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Biomedical subjects

L Gandola

Publications and source records attributed to L Gandola.

At least 19 recordsLinked to original sources
PubMed2006

A case of relapsing glioblastoma multiforme responding to vinorelbine.

Childhood malignant gliomas are rare and their clinical behavior is almost as aggressive as in adults: they resist treatment, progress rapidly and often spread. Therapeutic strategies at relapse deserve an experimental approach, since none of the conventional-dose treatments have demonstrated a clear superiority over the others and no randomized trials have proved that high-dose chemotherapy is better than conventional treatment. Vinorelbine is a semi-synthetic vinca alkaloid with an in vitro and in vivo experimentally proven broad spectrum of activity, including against malignant brain glioma. We report our experience with a 19-year-old girl with glioblastoma multiforme (GBM) of the deep temporal region recurring 6 months after completing an intensive treatment that included preradiation chemotherapy (chemotherapy as a preradiation "sandwich" phase) with a myeloablative course of thiotepa, tumor bed radiotherapy and postradiation maintenance chemotherapy. The GBM proved fully responsive to intravenous vinorelbine, with a subsequent progression-free interval lasting more than 24 months. This case report suggests that vinorelbine is effective against high-grade pediatric glioma and, since this evidence has only one precedent in the literature (and given the generally poor prognosis for this tumor), even this single success seems worth reporting.

Adult↗
PubMed2006

Transitory, spontaneously recovering, peripheral facial nerve palsy after vinorelbine administration.

Childhood intrinsic brain-stem gliomas have a dismal prognosis. Different treatment strategies have been adopted over the years without changing the final outcome of this ominous disease. Due to this grim prognosis, experimental therapeutic designs are worthwhile. Vinorelbine is a semi-synthetic vinca alkaloid that has demonstrated a broad spectrum of activity both in in vitro and in vivo experimental systems. By adopting vinorelbine during and after focal radiotherapy in the last two years, we have tried to evocate its known synergistic effect in brain-stem tumour control. Vinorelbine was administered intravenously before, during and after radiotherapy on tumour bed for a total duration of 10 months. All the consecutive patients whose clinical and radiological features corresponded to the diagnosis of an intrinsic brain-stem tumour, i.e., diffuse pontine glioma, have been accrued to this treatment protocol since July 2002. A histological assessment was not required. All patients were treated during hospital stay or in the outpatient clinic at the Istituto Nazionale Tumori of Milan (n=12) and at the Pediatric Clinic of Policlinico in Catania (n=1). Two of the thirteen patients so far treated have developed multiple subsequent, and transitory, episodes of monolateral peripheral facial nerve palsy during vinorelbine administration. The palsy always completely and spontaneously resolved at a short interval-around 30 min-after the end of the drug infusion. Obvious tumour progression was excluded by means of MRI; therefore the drug was administered as scheduled until the end of the treatment. We describe possible neurological and oncological implications of this unusual side effect, until now not reported in any other series dealing with vinorelbine as adjuvant treatment.

Bell Palsy↗
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↗
PubMed2002

Intrathecal methotrexate affects cognitive function in children with medulloblastoma.

BACKGROUND: Cognitive impairment occurs after malignant brain tumor treatment in children, following brain radiotherapy and systemic and intrathecal chemotherapy. OBJECTIVES: 1) To compare two groups of children who underwent surgery for cerebellar medulloblastoma with their cousins and siblings, assessing intelligence, executive function, attention, visual perception, and short-term memory. Both groups were treated with the same combined radiotherapy-chemotherapy, but differed in that only one group received intrathecal methotrexate (MTX+). 2) To relate these measures to MRI findings (leukomalacia). RESULTS: The two groups performed worse than their control subjects in all tests. The MTX+ group younger than 10 years performed significantly worse in all tests, particularly executive ones. The group older than 10 years performed significantly worse only in short-term memory. Younger patients without MTX performed significantly worse than controls only in some neuropsychological measures; there were no differences between older patients and control subjects. Only in the MTX+ group was there a direct correlation between extent of leukomalacia and performance in some tests. CONCLUSIONS: The administration of intrathecal methotrexate to children with medulloblastoma worsens the cognitive deficits induced by chemotherapy and radiotherapy. The use of intrathecal methotrexate in the treatment of medulloblastoma and other malignancies should be reassessed.

Adolescent↗
PubMed2002

The inflammatory marker serum eosinophil cationic protein (ECP) compared with PEF as a tool to decide inhaled corticosteroid dose in asthmatic patients.

