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Biomedical subjects

D Civalleri

Publications and source records attributed to D Civalleri.

At least 37 records · Page 2Linked to original sources
PubMed1994

[Hyperthermia in adjuvant therapy of locally advanced carcinoma of the rectum. Study protocol and initial clinical experience].

Since January 1992 a feasibility study was set up to establish the possible role of pelvic hyperthermochemotherapy for the local control of rectal cancer. Patients with resectable rectal cancer (clinical stage III-IV) are eligible for the study. Only patients submitted to abdominoperineal resection with or without extended pelvic linfoadenectomy (PLND) and/or resection of contiguous organs are included in the initial pilot phase of the study. Until now, two patients with stage III rectal cancer submitted to abdominoperineal resection and PLND have been treated. A single (40 mg) push of MMC was injected in the circuit with median local temperature of 46.0 +/- 0.3 and 45.9 +/- 0.5 degrees C and the pelvis was perfused for 60 min. There were no local or systemic complications. The ratio between the pelvis and plasma AUCs showed a high local pharmacokinetic advantage. The treatment can contribute to complete the standard protocols of adjuvant therapy. Since the simple decrease of local recurrence could represent an important clinical aim, this experience, even initial, supports us to continue the study.

Aged↗
PubMed1994

End-to-end arteriovenous fistula for chronic haemodialysis: 11 years' experience.

Between January 1979 and December 1989, an end-to-end arteriovenous fistula for chronic haemodialysis was performed at the anatomical snuffbox in 140 patients with a mean age of 51 (range 14-81) years and at the wrist in 248 with a mean age of 53 (range 19-83) years. The choice of site depended on the characteristics of the vessels and on the arterial blood pressure. No operative mortality, major complications or side effects occurred. The primary median patency for the arteriovenous fistula at the anatomical snuffbox was 36 months with a patency rate of 77.3% at 1 year, 36.3% at 5 years and 18.9% at 10 years. For the arteriovenous fistula at the wrist the median patency was 64 months and the patency rate 75.5% at 1 year, 54.5% at 5 years and 30.7% at 10 years. The higher incidence of thromboses in the patients with a fistula in the snuffbox may reflect an excessive enthusiasm for this technique because of initially promising results.

Adolescent↗
PubMed1993

In situ lung perfusion with cisplatin. An experimental study.

BACKGROUND: This research work was planned to evaluate the soundness of in situ lung perfusion as a regional administration modality of chemotherapeutic agents. METHODS: Sixteen pigs were randomly divided into four groups and received cisplatin (2.5 mg/kg) through the pulmonary artery using one of the following techniques: stop-flow (Group 1); stop-flow/out-flow occlusion (Group 2); lung perfusion (Group 3); or lung perfusion with 5 mg/kg of infused drug (Group 4). Serial blood (carotid, pulmonary artery and vein) and tissue samples (lung and mediastinal node), were taken before, at completion of, and 5, 10, 15, 30, 60, 120, 180 and 240 minutes after cisplatin infusion for blood gas and platinum content measurement. Blood circulation was restored to the treated organ (for 60 minutes). The animals were killed, and specimens from lung, thyroid, esophagus, heart, liver, spleen, adrenal glands, kidney, bone marrow, stomach, ileum, colon, psoas muscle, and skin were obtained. Platinum concentrations in plasma, plasma ultrafiltrate (free platinum) urine, and tissues were determined by flameless atomic absorption spectroscopy. Lung damage was evaluated by light and electron microscopic examination. RESULTS: Greater systemic plasma, lower pulmonary plasma, and tissue platinum levels were detected when cisplatin was given using the stop-flow technique with respect to the other administration modalities. No significant difference in regional and systemic platinum exposure was found between Groups 2 and 3. However, lung perfusion resulted in higher mediastinal node and lower bone marrow platinum values. Morphologic alterations and impairment of gas exchanges in the treated lung were not dependent on the applied infusion technique. CONCLUSION: This study provides the pharmacokinetic rationale for the application of lung perfusion to patients with pulmonary metastases.

Animals↗
PubMed1992

[Continuous sinusoid systemic Fudr infusion in advanced colorectal carcinoma. Preliminary experience].

Sinusoidal circadian continuous infusion with a maximal flow rate in the afternoon (3-9 pm) reduces Fudr toxicity. In order to estimate if the reported lower toxicity is merely due to the quasi-intermittence of the daily dose or to the circadian rhythm of infusion. Ten patients with widespread cancer (9 colorectal and 1 renal) underwent sinusoidal continuous iv Fudr infusion with the peak level in antiphase (ie 68% of the dose from 3 to 9 am) as compared with the Römeling shape. An initial dose of 0.15 mg/kg/d for 14 days monthly has been given, escalating it every cycle by 0.025 mg/kg/d increments until toxicity. Mean (+/- SD) number of cycles has been 4.1 +/- 2.1 (range 2-8), maximal dose given has been 0.2 mg/kg/die in 5 patient and mean dose intensity of 0.570 +/- 0.04. Gastrointestinal toxicity consisted of nausea/vomiting WHO grade 1 in one patient and diarrhoea grade 1 in two, grade 2 and 3 in one and one case. Toxicity and dose intensity of both sinusoidal infusion seem to be similar and allow higher dose of Fudr than continuous constant infusion. Some other studies have to be done to include pharmacokinetics evaluation in order to estimate chronobiologic implication in continuous Fudr infusion.

