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Biomedical subjects

M Natale

Publications and source records attributed to M Natale.

At least 19 recordsLinked to original sources
PubMed2007

A rare symptomatic presentation of ecchordosis physaliphora: neuroradiological and surgical management.

We report a case of ecchordosis physaliphora, an uncommon benign lesion originating from embryonic notochordal remnants, intradurally located in the prepontine cistern, that unusually presented associated with symptoms. MRI detected and precisely located the small mass. At surgery, a cystic gelatinous nodule was found ventral to the pons, contiguous with the dorsal wall of the clivus via a small pedicle. Histological examination diagnosed the lesion as an ecchordosis physaliphora. Here we focus on the analysis of the neuroradiological aspects that play a crucial role from both a diagnostic and a therapeutic standpoint.

Central Nervous System Diseases↗
PubMed2005

Ulcerative and mutilating variant of carpal tunnel syndrome.

Cutaneous involvement in severe carpal tunnel syndrome is secondary to damage to sensory and autonomic fibers of the median nerve. We report the case of a 63 year old man who presented skin and bone lesions, confined to the sensory zones of both median nerves. The lesions consisted of dystrophic modifications of the fingernails, progressive sclerosis, skin thickening and ulcerations on the fingers, acro-osteolysis, and purulent inflammation with subsequent auto-amputation of the distal phalanx of the right index finger. Clinical, neurophysiological and surgical findings are reported. The recovery of the ulcerative lesions suggests the reversibility of autonomic disturbances after surgery.

Acro-Osteolysis↗
PubMed2004

Post traumatic retropharyngeal pseudomeningocele.

The authors report a case of a 33-year-old man who presented, during recovery from coma due to severe head injury, dysphagia and respiratory failure. Magnetic resonance, retrograde radionuclide myelography and computerized tomographic myelography identified a pseudomeningocele in the retropharyngeal space due to a tear of the left C2 radicular sleeve. After failed medical management, the patient underwent lumbo peritoneal shunt. Magnetic resonance controls showed progressive collapse of the collection. After 3 months the patient was able to breathe spontaneously and to swallow. The authors describe pathogenesis, diagnostic strategy and principles of treatment of traumatic retropharyngeal pseudomeningoceles.

Adult↗
PubMed2001

Unusual manifestation of vertebral osteoid osteoma: case report.

We report the case of a 64 year-old man with a clinical history suggesting a low thoracic-cord involvement, in which an unexpected vertebral osteoid osteoma was discovered. The patient underwent MRI of the thoraco-lumbar spine, which included sagittal and axial T1-weighted images, and sagittal double-echo T2-weighted images. Subsequently, CT scan was carried out with 2-mm-thick axial sections, aimed at T10 vertebra. Magnetic resonance imaging disclosed an extra-axial mass at T10 level. Computed tomography scan suggested an osteoid osteoma of the tenth thoracic vertebra, involving the lamina with marked sclerosis and prevalently endocanalar extension. Histology following surgical resection confirmed the diagnosis. In the reported case CT scan provided the correct pre-operative diagnosis of osteoid osteoma despite its unusual clinical--anamnestic presentation. Magnetic resonance imaging was useful in establishing the relationship of the neoplasm with the spinal cord.

Diagnosis, Differential↗
PubMed2001

A weekly regimen of cisplatin, paclitaxel and topotecan with granulocyte-colony stimulating factor support for patients with extensive disease small cell lung cancer: a phase II study.

