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Biomedical subjects

F Boccardo

Publications and source records attributed to F Boccardo.

At least 91 records · Page 5Linked to original sources
PubMed1993

The synthetic retinoid fenretinide lowers plasma insulin-like growth factor I levels in breast cancer patients.

We studied the effect of fenretinide [N-(4-hydroxyphenyl)retinamide (4-HPR)], a synthetic analogue of retinoic acid, on plasma insulin-like growth factor I (IGF-I) levels in a consecutive cohort of stage I breast cancer patients belonging to a randomized phase III trial of breast cancer chemoprevention. Thirty-two women receiving 4-HPR 200 mg/daily and 28 untreated controls entered the study. IGF-I levels were determined after acid-ethanol extraction, on plasma obtained at randomization and after a mean time of 10.8 +/- 0.3 months. At baseline, there was no difference in IGF-I levels between the two groups [152.9 +/- 9.4 versus 159.2 +/- 7.0 ng/ml in treated and control group (P = 0.59), respectively]. After follow-up time, while plasma IGF-I levels were unchanged in control patients (163.3 +/- 7.4 ng/ml; P = 0.5), they were significantly reduced to 134.6 +/- 8.1 ng/ml in the patients treated with 4-HPR (P = 0.003 and P = 0.011 versus baseline and control values, respectively). Multiple regression analysis showed that treatment was the only determinant of IGF-I decline. Moreover, the interaction between treatment and age was significant, in that the decrease of IGF-I levels induced by 4-HPR administration was much more pronounced in younger patients, while an age-related decline was observed in controls. We conclude that the synthetic retinoid 4-HPR lowers circulating IGF-I levels in early breast cancer patients. Although the importance of this observation for the clinical prevention of breast cancer remains to be established, it further substantiates the rationale of the combination of 4-HPR with tamoxifen, which is known to decrease IGF-I as well and to act synergistically with the retinoid in preclinical models.

Anticarcinogenic Agents↗
PubMed1993

Carboplatin in advanced hormone refractory prostatic cancer patients.

25 patients with measurable or evaluable metastatic prostate cancer, progressive after hormonal treatment, were treated weekly with carboplatin 150 mg/m2 intravenously. The weekly schedule allowed higher dose intensity carboplatin administration with respect to the common monthly cycles. Toxicity was manageable even in elderly patients with extensive bone metastases and consisted primarily of myelosuppression. 4 out of 24 evaluable patients (17%) had a partial response and 12 (50%) had disease stabilisation. The median response duration was 7 months. Prostate-specific antigen and prostatic acid phosphatase serial values showed a correlation with disease response in only 47 and 50% of patients, respectively. These results suggest that carboplatin possesses a moderate but definite activity in prostate cancer patients.

Acid Phosphatase↗
PubMed1993

Goserelin acetate with or without flutamide in the treatment of patients with locally advanced or metastatic prostate cancer. The Italian Prostatic Cancer Project (PONCAP) Study Group.

From March 1987 to December 1990, 373 patients with stage C and D prostate cancer were randomized to receive either goserelin acetate alone or goserelin acetate plus flutamide. At a median follow-up time of 24 months, there was no significant difference in the response rate, progression-free and overall survival between the two treatment groups. In particular, median time to progression was 18 months in the goserelin arm and 24 months in the combined treatment arm (P = 0.09). However, median time to progression in stage D patients was 12 months in both treatment groups. Median time to death was 32 and 34 months, respectively. The combination regimen produced a more rapid normalisation of prostatic acid phosphatase levels and a prompt relief of bone pain. However, significantly more patients in the combination arm experienced treatment-related side-effects such as diarrhoea and increases in transaminase levels. The concurrent use of goserelin acetate and flutamide does not seem to significantly improve the results that can be achieved with goserelin acetate alone.

Acid Phosphatase↗
PubMed1993

Long-term endocrine effects of administration of either a non-steroidal antiandrogen or a luteinizing hormone-releasing hormone agonist in men with prostate cancer.