Circadian Rhythm↗
PubMed1992

[Clinical use of a totally implantable and programmable pump for the infusion of drugs].

Totally implantable programmable systems allow preordained complex continuous infusion of drugs. Sixteen totally programmable implantable pumps (Medtronic DAD) have been implanted in fifteen advanced colorectal and renal cancer patients for continuous ia and iv sinusoidal Fudr infusion. Median duration of pump function was 125 days (range 46-468), there was observed only one case of malfunction device which required the implant of a new device, and three complications of pump pocket (seroma, hematoma and infection) without interrumption of chemotherapy for clinical causes. The use of totally implantable programmable systems provides and important clinical improvement in controlled long-term drugs administration improving quality of life and duration of chemotherapy.

Antineoplastic Agents↗
PubMed1991

Liver and tumor uptake and plasma pharmacokinetic of arterial cisplatin administered with and without starch microspheres in patients with liver metastases.

Arterial chemoembolization of liver tumors should improve regional treatment by reducing native blood flow of the whole organ and redistributing residual flow toward hypovascular masses. Plasma cisplatin pharmacokinetics and its tissue uptake and relative tumor and liver vascularity were studied during surgical placement of arterial catheters in four patients and in four patients with colorectal metastases given intraoperative arterial cisplatin (DDP, 25 mg/m2), with an without coadministration of 600 mg degradable starch microspheres (DSM). Mean (+/- standard deviation) filterable plasma platinum levels peaked later (2 minutes) and were significantly lower after DDP with DSM (1.23 +/- 0.69 micrograms/ml) than after DDP alone (2.13 +/- 0.43 micrograms/ml, P less than 0.05), with the area under the curve (AUC0-30 min) values of 15.8 +/- 5.5 and 25.1 +/- 3.8 micrograms x min/ml (P less than 0.05), respectively. No differences in urine excretion, total body clearance, or plasma protein binding of platinum were observed. Tissue biopsies were started 15 minutes after DDP administration and completed in all cases within 5 minutes. Tumor platinum concentrations were significantly higher after DDP with DSM (3.03 +/- 1.60 micrograms/g) than after DDP alone (0.67 +/- 0.49 micrograms/ml, P less than 0.05). Liver concentrations and tumor-liver ratios of platinum also were higher, although not significantly, after DDP with DSM. Preoperative vascularization, studied with arterial perfusion scan, influenced individual tissue drug uptake in cases given DDP alone, with the lowest tumor levels in cold masses. Very high and almost superimposable liver and tumor concentrations were measured in those receiving DDP and DSM. The latter phenomenon was irrespective of native vascularization, indicating that DSM administration induced both an increased whole-liver extraction of the drug and a redistribution of blood flow and flow-dependent tissue uptake of platinum.

Chemoembolization, Therapeutic↗
PubMed1991

A phase I study of recombinant interleukin-2 intraperitoneal infusion in patients with neoplastic ascites: toxic effects and immunologic results.

A phase I study to evaluate the use of i.p. infusion of recombinant interleukin-2 (rIL-2) was planned. The following dose levels were calculated: 0.1, 0.3, 1.0, 3.0 and 10 mg/m2/day for 14 days, but only the second levels were reached. In this trial the acute toxic effects at this dosage included cardiac ischemia, transient liver impairment and septic peritonitis. The maximum tolerated dose (MTD) was 0.3 mg/m2/day for 14 days. In addition, two patients developed peritoneal fibrosis. No objective responses were observed. Therefore, in order to explore the biological activity of low (nontoxic) doses, three patients (one untreated and two previously treated with rIL-2) were infused with 0.01 and 0.03 mg/m2/day for 7 days. Potentiation of cytolytic activities in peritoneal lymphocytes and activation of a lymphokine cascade in the ascitic fluid were observed at doses ranging from 0.03 mg/m2/day to 0.3 mg/m2/day. These findings in association with the toxic effects observed at the MTD suggest the use of the minimum effective dose for future locoregional immunotherapeutic protocols.

Adult↗
PubMed1990

[Hyperthermic-antiblastic isolation perfusion for advanced melanoma of the limbs. The technic, immediate results and a review of the literature].

Hyperthermic antiblastic isolated perfusion is a method largely used for the treatment of locally advanced limb melanoma. The method requires vascular isolation and hyperthermic perfusion of the limb using an extracorporeal circuit and administering the melphalan as antiblastic drug. Twenty-six patients with primary or recurrent melanoma of the limbs have undergone this treatment at our Institute. There were no cases of operative mortality and systemic toxicity was negligible. The local complications were transitory and no patient showed symptoms of nervous toxicity or permanent functional damage. Two cases of deep thrombophlebitis and two of lymphocele were documented a few months after treatment. Four clinically complete responses, 3 partial and 2 cases of stable disease were observed in the 9 patients treated with unexcised lesions. Our data like the totality of the present experience points to the safety of this method in the therapy of locally advanced limb melanoma. Nevertheless further controlled studies are required to define its role in order to improve survival.

