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1.
Brain Inj ; 34(13-14): 1714-1722, 2020 12 05.
Article in English | MEDLINE | ID: mdl-33190555

ABSTRACT

OBJECTIVE: To investigate the relationships between (a) the psychological status of the caregiver, (b) the specific features of caregiving as perceived by the cognitive therapist in neuro-rehabilitation, (c) the caregivers' subjective approach to neuro-rehabilitation, and (d) the functional outcome of the patient. METHODS: Twenty-four patients with severe acquired brain injury and their 24 caregivers participated in this observational study. Caregivers underwent a psychological assessment examining emotional distress, burden and family strain; their subjective approach to neuro-rehabilitation has been evaluated by two specific answers. The patients' cognitive therapists responded to an ad-hoc questionnaire, namely the "Caregiving Impact on Neuro-Rehabilitation Scale" (CINRS), evaluating the features (i.e., amount and quality) of caregiving. Finally, the functional outcome of the patient was assessed through standardized scales of disability and cognitive functioning. RESULTS: The caregivers' psychological well-being was associated to the features of caregiving, to the subjective approach to neuro-rehabilitation, and to the functional recovery of their loved ones. A better caregivers' approach to neuro-rehabilitation was also associated to an overall positive impact of caregiving in neuro-rehabilitation and to a better functional outcome of the patients. CONCLUSIONS: We posited a virtuous circle involving caregivers within the neuro-rehabilitation process, according to which the caregivers' psychological well-being could be strictly associated to a better level of caregiving and to a better functional outcome of the patients that, in turn, could positively influence the caregivers' psychological well-being. Although preliminary, these results suggest a specific psycho-educational intervention, aimed at improving the caregivers' psychological well-being and at facilitating their caring of the loved one.


Subject(s)
Brain Injuries , Caregivers , Adaptation, Psychological , Humans , Stress, Psychological , Surveys and Questionnaires
2.
Ann Oncol ; 30(6): 921-926, 2019 06 01.
Article in English | MEDLINE | ID: mdl-30778520

ABSTRACT

BACKGROUND: In human epidermal growth factor receptor 2 (HER2+) breast cancers, neoadjuvant trials of chemotherapy plus anti-HER2 treatment consistently showed lower pathologic complete response (pCR) rates in hormone receptor (HR) positive versus negative tumors. The PerELISA study was aimed to evaluate the efficacy of a de-escalated, chemotherapy-free neoadjuvant regimen in HR+/HER2+ breast cancer patients selected on the basis of Ki67 inhibition after 2-week letrozole. PATIENTS AND METHODS: PerELISA is a phase II, multicentric study for postmenopausal patients with HR+/HER2+ operable breast cancer. Patients received 2-week letrozole, and then underwent re-biopsy for Ki67 evaluation. Patients classified as molecular responders (Ki67 relative reduction >20% from baseline) continued letrozole and started trastuzumab-pertuzumab for five cycles. Patients classified as molecular non-responders started weekly paclitaxel for 13 weeks combined with trastuzumab-pertuzumab. Primary aim was breast and axillary pCR. According to a two-stage Simon's design, to reject the null hypothesis, at least 8/43 pCR had to be documented. RESULTS: Sixty-four patients were enrolled, 44 were classified as molecular responders. All these patients completed the assigned treatment with letrozole-trastuzumab-pertuzumab and underwent surgery. A pCR was observed in 9/44 cases (20.5%, 95% confidence interval 11.1% to 34.5%). Among molecular non-responders, 16/17 completed treatment and underwent surgery, with pCR observed in 81.3% of the cases. PAM50 intrinsic subtype was significantly associated with Ki67 response and pCR. Among molecular responders, the pCR rate was significantly higher in HER2-enriched than in other subtypes (45.5% versus 13.8%, P = 0.042). CONCLUSIONS: The primary end point of the study was met, by reaching the pre-specified pCRs. In patients selected using Ki67 reduction after short-term letrozole exposure, a meaningful pCR rate can be achieved without chemotherapy. PAM50 intrinsic subtyping further refines our ability to identify a subset of patients for whom chemotherapy might be spared. EUDRACT NUMBER: 2013-002662-40. CLINICALTRIALS.GOV IDENTIFIER: NCT02411344.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Ki-67 Antigen/metabolism , Receptor, ErbB-2/metabolism , Receptors, Estrogen/metabolism , Receptors, Progesterone/metabolism , Aged , Aged, 80 and over , Antibodies, Monoclonal, Humanized/administration & dosage , Breast Neoplasms/metabolism , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Carcinoma, Ductal, Breast/drug therapy , Carcinoma, Ductal, Breast/metabolism , Carcinoma, Ductal, Breast/pathology , Carcinoma, Ductal, Breast/surgery , Carcinoma, Lobular/drug therapy , Carcinoma, Lobular/metabolism , Carcinoma, Lobular/pathology , Carcinoma, Lobular/surgery , Dose-Response Relationship, Drug , Female , Follow-Up Studies , Humans , Letrozole/administration & dosage , Middle Aged , Neoadjuvant Therapy , Neoplasm Invasiveness , Prognosis , Remission Induction , Trastuzumab/administration & dosage
3.
Ann Oncol ; 29(12): 2328-2333, 2018 12 01.
Article in English | MEDLINE | ID: mdl-30219886