The objective of this study was to compare the inflammatory marker eosinophil cationic protein (ECP) with peak expiratory flow (PEF) in determining the therapeutic needs of inhaled corticosteroids in asthma patients assessed as asthma symptoms. A randomized, single-blind study over 6 months was performed at six specialist centres in Europe. In total, 164 adult patients with moderate to severe symptomatic asthma and regular use of inhaled corticosteroids were included. After a run-in period of 2 weeks patients were randomly allocated to the ECP or the PEF monitoring group. The dose of inhaled cort costeroids was adjusted every fourth week based on the current serum ECP value or pre-bronchodilator morning PEF values as surrogate markers of therapeutic needs. At the end of the study there were no statistically significant differences in the mean daily symptom score or the percentage of symptom-free days between the two groups. The mean daily dose of inhaled corticosteroids was similar in the two groups at the start of the study but the algorithms used to adjust the dose of inhaled corticosteroids resulted in an increased use of inhaled corticosteroids in both groups. The mean daily dose of inhaled corticosteroids over the whole study period was significantly lower in the ECP group compared withthe PEF group (1246 vs. 1667 microg, P = 0.026). In the ECP group, forced expiratory volume in I sec (FEV)% predicted was lower at the end ofthe study compared with the begining (92% vs. 87%, P = 0 .0009), although there was no significant difference between the two groups. None of the used algorithms for ECP and PEF led to improvement in symptom scores, in spite of increased doses of inhaled corticosteroids. In this respect, both methods were equivalent and insufficient. Recommendations suggesting lung function tests in current guidelines may be difficult to translate into clinical practice, however, a combination of inflammatory markers, lung function and symptoms may still improve asthma control.

Administration, Inhalation↗
PubMed2001

Undifferentiated nasopharyngeal carcinoma in children and adolescents: comparison between staging systems.

BACKGROUND: New criteria for classifying nasopharyngeal carcinoma were defined in the 5th edition of the American Joint Committee on Cancer (AJCC) staging manual. We investigated the clinical implications of the new system by comparing it with the 4th edition in a cohort of pediatric undifferentiated nasopharyngeal carcinoma (UNPC). PATIENTS AND METHODS: We retrospectively restaged 54 patients younger than 17 years who had biopsy-proven UNPC, treated between 1965 and 1999 in a single institution. RESULTS: Using the 5th edition an overall downstaging of the population according to T status, N status, and stage grouping was evident along with a better correlation with likelihood of survival. The comparison between local and advanced disease according to T stage (T1+T2 vs. T3+T4) became highly significant in the new system (P = 0.0011 vs. P = 0.067 in the 4th edition). CONCLUSIONS: As far as prognostic categories are concerned, the 5th edition of the AJCC staging manual appears to be an improvement over the previous classification, even though for pediatric patients a uniform distribution among stages cannot be observed because most children present with advanced disease. The overall downstaging should be taken into consideration for the stratification of patients in future trials.

Adolescent↗
PubMed2001

Effects of recombinant human granulocyte-macrophage colony-stimulating factor in an intensive treatment program for children with Ewing's sarcoma.

BACKGROUND AND OBJECTIVES: A treatment program including polychemotherapy at progressively escalating doses and sequential hemi-body irradiation (HBI) was adopted between 1987-1994 at our Pediatric Unit for high risk Ewing's sarcoma. Granulocyte-macrophage colony-stimulating factor (GM-CSF) was added to the treatment program in a phase II study fashion to evaluate, in a pediatric setting, its tolerability, as well as its impact on drug dose escalation and on the need for supportive care. DESIGN AND METHODS: The study was open-label and sequential; GM-CSF administration (5 microg/Kg s.c./d x10) was planned after each chemotherapy cycle and after each HBI session in 18 consecutive patients (group A). Thirty-eight additional patients (group B) were treated by the same therapeutic program, without GM-CSF. In 12 patients (6 in each group) long-term bone marrow cultures (LTBMC) were performed to evaluate the myeloproliferative potential throughout the chemotherapeutic program. RESULTS: Seven of 18 (39%) patients experienced side effects from GM-CSF; 3/7 discontinued GM-CSF due to anaphylactic symptoms. The degree of neutropenia, as well as the frequency of infectious episodes and the need for supportive care were significantly lower in group A than in group B. Iatrogenic thrombocytopenia, and the possibility of performing drug-dose escalation were similar in the two groups. The 5-year event-free survival probabilities for group A and B were similar. LTBMC showed that the chemotherapy-related depletion of myeloid precursors could be more pronounced in patients receiving GM-CSF cyclically. INTERPRETATION AND CONCLUSIONS: In this series, GM-CSF was shown to be effective on iatrogenic neutropenia and related complications, with no impact on thrombopoiesis, drug dose escalation and outcome.

