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Biomedical subjects

A Vigani

Publications and source records attributed to A Vigani.

At least 19 recordsLinked to original sources
PubMed2002

A dose finding study of carboplatin and gemcitabine in advanced non-small cell lung cancer.

The excellent activity of the cisplatin-gemcitabine combination and favorable toxicological profile of carboplatin are the basis of carboplatin-gemcitabine combination therapy for non-small cell lung cancer. We carried out a dose-finding study with the aim of establishing the maximum tolerated dose (MTD) of carboplatin on day 1 in combination with gemcitabine at the dose of 1000 mg/m2 on days 1 and 8 in a 21-day cycle. The starting dose level for carboplatin was the area under the concentration time curve (AUC) 4 mg/ml/min. 18 patients were treated and a dose limiting toxicity was observed in 2 cases at the level of AUC 6 mg/ml/min. AUC 5 mg/ml/min was considered as the MTD for carboplatin in our regimen. Notably, 7 objective responses were observed.

Aged↗
PubMed2001

Anthracyclines in non-small cell lung cancer.

The literature concerning the use of anthracyclines in the treatment of non-small cell lung cancer (NSCLC) is reviewed here. Overall, the activity of doxorubicin (DOXO) is unsatisfactory, whereas, the analogous epidoxorubicin (EPI) yields a 30% response rate (RR) when administered at intermediate-high doses. All active drugs, including EPI, should be considered to design the most active combination. Mainly, in the setting, in which an objective response is very important, for instance the neo-adjuvant pre-operatory setting.

Antibiotics, Antineoplastic↗
PubMed2001

A three-drug regimen (gemcitabine, ifosfamide and cisplatin) for advanced non-small-cell lung cancer.

We have carried out a pilot study on 25 non-small cell lung cancer patients, administering the combination of gemcitabine at the dose of 1000 mg/m2 on days 1 and 8, ifosfamide 1500 mg/m2 on days 1 and 2 (plus mesna as uroprotector) and cisplatin 40 mg/m2 on days 1 and 2, every 21 days. Granulocyte Colony Stimulating Factor was employed in all cases from day 10 to day 18 at the dose of 300 microg daily. An objective response was observed in 11 cases (44%). The regimen was active, but toxicity was remarkable with some cases of severe myelosuppression and mucositis.

Aged↗
PubMed1999

A phase II study of a three-drug combination (cisplatin, ifosfamide and vinorelbine) plus granulocyte-colony stimulating factor in advanced non small cell lung cancer.

Twenty-nine patients with advanced non-small-cell lung cancer (NSCLC) were treated with a combination of cisplatin 20 mg/m2 days 1-3, ifosfamide 1500 mg/m2 days 1-2 (plus mesna as uroprotector) and vinorelbine 25 mg/m2 days 1 and 5; filgrastim was given at the dose of 300 microg subcutaneously from day 8 to day 15. A response rate of 28% was observed. The activity of this combination in an outpatient setting, with acceptable toxicity, has been demonstrated.

Adult↗
PubMed1998

A phase II trial of carboplatin, methotrexate and fluorouracil in fluorouracil-pretreated colorectal cancer.

5-Fluorouracil and leucovorin combination is the most commonly applied chemotherapy treatment for colorectal cancer patients, both in the adjuvant setting and for advanced disease. Patients resistant or refractory to the 5-fluorouracil-leucovorin combination have been treated in this phase II trial with carboplatin plus methotrexate and fluorouracil in sequence. Twenty patients with measurable lesions from advanced colorectal cancer were entered in the trial. The treatment plan was carboplatin 300 mg/m2 day 1, methotrexate 40 mg/m2 day 1, fluorouracil 600 mg/m2 day 2, every 21 days. Two patients with liver metastasis had a partial response. Median survival was 12 months (range 4-24). Toxicity was acceptable and no patient had to be hospitalized because of the treatment. In this set of patients activity of the new combination is marginal.

