Which endocrine treatment is preferred today for prostatic carcinoma?].

There is so far no evidence that the newest hormone compounds, such as progestational agents, antiandrogens or estramustine phosphate, yield better results than low dose estrogens or orchidectomy in previously untreated patients. Castration and the other modalities of androgen deprivation, although they can cause a measurable objective regression in less than half of cases, do often induce a marked, sometimes long-lasting subjective improvement and can delay progression. It has not yet been clearly established whether or not hormone therapy can bring about a prolongation in survival. The critical point still remains our poor understanding of the causes of acquired hormone resistance and our inability to prevent it. Further studies on hormone receptors and steroid metabolism in normal and neoplastic cells might lead to progress in this field. The unsolved problem, whether resistance is due to a selection of clones resistant to hormones ab initio or to acquired biochemical characteristics in cells that were initially responsive, might be of great practical significance. A reliable test, able to detect sensitivity or resistance towards hormone therapy before any treatment is given, would be extremely helpful. Unfortunately, neither the most sophisticated hormone balance studies nor receptor determinations have led to clinically useful implications.

Androgen Antagonists↗
PubMed1984

Adjuvant chemotherapy of superficial transitional cell bladder carcinoma: preliminary results of a European organization for research on treatment of cancer. Randomized trial comparing doxorubicin hydrochloride, ethoglucid and transurethral resection alone.

Patients with superficial transitional cell carcinoma of the bladder were entered in a randomized clinical trial to compare the efficacies of transurethral resection alone or followed by bladder instillation of doxorubicin hydrochloride or ethoglucid (Epodyl) for 1 year. Results showed that adjuvant chemotherapy with the selected drugs prolonged the mean interval between recurrences. Mild systemic toxicity and chemical cystitis were observed in 3 and 3 per cent, respectively, of the patients given ethoglucid, and in 5 and 4 per cent, respectively, of those taking doxorubicin.

Carcinoma, Transitional Cell↗
PubMed1984

Treatment of bladder cancer with intravesical instillation of adriamycin.

Intravesical treatment with adriamycin has been extensively employed in the last decade. In the treatment of carcinoma in situ complete responses have been reported in about 60% of cases. Its efficacy is probably lower in the therapy of multiple or diffuse low stage transitional cell carcinoma that is too extensive to be completely resected by conventional transurethral surgery. In such circumstances, including cancer in situ, adriamycin compares favorably with other local forms of treatment. The prophylactic use of intravesical instillation of Adriamycin has been studied more extensively. Preliminary results of controlled randomized trials implemented from the EORTC Urological Group show that adriamycin instillations significantly reduce recurrence rate after TUR. The treatment is well tolerated. Systemic absorption is virtually absent, and no severe drug-related side effects have ever been reported. Chemical cystitis is occasionally observed, especially if multiple instillations are started immediately after TUR, or in the presence of additional inflammatory conditions, such as previous irradiation or bacterial cystitis.

Antineoplastic Agents↗
PubMed1984

Current status of bladder cancer protocols in the EORTC Genito-Urinary Group.

This report gives an updated account of the phase II and III bladder studies conducted by the Genito-Urinary Cooperative Group of the EORTC. All phase II studies screen for activity in patients with measurable advanced disease. All phase III studies are randomized studies aimed at controling the recurrence rate of superficial bladder tumors. This long term planning on chemotherapy and chemoprevention will be continued in an orderly fashion and expanded with the evaluation of radiotherapy, surgery and/or immunology regimens for tumor control in the near future.

Antineoplastic Agents↗
PubMed1983

Cooperative studies of chemoprophylaxis after transurethral resection of bladder tumors.

Large cooperative trials are more likely than series studied by small groups to bring about significant progress in the field of intravesical adjuvant chemotherapy of superficial bladder tumor. Multicenter randomized trials involving large numbers of patients have been conducted in Europe by the EORTC Urological Group. The Group's main objectives were to compare the efficacy of thio-TEPA, VM-26, epodyl, Adriamycin, and cisplatin, against no treatment, and to study the prophylactic effect of oral pyridoxine and evaluate the main prognostic factors. The results obtained so far are reported. Preliminary information is also given about the Blinst study, a multicenter open investigation of local chemotherapy with doxorubicin (Adriamycin), with special reference to evaluation of the importance of different modalities of treatment with a single drug.

Antineoplastic Agents↗
PubMed1983

[Chemotherapy of bladder tumors. Indications and value of loco-regional and systemic application].

Systemic chemotherapy of advanced and metastatic bladder carcinomas leads to tumor regression and shows a palliative effect on symptomatic lesions in some of the cases, but the duration of the effect is limited. The value of an adjuvant chemotherapy following radical surgery or radiotherapy is not evaluated in clinical studies. Local chemotherapy induces complete regression of multifocal superficial bladder tumors in many cases. Of special interest are the results of treatment of carcinoma in situ by doxorubicin. Furthermore the intravesical chemotherapy has become widely used with a prophylactic goal in mind after complete transurethral resection of superficial bladder tumors. Aims and preliminary results of randomized clinical EORTC trials are reported.

Antineoplastic Agents↗
PubMed1982

Kelfiprim, a new sulpha-trimethoprim combination, versus cotrimoxazole, in the treatment of urinary tract infections: a multicentre, double-blind trial.

A new combination of trimethoprim with a sulphonamide, named Kelfiprim, differs from cotrimoxazole in that: a) the sulpha drug is sulphamethopyrazine instead of sulphamethoxazole; b) the trimethoprim to sulpha ratio is 5:4 instead of 1:5; c) the presence of a long-acting sulphonamide allows the administration of a daily dose of one capsule, following an initial loading dose of two capsules; d) a reduced amount of trimethoprim is given, as compared to cotrimoxazole, without any decrease of efficacy. Kelfiprim [KP] was compared to cotrimoxazole [Co] in a multicentre double blind trial. Sixty four patients suffering from acute and chronic infections of the upper and lower urinary tract entered the study. Urine sterilisation and clinical improvement without relapses showed no differences from the two treatment groups. Tolerance was excellent except in two patients, one treated with KP and the other treated with Co, who showed a transient exanthema.

Clinical Trials as Topic↗