Adolescent↗
PubMed2000

Successful in vivo purging of CD34-containing peripheral blood harvests in mantle cell and indolent lymphoma: evidence for a role of both chemotherapy and rituximab infusion.

Elimination of tumor cells ("purging") from hematopoietic stem cell products is a major goal of bone marrow-supported high-dose cancer chemotherapy. We developed an in vivo purging method capable of providing tumor-free stem cell products from most patients with mantle cell or follicular lymphoma and bone marrow involvement. In a prospective study, 15 patients with CD20(+) mantle cell or follicular lymphoma, bone marrow involvement, and polymerase chain reaction (PCR)-detectable molecular rearrangement received 2 cycles of intensive chemotherapy, each of which was followed by infusion of a growth factor and 2 doses of the anti-CD20 monoclonal antibody rituximab. The role of rituximab was established by comparison with 10 control patients prospectively treated with an identical chemotherapy regimen but no rituximab. The CD34(+) cells harvested from the patients who received both chemotherapy and rituximab were PCR-negative in 93% of cases (versus 40% of controls; P =.007). Aside from providing PCR-negative harvests, the chemoimmunotherapy treatment produced complete clinical and molecular remission in all 14 evaluable patients, including all 6 with mantle cell lymphoma (versus 70% of controls). In vivo purging of hematopoietic progenitor cells can be successfully accomplished in most patients with CD20(+) lymphoma, including mantle cell lymphoma. The results depended on the activity of both chemotherapy and rituximab infusion and provide the proof of principle that in vivo purging is feasible and possibly superior to currently available ex vivo techniques. The high short-term complete-response rate observed suggests the presence of a more-than-additive antilymphoma effect of the chemoimmunotherapy combination used.

Adult↗
PubMed2000

Management of medulloblastoma and ependymoma in infants: a single-institution long-term retrospective report.

To reduce the sequelae from CNS irradiation (RT), 16 children younger than 3 years with medulloblastoma-PNET (13 cases) and ependymoma (3 cases) were treated between 1987-1993 according to different postsurgical chemotherapy (CT) programs. None of these patients presented with metastases. Eleven patients were rendered disease-free by surgery, while 5 had residual tumor. Adjuvant therapy depended on patients' age, postsurgical status and parents' consent to radiotherapy (RT). Nine of the 16 infants remained alive in continuous complete remission from the first neoplasm (median follow-up 7 years). Three of them had been treated with CT alone and 6 with combined CT + RT (posterior fossa 4, whole CNS 2). Seven patients relapsed a median of 13 months after diagnosis, and all 7 of them died of their disease. Despite the omission of RT in 6 of the 16 patients and administration of only focal RT in 8 of the 16, the outcome of this series was satisfactory. Local failure (in 5/7 patients) was the major problem, despite the high dose of RT used in 2 of these 5. In 4 of 6 evaluable children school performance was satisfactory. One child in whom the entire CNS was irradiated developed glioblastoma multiforme 120 months after the first diagnosis of medulloblastoma.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1998

Haemodynamic response during initiation of non-invasive positive pressure ventilation in COPD patients with acute ventilatory failure.

The aim of this study was to check non-invasively the acute haemodynamic effects of non-invasive positive pressure ventilation (NPPV) initiation in patients with chronic obstructive pulmonary disease (COPD) and acute ventilatory failure (AVF). Nineteen consecutive COPD patients with AVF were evaluated clinically and echocardiographically during spontaneous breathing with O2 supplementation and during NPPV plus O2. NPPV was administered with a scheduled inspiratory pressure of 15 cmH2O and an expiratory pressure of 4 cmH2O, via facial mask. Arterial blood gas improved significantly (pH and PaCO2; P < 0.001) during NPPV administration in all patients; none had hypotension or acute arrhythmia. Doppler echocardiographic evaluation was feasible in most of the patients (16/18). With reference to baseline values, no significant changes in pulmonary artery pressures and cardiac output (CO) were observed by Doppler echocardiography in most patients. Only four patients (21%) showed a significant reduction (> 15%) of CO during NPPV. No correlation was found between decreased CO and baseline data, but three patients showing CO reduction had poor tolerance to mask ventilation and did not improve respiratory rate during NPPV. It was concluded that the initiation of NPPV by facial mask does not alter haemodynamics acutely in most COPD patients with AVF, but individual patients may experience reduction in CO in spite of adequate oxygen saturation levels. This suggests that caution should be used when applying pre-determined and fixed pressures during NPPV. Monitoring haemodynamics by Doppler echocardiography may be useful for early detection of haemodynamic alterations due to NPPV application in patients with AVF.

