Search PubMed⌕ Search

Biomedical subjects

M Mandalà

Publications and source records attributed to M Mandalà.

At least 19 recordsLinked to original sources
PubMed2006

Venous thromboembolism and cancer: guidelines of the Italian Association of Medical Oncology (AIOM).

Thromboembolic complications represent one of the most important cause of morbidity and mortality in cancer patients. Although several data have been published demonstrating the strong association between cancer and venous thromboembolism (VTE), there is poor perception, among oncologists, of the level of risk of thrombosis and of relevance of managing VTE in these patients. The Associazione Italiana di Oncologia Medica (AIOM) has provided some recommendations to direct clinical practice according to evidence-based data concerning cancer and VTE. In fact, we conducted an extensive literature review (1996-2005) to produce evidence-based recommendations to improve perceptions of the magnitude of this risk among Italian medical and surgical oncologists and alert on the new approaches to prophylaxis and treatment of VTE in cancer patients. Levels of evidence are given according to a five-point rating system, and similarly for each key recommendation a five-point rating system suggests if the evidence is strong and indicate that the benefits do, or do not, outweigh risks and burden.

Anticoagulants↗
PubMed2005

Midazolam for acute emesis refractory to dexamethasone and granisetron after highly emetogenic chemotherapy: a phase II study.

GOALS OF THE WORK: To assess whether the addition of midazolam to dexamethasone and granisetron could ameliorate the refractory acute nausea and/or vomiting caused by a highly emetogenic platinum-based chemotherapy. PATIENTS AND METHODS: Enrolled in the study were 30 consecutive adult patients with refractory acute emesis. Nausea and vomiting were assessed by physicians and graded according to the NCI common toxicity criteria. Nausea was further self-assessed by patients using a visual analogue scale. Statistical analysis was performed by nonparametric tests. RESULTS: With the introduction of midazolam, 73% of patients had a reduction of at least one grade in nausea and vomiting intensity in comparison with the previous cycle of chemotherapy. From the second cycle, six patients (23%) had complete control of acute vomiting, a benefit that usually persisted in the subsequent cycles. Five more patients achieved complete control of acute vomiting during the third course; this effect persisted in the subsequent courses as well. The average relative reduction in acute nausea and vomiting grade from the first to the second course was 48% (95% CI 34-62%) and 48% (95% CI 31-65%), respectively. A significant difference in acute nausea and vomiting over all the six courses of chemotherapy administered was recorded (Friedman ANOVA, P <0.0001). Comparing each course with any subsequent course, a significant reduction in acute nausea and vomiting was observed between the first and second course, the first and third course, and the first and fourth course. CONCLUSIONS: Our results suggest that midazolam may be a useful adjunct to standard antiemetic drugs for patients receiving highly emetogenic cisplatin-based chemotherapy. A randomized trial is warranted to confirm these results.

Adult↗
PubMed2005

Acute vestibular neuritis: prognosis based upon bedside clinical tests (thrusts and heaves).

We compared bedside tests of vestibulo-ocular function (head thrust and head heave signs) with caloric testing results in 68 patients with acute vestibular neuritis seen at onset and in follow-up for one year. The head thrust and head heave signs each were strong predictors of a decreased probability of recovery, and if both were present, there was a trend for a slower recovery and a further decrease in the probability of recovery. If the head thrust sign was absent, recovery was assured. Our results suggest that careful bedside testing of semicircular canal (head thrust maneuver) and otolith (head heave maneuver) function provides useful information for predicting prognosis in patients with acute vestibular neuritis.

Acute Disease↗
PubMed2005

Sensitivity and specificity of mastoid vibration test in detection of effects of vestibular neuritis.

