Biomedical subjects

A Marchianò

Publications and source records attributed to A Marchianò.

At least 19 recordsLinked to original sources

PubMed2005

Stage 4 neuroblastoma: sequential hemi-body irradiation or high-dose chemotherapy plus autologous haemopoietic stem cell transplantation to consolidate primary treatment.

The aim of the present study was to evaluate the effectiveness of two consecutive nonrandomised treatment programs applied between 1989 and 1999 at the Istituto Nazionale Tumori of Milan in an unselected cohort of 59 children over the age of one with stage 4 neuroblastoma. Both treatment programs consisted of two phases, the induction of the remission phase and the consolidation phase. The induction of the remission phase consisted of intensive chemotherapy, and remained the same throughout the study period. The consolidation phase consisted of sequential hemi-body irradiation (HBI) (10 Gy per session, 6 weeks apart) in the first period (1988-June 1994) and sequential high-dose cyclophosphamide, etoposide, mitoxantrone+L-PAM and autologous haemopoietic stem cell transplantation in the second (July 1994-1999). Intention-to-treat analysis revealed a significantly better outcome for patients treated with the second program, the 5-year event-free survival probability being 0.12 for program 1 and 0.31 for program 2 (P=0.03). This finding led us to conclude that sequential HBI is useless as consolidation treatment. The high-dose chemotherapy adopted in the second program enabled a proportion of patients to obtain long-term survival but, since the clinical results remain unsatisfactory, new treatment strategies are warranted.

Adolescent↗

PubMed2003

Phase II study of pemetrexed disodium (Alimta) administered with oral folic acid in patients with advanced gastric cancer.

BACKGROUND: The aim of this study was to assess the activity of pemetrexed in patients with advanced gastric cancer. PATIENTS AND METHODS: Thirty-eight eligible patients (median age 60 years) received pemetrexed 500 mg/m(2) every 3 weeks. Since toxicity was considerable in the first six patients, the protocol was amended to supplement subsequent patients with oral folic acid (5 mg/day on days -2 to +2 of every cycle). RESULTS: Among 36 stage IV patients evaluable for efficacy (six non-supplemented\30 supplemented), there were two complete and six partial responses. The response rate was 21% (95% confidence interval 8% to 32%) according to intention-to-treat analysis. All responding patients were in the supplemented group. The median duration of response was 4.6 months and the median survival was 7.8 months. Five of six non-supplemented patients (83%) developed grade 3/4 neutropenia; two (33%) unsupplemented patients discontinued; two (33%) patients died due to toxicity. In the supplemented group, 12 of 32 patients (37%) had grade 3/4 neutropenia. None of the supplemented patients discontinued treatment due to hematological toxicity. Severe non-hematological toxicities were infrequent. CONCLUSIONS: The activity of pemetrexed is promising in light of the tumor burden in these patients (all patients were stage IV and 39% had three or more organs involved). Toxicities were remarkably decreased with folic acid supplementation. Combination studies are warranted.

Adenocarcinoma↗

PubMed2001

Intraarterial chemotherapy with polyoxyethylated castor oil free paclitaxel, incorporated in albumin nanoparticles (ABI-007): Phase I study of patients with squamous cell carcinoma of the head and neck and anal canal: preliminary evidence of clinical activity.

BACKGROUND: This study was designed to determine the feasibility, maximum tolerated dose, and toxicities of intraarterial administration of paclitaxel-albumin nanoparticles in patients with advanced head and neck and recurrent anal canal squamous cell carcinoma. Antitumor activity also was assessed. METHODS: Forty-three patients (31 with advanced head and neck and 12 with recurrent anal canal squamous cell carcinoma) were treated intraarterially with ABI-007 every 4 weeks for 3 cycles. In total, 120 treatment cycles were completed, 86 in patients with head and neck carcinoma (median, 3 cycles; range, 1-4) and 34 in patients with anal canal carcinoma (median, 3 cycles; range, 1-4). ABI-007 was compared preliminarily with Taxol for in vitro cytostatic activity. Increasing dose levels from 120 to 300 mg/m2 were studied in 18 patients. Pharmacokinetic profiles after intraarterial administration were obtained in a restricted number of patients. RESULTS: The dose-limiting toxicity of ABI-007 was myelosuppression consisting of Grade 4 neutropenia in 3 patients. Nonhematologic toxicities included total alopecia (30 patients), gastrointestinal toxicity (3 patients, Grade 2), skin toxicity (5 patients, Grade 2), neurologic toxicity (4 patients, Grade 2) ocular toxicity (1 patient, Grade 2), flu-like syndrome (7 patients, Grade 2; 1 patient, Grade 3). In total, 120 transfemoral, percutaneous catheterization procedure-related complications occurred only during catheterization of the neck vessels in 3 patients (2 TIA, 1 hemiparesis) and resolved spontaneously. CONCLUSIONS: Intraarterial administration of ABI-007 by percutaneous catheterization does not require premedication, is easy and reproducible, and has acceptable toxicity. The maximum tolerated dose in a single administration was 270 mg/m2. Most dose levels showed considerable antitumor activity (42 assessable patients with 80.9% complete response and partial response). The recommended Phase II dose is 230 mg/m2 every 3 weeks.