Aged↗
PubMed1998

A dose finding study for the combination of epidoxorubicin and vinorelbine, delivered every two weeks with G-CSF support, in advanced breast cancer.

The aim of this study was to find the maximum tolerated dose of epidoxorubicin as part of a regimen with vinorelbine at the dose of 25 mg/m2 on days 1 and 5, every 2 weeks in patients with advanced breast cancer. The optimal dose intensity of the two drugs was supported by administration of granulocyte colony stimulating factor (G-CSF) on days 7-12. Patients were treated with epidoxorubicin at three different dose levels (50-65-80 mg/m2 on day 1 of each cycle). No dose limiting toxicity was observed in the first three patients (treated at the dose of 50 mg/m2). We observed one case of dose limiting toxicity out of the 6 patients treated with 65 mg/m2 and 3/3 cases among patients treated with 80 mg/m2. We conclude that 65 mg/m2 is the maximum tolerated dose of epidoxorubicin in this regimen, which is also able to maintain adequate dose intensities.

Adult↗
PubMed1997

Combined cisplatin, doxorubicin, and mitomycin for the treatment of advanced pleural mesothelioma: a phase II FONICAP trial. Italian Lung Cancer Task Force.

BACKGROUND: In a previous FONICAP trial, the combination of doxorubicin (D) and cisplatin (P) yielded an objective response rate of 25% and a subjective response rate of 50% in patients with mesothelioma. In human mesothelioma cell lines, mitomycin (M) showed a synergic activity with P and in a recent randomized study, the combination of M and P showed slightly superior activity when compared with the PD regimen. METHODS: The authors tested the activity and toxicity of a combination chemotherapy regimen including P, 60 mg/m2, D, 60 mg/m2, and M, 10 mg/m2, all by intravenous infusion on Day 1 every 28 days in a Phase II study. RESULTS: Twenty-four chemotherapy-naive mesothelioma patients were enrolled in the study. Patient characteristics were the following: the median age was 58 years; the median performance status was 1; there were 6 Stage I patients, 15 Stage II patients, 2 Stage III patients, and 1 Stage IV patient; and 10 patients had previous asbestos exposure. All patients had pretreatment symptoms: 13 had chest pain, 9 had pleural effusion, and 7 had dyspnea. A total of 78 cycles of chemotherapy were administered. The only significant side effect was myelosuppression, with only 9.5% of patients having Grade 4 toxicity. Among 23 patients evaluable for response, 5 achieved a partial response (20.8%; 95% confidence interval, 7.1-42.1%), 9 had stable disease, and 9 had progressive disease (including 1 early death). One patient was not evaluable because of treatment refusal. A clinical improvement was observed in 7 of 24 patients (29%). CONCLUSIONS: The combination of PDM in patients with pleural mesothelioma is feasible and moderately active. However, the observed level of activity is similar to that obtained with other two-drug regimens.

Adult↗
PubMed1997

Phase II study of vinorelbine and ifosfamide in anthracycline resistant metastatic breast cancer.

The new combination of ifosfamide and vinorelbine was evaluated in a phase II study of patients with metastatic breast cancer. All the patients had evaluable or measurable lesions resistant to the combination of cyclophosphamide, epidoxorubicin and 5-fluorouracil. Out of 25 patients entered the trial, 7 achieved an objective response (28%) (95% C.I. 12-49.3). Ten patients (40%) experienced stable disease and the remaining patients (30%) progressive disease. The median time to progression was 4 months (range 2-12+). The activity of the ifosfamide-vinorelbine combination has been demonstrated and the toxicity was acceptable.

Adult↗
PubMed1997

Second line chemotherapy with ifosfamide as outpatient treatment for advanced bladder cancer.