Aim of this study was to determine sensitivity and specificity of the mastoid vibration test in patients who had suffered an attack of vestibular neuritis. Results were compared with the caloric test and two bedside tests of vestibular function (head shaking test and head thrust test). Results are reported in 28 patients who had a residual vestibular deficit 6 months after acute neuritis and in 25 healthy subjects. Mastoid vibration nystagmus was evoked in 21 patients but not in controls. In these patients, mastoid vibration test had a sensitivity of 75% and specificity of 100%. Since one patient had inverted mastoid vibration nystagmus, specificity of identification on the pathological side was 95%. Sensitivity of the test increased with increasing severity of the vestibular lesion. Indeed, mastoid vibration nystagmus was induced in 93% of patients with caloric paralysis and in 58% of those with caloric paresis. Nystagmus could usually be modulated or elicited by stimulation of either mastoid. In the few patients in whom mastoid vibration nystagmus was elicited only from one side, or when there was a clear difference in intensity of the nystagmus induced on the two sides, the stimulated side was more often the affected side. Four patients still showed spontaneous nystagmus. The caloric test was abnormal in 26/28 patients (93%) with paralysis in 16 and paresis in 12; 71% of patients had a head shaking induced nystagmus: 64% had an asymmetrical response in head thrust test. In conclusion, mastoid vibration test was overall more sensitive than head thrust test. Mastoid vibration test was slightly less sensitive than head shaking test in patients with severe residual deficit and more sensitive in patients with partial deficit. Mastoid vibration test, a valid, low cost clinical screening test for rapid detection of asymmetrical vestibular function, does not cause patient discomfort. It is suggested that this test be included in the diagnostic workup of all patients with suspected vestibular dysfunction.

Acute Disease↗
PubMed2005

Quality of life and psycho-social development in children with otitis media with effusion.

Purpose of this study was to correlate results from a survey on otitis media and the State-Trait Anxiety Inventory test. This survey investigated prevalence of otitis media (OM) in our territory, influence on development of language and personality and social costs. State-Trait Anxiety Inventory is a suitable test to differentiate state anxiety caused by a specific event [in this case, otitis media with effusion (OME)] from a trait anxiety (anxious personality) in parents and caregivers. The otitis media study was conducted, retrospectively, in two primary public schools in Colle Val D'Elsa (Siena) on 252 children (6-11 years old). The State-Trait Anxiety Inventory test had been administered to the parents or caregivers of 20 paediatric outpatients (4-12 years, mean 6.8) at the ENT Department of Siena University. The results of the OM survey showed a correlation between OM and difficulties in speech and reading, delayed answering and limited vocabulary. All these problems improved as children grew up. On the other hand, psycho-social development appeared to be more problematic even in the 4th and 5th class, mostly due to persistent attention disturbances. In the State-Trait Anxiety Inventory test, 50% of parents or caregivers had a high state-anxiety score and so were mostly concerned with health status of the children. The State-Trait Anxiety Inventory results indicated that 50% of parents or caregivers had a high trait-anxiety score and thus had an anxious personality. These findings could be helpful in understanding the real severity of symptoms. The two proposed tests could provide complementary data to evaluate children with OME: the OM survey can be used as a screening test to detect children with non-symptomatic OME, to establish whether delayed language development may be associated with OME, to predict prognosis and children's quality of life as well as social costs of OME; the State-Trait Anxiety Inventory test can be used to reveal a state or a trait anxiety in parents and caregivers in order to better understand their point of view. Parents' and caregivers' personality has a marked influence on the impact of OME on the children's quality of life. Quality of life in children with otitis media with effusion is one of the most important parameters to be taken into consideration on account of the possible correlation with problems in development.

Child↗
PubMed2004

Factor V Leiden and G20210A prothrombin mutation and the risk of subclavian vein thrombosis in patients with breast cancer and a central venous catheter.