The present study was aimed at defining the antitumour activity of the cisplatin-paclitaxel-topotecan (CPT) weekly administration with G-CSF support in chemo-naive SCLC patients with extensive disease (ED-SCLC). Chemonaive ED-SCLC patients received cisplatin 40 mg/m(2), paclitaxel 85 mg/m(2), and topotecan 2.25 mg/m(2)weekly, with G-CSF (5 microg/kg days 3-5) support, for a maximum of 12 weeks. 37 patients were treated, for a total of 348 cycles delivered. 8 complete responses (22%) and 22 partial responses (59%) were recorded, giving an 81% [95% CI = 65-92%] ORR. At a 13-month (range, 4-26) median follow-up, median progression-free and overall survival were 8 months and 12.5 months, with 1-year and 2-year projected survivals of 55% and 21%, respectively. No toxic deaths occurred. Grade 4 neutropenia and thrombocytopenia occurred in 6 and 3 patients, respectively. Only one case of neutropenic sepsis was recorded, while haemorrhagic thrombocytopenia was never observed. Diarrhoea, paraesthesias and fatigue were the main nonhaematologic toxicities being severe in 6, 2 and 10 patients, respectively. The weekly CPT combination with G-CSF support represents a well tolerated therapeutic approach in chemo-naive ED-SCLC patients. The activity rate seems at least similar to that achievable with the standard front-line approaches.

Adult↗
PubMed2001

Can estrogen influence the response to noxious stimuli?

STUDY OBJECTIVES: To evaluate estrogen-induced alternations in noxious stimuli response. DESIGN: Randomized, prospective, double-blind study. SETTINGS: Tertiary-care academic medical center. PATIENTS: 40 ASA physical status I and II women at the beginning and conclusion of an in vitro fertilization stimulation cycle. INTERVENTIONS: Stimuli were applied to the fingers of the dominant hand via a Basile Analgesy-Meter, which applied increasing pressure (g/cm(2)) in a continuous fashion, and ice water immersion. MEASUREMENTS: Serum hormonal concentrations and responses to noxious (pressure and cold thermal) stimuli were studied. MAIN RESULTS: Estrogen and progesterone concentrations changed from 377 +/- 323.42 pg/mL to 2078.05 +/- 1175.92 pg/mL (p < 0.001) and 1.20 +/- 0.56 to 1.03 +/- 0.35 ng/mL (p = NS), respectively. Although no significant difference was noted in the response to pressure (16.92 +/- 4.41 to 17.85 +/- 4.95 g/cm(2)), a significant reduction in the tolerance to ice water immersion (34.18 +/- 28.29 to 24.05 +/- 23.02 s) was observed. CONCLUSIONS: High estrogen concentrations are associated with significantly lower tolerance to cold, but not pressure stimuli.

Adult↗
PubMed2000

Randomized trial comparing cisplatin, gemcitabine, and vinorelbine with either cisplatin and gemcitabine or cisplatin and vinorelbine in advanced non-small-cell lung cancer: interim analysis of a phase III trial of the Southern Italy Cooperative Oncology Group.

PURPOSE: In our previous phase II study, the cisplatin, gemcitabine, and vinorelbine (PGV) regimen produced a median survival time (MST) of approximately 1 year in advanced non-small-cell lung cancer (NSCLC) patients. The present study was aimed at comparing the MST of patients treated with this triplet regimen with the MSTs of patients receiving cisplatin and vinorelbine (PV) or cisplatin and gemcitabine (PG). PATIENTS AND METHODS: From April 1997, patients with locally advanced or metastatic NSCLC, an age of < or = 70 years, and an Eastern Cooperative Oncology Group performance status < or = 1 were randomized to receive one of the following regimens: cisplatin 50 mg/m(2), gemcitabine 1,000 mg/m(2), and vinorelbine 25 mg/m(2) on days 1 and 8 every 3 weeks (arm A); cisplatin 100 mg/m(2) on day 1 and gemcitabine 1,000 mg/m(2) on days 1, 8, and 15 every 4 weeks (arm B); or cisplatin 120 mg/m(2) on days 1 and 29 and vinorelbine 30 mg/m(2)/wk (arm C). According to the two-stage design for phase III trials, an interim analysis was planned when the first 60 patients per arm were assessable for survival. RESULTS: The survival data of 180 NSCLC patients (stage IIIB, 76 patients; stage IV, 104 patients) were analyzed in April 1999. Overall, 128 patients had died (PGV, n = 33; PG, n = 42; and PV, n = 53). The MST of patients in the PGV, PG, and PV arms was 51, 42, and 35 weeks, respectively, and the corresponding 1-year projected survival rates were 45%, 40%, and 34%, respectively. When only patients with stage IV disease were considered, an even stronger difference was seen between PGV (MST = 47 weeks) and both PG (34 weeks) and PV (27 weeks). At multivariate Cox analysis, the estimate hazard of death for patients receiving PGV compared with those receiving PV was 0.35 (95% confidence interval, 0.16 to 0.77; P <.01). The response rates were 47% in the PGV arm, 30% in the PG arm, 25% in the PV arm. Both hematologic and nonhematologic toxicities were not substantially worse in patients who received the PGV regimen. CONCLUSION: The PGV regimen is associated with a substantial survival gain (MST > 3 months longer) when compared with the PV combination. Because this difference in survival met one of the early stopping rules, the accrual in the PV arm has been stopped (null hypothesis rejected). Enrollment still continues in the PGV and PG arm to ascertain whether the PGV regimen can also produce a significantly longer survival than that obtained with the PG regimen.