Aged↗
PubMed1998

Inhaled corticosteroids reduce neutrophilic bronchial inflammation in patients with chronic obstructive pulmonary disease.

BACKGROUND: Airways inflammation is a feature of chronic obstructive pulmonary disease (COPD), but the role of corticosteroids in the management of clinically stable patients has yet to be established. A randomised controlled study was carried out to investigate the effect of high dose inhaled beclomethasone dipropionate (BDP) administered for two months to patients with stable, smoking related COPD. Sputum induction was used to evaluate bronchial inflammation response. METHODS: 34 patients (20 men and 14 women) were examined on three separate occasions. At the initial clinical assessment (visit 0), spirometry and blood gas analysis were performed. On visit 1 (within one week of visit 0) sputum induction was performed and each patient was randomised to receive either BDP 500 micrograms three times daily (treated group) or nothing (control group). After two months (visit 2), all patients underwent repeat clinical assessment, spirometry, and sputum induction. RESULTS: There were no differences in sputum cell counts between the groups at baseline. After two months of treatment, induced sputum samples from patients in the treated group showed a reduction in both neutrophils (-27%) and total cells (-42%) with respect to baseline, while the control group did not (neutrophils +9%, total cells +7%). Macrophages increased in the treated group but not in the control group. The mean final value of sputum neutrophils was 52% in the treated group and 73.3% in the control group (95% confidence interval (CI) -27.2 to -15.4). The mean final value of sputum macrophages was 35.8% in treated group and 19.3% in control group (95% CI 10.3 to 22.8). The differences between the treated and control groups for neutrophils (-21.3%), macrophages (+16.5%), and total cells (-65%) were significant. Spirometry and blood gas data did not change from baseline in either patient group. CONCLUSIONS: A two month course of treatment with high dose inhaled BDP reduces significantly neutrophil cell counts in patients with clinically stable, smoking related COPD. Further studies on the effectiveness of inhaled steroids in COPD are needed to confirm the clinical importance of this observation.

Administration, Inhalation↗
PubMed1997

High-dose chemotherapy and autologous bone marrow transplantation compared with MACOP-B in aggressive B-cell lymphoma.

BACKGROUND: We compared a regimen of six chemotherapeutic agents administered sequentially at high doses, followed by myeloablative treatment and bone marrow transplantation, with a regimen of methotrexate, doxorubicin, cyclophosphamide, vincristine, prednisone, and bleomycin (MACOP-B) as initial or salvage treatment for adults with diffuse large-cell lymphoma. METHODS: Ninety-eight eligible patients with diffuse large-cell lymphoma of the B-cell type were randomly assigned to receive either MACOP-B (50 patients) or high-dose sequential therapy (48 patients). The study design allowed for patients in whom the assigned treatment failed to cross over to the other treatment group. RESULTS: After a median follow-up of 55 months, the patients given high-dose sequential therapy, as compared with those treated with MACOP-B, had significantly higher rates of complete response (96 percent vs. 70 percent, P=0.001), freedom from disease progression (84 percent vs. 49 percent, P<0.001), freedom from relapse (88 percent vs. 70 percent, P=0.055), and event-free survival (76 percent vs. 49 percent, P=0.004). The difference in overall survival at seven years, which also favored the group assigned to high-dose sequential therapy, was marginally significant (81 percent vs. 55 percent, P=0.09). CONCLUSIONS: High-dose sequential therapy is superior to standard-dose MACOP-B for patients with diffuse large-cell lymphoma of the B-cell type.

Adolescent↗
PubMed1996

Noninvasive mechanical ventilation improves the immediate and long-term outcome of COPD patients with acute respiratory failure.

Noninvasive positive pressure ventilation (NPPV) has been proposed in COPD patients with acute on chronic respiratory failure (ACRF) in order to avoid endotracheal intubation and to improve immediate outcome, but long-term outcome of this therapeutic approach is still undefined. We evaluated short- and long-term (1 year) outcome of early administration of NPPV in 24 patients with ACRF due to exacerbated COPD (Group A) in comparison with 24 matched historical-control patients treated conventionally (Group B). Patients of Group A were initially treated with NPPV via nasal mask in the presence of pH < or = 7.32, and/or Pa,O2 < 7.98 kPa, and/or Pa,CO2 > 7.18 kPa, plus signs of respiratory distress. In-hospital survival rate was not significantly different in Group A vs Group B, but the patients treated with NPPV showed an earlier improvement in blood gases and a better pH and respiratory rate at discharge. Only 2 patients of Group A needed endotracheal intubation as compared with 9 of Group B. Hospital stay was significantly reduced in survivors of Group A vs Group B. Further severe relapses of ACRF in Group A were treated using NPPV. The number and length of further hospitalizations for pulmonary exacerbations were significantly higher in Group B compared with Group A. The survival rate at 12 months was significantly lower in Group B than in Group A (50% vs 71%). In conclusion, NPPV administration in patients with ACRF due to exacerbated COPD improves not only immediate but also long-term outcome.

