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Giammaria Fiorentini

Publications and source records attributed to Giammaria Fiorentini.

16 recordsLinked to original sources
PubMed2006

Adjuvant intra-arterial 5-fluoruracil, leucovorin, epirubicin and carboplatin with or without systemic gemcitabine after curative resection for pancreatic adenocarcinoma.

BACKGROUND: The role of adjuvant therapy in pancreatic cancer remains controversial. Gemcitabine given systemically seems to be effective; intra-arterial chemotherapy (IAC) has a deep rationale. PATIENTS AND METHODS: The goal was to evaluate the impact of postoperative IAC followed or not by systemic gemcitabine in patients after curative resection for pancreatic adenocarcinoma. 5-fluoruracil 750 mg sq m(-1), leucovorin 75 mg sq m(-1), epirubicin 45 mg sq m(-1), carboplatin 225 mg sq m(-1) were administered every 3 weeks into celiac axis for three cycles (FLEC regimen), then gemcitabine at the dosage of 1 g sq m(-1) on days 1, 8 and 15 every 4 weeks for 3 months (FLECG regimen). RESULTS: Forty-seven patients entered the study. The first 24 received only IAC (FLEC regimen), the other 23 received the same intra-arterial regimen followed by systemic gemcitabine (FLECG regimen). After a median follow-up of 16.9 months, 29 patients recurred (61.7%). Median disease free survival (DFS) was 18 months and median overall survival (OS) was 29.7 months. One-year DFS was 59.4% and 1-year OS was 75.5%. Main grade 3 toxicity related to IAC was only nausea/vomiting in 4%; regarding gemcitabine, grade 3 toxicities were anaemia 8%, leukopenia 8%, thrombocitopenia 17%, nausea/vomiting 4%. CONCLUSIONS: FLEC regimen with or without gemcitabine is active with a very mild toxicity and results are very encouraging in an adjuvant setting.

Adenocarcinoma↗
PubMed2005

Phase II study of hepatic intraarterial epirubicin and cisplatin, with systemic 5-fluorouracil in patients with unresectable biliary tract tumors.

BACKGROUND: Patients with unresectable biliary tract carcinomas have a very poor prognosis. To improve the efficacy and tolerance of the ECF regimen (epirubicin at a dose of 50 mg/m2, cisplatin at a dose of 60 mg/m2, and 5-fluorouracil [5-FU] at a dose of 200 mg/m2 per day by continuous infusion), the authors designed a novel approach that combined locoregional and systemic chemotherapy with the same agents at the same dosages. METHODS: Thirty consecutive patients with advanced or metastatic biliary tumors were treated with epirubicin at a dose of 50 mg/m2 and cisplatin at a dose of 60 mg/m2 administered as a bolus in the hepatic artery on Day 1, combined with systemic continuous infusion of 5-FU at a dose of 200 mg/m2 per day, from Day 1 to Day 14, every 3 weeks. RESULTS: Tumor sites were the intrahepatic bile ducts in 25 patients and the gallbladder in 5 patients. The overall response rate was 40% (12 of 30 patients), including 1 complete response and 11 partial responses. Stable disease was observed in 12 of 30 patients (40%) and progressive disease in 6 of 30 patients (20%). The median progression-free and overall survival periods were 7.1 and 13.2 months, respectively, and the 1-year and 2-year survival rates were 54% and 20%, respectively. Performance status improved in 9 of 30 patients (30%) and a weight gain of > 7% was observed in 4 of 30 patients (13%). The treatment was well tolerated with minimal hematologic toxicity. The major clinical problem was the deep venous thrombosis related to the central venous catheter, which occurred in 5 patients (17%). CONCLUSIONS: This novel combined locoregional and systemic chemotherapeutic regimen was found to be active and safe for patients with advanced biliary tract carcinoma.

Adenocarcinoma↗
PubMed2003

Hypoxic pelvic and limb perfusion with melphalan and mitomycin C for recurrent limb melanoma: a pilot study.