Adult↗
PubMed2000

Interim analysis of a phase III trial comparing cisplatin, gemcitabine, and vinorelbine vs. either cisplatin and gemcitabine or cisplatin and vinorelbine in advanced non small-cell lung cancer. A Southern Italy Cooperative Oncology Group Study.

In a previous phase II randomized study, a cisplatin/gemcitabine/vinorelbine (PGV) regimen produced a 50-week median survival time (MST) in advanced non small-cell lung cancer (NSCLC) patients. The present trial was planned to randomly compare the outcome of patients treated with this new triplet regimen with those of patients receiving either cisplatin plus vinorelbine (PV) or cisplatin plus gemcitabine (PG) doublet combinations. One hundred eighty patients with stage IIIB (76) or IV (104) disease, aged <or= 70 years, and with Eastern Cooperative Oncology Group performance status (ECOG PS) <or= 1, were randomly allocated to receive: cisplatin, 50 mg/m2 plus gemcitabine, 1000 mg/m2 plus vinorelbine, 25 mg/m2 (PGV) on days 1 and 8 every 3 weeks; cisplatin, 100 mg/m2 on day 1 plus gemcitabine, 1000 mg/m2 (PG) on days 1, 8, and 15 every 4 weeks; cisplatin, 120 mg/m2 on days 1 and 29 plus vinorelbine, 30 mg/m2/week (PV). At the planned interim analysis, the MST of patients in the PGV, PG, and PV arms was 51, 42, and 35 weeks, respectively. The hazard of death (Cox analysis) for patients receiving PGV compared with those receiving PV was 0.35 (95% confidence index [CI], 0.16-0.77, P = 0.0058). The response rate was 47% in the PGV arm, 30% in the PG arm, and 25% in the PV arm. Severe neutropenia (75% vs. 45%), and vomiting (50% vs. 15%) significantly affected more patients in the PV than in the PGV arm. Since the difference in survival met early stopping rules, accrual to the PV arm was suspended. Enrollment still continues in the PGV and PG arms to ascertain whether the triplet regimen has a more significant effect on survival than that produced with the PG regimen.

Clinical Trial↗
PubMed1999

Cisplatin-topotecan-paclitaxel weekly administration with G-CSF support for ovarian and small-cell lung cancer patients: a dose-finding study.

PURPOSE: Paclitaxel (PTX) and topotecan (TPT) have shown promising antitumor activity in both ovarian cancer (OC) and small-cell lung cancer (SCLC) patients. This phase I study was aimed at determining the maximum tolerable dose (MTD) of TPT given weekly over 30 min in combination with fixed doses of cisplatin (CDDP) and (PTX), and with G-CSF support. PATIENTS AND METHODS: Forty-four patients with OC (19) or SCLC (25), either chemo-naïve (20) or pretreated (24) received CDDP 40 mg/m2, PTX 85 mg/m2 (one-hour infusion) and escalating TPT doses (starting from 0.75 mg/m2) in a 30-min infusion in weekly administration. Filgrastim 5 mg/kg was administered on days 3 to 5 of each week. RESULTS: Eight different dose levels were tested for a total of 295 delivered cycles. The dose escalation was interrupted at the TPT dose of 2.50 mg/m2. No toxic deaths occurred in this study. Grade 3 to 4 neutropenia, thrombocytopenia, and anemia occurred in 15 patients (36 cycles), seven patients (15 cycles), and four patients (five cycles), respectively. Severe vomiting and diarrhoea occurred in seven and four patients. Peripheral neuropathy was recorded in 11 patients (42 cycles), but it was never severe. An overall 11 of 19 (58%) OC and 11 of 25 (44%) SCLC patients obtained objective responses. Eight patients showed complete responses (three OC and three SCLC). Among the 20 chemo-naïve patients, 9 of 11 (82%) OC and seven of nine (78%) SCLC responded. CONCLUSIONS: The CDDP/TPT/PTX weekly administration with filgrastim support represents a well-tolerated and active therapeutic approach in both chemo-naïve and pretreated OC and SCLC patients. A weekly dose of TPT of 2.25 mg/m2 is recommended for the phase II study.