BACKGROUND: To analyze the influence of the prothrombotic gene mutation factor V G1691A (factor V Leiden) and prothrombin G20210A on the risk of a first episode of catheter-related deep venous thrombosis (DVT) in a group of patients with breast cancer treated with chemotherapy. PATIENTS AND METHODS: Between January 1999 and February 2001, the occurrence of a first symptomatic DVT was investigated in a cohort of 300 consecutive patients with locally advanced or metastatic breast cancer treated at a single institution with fluorouracil-based chemotherapy, administered continuously through a totally implanted access port. A nested case-control study included 25 women (cases) with catheter-related DVT and 50 controls without DVT matched with cases for age, identical chemotherapy, stage of disease and prognostic features. The G1691A factor V and G20210A prothrombin mutation genotypes were analyzed. RESULTS: Five cases [20%; 95% confidence interval (CI) 9% to 39%)] and two controls (4%; 95% CI 1% to 14%) were heterozygous carriers of G1691A factor V (P = 0.04). The age-adjusted odds ratio for catheter-related DVT was 6.1 (95% CI 1.1-34.3). Only one patient (case) had the G20210A prothrombin gene mutation. Time from start of chemotherapy infusion to DVT was not significantly different between patients with (median 31 days) and without (median 43 days) G1691A factor V mutation (P = 0.6). CONCLUSIONS: Factor V Leiden carriers with locally advanced or metastatic breast cancer have an increased risk of developing catheter-related DVT during chemotherapy.

Adult↗
PubMed2004

Incidence of chemotherapy-induced amenorrhea depending on the timing of treatment by menstrual cycle phase in women with early breast cancer.

BACKGROUND: The aim of this study was to characterize the factors associated with chemotherapy-induced amenorrhea (CIA) and to examine whether the phase of the menstrual cycle at chemotherapy start could affect the rate of CIA in premenopausal women with early breast cancer. METHODS: CIA was defined as the cessation of menses for at least 3 months during or after chemotherapy. Menstrual phase was defined as days 1-6, follicular phase as days 7-14, luteal phase as days 15-20 and premenstrual phase as days 21-28. Univariate and multivariate predictors of CIA were examined. RESULTS: Among 111 premenopausal women, univariate analysis showed a higher incidence of CIA in patients treated in the follicular phase rather than in other menstrual cycle phases (67.6% compared with 45.5%; P=0.03). The rate of CIA increased with age: 65.2% and 45.8% in patients aged >42 and </=42 years, respectively (P=0.05). Upon multivariate analysis these differences remained statistically significant and duration of chemotherapy of more than six cycles correlated significantly with the incidence of CIA (P=0.03). CONCLUSIONS: The major implication of this analysis is that the timing of treatment within the menstrual cycle may potentially modulate the onset of CIA. This work and its future confirmation using prospective randomized trials would be useful in predicting the likelihood of CIA and in counseling breast cancer patients, especially those with a good prognosis who benefit less from chemical castration.

Adult↗
PubMed2004

Single-agent epirubicin as primary chemotherapy in T2-T3, N0-N2, M0 breast carcinoma: 6-year follow-up.

OBJECTIVE: Single-agent epirubicin was tested as primary chemotherapy treatment in patients with early breast cancer >3 cm. METHODS: 100 women with locally advanced breast cancer >3 cm were treated with three cycles of single-agent epirubicin at a dose of 120 mg/m2. All patients showing tumor shrinkage to less than 3 cm were considered candidates for conservative surgery (quadrantectomy); in the remaining patients modified radical mastectomy was carried out. Postsurgical treatment consisted of CMF chemotherapy except for postmenopausal node-positive, estrogen-positive patients who were assigned to hormonal treatment with tamoxifen and postmenopausal node-negative, estrogen-positive ones who did not receive any treatment. RESULTS: Quadrantectomy was carried out in 71 patients. At the median follow-up time of 69 months, the relapse rate was 29.6% among patients who underwent quadrantectomy (21 out of 71) and 58.6% among patients who underwent modified radical mastectomy (17 out of 29). CONCLUSIONS: Single-agent chemotherapy with anthracyclines could appear to be an effective treatment in inducing a tumor downstaging in patients with early breast cancer >3 cm. This treatment can be administered outside clinical trials in patients who desire to preserve their body integrity. Further prospective, randomized trials are needed in order to validate and better define the role of epirubicin in the neoadjuvant strategy of breast cancer patients.

Adult↗
PubMed2003

Vinorelbine and carboplatin in inoperable non-small cell lung cancer: a monoinstitutional phase II study.