Acute Disease↗
PubMed1995

[Not Available].

An open, multicenter non-comparative study was carried out in 8 centres in Italy to evaluate the efficacy, safety and tolerability of cefixime (Suprax - Lederle), a third generation oral cephalosporin administered once daily to patients affected by exacerbation of chronic bronchitis. All patients, 124 males and 21 females, aged between 50 and 85, were treated with Suprax at the dose of 400 mg/day for a mean period of 7.4 days. Clinical and laboratory examinations were performed at: T0 (beginning of treatment), T1 (3-4 days after the beginning of treatment), T2 (end of treatment). The following signs/symptoms were recorded in order to evaluate the therapeutic efficacy: sputum quality and quantity, cough, dyspnoea, fever, bronchospasm, chest clinical findings. All these signs and symptoms significantly improved (p between < 0.001 and < 0.05; mean improvement for sign, weighted for time of improvement). Bio-humoral parameters were also recorded in order to evaluate potential therapeutic influences. A significant decrease was observed (p < 0.01 Student t test for paired data) in the white blood cell count and the leukocyte formula. The datum regarding the white blood cell count and leukocyte formula is to be considered a primary effect of the treatment, proving its success. A microbiological search for the pathogen responsible for the infectious process was also performed: in 70/145 subjects the responsible pathogen was identified. The micro-organism was eradicate in 66/70 at T2 (94.3%), the difference T0 = T2 is significant. The X-Ray evidence suggesting a chronic bronchitis, was also evaluated in 81 patients. At T2, in 75/81 subjects the X-Ray evidence turned out to be negative, while in 6/81 it remained positive. This difference was statistically significant (p < 0.01 sign test). An overall clinical evaluation showed a therapeutic success in 133/145 treated patients (91.7%). No side effects were observed.

English Abstract↗
PubMed1995

Heterozygosity for homocysteinuria: a detectable and reversible risk factor for pulmonary thromboembolism.

Heterozygosity for homocysteinuria is a common, inherited autosomal condition that has recently been considered as an independent cardiovascular risk factor. In vitro and in vivo results suggest that this condition, like the homozygous form, is also a risk factor for deep-venous thrombosis and pulmonary thromboembolism. We report a case of recurrent pulmonary thromboembolism in a young woman with familial hyperhomocysteinaemia. The relative frequency of this condition, as well as its simple and harmless cure, make testing for heterozygosity for homocysteinuria useful and profitable in the prevention of pulmonary thromboembolism, above all in younger subjects with a significant case history.

Adult↗
PubMed1995

International guidelines and educational experiences in an out-patient clinic for asthma.

In June 1989, an out-patient clinic for asthma was instituted at Crema Hospital, Italy. Up to November 1994, 430 adult asthmatics were recruited, classified and managed according to the recommendations of the international guidelines. The aims of this study are to verify: 1) whether the organization of the clinic could maintain asthma under control and reduce hospital admissions; and 2) whether the traditional educational approach could be implemented by lessons in the school of asthma to improve the control of asthma symptoms and/or admissions. The data reported refer to the first 360 asthmatics attending the clinic between 1989 and 1994: 53, 45 and 2% of them were suffering from extrinsic, intrinsic and occupational asthma, respectively. On recruitment, forced expiratory volume in one second (FEV1) was < 80% of predicted in 170 patients, and arterial oxygen tension (Pa,O2) 8.0 kPa (< 60 mmHg) in 27 patients. After the admission visit, 190 patients (53%) were classified as mild, 97 (27%) as moderate, and 73 (20%) as severe asthmatics. In May 1993, a school of asthma was organized. Forty four patients were recruited, stratified according to the severity of their asthma and randomized into two groups: 22 patients attended the school, and 22 patients did not. Each group consisted of 5, 10 and 7 patients with mild, moderate and severe asthma, respectively. The school comprised four lessons twice a week. One year after the end of the school, we could find no differences between the two groups (school versus controls) with regard to the number of urgent care visits (9 vs 9), scheduled visits (22 vs 21) and hospital admissions (2 vs 2).

Adult↗