ABSTRACT

Background: Chemotherapy plus 1-year trastuzumab is the standard adjuvant treatment of HER2-positive breast cancer. The efficacy of less extended trastuzumab exposure is under investigation. The short-HER study was aimed to assess the non-inferiority of 9 weeks versus 1 year of adjuvant trastuzumab combined with chemotherapy. Patients and methods: HER2-positive breast cancer patients with node-positive or, if node negative, with at least one risk factor (pT>2 cm, G3, lympho-vascular invasion, Ki-67 > 20%, age ≤35 years, or hormone receptor negativity) were randomly assigned to receive sequential anthracycline-taxane combinations plus 1-year trastuzumab (arm A, long) or plus 9 weeks trastuzumab (arm B, short). This study was designed as a non-inferiority trial with disease-free survival (DFS) as primary end point. A DFS hazard ratio (HR) <1.29 was chosen as the non-inferiority margin. Analyses according to the frequentist and Bayesian approach were planned. Secondary end points included 2-year failure rate and cardiac safety. Results: A total of 1254 patients from 82 centers were randomized (arm A, long: n = 627; arm B, short: n = 626). Five-year DFS is 88% in the long and 85% in the short arm. The HR is 1.13 (90% CI 0.89-1.42), with the upper limit of the CI crossing the non-inferiority margin. According to the Bayesian analysis, the probability that the short arm is non-inferior to the long one is 80%. The 5-year overall survival (OS) is 95.2% in the long and 95.0% in the short arm (HR 1.07, 90% CI 0.74-1.56). Cardiac events are significantly lower in the short arm (risk-ratio 0.33, 95% CI 0.22-0.50, P < 0.0001). Conclusions: This study failed to show the non-inferiority of a shorter trastuzumab administration. One-year trastuzumab remains the standard. However, a 9-week administration decreases the risk of severe cardiac toxicity and can be an option for patients with cardiac events during treatment and for those with a low risk of relapse. Trial Registration: EUDRACT number: 2007-004326-25; NCI ClinicalTrials.gov number: NCT00629278.