Adult↗
PubMed1999

Cisplatin, gemcitabine, and vinorelbine combination therapy in advanced non-small-cell lung cancer: a phase II randomized study of the Southern Italy Cooperative Oncology Group.

PURPOSE: In a previous phase I study cisplatin (CDDP), gemcitabine (GEM), and vinorelbine (VNR) combination therapy was safe and very active in patients with non-small-cell lung cancer (NSCLC). This study was aimed at better defining the activity and toxicity of this regimen. PATIENTS AND METHODS: One hundred eleven chemotherapy-naive patients, age < or = 70 years, with stage IIIB or IV NSCLC and a performance status of 0 or 1 (Eastern Cooperative Oncology Group scale) were randomized to two treatment arms. Patients on arm A received CDDP 50 mg/m2, GEM 1,000 mg/m2, and VNR 25 mg/m2 on days 1 and 8 of an every-3-weeks cycle (57 patients). Patients on arm B received CDDP 80 mg/m2, epirubicin 80 mg/m2, and vindesine 3 mg/m2, all delivered on day 1 every 4 weeks, plus lonidamine orally 150 mg three times daily (54 patients). In December 1996, randomization was stopped early, and an additional 30 patients were treated with the experimental regimen to obtain a more accurate estimation of its activity rate. RESULTS: Among 87 patients who received the CDDP-GEM-VNR combination, four complete responses (CRs) and 46 partial responses (PRs) were observed, for an overall response rate of 57% (95% confidence interval [CI], 46% to 68%). Two CRs and 18 PRs were recorded among 54 patients on arm B, giving a 37% activity rate (95% CI , 24% to 51%). After a median follow-up duration of 19 months, the median progression-free and overall survival durations were 32 and 50 weeks in arm A, and 18 and 33 weeks in arm B, respectively. World Health Organization grade 3 to 4 neutropenia and thrombocytopenia occurred in 46% and 14% of patients in arm A and in 22% and 11% of those in arm B, respectively. Severe nonhematologic toxicity was uncommon in both arms. CONCLUSION: The CDDP-GEM-VNR combination is a highly effective treatment for patients with advanced NSCLC and has a manageable toxicity. A phase III trial comparing this new combination with both CDDP-VNR and CDDP-GEM regimens is underway.

Adult↗
PubMed1999

Cisplatin, gemcitabine, and paclitaxel in locally advanced or metastatic non-small-cell lung cancer: a phase I-II study. Southern Italy Cooperative Oncology Group.