Adult↗
PubMed1990

[Distal gastrectomy with Y gastroenteroanastomosis not associated with vagotomy in elective surgical treatment of gastroduodenal ulcer. Clinical and functional long-term results].

During the period 1977-1984, 53 patients with peptic ulcer resistant to H2-blockers (29 gastric and 24 duodenal ulcers) were submitted to distal gastrectomy with Roux-en-Y gastroenteroanastomosis not associated with vagotomy. The indication was used as an alternative to proximal vagotomy in cases with delayed gastric emptying, high acid output, perforation or bleeding. The study plan consisted of serial clinical and instrumental controls including determination of basal (BAO) or maximal (MAO) acid output. Operative mortality was nil. At various times after the operation, 4 patients died for unrelated reasons and 3 were lost to follow-up. Median follow-up was 84 months with an interval of from 4 to 137 months. Fifty-one patients were followed up for at least one year and 49 for at least two. Five patients (2 gastric and 3 duodenal ulcers) developed peptic recurrences (Visick IV, 9.8%) by the end of the first postoperative year and, in all cases but one, healed stably by the second year after medical (3 cases) or surgical (1 case) therapy. In the remaining patients, Visick was grade III in 6 cases (4 gastric and 2 duodenal ulcers), grade II in 6 and grade I in 34. Before operation, mean values (+/- SD) of BAO and MAO were respectively 5.84 +/- 5.03 and 29.6 +/- 18.6 mEq/h. In the immediate postoperative period there was a considerable reduction in BAO (p less than 0.02) and MAO (p less than 0.03) which continued up to the third postoperative year with a tendency to further progressive reduction in MAO. In spite of a considerable individual variability in dimensions and temporal evolution, the phenomenon occurred qualitatively in all cases. No significant difference was observed in the behaviour of BAO and MAO in gastric ulcers by comparison with duodenal ulcers and in cases with recurrence and Visick III compared to those with a favourable clinical result.

Adult↗
PubMed1989

Changes in vascularity of liver tumours after hepatic arterial embolization with degradable starch microspheres.

The role of vascularity as a prognostic factor was investigated in 35 patients undergoing arterial chemotherapy for liver tumours. Compared with parenchyma, tumour vascularity was classified as hot (18 cases), cold (12 cases), and mixed (12 cases) using 99mTc-macroaggregated albumin (MAA) hepatic arterial scans. The proportion of patients showing complete and partial responses to treatment was higher in the hot group (56 per cent) than in the combined cold and mixed group (12 per cent). In 15 cases (six hot, six cold and three mixed lesions), additional MAA scans were performed immediately after arterial embolization with degradable starch microspheres (DSMs). Either complete or partial reversal of tumour vascularity was observed after DSM-embolization in five and seven cases respectively, two and two of them respectively showing native cold lesions. As tumour vascularity appears to be a prominent prognostic factor, DSM-embolization should improve the efficacy of treatment by improving liver extraction of drugs and causing flow redistribution towards hypovascular areas.

Aged↗
PubMed1989

Intraperitoneal infusion of recombinant interleukin-2 in malignant ascites in patients with gastrointestinal and ovarian cancer.

In a phase-I-study recombinant interleukin-2 (rIL-2) in a dose from 0.01 to 0.3 mg/m2/day for 7 to 14 days was infused intraperitoneally. Side effects were fever and fluid retention. 2 patients showed a bacterial peritonitis after paracentesis. The investigations showed that the intraperitoneal (i.p.) administration of interleukin-2 activates the whole lymphokine cascade.

Catheters, Indwelling↗
PubMed1988

Regional pharmacokinetic selectivity of intraperitoneal cisplatin in ovarian cancer.

Five patients with intraabdominal ovarian cancer, 4 of whom with concomitant ascites, refractory to cisplatin-containing combination chemotherapy were treated with intraperitoneal cisplatin. Cisplatin, 90 mg/m2, was administered intraperitoneally in 2 liters of warm 0.9% NaCl with a 4-hour dwelling time on day 1 q 21 days. Platinum concentrations in plasma, ascites, ultrafiltrates of plasma and ascites, and urine were assayed by flameless atomic absorption spectrophotometry and determinations were verified by neutron activation analysis. Peak total and ultrafiltrable plasma platinum levels were 1.63 +/- 0.6 and 0.76 +/- 0.3 microgram/ml, respectively. Peritoneal clearance of total platinum (PA) was 21 ml/min whereas body clearance of total platinum was on the average 13.8 times PA, varying from 171 to 429 ml/min; the mean AUC (peritoneum) to AUC (plasma) ratio was 11 +/- 3. In 2 patients control of ascites was obtained, in 1 of these patients prior positive cytology became negative after her first intraperitoneal course. No nephrotoxicity was observed and gastrointestinal toxicity was mild. No catheter-related infections were observed. Intraperitoneal cisplatin therapy is well tolerated, pharmacokinetically rational and may be useful in managing ovarian cancer patients with malignant ascites or minimal residual disease at second-look laparotomy.

Aged↗