Subject(s)
Antineoplastic Agents, Immunological/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Breast Neoplasms/therapy , Cardiotoxicity/epidemiology , Trastuzumab/administration & dosage , Adult , Aged , Anthracyclines/administration & dosage , Anthracyclines/adverse effects , Antineoplastic Agents, Immunological/adverse effects , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Antineoplastic Combined Chemotherapy Protocols/standards , Breast Neoplasms/mortality , Breast Neoplasms/pathology , Bridged-Ring Compounds/administration & dosage , Bridged-Ring Compounds/adverse effects , Cardiotoxicity/etiology , Chemotherapy, Adjuvant/adverse effects , Chemotherapy, Adjuvant/methods , Chemotherapy, Adjuvant/standards , Disease-Free Survival , Drug Administration Schedule , Female , Humans , Mastectomy , Middle Aged , Neoplasm Recurrence, Local , Neoplasm Staging , Receptor, ErbB-2/metabolism , Taxoids/administration & dosage , Taxoids/adverse effects , Time Factors , Trastuzumab/adverse effects
4.
Ann Oncol ; 28(11): 2820-2826, 2017 Nov 01.
Article in English | MEDLINE | ID: mdl-28950305

ABSTRACT

BACKGROUND: B490 (EudraCT# 2011-002564-24) is a randomized, phase 2b, noninferiority study investigating the efficacy and safety of first-line cetuximab plus cisplatin with/without paclitaxel (CetCis versus CetCisPac) in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). PATIENTS AND METHODS: Eligible patients had confirmed R/M SCCHN (oral cavity/oropharynx/larynx/hypopharynx/paranasal sinus) and no prior therapy for R/M disease. Cetuximab was administered on day 1 (2-h infusion, 400 mg/m2), then weekly (1-h infusions, 250 mg/m2). Cisplatin was given as a 1-h infusion (CetCis arm: 100 mg/m2; CetCisPac arm: 75 mg/m2) on day 1 of each cycle for a maximum of six cycles. Paclitaxel was administered as a 3-h infusion (175 mg/m2) on day 1 of each cycle. After six cycles, maintenance cetuximab was administered until disease progression or unacceptable toxicity. The primary end point was progression-free survival (PFS). We assumed a noninferiority margin of 1.40 as compatible with efficacy. RESULTS: A total of 201 patients were randomized 1 : 1 to each regimen; 191 were assessable. PFS with CetCis (median, 6 months) was noninferior to PFS with CetCisPac (median, 7 months) [HR for CetCis versus CetCisPac 0.99; 95% CI: 0.72-1.36, P = 0.906; margin of noninferiority (90% CI of 1.4) not reached]. Median overall survival was 13 versus 11 months (HR = 0.77; 95% CI: 0.53-1.11, P = 0.117). The overall response rates were 41.8% versus 51.7%, respectively (OR = 0.69; 95% CI: 0.38-1.20, P = 0.181). Grade ≥3 adverse event rates were 76% and 73% for CetCis versus CetCisPac, respectively, while grade 4 toxicities were lower in the two-drug versus three-drug arm (14% versus 33%, P = 0.015). No toxic death or sepsis were reported and cardiac events were negligible (1%). CONCLUSION: The two-drug CetCis regimen proved to be noninferior in PFS to a three-drug combination with CetCisPac. The median OS of both regimens is comparable with that observed in EXTREME, while the life-threatening toxicity rate appeared reduced. CLINICAL TRIAL NUMBER: EudraCT# 2011-002564-24.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Squamous Cell/drug therapy , Head and Neck Neoplasms/drug therapy , Neoplasm Recurrence, Local/drug therapy , Adult , Aged , Aged, 80 and over , Carcinoma, Squamous Cell/secondary , Cetuximab/administration & dosage , Cisplatin/administration & dosage , Female , Follow-Up Studies , Head and Neck Neoplasms/pathology , Humans , Lymphatic Metastasis , Male , Middle Aged , Neoplasm Recurrence, Local/pathology , Paclitaxel/administration & dosage , Prognosis , Survival Rate
5.
Arch Clin Neuropsychol ; 37(4): 753-761, 2022 May 16.
Article in English | MEDLINE | ID: mdl-34933340