The claimed ability of non-steroidal antiandrogens to preserve libido and sexual potency is sought as a potential improvement in the palliative management of prostate cancer. A critical issue for the clinical use of these compounds is, however, the reported evidence in the rat of an excessive increase in testosterone concentrations as a consequence of the androgen negative feedback interruption. On the other hand, the recovery of testicular function after long-term inhibition by luteinizing hormone-releasing hormone (LHRH) analogs is also an important concern in view of the proposed use of these compounds for the treatment of several non-malignant conditions. We addressed these issues by studying the long-term endocrine effects induced by the administration of either the non-steroidal antiandrogen nilutamide or the depot preparation of D-Trp6-LHRH in men with prostate cancer. Treatment with the antiandrogen induced a marked increase in gonadotropin levels, LH concentrations rising from a mean (SEM) of 17.5 +/- 1.6 to a maximum of 56.6 +/- 6.9 kU/l (p < 0.001), while mean testosterone and 17 beta estradiol-concentrations rose only by about 50% and 70% over pretreatment values, testosterone levels reaching a plateau after 1 month of treatment. In the subjects treated with the LHRH agonist, 6 months after discontinuation of long-term administration the mean (+/- SEM) LH had risen to 36.9 +/- 6.8 IU/l while mean testosterone levels were still as low as 1.7 +/- 0.7 and rose only to a maximum of 4.2 +/- 1 nmol/l after high-dose human chorionic gonadotropin loadings.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed1992

Phase II study with lonidamine in the treatment of hormone-refractory prostatic cancer patients.

Twenty-one patients with metastatic prostate cancer who had become refractory to hormonal therapies received lonidamine (150 mg tid and 600 mg daily dose in 17 and 4 patients, respectively). In all but 4 patients, treatment was continued until disease progression or the development of severe toxicity. Toxicity was minimal and reversible (score 1 or 2) and included myalgia (8 cases), arthralgia (6 cases), gastrointestinal toxicity (11 cases), fatigue (14 cases) and testicular pain (9 cases). The response was evaluated after at least one month of therapy with lonidamine, according to NPCP-USA recommendations. Of 21 patients who entered the study, only 15 were evaluable for response; 2 died (1 for severe toxicity and 1 for drug-unrelated reasons). No objective response was obtained in the series. In fact, only 6 patients achieved stable disease and 9 progressed. Median survival time from the beginning of treatment was no longer than that of patients in a similar condition who were treated with standard palliative maneuvers. We conclude that this therapeutic approach with lonidamine is not active in hormone-refractory prostatic cancer patients with distant metastasis.

Aged↗
PubMed1992

Treatment of advanced pancreatic carcinoma with the somatostatin analogue BIM 23014. Preliminary results of a pilot study.

Treatment of advanced pancreatic cancer has not improved substantially in recent years. The search for new agents or new therapeutic modalities may be critical for further development in the therapy of this disease. Experimental and clinical findings suggest that it might be possible to develop a new hormonal therapy for exocrine cancer of the pancreas based on new somatostatin analogues. Preliminary results indicate clinical activity and increased survival in some patients. In this study, 19 patients with advanced exocrine pancreatic carcinoma were given the somatostatin analogue BIM 23014 using a range of doses from 250 micrograms/day to 1 mg/day. One patient had a partial response, 6 patients had stable disease, and 11 had progressive disease. Six patients showed a sharp improvement in pain and performance status. Side effects were mild. Plasma levels of growth hormone were evaluated in ten patients and remained unchanged. The clinical activity observed, even if limited, warrants further investigation using more appropriate schedules and administration techniques.

Antineoplastic Agents↗
PubMed1992

Chemotherapy versus tamoxifen versus chemotherapy plus tamoxifen in node-positive, oestrogen-receptor positive breast cancer patients. An update at 7 years of the 1st GROCTA (Breast Cancer Adjuvant Chemo-Hormone Therapy Cooperative Group) trial.