We have carried out a phase II study in advanced or metastatic transitional cell carcinoma of the bladder. Eligible patients had unresectable bladder cancer, previously treated with one line of systemic chemotherapy. Treatment consisted of ifosfamide 1000 mg/sm in a 2-hour infusion for 5 consecutive days from d.1 to d.5. Mesna was administered intravenously at a 20% of the ifosfamide dosage before ifosfamide and orally at 40% after 4 and 8 hours from the ifosfamide infusion. Twenty patients entered the study and received a total of 62 cycles: the treatment resulted feasible on an outpatient basis, with mild toxicity. Only one partial response was observed. With this dose and schedule, ifosfamide appeared less effective than in a previous report at higher doses. Toxicity was acceptable.

Administration, Oral↗
PubMed1996

Tamoxifen and interferon-beta for the treatment of metastatic breast cancer.

It has been demonstrated, both in breast cancer cell lines and in metastatic breast cancer patients with cutaneous lesions that could be biopsied, that treatment with interferon beta (IFN-B) can increase expression of both estrogen (ER) and progesterone receptors (PgR). To evaluate the efficacy and toxicity of the combination of IFN and tamoxifen, 33 metastatic breast cancer patients were treated with the following regimen: IFN-B, 6.0 million units intramuscularly IU 3 times a week for two consecutive weeks followed by IFN-B 6.0 million IU im 3 times a week with concomitant tamoxifen 20 mg orally daily. Patients were pre and postmenopausal with median age of 60 years, median ECOG PS of 0, either ER positive or unknown, and had not received prior hormone therapy for metastatic disease. Overall objective response was observed in 9 (27%) patients. Complete response was observed in 2 cases and partial response in 7 patients. Median duration of response was 7 months (range 2-10). A higher response rate was observed in patients with predominantly soft tissue disease (38%) compared to patients with either dominant bone (18%) or visceral lesions (17%). Toxicity was mild and reversible: low grade fever in 30% of patients and flu-like symptoms in 9% of cases. It appears that IFN-B does not improve the efficacy of tamoxifen in an unselected population of metastatic breast cancer.

Abdominal Neoplasms↗
PubMed1996

Carboplatin and vinorelbine in advanced non-small-cell lung cancer.

A total of 32 patients with advanced non-small-cell lung cancer were treated with carboplatin (350 mg/m2, day 1) and vinorelbine (days 1 and 8) every 28 days. A response rate of 28% (95% confidence limits 12.5 - 43.7%) was observed. The activity of this combination was demonstrated in an outpatient setting with acceptable toxicity.

Adult↗
PubMed1996

A feasibility study of accelerated polychemotherapy with cisplatin, epidoxorubicin and cyclophosphamide (PEC) in advanced ovarian cancer.

We have evaluated the feasibility of an increase in dose intensity of the cisplatin, epidoxorubicin and cyclophosphamide (PEC) regimen, with granulocyte colony-stimulating factor (G-CSF) support, in 22 patients with advanced ovarian cancer. Twenty-one patients (95.4%) received six cycles of treatment: of these, 13 (61.9%) were also able to repeat cycles every 14 days as planned. Marrow toxicity was similar to that observed during conventional treatments. No severe mucositis or thrombocytopenia was observed. A clinical complete response was observed in 9 out of 16 evaluable patients (56.2%).

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1995

Carboplatin, methotrexate, and vinblastine in outpatients with advanced transitional cell carcinoma of the bladder.

Twenty outpatients with locally advanced (inoperable) or metastatic transitional cell carcinomas of the bladder were treated with carboplatin (300 mg/m2 i.v., day 1) + methotrexate (40 mg/m2 days 1 and 8) + vinblastine (6 mg/m2 days 1 and 8) (CaMV), every 4 weeks. One patient died of disease progression before completing at least 2 cycles of chemotherapy. Seven patients (35%) obtained a partial response; 8 had disease stabilization (40%) and 4 progressed (20%). Median duration of response was 3 months (range: 3-9), and median overall survival was 12+ months (range: 1-18+). None of the patients suffered grade IV toxicities, and no nephro-, neuro-, or ototoxicity was observed.

Aged↗
PubMed1995

Randomized cooperative study of perioperative chemotherapy in breast cancer.