ABSTRACT

OBJECTIVE: Impaired self-awareness (ISA) of altered functional capacities is a common sequelae of severe acquired brain injury that can severely hamper neuro-rehabilitation in this clinical population. ISA is frequently associated with anosodiaphoria and/or apathy. Although several scales are available to measure apathy, no tools have been published to specifically assess anosodiaphoria after acquired brain injury. In this paper, we reported an initial effort to develop an anosodiaphoria subscale in a commonly used measure of ISA, that is, the Patient Competency Rating scale-neurorehabilitation form (PCRS-NR). METHOD: A sample of 46 participants with severe acquired brain injury completed a functional, ISA, apathy, and anosodiaphoria assessment. One informal caregiver of each patient participated in the study. Thus, we were able to obtain external data on his/her level of functional competencies, and self-awareness, which allowed separating patients with low self-awareness (LSA) from those with high self-awareness (HSA). Finally, the patients were compared with 44 healthy age-gender-years of formal education matched control participants (HCs). RESULTS: Compared to both patients with HSA and HCs, patients with LSA demonstrated greater anosodiapvhoria and lower levels of functioning than both HSA patients and HCs. A stronger relationship emerged between ISA and anosodiaphoria rather than with apathy. CONCLUSIONS: These initial findings provide support that PCRS scale can be adapted to measure anosodiaphoria as well as ISA. The findings reveal a stronger correlation between this measure of anosodiaphoria and ISA compared with the correlation of apathy to ISA. The present method for measuring anosodiaphoria takes into account the actual levels of patients' functioning.


Subject(s)
Agnosia , Apathy , Brain Injuries , Agnosia/complications , Awareness , Brain Injuries/complications , Brain Injuries/diagnosis , Female , Humans , Male , Neuropsychological Tests
6.
J Small Anim Pract ; 62(2): 150-155, 2021 02.
Article in English | MEDLINE | ID: mdl-31512264

ABSTRACT

This case series describes a novel mini coeliotomy approach using a radial, atraumatic self-retaining retractor for the retrieval of migrant plant foreign bodies from the iliopsoas muscles of six male dogs under intra-operative ultrasonographic guidance. Four dogs had a history of pulmonary disease potentially compatible with inhalation of a foreign body approximately 2-4 months before presentation. Under ultrasonographic guidance, the grass awns were identified in the iliopsoas muscle and were completely removed. In this case series, the annular ring device provided an excellent view of the surgical field for intra-abdominal manipulations. Patient follow-up at 15 days and 6 to 12 months after surgery indicated a full recovery, and no grass awn fragment residues were identified.


Subject(s)
Dog Diseases , Foreign Bodies , Foreign-Body Migration , Animals , Dog Diseases/surgery , Dogs , Foreign Bodies/diagnostic imaging , Foreign Bodies/surgery , Foreign Bodies/veterinary , Foreign-Body Migration/veterinary , Male , Poaceae , Ultrasonography
7.
Sci Robot ; 6(51)2021 02 24.
Article in English | MEDLINE | ID: mdl-34043528

ABSTRACT

Future robotic systems will be pervasive technologies operating autonomously in unknown spaces that are shared with humans. Such complex interactions make it compulsory for them to be lightweight, soft, and efficient in a way to guarantee safety, robustness, and long-term operation. Such a set of qualities can be achieved using soft multipurpose systems that combine, integrate, and commute between conventional electromechanical and fluidic drives, as well as harvest energy during inactive actuation phases for increased energy efficiency. Here, we present an electrostatic actuator made of thin films and liquid dielectrics combined with rigid polymeric stiffening elements to form a circular electrostatic bellow muscle (EBM) unit capable of out-of-plane contraction. These units are easy to manufacture and can be arranged in arrays and stacks, which can be used as a contractile artificial muscle, as a pump for fluid-driven soft robots, or as an energy harvester. As an artificial muscle, EBMs of 20 to 40 millimeters in diameter can exert forces of up to 6 newtons, lift loads over a hundred times their own weight, and reach contractions of over 40% with strain rates over 1200% per second, with a bandwidth over 10 hertz. As a pump driver, these EBMs produce flow rates of up to 0.63 liters per minute and maximum pressure head of 6 kilopascals, whereas as generator, they reach a conversion efficiency close to 20%. The compact shape, low cost, simple assembling procedure, high reliability, and large contractions make the EBM a promising technology for high-performance robotic systems.