504 evaluable node positive oestrogen receptor (ER) positive breast cancer patients were randomly allocated to receive either 5 years tamoxifen treatment or chemotherapy [six courses of cyclophosphamide, methotrexate and 5-fluorouracil (CMF) followed by 4 courses of epirubicin] or a combination of both treatments. At a median follow-up of 5 years tamoxifen appeared to be more effective than chemotherapy, the difference being highly significant in postmenopausal women. The addition of chemotherapy to tamoxifen was not able to significantly improve the results achieved by tamoxifen alone, irrespective of menopausal status. Trends were similar even after stratification for the number of involved nodes. The protective effect of tamoxifen in terms of reduction of the odds of death increased with time and no rebound phenomena on recurrence or death has occurred so far after the completion of tamoxifen treatment. Overall, the prognostic value of number of involved nodes and of progesterone receptor (PgR) status was confirmed by multivariate analysis. However, the predictive value of PgR was lost in patients receiving tamoxifen alone. Similarly, the degree of ER positivity was not predictive of the response to tamoxifen. Tamoxifen treatment should still be regarded as the gold standard for postmenopausal ER positive patients. In younger women the antioestrogen proved to be safe and at least as effective as chemotherapy. However, the analysis of the annual risks suggests that the concurrent or the sequential use of chemotherapy and tamoxifen might represent a more appropriate treatment for this patient subset, particularly for those with four or more involved nodes. Different cut-offs of ER and PgR assays from those we have arbitrarily employed in the present analysis should probably be used to select more properly the patients who can benefit from endocrine therapy.

Adult↗
PubMed1992

Steroid and cation correlations in human breast cyst fluid: preliminary findings.

Gross cystic disease (GCD) of the breast imparts a minimal risk for the development of breast cancer. Relative to serum, breast cyst fluid (BCF) in patients with GCD is highly concentrated in androgens, estrogens, certain enzymes, and bioactive polypeptides. In addition, the cations, sodium and potassium, vary markedly and inversely in BCF. We have focused on the levels of estriol-3-sulfate (E3S), which are several orders of magnitude greater in BCF than in blood. In this preliminary study, about 55 specimens of BCF were analyzed for E3S, its possible precursors, estrone sulfate (E1S) and dehydroisoandrosterone sulfate (DHAS), and the cations, sodium and potassium. The data were analyzed statistically by linear regression analysis. E3S correlated directly with both E1S and DHAS (p less than 0.002), and inversely with the Na/K ratio (p less than 0.003). Low Na/K ratio has been associated with secretory processes in cyst epithelium. The data suggest that E3S may originate via 16 alpha-hydroxylation of estrogen in the cyst and that elevated E3S levels may be indicative of a secretory epithelium. This is part of an ongoing prospective study involving 400 subjects with GCD to see whether hormonal and enzymic profiles can be related to cancer risk.

Aryl Hydrocarbon Hydroxylases↗
PubMed1991

EGF in breast cyst fluid: relationships with intracystic androgens, estradiol and progesterone.

The relationship between intracystic levels of epidermal growth factor (EGF) and those of dehydroepiandrosterone sulphate (DHEA-S), delta-4-androstenedione (delta-4-A), 17-beta-estradiol (17-beta-E) and progesterone (PROG) have been studied in 77 breast cyst fluid (BCF) samples. EGF and all tested hormones appeared to be inversely correlated with the intracystic Na+/K+ ratio (p less than 0.001). Consequently, when the BCFs were subdivided according to the Na+/K+ ratio, significantly higher levels of EGF, DHEA-S, delta-4-A, 17-beta-E and PROG were found in Na+/K+ less than 3 BCFs compared with Na+/K+ greater than 3 BCFs (p less than 0.001 in all cases). Strong direct relationships were found among all steroid hormones when they were correlated to one another (p less than 0.001). Intracystic EGF concentration was directly and significantly correlated with each tested hormone (p less than 0.001). However, the relationship between EGF and steroid hormones appeared to be different in the 2 BCF types (Na+/K+ less than 3 or greater than 3).