Adult↗

PubMed2001

Phase I/II study of gemcitabine in association with vinorelbine for metastatic breast cancer.

BACKGROUND: Gemcitabine (G) and vinorelbine (V) have favorable safety profile and antitumor activity in metastatic breast cancer. To exploit their different mechanism of action and lack of overlapping toxicity, we performed a phase I and II study of G and V in combination. PATIENTS AND METHODS: Fifty-three patients with metastatic breast cancer were treated. In the dose-finding phase, seven cohorts of patients (22 women) received increasing doses to determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of the combination. Patients recruited in the phase II portion of the study (31 women) received the dose level immediately below the one defined as MTD (i.e., G 1200 mg/m2, V 30 mg/m2, on day 1 and day 8, every 3 weeks). RESULTS: Dose escalation was discontinued at G 1400mg/m2 and V 30 mg/m2 because of toxic death due to thrombocytopenia and CNS hemorrage. No other limiting toxicities were observed, and tolerability was similar at all dose levels studied in the escalation portion of the study. The main toxicity was granulocytopenia of grade 3/4 in 36 and 48% of the patients on phase I and II respectively, without episodes of neutropenic fever. Thrombocytopenia was uncommon. Other side effects were usually mild to moderate. In 46 evaluable patients, the response rate was 24% (complete response 7%, partial response 17%). Disease stabilization was observed in further 17%. The median duration of response was 12 months (range 5-14) and the median survival was 20 months (range 1 to 45+). CONCLUSIONS: G and V, on day 1 and 8 of 3-weekly cycles, can safely be administered to patients with metastatic breast cancer at the dose of 1200 and 30 mg/m2, respectively. The antitumor activity of G and V in combination was similar to that reported when using either drug as single agent.

Adult↗

PubMed2001

[Percutaneous implant of Denver peritoneovenous shunt: a new opportunity for the interventional radiologist].

PURPOSE: The study is aimed at presenting our experience in the implant of Denver peritoneovenous shunts. Medical treatment-resistant ascites, either neoplastic or related to hepatic failure, is highly symptomatic and its treatment is indicated in order to improve patients' quality of life. One of the most efficient methods of treatment consists in implanting a peritoneovenous shunt. The availability of this device and its percutaneous implantation provide Interventional Radiologists with the possibility of expanding their repertoire. MATERIAL AND METHODS: Thirteen shunts were implanted in 12 patients, 10 with neoplastic ascites and 2 with hepatic failure-related ascites. In 1 patient a second device had to be implanted. All the procedures were performed in the Interventional Radiology Department, under local anesthesia and mild sedation. The central venous access was by the subclavian vein in 7 cases and the internal jugular vein in 6 cases. The puncture kit is consists of 2 needles, 1 for venous puncture and 1 for peritoneal puncture, 2 angiographic J-guide wires, 2 peel-away introducers, and a chamber containing the double valve-pump connected with both the venous and the peritoneal catheters. The whole device is placed subcutaneously thus allowing fluids to flow from the peritoneum to the vein either spontaneously, if intra-abdominal pressure exceeds 3cm of water, or by manual compression exerted on the pump itself. RESULTS: All implants were successfully performed. One transient complication occurred consisting in a mild inflammatory reaction along the subcutaneous catheter route, which promptly solved by antibiotic therapy. So far a total of 1773 catheter/days have been accumulated. 7/10 of the neoplastic patients died from progressive disease after 915 catheter/days (median 120, range 30-180). In a cirrhotic patient the first shunt occluded after 430 days due to hemoperitoneum caused by hepatic biopsy: it was removed and a new one implanted. Five shunts are in now use, with a follow-up of 30, 48, 70, 120 and 160 days each. DISCUSSION: The implanting technique was well tolerated by all patients and it could be performed under local anesthesia. The central vein puncture was easy for both accesses but the introducer diameter (12F) and the possibility of clavicle pinch-off induced us to use the internal jugular approach in the last six cases, which provided a reduced risk of pneumothorax and a better catheter track. In the patients with neoplastic ascites we observed neither disease dissemination nor changes in the patients' changed related to the shunt. Our results show that the implant of Denver venous-peritoneal shunts is a relatively easy procedure, which can be performed by Interventional Radiologists on a regular basis.