Hypoxic pelvic and limb perfusion by means of a balloon occlusion technique was evaluated in patients with recurrent melanoma of the lower limbs who were non-responders to isolated hyperthermic limb perfusion or who were not eligible for this procedure. A pilot study was performed in 17 patients, who underwent hypoxic pelvic and limb perfusion with 50 mg/m(2) of melphalan or 50 mg/m(2) of melphalan and 25 mg/m(2) of mitomycin C. Each procedure was followed by haemofiltration. A leakage monitoring study was performed in five of the 17 patients. The response rate and time to disease progression were the primary endpoints, with overall survival as the secondary endpoint. During the procedures there were no technical, haemodynamic or vascular complications, and no deaths occurred during surgery or in the postoperative period. Significant leakage (median 40%) was measured in the five patients studied. No severe systemic or regional toxicity was observed. After one course of treatment, the objective response rate was 47% (95% confidence interval 22.5-71.5%), the median time to disease progression was 10 months (range 2-40 months), and the 3 year overall survival was 20%. Hypoxic pelvic and limb perfusion seems to be a safe and effective treatment for patients with unresectable recurrent limb melanoma who are not eligible for isolated hyperthermic limb perfusion. Due to the non-homogeneity of the study, with some patients receiving a combination of melphalan and mitomycin C and others receiving only melphalan, it is not possible to make definite conclusions with regard to efficacy. Further studies are necessary to establish whether the response rates can be improved by using different drug regimens.

Adult↗
PubMed2002

Deliberate hypoxic pelvic and limb chemoperfusion in the treatment of recurrent melanoma.

BACKGROUND: The treatment of patients with advanced or recurrent pelvic melanoma, which are often associated with lesions in the lower limbs, is still unsatisfactory and controversial. A simplified hypoxic pelvic and limb perfusion has been recently recommended to provide therapeutic options for palliation and possibly cure. METHODS: A nonrandomized and noncontrolled phase II experimental study was performed in 11 patients with symptomatic unresectable recurrent melanoma of the pelvis and limb. Patients were submitted to hypoxic pelvic and limb perfusion with 25 mg/m(2) of melphalan, 50 mg/m(2) of cisplatin, 300 mg/m(2) of dacarbazine, and 75 mg/m(2) of epirubicin by means of a simplified balloon occlusion technique. Response rate and time to disease progression were the primary endpoints; overall survival was the secondary endpoint. RESULTS: During the procedures there were no technical, hemodynamic, or vascular complications, and no deaths occurred during surgery or in the postoperative period. Response rate was 82% (95% confidence interval, 58% to 100%). Median time to disease progression was 12 months (range 9 to 30 months). Three-year overall survival was 34%. CONCLUSIONS: Hypoxic pelvic and limb perfusion is a safe and good palliative treatment for patients with unresectable recurrent melanoma. Further studies are necessary to to confirm these data and to establish if refinements can be made with acceptable toxicity.

Adult↗
PubMedDate not supplied

Irinotecan hepatic arterial infusion chemotherapy for hepatic metastases from colorectal cancer: a phase II clinical study.

AIMS AND BACKGROUND: The advantage of delivering chemotherapy by hepatic arterial infusion is the acquisition of a high concentration of the drug in the target. Irinotecan (CPT-11) is active for the treatment of advanced colorectal cancer. In phase I studies, doses of 20 mg/m2/d for 5 days given every 4 weeks as continuous infusion or 200 mg/m2 as a short 30-min infusion given every 3 weeks is recommended for phase II studies. METHODS AND STUDY DESIGN: Twelve patients with a median liver substitution of 30% (20-50%) were enrolled, 6 progressed after a FOLFOX-induced partial response and 6 progressed after 5-fluorouracil and folinic acid. All patients had a surgically (n = 6) or angiographically placed port (n = 6). They received hepatic arterial infusion chemotherapy with CPT-11 (200 mg/m2) on an out-patient basis, every 3 weeks as a short 30-min infusion for six cycles. RESULTS: Four partial responses were observed (33%) lasting 24, 15, 12 and 8+ weeks, 3 stable disease (25%) lasting more than 12 weeks, and 5 progressions (41%). Six patients (50%) presented a >30% reduction in CEA. Toxicity was G2 diarrhea in 5 patients (41%) and G2 myelosuppression in 6 (50%); one patient had abdominal right upper quadrant pain requiring analgesics. CONCLUSIONS: CPT-11 is active as hepatic arterial infusion chemotherapy in liver metastases from colorectal cancer and can rescue systemically pretreated patients. Our schedule seems safe, feasible and well accepted on an out-patient basis.