PURPOSE: Because both cisplatin-paclitaxel and cisplatin-gemcitabine combinations are generally considered to be among the most active regimens in non-small-cell lung cancer (NSCLC) patients, this study aimed to determine the maximum-tolerated dose (MTD) of paclitaxel when combined with fixed doses of cisplatin and gemcitabine in advanced NSCLC patients and aimed to define the therapeutic activity of this new regimen. PATIENTS AND METHODS: From October 1996 to September 1998, 75 patients with stage IIIB-IV NSCLC, who were either chemotherapy-naive (65 patients) or who had been pretreated (10 patients), received fixed doses of cisplatin (50 mg/m(2)) and gemcitabine (1,000 mg/m(2)) and escalating doses of paclitaxel in a 1-hour infusion, all on days 1 and 8, every 3 weeks. RESULTS: Five different paclitaxel doses were tested, for a total of 275 cycles delivered. The escalation was stopped at the paclitaxel dose of 75 mg/m(2) in pretreated patients, whereas it continued to 150 mg/m(2) in chemotherapy-naive patients. A total of 65 chemotherapy-naive patients were treated. A paclitaxel dose of 125 mg/m(2) was recommended for phase II, and a total of 39 patients were treated at this level, for a total of 158 cycles delivered. No treatment-related deaths occurred. Five patients were hospitalized because of sepsis, and packed RBC transfusion was required in 13 patients. Grade 4 neutropenia and thrombocytopenia occurred in 23 (31%) and eight (11%) patients, respectively. Overall, 74 of the 75 patients were assessable for response. Four complete (CR) and 38 partial (PR) responses were recorded, for an overall response rate (ORR) of 57%. Three of the ten pretreated patients achieved a PR, compared with four CRs and 35 PRs in the 64 chemotherapy-naive patients (ORR, 61%). Thirty-eight of 39 patients included in phase II were assessable for response and quality of life (QOL) (one patient's disease was not measurable). Two CRs and 24 PRs were recorded in this group, for an ORR of 68% (95% confidence interval, 51% to 82%). The QOL score improved in 27 of 38 (71%) patients. The median survival time was 15 months in the 65 chemotherapy-naive patients, but it had not yet been reached in the 39 patients included in phase II, for whom the 1-year projected survival was 70%. CONCLUSION: The cisplatin-gemcitabine-paclitaxel combination is a feasible and well-tolerated approach in advanced NSCLC patients. Both a major response and a QOL improvement can be obtained in a high proportion of patients, with a median survival time exceeding 1 year. A phase III trial comparing this combination with other effective regimens is under way.

Adult↗
PubMed1997

Suppression of nocturnal plasma melatonin levels by evening administration of sodium valproate in healthy humans.

To investigate the role of gamma-aminobutyric acid (GABA) in the modulation of human melatonin production, we studied the effects of the acute administration of the GABAergic drug, sodium valproate (VAL), on nocturnal blood melatonin levels in healthy subjects. To this purpose, 4 healthy men and 3 healthy women, aged 24-33 years, underwent three experimental sessions in which they received orally 400 mg VAL, 800 mg VAL, or placebo, in random order, according to a double-blind design. The drug administration was done at 19:00 hours; thereafter, blood samples were collected over the night, in dark conditions with the help of a red light. As compared to placebo, VAL, at the dosage of both 400 and 800 mg, significantly suppressed nocturnal blood melatonin levels, the higher dose being slightly more effective than the lower one. The maximum suppression coincided with the highest plasma levels of valproic acid. These findings support the view that endogenous GABA may participate in the modulation of the activity of the human pineal gland.

Adult↗
PubMed1997

Cisplatin, gemcitabine and vinorelbine in locally advanced or metastatic non-small-cell lung cancer: a phase I study.