Subject(s)
Artificial Organs , Muscles , Robotics , Smart Materials , Biomimetic Materials , Biomimetics/instrumentation , Equipment Design , Humans , Mechanical Phenomena , Muscle Contraction , Robotics/instrumentation , Static Electricity , Stimuli Responsive Polymers , Transducers
8.
Radiol Med ; 115(7): 1101-10, 2010 Oct.
Article in English, Italian | MEDLINE | ID: mdl-20680502

ABSTRACT

PURPOSE: Vertebral fractures (VFs) are the hallmark of osteoporosis and are responsible for almost 70,000 hospital admissions yearly, implying social costs and impaired quality of life for patients. In recent years, several techniques, both qualitative and quantitative, have been proposed for VF diagnosis, but a gold standard is not yet available and the visual semiquantitative (VSQ) assessment proposed by Genant remains the most validated. However, given the lack of a standardised method, in clinical practice, the diagnosis of VF is often missed, and patients are not correctly assessed. The aim of our study was to estimate the percentage of VFs not detected in clinical practice in italian population using the VSQ method and a new morphometric technique. MATERIALS AND METHODS: In 283 postmenopausal women referred to our clinic for osteoporosis screening, we performed a clinical examination, plain spinal radiographs (for VSQ assessment) and digital computerised morphometry (DCM) to assess VFs. Bone density was measured using dual-energy X-ray absorptiometry (DXA). RESULTS: Forty-seven percent of patients had a T score <-2.5 standard deviations (SD), and 35.2% were osteopenic, but no significant correlations between T score and grade or number of fractures were found. DCM identified VFs in 38.5% of patients versus 32.5% using the VSQ method. Overall, 280 VFs were detected by DCM and 236 by VSQ, whereas only 105 were recognised by the reports. CONCLUSIONS: VFs went undetected in 55.5% according to the VSQ method on standard spinal radiographs. Therefore, the morphometric technique may be helpful when performed with the semiquantitative approach to improve recognition of VFs. However, other studies are needed to further validate the utility of this new morphometric technique in clinical practice.


Subject(s)
Osteoporotic Fractures/diagnostic imaging , Spinal Fractures/diagnostic imaging , Aged , Female , Humans , Middle Aged , Osteoporotic Fractures/diagnosis , Radiography , Sensitivity and Specificity , Spinal Fractures/diagnosis , Spine/diagnostic imaging
9.
Radiol Med ; 114(8): 1267-82, 2009 Dec.
Article in English | MEDLINE | ID: mdl-19902328

ABSTRACT

PURPOSE: The authors sought to evaluate the potential of magnetic resonance (MR) imaging with superparamagnetic iron oxide (SPIO) contrast material for identifying, characterising and differentiating dysplastic nodules (DN) and hepatocellular carcinoma (HCC) in the cirrhotic liver by correlating the results with pathological findings on the explanted liver. MATERIAL AND METHODS: MR imaging was used to study the liver of 400 cirrhotic patients awaiting liver transplantation, 31 of whom were selected to receive a liver. Of these 31 patients, we included in the study 22 patients (mean age 53 years; range 46-57 years) who underwent liver transplantation within 12-24 h after MR examination. Patients were studied with a 1.5-T device, and scans were acquired before and after the administration of paramagnetic contrast material. For every lesion, we recorded signal intensity on unenhanced baseline T1- and T2-weighted images and enhancement pattern after SPIO administration. Histological examination of the entire liver provided the definitive diagnosis of the lesions. RESULTS: Histological examination identified 59 lesions: 14 HCC, 4 HCC-DN, 39 DN, and 2 cystoadenomas. Among the 14 HCC, three were well differentiated, eight were moderately differentiated and three were poorly differentiated. Of the 39 DN, 28 were low-grade and 11 high-grade lesions. Unenhanced baseline MR imaging correctly identified and characterised 20 lesions, equal to 33.90% of all lesions: 6 HCC, 12 DN and 2 DN with a subfocus of HCC. SPIO-enhanced MR imaging showed greater sensitivity detecting and characterising 45 lesions, equal to 76.27% of all lesions identified at histology: 14 HCC, 27 DN and 4 DN with subfocus of HCC. SPIO administration improved the sensitivity of MR imaging in lesion detection and characterisation by 42.37%. False negative results with SPIO-enhanced MR imaging occurred in 12 DN (31%), which histological examination revealed to be low-grade DN with a diameter <1 cm. CONCLUSIONS: SPIO-enhanced MR imaging proved to be of value in detecting and characterising lesions in the cirrhotic liver, allowing differentiation of DN from HCC and providing an early diagnosis of neoplastic degeneration of DN.


