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Biomedical subjects

A Dominici

Publications and source records attributed to A Dominici.

30 records · Page 2Linked to original sources
PubMedDate not supplied

Gemcitabine plus Epi-doxorubicin as first-line chemotherapy for bladder cancer in advanced or metastatic stage: a phase II.

Combination chemotherapy with newer, more active drugs in patients with advanced and/or metastatic bladder cancer might show improved response rate and survival. Gemcitabine (GEM) and Epidoxorubicin (EPI) have demonstrated activity in this disease. In addition, experimental studies in vitro have shown that the two agents have additive-synergistic effects when used in combination. Our prior phase I dose-finding study in previously untreated patients with advanced or metastatic bladder cancer defined recommended doses for further trials of GEM 1000 mg/m2 and EPI 25 mg/m2 on days 1, 8 and 15 every 28 days. A phase II trial at this dose level was initiated in previously untreated patients to assess efficacy and toxicity. Eligible patients had measurable disease; Karnofsky performance status (PS) of > 40; no prior chemotherapy; and adequate bone marrow reserve, cardiac, hepatic and renal function. Thirty- one patients (22 males, 9 females) with median age of 64 (range 44-75) and median PS of 80 were accrued, and all were eligible. Twelve patients had T4N1-2 M0, 8 had lymph node only metastases, while 11 had visceral metastases (liver, bone, lung). A total of 181 cycles was administered (range 3-7 per patient). Major toxicities (WHO grade > or = 3) were: neutropenia in 5 patients, thrombocytopenia in 2 patients, and anemia in 2 patients. Three patients had febrile neutropenic episodes and only 3 patients required dose reduction. Grade 1-2 non-hematological toxicities included nausea/vomiting, stomatitis and alopecia. No cardiac toxicity was observed. Of the 30 response evaluable patients, 17 (57%) demonstrated a major response (3 complete and 14 partial) (95% CI: 39%-75%), 7 had stable disease (23%) and 6 progressed (20%). These preliminary results confirm the phase I observation that the combination of GEM--EPI is highly active in the treatment of advanced and metastatic bladder cancer with a favourable toxicity profile.

Adult↗
PubMedDate not supplied

Double blind study of the pharmacodynamic and clinical activities of 5682 SE in venous insufficiency. Advantages of the new micronized form.

A randomized double blind multicenter trial was performed to study the pharmacodynamic and clinical activities of 5682 SE, in comparison with diosmin (active principle) well recognised for many years. 5682 SE is a purified micronized flavonoid fraction containing 450 mg of diosmin and 50 mg of hesperidin per tablet. 90 patients with chronic venous insufficiency of the lower limbs stabilized for one year entered the study. They received either 2 tablets of 5682 SE or 900 mg of diosmin a day during two months. The following parameters were studied: functional clinical symptoms in the legs, ankle and calf circumferences measurements, strain-gauge plethysmographic parameters with 20, 40 and 60 mmHg venous occlusion, clinical and biochemical acceptabilities. In both groups of patients, the data showed statistically significant changes. But the improvement in the clinical symptoms and the decreases in the venous outflow parameters were more substantial with 5682 SE than with diosmin. The clinical and laboratory acceptabilities were equal in both groups. Due to its pharmacodynamic and clinical activities which are more considerable than those of non-micronized diosmin, the results of this study show the therapeutic advantage of 5682 SE in chronic venous insufficiency.

Adult↗