Adult↗
PubMed1991

Phase II study of the pure non-steroidal antiandrogen nilutamide in prostatic cancer. Italian Prostatic Cancer Project (PONCAP).

The activity of the pure non-steroidal antiandrogen nilutamide as a single agent was evaluated in 44 patients with metastatic carcinoma of the prostate. Objective (partial) response rates (95% confidence limits) were 38.5 (18.7)% in 26 previously untreated patients and 5.5 (11%) in 18 patients progressing on primary androgen suppressive procedures. The most frequent side-effects were decreased adaptation to darkness (29.5%), slight nausea (31.8%) and alcohol intolerance (18.2%). In addition, treatment was discontinued in 3 patients because of gastrointestinal symptoms. A non-significant increase in testosterone levels was shown in the untreated group during the first month of treatment, after which the levels remained stable. About half of the sexually active men claimed the maintenance of libido and sexual potency during treatment. Although our study confirms a significant incidence of visual disturbances, the activity data coupled with the ability of maintaining sexual interest suggest that single therapy with non-steroidal antiandrogens may deserve comparison to conventional endocrine treatment in controlled trials.

Aged↗
PubMed1991

Monotherapy with nilutamide, a pure nonsteroidal antiandrogen, in untreated patients with metastatic carcinoma of the prostate. The Italian Prostatic Cancer Project.

A total of 26 previously untreated patients with metastatic carcinoma of the prostate received the pure nonsteroidal antiandrogen nilutamide as a single agent. Objective response rate was 38.5 +/- 18.7% (95% confidence interval). Median progression-free survival and median survival were 9 and 23 months, respectively. Of 13 patients with progression on antiandrogen 5 showed an additional objective response to a second-line endocrine treatment. The drug was generally well tolerated, except for 2 patients who discontinued treatment because of moderate gastrointestinal symptoms. Approximately a third of the patients complained of decreased adaptation to darkness. An electroretinogram and dark adaptation test revealed the presence of functional damage and visual complaints reversed in all patients on cessation of therapy. The other most frequent side effects were slight nausea (26.9% of the patients) and alcohol intolerance (19.2%). A nonsignificant increase in testosterone levels was shown within 1 month of treatment, after which the levels remained stable. Approximately half of the sexually active men claimed maintenance of libido and sexual potency during treatment. A slightly significant increase in hemoglobin was observed during the long term, suggesting the occurrence of a trophic effect by androgens on erythropoiesis. The results indicate that nilutamide as a single agent has an acceptable toxicity and a moderate activity, and may maintain sexual interest in a discrete number of cases. Whether monotherapy with nonsteroidal antiandrogens offers a valid option in the palliation of advanced disease remains to be seen in comparative prospective trials.

Androgen Antagonists↗
PubMed1991

A multicenter randomized trial comparing the luteinizing hormone-releasing hormone analogue goserelin acetate alone and with flutamide in the treatment of advanced prostate cancer. The International Prostate Cancer Study Group.

A prospective randomized trial was conducted to compare the effects of the nonsteroidal antiandrogen flutamide (250 mg. 3 times daily) plus the luteinizing hormone-releasing hormone analogue goserelin acetate (Zoladex) (3.6 mg. subcutaneous depot injection every 28 days) with goserelin acetate alone in advanced prostatic carcinoma. A total of 571 eligible patients, of whom 57% had distant metastases, showed no difference in subjective or objective response rates, interval to progression, treatment failure or survival after a median followup of 2 years. In the combination group more patients had an early decrease in elevated levels of tumor markers and the small number of patients with an increase in signs and symptoms within the first 4 weeks showed a significant decrease. However, increased gastrointestinal and hepatic toxicity in the combination group resulted in 44 patients being withdrawn from the trial. These results indicate that the combination of goserelin acetate with flutamide provides no long-term clinical benefit in patients with advanced prostatic carcinoma compared to goserelin acetate alone.