PURPOSE: The aim of this multicentric randomized trial was to determine whether reducing the interval between surgery and chemotherapy improves the outcome of breast cancer patients. PATIENTS AND METHODS: Between June 1985 and July 1992, 600 breast cancer patients, clinical stages T1-3A,N0-2,M0 were randomly assigned to a perioperative cycle (PC) of cyclophosphamide 600 mg/m2, epidoxorubicin 60 mg/m2, and fluorouracil 600 mg/m2 (CEF). Node-negative (N-) patients did not receive any further treatment. Node positive (N+) patients received 11 cycles if previously given PC, or 12 cycles of CEF alternated with cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2 (CMF). In addition, N+ patients received concomitant or sequential 5-year tamoxifen therapy. RESULTS: At a median follow-up duration of 5.7 years, no significant difference in survival (88% v 84%, P = .3) between the two treatment arms was seen. However, a difference of borderline significance in relapse-free survival (RFS; 76% v 70%, P = .053) was evident. A significant survival advantage for the PC arm was detected only in the estrogen receptor-negative (ER-) patients (P = .003). RFS was significantly improved in N- patients, postmenopausal patients, and ER- patients. Multivariate analyses show that pathologic tumor size, nodal status, receptor status, and treatment (only in ER- patients) are significantly correlated with survival and RFS. PC toxicity did not influence wound healing. CONCLUSION: This study provides preliminary evidence that PC positively affects relapse rate and survival in some subgroups, namely, ER- patients.

Adult↗
PubMed1991

Effect of recombinant human tumor necrosis factor on A2774 human ovarian cancer cell line: potentiation of mitoxantrone cytotoxicity.

Recombinant human tumor necrosis factor (rHuTNF) is a macrophage-secretory protein with antitumor activity. In vivo and in vitro cytotoxicity studies have been carried out to test the effectiveness of rHuTNF alone or in combination with chemotherapeutic agents. We have evaluated the direct cytotoxic effect of rHuTNF on a human epithelial ovarian cancer cell line in vitro (A2774), alone, or in combination with mitoxantrone (Mit), a topoisomerase II (Topo II) targeted drug. Our results not only suggest that rHuTNF is directly cytotoxic, but also that it is able to induce a very strong potentiation of Mit cytotoxicity.

Dose-Response Relationship, Drug↗
PubMed1990

8-methoxycaffeine-induced protein-associated DNA breaks in isolated L1210 cell nuclei.

8-methoxycaffeine (8-MOC) is a caffeine derivative more potent than its parental compound in inducing chromosomal aberrations. 8-MOC has been postulated to produce chromosomal aberrations by DNA topoisomerase II inhibition. The effect of 8-MOC on nuclear DNA were studied by alkaline elution experiments and compared with those of Ellipticine and Adriamycin (ADR). Like Ellipticine and ADR, 8-MOC induced single strand breaks (SSBs), double strand breaks (DSBs), and DNA-protein cross-links (DPCs) in a bell-shaped manner with respect to drug concentration. As in the case of ADR and Ellipticine, 8-MOC induced equal SSB and DPC frequencies. These results could suggest that 8-MOC induces DNA breaks by interacting with DNA topoisomerase II or with a similar DNA metabolism enzyme.

Animals↗
PubMed1990

[Use of reconstituted basal membranes for the study of invasion of human tumor cells: current status and future prospects].

Tumor metastasis is the major cause of death of oncology patients. One of the characteristic properties acquired by the metastatic cell is the ability to cross basement membranes. These are compartments of extracellular matrix composed largely by collagen type IV, laminin and a heparan sulphate proteoglycan. Here we review the use of a reconstituted basement membrane (Matrigel) in the Boyden chamber assay (Chemoinvasion Assay) for the assessment of the invasiveness of tumor cells of human origin. The possibility of using this test for the rapid evaluation of human tumor specimens from operated patients is discussed.

Basement Membrane↗