Aged↗
PubMedDate not supplied

Selected hypoxic stop-flow perfusions: indication and limits.

AIMS AND BACKGROUND: The treatment of unresectable cancers is still one of the main medical challenges. Stop-flow perfusion has been used as locoregional chemotherapy based on blood supply blockage of the tumor-bearing area. The aim of the present paper is to report our personal experience in the clinical use of hypoxic stop-flow perfusion and discuss future prospects for research. METHODS AND STUDY DESIGN: Since December 1997 more than 500 stop-flow perfusions have been performed at the University of L'Aquila. Hypoxic perfusion was adopted for the following indications: recurrent rectal cancer, advanced pancreatic cancer, recurrent pelvic and limb melanoma, and recurrent limb melanoma. RESULTS: For recurrent rectal cancer median survival was 12.2 months, for advanced pancreatic cancer 9.6 months, for recurrent pelvic and limb melanoma 34.4 months, and for recurrent limb melanoma 23.8 months. CONCLUSIONS: Based on these encouraging results, stop-flow perfusion should be considered an effective treatment. Future fields of research include tailored chemotherapy and hyperthermia.

Antineoplastic Combined Chemotherapy Protocols↗
PubMedDate not supplied

High-dose chemotherapy in adult patients with germ cell tumors.

BACKGROUND: Approximately 80% of patients with advanced germ cell tumors (GCTs) can be cured with cisplatin-based chemotherapy. Patients with poor-prognosis disease have a cure rate of only 50%, whereas patients with first relapse have only a 25% chance of prolonged survival and potential cure following standard therapy. High-dose chemotherapy (HDC) is being investigated in patients with GCTs to improve the results of salvage treatment and in first-line setting for poor prognosis disease. METHODS: The authors review the results of the clinical trials that have evaluated the role of HDC in GCT patients. Data were obtained using a computer-assisted MEDLINE search, and meeting abstracts with clinical relevance in this field were hand-searched. Open randomized phase III studies are described and examined. RESULTS: Several phase II studies have shown a possible benefit for patients with recurrent disease, but the preliminary results of a phase III randomized trial did not demonstrate a survival advantage for HDC after three courses of standard-dose chemotherapy in the salvage therapy of patients in whom first-line treatment has failed. Three prospective, randomized trials are evaluating the role of HDC in a first-line setting. CONCLUSIONS: New HDC strategies are emerging, involving new drugs (eg, paclitaxel), intensive induction regimens, and upfront and/or multiple courses of HDC. The evaluation of mature data of randomized trials will better define the role of HDC in this disease.

Adult↗
PubMedDate not supplied

Oxaliplatin hepatic arterial infusion chemotherapy for hepatic metastases from colorectal cancer: a phase I-II clinical study.