Adult↗

PubMed2000

Percutaneous radio-frequency thermal ablation of nonresectable hepatocellular carcinoma after occlusion of tumor blood supply.

PURPOSE: To evaluate the usefulness of percutaneous radio-frequency (RF) thermal ablation of nonresectable hepatocellular carcinoma (HCC) after occlusion of the tumor arterial supply. MATERIALS AND METHODS: Sixty-two patients with cirrhosis and biopsy-proved HCC underwent RF ablation after interruption of the tumor arterial supply by means of occlusion of either the hepatic artery with a balloon catheter (40 patients) or the feeding arteries with gelatin sponge particles (22 patients). RESULTS: After a single RF procedure in 56 patients and after two procedures in six patients, spiral computed tomography (CT) demonstrated a nonenhancing area corresponding in shape to the previously identified HCC, which was suggestive of complete necrosis. No major complications occurred. Two patients subsequently underwent surgical resection; the remaining 60 patients were followed up with spiral CT. During a mean follow-up of 12.1 months, 11 HCC nodules showed areas of local progression; 49 were identified as nonenhancing areas with a 40%-75% reduction in maximum diameter. The 1-year estimate of failure risk was 19% for local recurrence and 45% for overall intrahepatic recurrence. The estimated 1-year survival was 87%. Histopathologic analysis of one autopsy and two surgical specimens revealed more than 90% necrosis in one specimen and 100% necrosis in two. CONCLUSION: HCC nodules 3.5-8.5 cm in diameter can be ablated in one or two RF sessions after occlusion of the tumor arterial supply.

Aged↗

PubMed1999

First clinical experience with a high-capacity implantable infusion pump for continuous intravenous chemotherapy.

PURPOSE: To evaluate the efficiency of a new high-capacity pump for systemic venous chemotherapy and to verify the quality of implantation by interventional radiology staff. METHODS: A total of 47 infusion pumps with a 60-ml reservoir and variable flow rates (2, 6, 8, or 12 ml/24 hr) were implanted by radiologists in 46 patients with solid tumor metastases requiring treatment with a single, continuously infused cytostatic agent. The reservoir was refilled transcutaneously, usually once weekly. The flow accuracy of the pump was assessed from actual drug delivery recorded on 34 patients over a minimum observation period of 180 days. RESULTS: No early complications occurred in any of the 47 implants in 46 patients. A total of 12 (25.53%) complications occurred between 3 and 24 months after implantation. Seven (14.90%) of these were due to the external design of the pump, while five (10.63%) were related to the central venous catheter. In the 34 patients available for pump evaluation (follow-up of at least 180 days), the system was used for a total of 14,191 days (range 180-911 days, mean 417.38 days), giving an overall complication rate of 0.84 per 1000 days of operation. The mean flow rate accuracy was 90.26%. CONCLUSION: The new implantable pump showed good flow rate accuracy and reliable operation. The pump-related complications were related to its external design and have now been corrected by appropriate modifications. From a radiologic and surgical viewpoint, the venous implantation procedure is identical to that of conventional vascular access devices and can be performed by radiologists familiar with these techniques. The current limitations lie in the high cost of the pump and, for certain drugs, the short time between refills.

Adult↗

PubMed1999

Double-blind, randomised, multicentre endocrine trial comparing two letrozole doses, in postmenopausal breast cancer patients.