PURPOSE: The objective of this study was to determine the maximally tolerable doses (MTDs) of vinorelbine (VNR) and gemcitabine (GEM) when combined with a fixed dose of cisplatin (CDDP). PATIENTS AND METHODS: Chemotherapy-naive patients with stage IIIB-IV non-small-cell lung cancer (NSCLC) received a fixed dose of CDDP (50 mg/m2) and escalating doses of VNR (starting from 20 mg/m2) and GEM (starting from 800 mg/m2) on days 1 and 8, every three weeks. The single escalation of GEM alone, by 200 mg/m2 at each step, was initially planned up to a dose of 1,200 mg/m2, to be followed by increments of the VNR dose of 5 mg/m2 at each step. RESULTS: Thirty-one patients were enrolled at five different dose levels. The escalation was stopped at level 4 (GEM 1,200 mg/m2 and VNR 25 mg/m2) since two of six patients of this cohort showed dose-limiting neutropenia at treatment cycle 1. Two different dose levels, GEM 1,200 mg/m2 + VNR 20 mg/m2, and GEM 1,000 mg/m2 + VNR 25 mg/m2 were fairly well tolerated. No treatment-related deaths occurred. Neutropenia was the main toxic effect, occurring in 76% of the total of 116 cycles delivered, and in 24% of them was of grades 3 or 4. A total of eight patients (26%) experienced grade 4 neutropenia lasting more than seven days; in five of them it occurred in the first course. Neutropenic fever was observed in four cases. Grade 4 thrombocytopenia occurred in only two patients. Non-hematologic toxicity was a minor problem in all patients but was never dose-limiting. No complete responses were obtained, but sixteen out of 31 (52%) patients achieved partial responses. The median duration of response was 20 (range 6-56+) weeks, while at a nine-month median follow-up, the median survival time has not yet been reached. To date, 18 patients are still alive. The one-year projected survival for all patients was 51%. CONCLUSIONS: Our results show that CDDP, VNR and GEM can be safely given together without substantial reductions in their individual dose intensities. In our opinion, the dose level of GEM 1,000 mg/m2 + VNR 25 mg/m2 given in combination with CDDP 50 mg/m2 on days 1 and 8 of a three-week cycle can be recommended for phase II trials, since it provides a better balance in dose intensity of GEM and VNR. A phase II randomised study is underway to establish the activity of this new regimen (at the above-cited dose level) in chemo-naive NSCLC patients.

Adult↗
PubMed1997

Decreased nocturnal secretion of melatonin in drug-free schizophrenics: no change after subchronic treatment with antipsychotics.

To evaluate the biosynthetic activity of the pineal gland in schizophrenia, the circadian rhythm of plasma melatonin was investigated in 9 drug-free chronic schizophrenics and in matched healthy subjects. In 7 of the patients, the 24-hour secretory pattern of the pineal hormone was reassessed after 10 weeks of treatment with antipsychotic drugs. In drug-free schizophrenics, the nocturnal increase in plasma melatonin levels was significantly blunted as compared to healthy subjects (p < 0.0001). Chronic treatment with antipsychotic drugs significantly improved psychotic symptomatology, but did not change the secretory pattern of melatonin. These data show that the biosynthetic activity of the pineal gland is impaired in chronic schizophrenia and that successful treatment with antipsychotic drugs does not go parallel with changes in the production of melatonin.

Adult↗
PubMed1995

Effects of lysine-arginine association on immune functions in patients with recurrent infections.

Combined L-lysine-L-arginine therapy is capable of inducting recovery in age-related decline of thymic activity in mice and in elderly humans. The clinical usefulness of the association has also been shown in children with recurrent respiratory infections, while an increase in the number of CD3+ lymphocytes has been shown in patients with chronic lymphatic leukaemia. Recently, in vitro effects of the association on neutrophil function have been reported. In particular, the association was able to increase random migration, chemotaxis, phagocytosis-associated- and f-MLP-induced chemiluminescence. In this paper the authors evaluate the effects of L-lysine-L-arginine combination (lisargin) on several humoral and cell-mediated immunologic parameters in patients with recurrent infection. An increase of neutrophil random migration and chemotaxis (evaluated by a new technique, based on a computer assisted image processing system) was found. Furthermore an increase in the absolute number of lymphocytes involved in cytotoxic activity and IgG levels was observed.

Adult↗
PubMed1993

Transient "cerebellar" mutism in lesions of the mesencephalic-cerebellar region.

Four patients aged from 20 to 48 years with transient mutism are presented: 3 patients underwent surgery for midline tumours of the mesencephalic-cerebellar region (medulloblastoma in two cases and pinealoblastoma in one), at times attached to one or both lateral recesses of the IV ventricle. One patient was hospitalized and treated for brain-stem ischemia. All patients developed mutism 48 to 72 hours after surgery; in the patient with brain-stem softening mutism appeared 72 hours after admission. All the patients had unimpaired consciousness and no deficits of lower cranial nerves. Speech, always normal in the first hours after surgery, was regained after a period of 6-16 weeks. Various hypotheses for this speech disorder are analyzed.

Adult↗