Oxaliplatin is a new drug active in the treatment of advanced colorectal cancer. Hepatic arterial infusion chemotherapy is under evaluation because of the high target dose and low general toxicity. Twelve patients with liver metastases from colorectal cancer were enrolled, all pretreated with evidence of progressive disease: three after a partial remission induced by oxaliplatin, folinic acid and 5-FU, three patients after a partial remission induced by irinotecan, folinic acid and 5-FU and six patients after failing a 5-FU and folinic acid regimen. They received hepatic arterial infusion chemotherapy with oxaliplatin as 30-min infusion on an outpatient basis every 3 weeks. Dose-limiting toxicity was observed at 175 mg/m2/cycle and consisted of obliteration of the hepatic artery in one patient, abdominal pain requiring morphine in one patient and severe hypotension requiring plasma expander in a third. Following phase 1, all patients received 150 mg/m2 for six cycles. We reported four cases of partial remission (33%) lasting 24, 15, 12 and 10+ weeks, respectively, 2 stabilisation of disease (17%) lasting more than 12 weeks and six progressions (50%). Six patients (50%) presented CEA reduction of > 30% and five patients (41%) showed an increase of > 8% of body weight. The median survival was 13 months (range 6-19). Oxaliplatin did not present significant toxicity for liver parenchyma and biliary tree. We advise that further studies be undertaken with oxaliplatin 150 mg/m2.

Aged↗
PubMedDate not supplied

Hepatic arterial chemotherapy in combination with systemic chemotherapy compared with hepatic arterial chemotherapy alone for liver metastases from colorectal cancer: results of a multi-centric randomized study.

Hepatic arterial infusion (HAI) chemotherapy is accepted to be an option in patients with non-resectable metastases from colorectal cancer confined to the liver. In a multi-istitutional trial, 76 patients were randomly assigned to receive HAI versus HAI plus systemic bolus 5-fluorouracil and leucovorin. The primary endpoint was survival, followed by response, recurrence and toxicity. Survival was longer for HAI plus systemic chemotherapy (HAI+SYC) than HAI (median, 20 vs. 14 months; p = 0.0033), as were responses (47.5% and 41.7%; p = 0.09) and time to hepatic progression (12 vs. 8 months; p = 0.039). Side effects included haematological toxicity that was mostly mild and reversible in 432 cases. Neutropenia grade 3 occurred in four patients in the HAI+SYC arm and one in the HAI arm. Diarrhoea occurred in 20% and 7% of patients and stomatitis occurred in 18% and 2%, respectively. On the contrary biliary toxicity was significant; twelve patients had evidence of bilirubin elevations of more than 3 mg/dl (six in each arm), and two had asymptomatic arterial biliary-tree fistulae: one in the HAI+SYC arm and one in the HAI arm. Grade 3 elevation in alkaline phosphatase and aminotransferase levels occurred in 26% and 24%, respectively. In conclusion, the combination of HAI+SYC is active and safe showing a clinical advantage with respect to simple HAI, increasing overall survival, response rate and time to progression.

Antimetabolites, Antineoplastic↗
PubMedDate not supplied

A phase II clinical study on relapsed malignant gliomas treated with electro-hyperthermia.

The purpose of this study was to evaluate the activity and toxicity of electro-hyperthermia (ET) on relapsed malignant glioma patients. Twelve patients with histologically diagnosed malignant glioma entered the study. Eight patients had glioblastoma multiforme, two had anaplastic astrocytoma grade III and two had anaplastic oligodendroglioma. All patients were pre-treated with temozolamide-based chemotherapy and radiotherapy. Hyperthermia with short radiofrequency waves of 13.56 MHz was applied using a capacitive coupling technique keeping the skin surface at 20 degrees C. The applied power ranged between 40-150 Watts and the calculated average equivalent temperature in the tumours was above 40 degrees C for more than 90% of the treatment duration. One complete remission and 2 partial remission were achieved, with a response rate of 25%. The median duration of response was 10 months (range 4-32). The median survival of the entire patient population was 9 months, with 25% survival rate at 1 year. ET appears to have some effectiveness in adults with relapsed malignant glioma.

Antineoplastic Agents, Alkylating↗
PubMedDate not supplied

Hepatic arterial chemotherapy with oxaliplatin, folinic acid and 5-fluorouracil in pre-treated patients with liver metastases from colorectal cancer.