Administration, Oral↗
PubMed1991

Anandron (RU 23908) in metastatic prostate cancer: preliminary results of a multicentric Italian study.

Between March 1986 and March 1987, 48 patients with stage D prostate carcinoma were entered into a multicentric pilot study using the pure nonsteroidal antiandrogen nilutamide (Anandron--RU 23908) at the dose of 100 mg t.i.d. as the only therapy until disease progression or the occurrence of toxicity. Minimum follow-up was 15 months. Median age of patients was 72 (56 to 83) and median initial Performance Status (PS) was 1 (0 to 3). Of the 48 patients, 29 were untreated, while 19 patients were progressing following treatment by orchiectomy, LHRH analogs, or other endocrine therapies. According to the National Prostatic Cancer Project (NPCP) criteria, 43 patients were evaluable for response. Overall best response in untreated patients was partial response (PR), 41.6%; stationary disease (SD), 54.1%; 73.6% of pretreated patients achieved SD. Median progression-free survival and overall survival in untreated patients were 325 and 696 days, respectively, and 174 and 447 days, respectively, in pretreated patients. The more common side effects were G.I. toxicity (65%), hemeralopia (27%), and alcohol intolerance (6.2%). Results of this study suggest that Anandron may be a safe and effective treatment for patients with advanced prostatic cancer.

Aged↗
PubMed1991

Evaluation of mucinous-like cancer antigen (MCA) in women with breast disease: preliminary results.

Mucinous-like cancer antigen (MCA) is a substance which is recognized by a novel monoclonal antibody, designated b12, when directed against a mixture of human breast cancer cell lines. The present study was carried out by means of a solid phase enzyme immuno assay to determine, prior to treatment, circulating levels of MCA in 131 women with malignant and in 99 with benign breast diseases (BBD). Statistical analysis did not reveal any significant difference between MCA values in healthy controls vs. BBD patients. By contrast, MCA levels were significantly higher in cancer patients as compared to the other groups (p less than 0.001). In particular, patients with metastatic disease had the highest MCA concentrations. The sensitivity and specificity of the test were 25.5 and 97.5%, respectively. The characteristics of MCA (low sensitivity, high specificity) encourage its evaluation as an indicator of tumor burden.

Adolescent↗
PubMed1991

[Original method of the treatment of achalasic megaesophagus with EEA stapler].

Esophageal sutures require the same general criteria applied for the realization of an intestinal suture. The lack of a serous membrane and the particular vascularization of the organ, though, make this portion of the gastroenteric tract very prone to serious complications. Undoubtedly, the introduction of new systems of suture renders easier, faster and more efficacious the work of the surgeon. In particular, the Authors stress the advantages that staplers can offer for the treatment of achalasic megaesophagus.

Aged↗
PubMed1991

Identification of breast cyst subpopulations: biochemical and morphological features.

The concentration of insulin-like growth factor-I (IGF-I) and its relationship to other biochemical parameters of cyst fluids was investigated in 94 cyst fluids of 86 women with gross cystic breast disease. The relationship between the biochemical parameters and the cytological features of breast fluids (presence or absence of apocrine cells) was also studied. IGF-I was detected in all tested fluids, with a concentration 50 to 100 times lower than that found in plasma. IGF-I concentration was higher in cysts with a Na+/K+ ratio greater than 3 (greater than 3) and was inversely related to both dehydroepiandrosterone sulfate (DHEA-S) and epidermal growth factor (EGF) concentration (p less than 0.001). It is suggested that Na+/K+ greater than 3 cysts have a higher permeability to plasma and extracellular fluids compared to Na+/K+ less than 3 cysts. Apocrine cells were found in 78% of Na+/K+ less than 3 fluids as well as in 53% of Na+/K+ greater than 3 fluids. A well-defined relationship was found between the biochemical parameters of breast fluids, but the presence of either IGF-I or EGF was not related to the morphology of breast cysts as assessed by cytological examination.

Biopsy, Needle↗