Biomedical subjects

Luciane Di Leone

Publications and source records attributed to Luciane Di Leone.

3 recordsLinked to original sources

PubMed2004

Outcome of pediatric recurrent and refractory malignant solid tumors following ifosfamide/carboplatin/etoposide (ICE): A phase II study in a pediatric oncology centre in Brazil.

BACKGROUND: Therapeutic trials using ifosfamide,carboplatin, and etoposide (ICE) regimen have suggested many patients with refractory/relapsed solid tumors may be rendered free of disease using this combination. The aim of this study was to assess the feasibility, response and toxicity of this regimen in a Brazilian Pediatric Oncology Centre. PROCEDURE: ICE, consisting of ifosfamide 3 g/m(2)/day x3 plus Mesna, etoposide 160 mg/m(2)/day x3, and carboplatin 400 mg/m(2)/day x2 was given at 21-28 days intervals. G-CSF was used for patients with hematological recovery greater than 4 weeks. RESULTS: Twenty-one patients younger than 18 years of age treated with this regimen were studied between July 1996 and November 2000. A total of 93 courses of ICE were administered. Leucopenia/neutropenia grades 3/4 were the most frequent severe adverse effects (82%). Grade 3/4 thrombocytopenia occurred in 73% of cycles, and anemia was common (61%). The most common grade 3/4 non-hematologic toxicities were fever and proved infection occurring in 25% and 14% of the courses, respectively. Two patients developed renal tubular damage. Other less common grade 3/4 non-hematologic toxicities included nausea and vomiting, hepatotoxicity, and stomatitis. The overall response rate (complete response/partial response) was 53%. The median progression-free interval was 15.3 months, with a median survival of 24.2 months. CONCLUSIONS: Although ICE was associated with severe myelosuppression it produced objective response in about half of the cases. The most important non-hematological toxicity was severe renal tubular damage. This regimen should only be used whenever hematological and infectious supportive care is available.

Adolescent↗

PubMed2002

Clinical and pharmacokinetic study of fractionated doses of oral etoposide in pediatric patients with advanced malignancies.

BACKGROUND: The purpose of this phase I study was to evaluate the toxicity profile, dose-limiting toxicities (DLT), maximum tolerated dose (MTD), and plasma pharmacokinetics of oral etoposide, and to recommend a safe fractionated dose for phase II trials in pediatric patients with refractory solid tumors. MATERIAL/METHODS: All patients had tumors no longer amenable to established forms of treatment. The initial dose of etoposide was 20 mg/m(2) TID for 14 days every 21 days (dose-level I). Etoposide plasma pharmacokinetics were studied on day 1 of treatment and determined by HPLC. RESULTS: Seventeen children were enrolled, 13 of whom were included in the pharmacokinetic study, for a total of 64 courses. Nine patients were included at dose-level I; grade 2-3 leucopenia was observed in 5. The dose was then raised to 25 mg/m(2) (dose-level II) in another 8 patients; grade 3-4 leucopenia was observed in 4. This dose-level was therefore considered the MTD. The DLT was neutropenia. In patients at dose-level I and II the maximum plasma etoposide concentration was 2.97 and 8.59 mg/ml, respectively. Drug levels > 1 microg/ml were maintained for about 6.3 hours following drug administration at both dose-levels. Partial response was observed in 1 patient and 4 patients showed stable disease. CONCLUSIONS: Prolonged oral etoposide was well tolerated by our patients. Considering the MTD, and the fact that the patients included at dose-level I achieved an adequate (>1 microg/ml) plasma concentration of etoposide for a sufficient time, this dose level was recommended for phase II studies in pediatric malignancies.

Administration, Oral↗

PubMedDate not supplied

[Clinical features in osteosarcoma and prognostic implications].

OBJECTIVE: To identify the clinical features in osteosarcoma and to investigate their influence on the prognosis of children and adolescents presenting this disease. MATERIAL AND METHODS: The records of children and adolescents with osteosarcoma treated by the Bone Tumors Group of the state of Rio Grande do Sul, Brazil, between January 1992 and December 2001 were reviewed. RESULTS: Fifty consecutive patients were included in this study. Mean age at diagnosis was 13 years (3-22); 68% of the patients were males. The primary site of disease was the femur in 50% of the patients, tibia in 30%, pelvis in 4%, humerus in 10%, fibula in 2% and other sites in 4%. Nineteen patients presented metastases at diagnosis (38%). All patients received chemotherapy and were treated with three different schemes. As for surgical treatment, 26 patients (52%) had an amputation and 17 (34%) received conservative surgery. Serum lactic dehydrogenase > 1,000 UI/ml (p = 0.0159, log rank), tumor necrosis < 90% and presence of metastases had a negative influence on prognosis. The overall 5-year survival was of 33.2+/-7.2% with mean follow-up of 36 months (6-126). Event-free survival was 29.7+/-7%. The 5-year event-free survival in non-metastatic patients was 45+/-10.7%, and zero in metastatic patients (follow-up of 78.4 and 18.7 months, respectively). Only two out of 19 metastatic patients are alive and free of disease at 18 and 30 months respectively. CONCLUSION: Metastatic disease at diagnosis, serum levels of serum lactic dehydrogenase > 1,000 UI/ml and tumor necrosis < 90% are predictors of unfavorable prognosis. The excessively high incidence of metastatic patients may suggest the presence of an aggressive pattern of disease in our population, or may indicate late diagnosis.

Adolescent↗