BACKGROUND: Hepatic arterial chemotherapy (HAC) is an effective treatment of liver metastases from colorectal cancer (CRC). Phase I and II studies have already shown the feasibility and efficacy of intra-arterial oxaliplatin (OXA). PATIENTS AND METHODS: Twenty-one pre-treated patients with liver metastases who received HAC with OXA/folinic acid (FA)/5-fluorouracil (5-FU) at our Division between March 2000 and November 2003, were clinically examined. Most patients were heavily pre-treated with two or more systemic chemotherapeutic regimes. All patients received a percutaneously implanted catheter into the hepatic artery through femoral or transaxillary access. Treatment was administered every 14 days: OXA 100 mg/m2 as a 12-hour infusion on day 1; FA 100 mg/m2 as a 2-hour infusion on days 2 and 3; 5-FU 2600 mg/m2 as a continuous infusion on days 2 and 3. RESULTS: Grade 3-4 toxicities were: asthenia (2 out of 21), transaminase elevation (2 out of 21) and pain (2 out of 21), nausea and vomiting (1 out of 21), neutropenia (1 out of 21), thrombocytopenia (1 out of 21) and neurotoxicity (1 out of 21). Main dose limiting toxicity was right upper quadrant pain. Response rates were: 5% complete response, 19% partial response, 28% stable disease and 48% progressive disease. Two patients became operable and underwent complete resection of liver disease. The median overall survival was 36.1 months. Two-year and 3-year survival rates were 62% and 52%, respectively. CONCLUSION: This regimen is feasible with low toxicity and with an encouraging overall tumor growth control (52%) in a subset of heavily pre-treated patients. Intra-arterial OXA/FA/5-FU should be considered for the treatment of patients pre-treated with systemic chemotherapies with liver metastases from CRC.

Adult↗
PubMedDate not supplied

Intra-arterial infusion of 5-fluorouracil, leucovorin, epirubicin and carboplatin (FLEC regimen) in unresectable pancreatic cancer: results of a ten-year experience.

UNLABELLED: The final results of a new regimen given intra-arterially for unresectable pancreatic cancer (UPC) are presented. PATIENTS AND METHODS: From January 1994 to January 2006, 5-fluorouracil 1,000 mg/m2, leucovorin 100 mg/m2, epirubicin 60 mg/m2 and carboplatin 300 mg/m2 were administered every 3 weeks into the celiac axis (CA) angiografically (FLEC regimen) to 211 patients with UPC. RESULTS: Seven hundred and sixty-four cycles were administered. Grade 3-4 hematological toxicity was observed in 24%; ematemesis in 4%; grade 3 gastrointestinal toxicity in 3%; grade 3 alopecia in 15%. One sudden death, a pre-infarction angina and a transitory ischemic attack were observed. No complications related to the angiographic procedure took place, but three tunica intima dissections of the iliac artery occurred; 7.6% of patients with partial responses and 50.7% with stable disease were observed. Two hundred and one patients have died; median overall survival was 9.2 months: 10.5 and 6.6 for stage III and IV, respectively. CONCLUSION: The FLEC regimen given intra-arterially is well-tolerated and effective in patients with UPC.

Adenocarcinoma↗
PubMedDate not supplied

Intra-arterial chemotherapy: a safe treatment for elderly patients with locally advanced breast cancer.

UNLABELLED: The feasibility, toxicity and local response rates of intra-arterial chemotherapy with 5-fluorouracil, epirubicin and mitomycin in patients over 75 years with locally advanced breast cancer was evaluated. PATIENTS AND METHODS: Ten patients were treated by the transfemoral Seldinger technique, with the catheter tip placed into the internal mammary artery. In order to evaluate the vessels perfusing the tumor, blue dye solution was infused before drug administration. The patients received 5-fluorouracil 750 mg/m2, epirubicin 30 mg/m2 and mitomycin 7 mg/m2 by bolus infusion. RESULTS: All patients were evaluated for toxicity and response. Twenty-two cycles were administered. The toxicity was mild and did not influence the patients' quality of life; the compliance was excellent. A response rate of 80% (8 out of 10) was obtained; the median overall survival was 33.5 months; no patient had local recurrence. CONCLUSION: Intra-arterial chemotherapy is an effective and safe treatment for locally advanced breast cancer in the elderly.

Aged↗