Chemotherapy regimens for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) provide typically palliation or limited symptom-free survival. We investigated the efficacy, in terms of response rate and time to progression, of a combination chemotherapy containing carboplatin and vinorelbine as a first-line treatment for inoperable NSCLC. Fifty-two consecutive patients with advanced NSCLC were treated with carboplatin AUC 6 according to Calvert's formula on day 1, combined with vinorelbine, 25 mg/m(2) on days 1 and 8. Therapy was given every 3 weeks. The median age was 66 years (range, 40-80); ECOG performance status was 0 in 20, 1 in 25 and 2 in 7 patients. According to an intent-to-treat analysis, response rate (partial and complete responses) in 52 assessable patients was 18/52 (34.6%; 95% confidence interval, 22-47%). In addition, 16 patients (30.8%) had stable disease and 18/52 (34.6%; 95% CI, 22-47%) progressed while on treatment. Median time to progression and overall survival were 7, 5 and 12.3 months, respectively. Grade 3/4 granulocytopenia was observed in 18/8 patients (34.6/15.4%). Grade 3/4 nadirs generally lasted no more than 7 days, and no neutropenic fever was reported. The treatment was generally very well tolerated: grade 1 or 2 nausea and vomiting was observed in 12 and 4 patients, respectively, and grade 2 neuropathy in 5% of cases. Statistical analysis did not highlight any significant differences in clinical benefit (partial and complete responses and stable disease), time to progression, or grade 3-4 hematologic and non-hematological toxicity according to age ( 65 years). Carboplatin AUC 6 and vinorelbine was found to be an efficacious regimen as a first-line treatment for inoperable lung cancer patients and was also subjectively very well tolerated in aged patients. The regimen warrants further investigation in the emerging subgroup of aged patients in order to draw firm conclusions.

Adult↗
PubMed2002

Recognizing features that are dissimilar in male and female breast cancer: expression of p21Waf1 and p27Kip1 using an immunohistochemical assay.

BACKGROUND: Male breast cancer (MBC) is an uncommon disease, and most of our current knowledge of its biology, natural history and treatment has been extrapolated from data on the disease in women. Information is still needed on the molecular biological properties of male breast tumors and their predictive relevance. Kinase inhibitor proteins (KIPs) p27Kip1 and p21Waf1 negatively regulate cell cycle progression by preventing the passage of cycling cells from G1 to S phase through G1 cyclin-dependent kinase activation. No studies exist on the role of these factors in male breast carcinoma. PATIENTS AND METHODS: We have retrospectively analyzed the immunohistochemical expression of p21Waf1 and p27Kip1 protein in 27 primary MBC and in 101 female breast cancers (FBC) treated at the European Institute of Oncology between 1997 and 2000. We also assessed sex hormone receptors status, p53, bcl-2 and c-erb-B2 protein expression, and Ki-67 labeling index. RESULTS: We observed a statistically significant difference in the immunostaining of KIPs p27Kip1 and p21Waf1 in male patients compared with females. Expression of p21Waf1 was observed in 19 of the 27 (70.3%) primary MBCs versus 29 of 101 FBC (29%). Fourteen of 22 negative c-erbB-2 MBCs cases expressed immunostaining for p21Waf1 (P = 0.05). p27Kip1 immunoreactivity was been detected in 26 of 27 (96.2%) male breast patients versus 39 of 101 FBC (39.3%) (P = 0.000). Highly positive staining for P27Kip1 was found in 21 of 25 androgen receptor-expressing samples. Higher levels of p27Kip1 were expressed in bcl-2-positive samples (17 of 20). Eighteen of 22 c-erbB-2-negative cases were strongly immunoreactive for p27Kip1. CONCLUSIONS: p27Kip1 and p21Waf1 immunoreactivity is higher in MBCs compared with FBCs. The findings of higher p27Kip1 and p21Waf1 immunostaining may be an additional predictive factor in MBC. These biological features could be possible indicators for different biological pathways in the tumorigenesis of MBCs.

Adult↗