Letrozole is an orally competitive aromatase inhibitor. This double-blind, randomised, multicentre trial was carried out to evaluate the endocrine effects of two doses of letrozole, 0.5 mg versus 2.5 mg orally daily, in postmenopausal advanced breast cancer patients progressing after tamoxifen. The pharmacokinetics of letrozole was also assessed. 46 patients entered the trial, 22 on letrozole 0.5 mg and 24 on 2.5 mg. A significant suppression of oestrone and oestradiol levels was achieved by both letrozole doses. Neither letrozole dose induced any changes in cortisol and aldosterone production at rest or after Synacthen stimulation. Androstenedione, testosterone, 17 alpha-OH progesterone, triiodothyronine (T3) thyroxine, (T4) and thyroid-stimulating hormone (TSH) plasma levels did not show any significant changes. Sex hormone binding globulin (SHBG), follicle-stimulating hormone (FSH) and luteinising hormone (LH) levels increased significantly over time. Plasma letrozole concentrations increased until reaching steady-state values after 1 month at the dose of 0.5 mg and after 2 months at 2.5 mg. In conclusion, both letrozole doses suppressed oestrogen levels without affecting adrenal activity.

Adult↗

PubMed1997

Hepatocellular carcinoma in patients who undergo liver transplantation: sensitivity of CT with iodized oil.

PURPOSE: To evaluate the diagnostic efficacy of computed tomography (CT) after hepatic intraarterial injection of iodized oil in patients with hepatocellular carcinoma (HCC). MATERIALS AND METHODS: Forty patients who underwent CT with iodized oil before orthotopic liver transplantation (OLT) were evaluated prospectively. All patients underwent digital subtraction angiography and injection of iodized oil during chemoembolization. CT during arterial portography (CTAP) was performed in 34 patients. The number of neoplastic nodules was assessed in explanted livers and compared with the radiologic results. RESULTS: Sixty-six HCC nodules were present in the explanted livers. CT with iodized oil enabled correct diagnosis in 38 of 66 lesions (58%), and the results were false-positive in two lesions (3%). Digital subtraction angiography had a sensitivity of 67% (44 of 66 nodules) and CTAP had a sensitivity of 85% (45 of 53 nodules). Four (6%) false-positive diagnoses were made at digital subtraction angiography and three (6%) at CTAP. The diagnostic efficacy of CT with iodized oil was significantly related to lesion diameter greater than 2 cm (P < .0001) and hypervascularity (P < .0001). CONCLUSION: CT with iodized oil failed to provide any substantial information in the pre-OLT staging of HCC: It was inaccurate for small HCC nodules (<2 cm) and intrahepatic metastases. Its sensitivity matched that of digital subtraction angiography and was statistically significantly inferior to that of CTAP.

Adult↗

PubMed1997

Placement of long-term central venous catheters in outpatients: study of 134 patients over 24,596 catheter days.

OBJECTIVE: Our goal was to investigate the feasibility of inserting long-term central venous access devices in outpatients using a simple technique that minimizes the risks of complications linked to venipuncture and errors in management. MATERIALS AND METHODS: We placed 147 central venous catheters (CVCs) in 134 patients under local anesthesia. No sedation was used, and all procedures were done in our radiology department. Of the 134 patients, 101 patients were included in the follow-up. Overall follow-up of patients was 24,596 catheter days (mean, 243.52 days). Percutaneous access, mostly by the subclavian vein, was done by micropuncture technique under fluoroscopic guidance. Six CVCs were untunneled, 36 were connected to totally subcutaneous ports, and 105 were tunneled. RESULTS: The only immediate complication was pneumothorax (3%). Late complications, expressed per 1000 catheter days, included CVC breakage (0.12), vascular thrombosis (0.08), catheter occlusion (0.04), dislodgment (0.24), and local or systemic infections (0.40). CONCLUSION: Outpatient CVC placement is feasible because the procedure is not adversely affected when the patient is not hospitalized. The drawbacks are identical to those faced by inpatients. Improved materials and more extensive information on the management of patients with long-term CVCs would help reduce complications further.

Ambulatory Care↗

PubMed1994

Chemoembolization of hepatocellular carcinoma in patients who undergo liver transplantation.

PURPOSE: To determine the efficacy of chemoembolization (CHE) for hepatocellular carcinoma (HCC) in patients with a cirrhotic liver. MATERIALS AND METHODS: Twenty-one patients with cirrhosis and 33 HCC nodules received a mean of 2.4 cycles of CHE before orthotopic liver transplantation (OLT). Iodized oil plus doxorubicin (13 patients) or mitoxantrone (eight patients) was injected into the hepatic artery. Twelve (57%) of the patients underwent terminal embolization with gelatin sponge pledgets. After OLT, the percentage of tumor necrosis was assessed in each HCC nodule. RESULTS: Twelve (36%) of 33 HCC nodules responded completely to CHE (necrosis > 90%). Successful treatment was statistically significantly related to nodular diameter greater than 2 cm (P = .03), solitariness (P = .0009), hypervascularity (P = .001), and good retention of iodized oil (P = .05). Seven (33%) of the patients had major complications; no death occurred in association with CHE. All patients survived OLT; in three patients (14%), HCC recurred a median of 21 months after OLT. CONCLUSION: CHE seems to be an effective treatment for HCC in patients with liver cirrhosis who await OLT.

Angiography, Digital Subtraction↗

PubMed1994

The Italian experience with SH U 508 A (Levovist) in breast disease.

The authors report their experience with color Doppler US of breast disease with a new parenteral contrast agent--i.e., SH U 508 A (Levovist)--in an international multicenter experimental trial. Over a 9-month period, 17 patients with 19 solid breast lesions were examined. A baseline color Doppler study was performed on every patient, together with a second exam after injecting the contrast agent into a peripheral vein to investigate possible changes in the depiction of tumor vessels, inside and around the lesions. The 19 nodules included 16 infiltrating ductal carcinomas, 2 fibroadenomas and 1 benign phylloid tumor. Levovist improved the depiction of tumor vessels in all cases and helped detect new vascular signals which had been missed on baseline images. The increase in color Doppler signal was graded as marked and mild: in 68.75% of ductal carcinomas and in the benign phylloid tumor signal increase was marked, while in 31.25% of carcinomas and in fibroadenomas signal increase was mild. All lesions exhibited vascular signals both inside and around the lesion; many afferent poles were also depicted. Our results demonstrate that conventional color Doppler semiology changes with the use of a contrast agent and pave the way for further studies on larger series of cases to assess new diagnostic criteria to differentiate breast lesions according to color Doppler signal patterns.

Adult↗

PubMed1994

US contrast enhancement with intra-arterial CO2 injection in the staging of hepatocellular carcinomas.

Liver US contrast enhancement was obtained with the intrahepatic arterial injection of CO2 in 45 hepatocellular carcinoma patients. Before digital subtraction angiography (DSA) all the patients underwent conventional US and CT of the liver; 20 patients also underwent CT during arterial portography (CTAP). Liver US contrast enhancement with CO2 exhibited the same sensitivity as DSA (92%) in demonstrating hypervascular HCCs and proved superior to the other diagnostic procedures -- 85% for CT and 78% for conventional US. DSA combined with echocarbography, with its 2D demonstration of liver anatomy, improved the correct staging of HCCs, for better treatment planning.

Angiography↗

PubMed1993

Color-Doppler ultrasound in ovarian masses: anatomo-pathologic correlation.

BACKGROUND AND AIMS: In the radiologic assessment of ovarian masses, the major difficulty consists in the late recognition and lack of parameters for a differential diagnosis between benign and malignant lesions, especially in the post-menopause when the incidence of cancer is higher. The use of a transvaginal probe and the color-Doppler examination have recently improved the study of the female pelvis. This study is aimed to verify the possibility of the color-Doppler imaging to differentiate between malignant and benign ovarian lesions during transvaginal echographies, on the basis of the qualitative and quantitative characteristics of the vascular pattern of the ovarian lesions. RESULTS: Twenty-six expansive ovarian lesions were studied: 8/26 showed no vascular signals and were considered benign as confirmed at histology. In the remaining lesions with some vascularization, the resistance index (RI) was evaluated: those with RI > 0.40 were considered benign, those with RI < 0.40 malignant. In 8/9 benign lesions and 7/9 malignant neoplasms, the results of color-Doppler were coherent with histology. The results showed a sensibility of 87.5% and a specificity of 88.8% for the transvaginal examination. CONCLUSIONS: The main advantages of the color-Doppler transvaginal examination are: the high frequency of visualization of the ovaries, even in postmenopausal patients; the definition of small lesions; the visualization of small parenchymal vessels, both physiologic and pathologic, and their quantitative analysis. The importance of the RI cutoff was critical for the differential diagnosis between benign and malignant lesions; we think that a cutoff of 0.50, instead of 0.40 proposed by other authors, would be far more appropriate.

Adult↗

PubMed1993

Non-resectable Stage IIIa-b lung carcinoma: a phase II study on continuous infusion of cisplatin and concurrent radiotherapy (plus adjuvant surgery).

Thirty-eight patients with non-resectable non-small-cell Stage IIIa-b lung cancer were treated in a Phase II study with radiotherapy (50 Gy in a 25-fraction split-course) plus con-current continuous infusion of cisplatin given at a daily dose of 6 mg/m2, with the aim of investigating its radiopotentiation properties. Treatments were given on an outpatient basis by means of a central venous catheter and a portable pump. Adjuvant surgery was undertaken when feasible. Toxicity was mild to moderate. The probability of a partial or complete locoregional response at 4 weeks after treatment completion was 83% (confidence limits at 95%: 13). Eighteen patients were resected. Overall 1-, 2- and 3-year progression-free survival probabilities were 42, 24 and 21%. These figures were 63, 37 and 24% in observed survival curves. Patients with squamous-cell tumors had observed survival rates of 82, 50 and 28% at 1, 2 and 3 years, compared to 42, 19 and 19% in patients with non-squamous histology. The high response and survival rates obtained at a low price according to toxicity require further investigation.

Adult↗

PubMed1992

Embolization and chemoembolization for hepatocellular carcinoma.

A check on the rationale for embolization and chemoembolization for hepatocellular carcinoma and a revisit to the background of the anatomy of blood supply to the liver is discussed. The technique of the embolization is different and mostly in the range of home made configuration. There is no data concerning the stability of different choices such as the popular mixture of cytotoxic agents and lipiodol. Therefore the authors have preferred the use of microencapsulated Mitomycin believing that this special formulation of the drug can attain the present best reproducibility. The survival of 32 treated patients was longer than the control group. Twelve, 36 and 60 month survival was 70%, 45% and 15% vs 37%, 0%, and 0% respectively.

Capsules↗

PubMed1992

[Combined use of real-time digital subtraction radioscopy and computerized tomography: potential advantages in diagnostic and interventional radiology].

The idea of combining fluoroscopy and CT arose from the daily practice in diagnostic and interventional radiology. A Diasonics OEC high-performance image intensifier complete with a digital subtraction system was connected to a Siemens Somatom-DRH CT scanner to work in tandem. CT is used for a localization in-depth and fluoroscopy for the subsequent maneuvers within an organ or body compartment. With this combination, complex procedures such as transarterial portography, percutaneous embolizations, pain treatment and manipulation for catheterization of the bile ducts and urinary tract could be performed in one place and in one session. CTF is especially useful when patients should not be moved about from room to room or undergo an examination in several sessions, as it happens with children or critically ill or contagious patients.

Adult↗

PubMed1991

Flexibility and efficacy of automatic continuous fluorodeoxyuridine infusion in metastases from a renal cell carcinoma.

Complete and lasting control of diffuse metastases from a renal cell carcinoma has been achieved by automatic continuous infusion of a single cytotoxic agent, fluorodeoxyuridine (FUDR). A patient with a single brain metastasis from renal cell carcinoma developed pulmonary, mediastinal, and retroperitoneal metastases after radical nephrectomy. A Medtronic Synchromed pump (Medtronic Inc., Minneapolis, MN) was implanted for the circadian systemic infusion of FUDR in 14-day courses with 14-day drug-free intervals. A complete response (CR) at all sites, was obtained in 3 months, and maintained for 22 months. After a second brain metastasis, treated by radiation therapy and cisplatin as radiosensitizer, a CR was obtained again and is now of 31 months' duration, which is four times the record to date. The overall hospitalization was 2 days. Acceptance of the pump is excellent and it functions precisely and reliably. This case should stimulate greater interest in techniques of automatic continuous infusion of cytostatics, given its greater efficacy and lower toxicity.

Brain Neoplasms↗