Subject(s)
Carcinoma, Hepatocellular/diagnosis , Contrast Media , Ferrosoferric Oxide , Focal Nodular Hyperplasia/pathology , Liver Cirrhosis/diagnosis , Liver Neoplasms/diagnosis , Magnetic Resonance Imaging , Carcinoma, Hepatocellular/etiology , Carcinoma, Hepatocellular/surgery , Cell Transformation, Neoplastic , Dextrans , Diagnosis, Differential , Early Detection of Cancer , Female , Humans , Liver Cirrhosis/complications , Liver Neoplasms/etiology , Liver Neoplasms/surgery , Liver Transplantation , Magnetite Nanoparticles , Male , Middle Aged , Predictive Value of Tests , Sensitivity and Specificity
10.
Clin Biochem ; 66: 103-105, 2019 Apr.
Article in English | MEDLINE | ID: mdl-30738031

ABSTRACT

We report a case of a heterophile antibodies interference in a new high-sensitivity troponin commercial immunoassay (cTNIH Siemens), observed in a patient with possible acute coronary syndrome (ACS). The analytical interference was investigated with standard laboratories procedures. The false positive result was found with different troponin methods and kits. We also investigated the protein sequence of cTnl and no sequence variants were detected. The discordance between clinical pictures and high concentration of cTnl, together with the collaboration between clinicians and laboratory staff avoided possible erroneous diagnosis and further invasive investigations to the patient.


Subject(s)
Chest Pain/blood , Troponin I/blood , Animals , Antibodies, Heterophile/immunology , Antibodies, Monoclonal/immunology , Cattle , False Positive Reactions , Goats , Humans , Immunoassay/methods , Male , Mice , Middle Aged , Sheep , Troponin I/immunology
11.
Breast ; 35: 115-121, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28711793

ABSTRACT

BACKGROUND: The BOLERO-2 trial reported efficacy and safety of Everolimus (EVE) and Exemestane (EXE) combination in HR+ advanced breast cancer (ABC) patients. The BALLET trial further evaluated the safety of EVE-EXE in HR+ ABC patients, without reporting efficacy data. Aim of the EVA real-life study was to collect data of efficacy and safety of EVE-EXE combination in the clinical setting, as well as exploring efficacy according to EVE Dose-Intensity (DI) and to previous treatment with Fulvestrant. PATIENTS AND METHODS: This study aimed to describe the outcome of ABC pts treated with EVE-EXE combination in terms of median duration of EVE treatment and ORR in a real-life setting. RESULTS: From July 2013 to December 2015, the EVA study enrolled 404 pts. Median age was 61 years (33-83). Main metastatic sites were: bone (69.1%), soft tissue (34.7%) and viscera (33.2%). Median number of previous treatments was 2 (1-7). 43.3% of the pts had received Fulvestrant. Median exposure to EVE was 31.0 weeks (15.4-58.3) in the whole population. No difference was observed in terms of EVE exposure duration according to DI (p for trend = 0.27) or type of previous treatments (p = 0.33). ORR and Disease Control Rate (DCR) were observed in 31.6% and 60.7% of the patients, respectively, with the lowest ORRs confined in CHT pre-treated patients or in those who received the lowest DI of EVE. Grade 3-4 adverse events (AEs) were reported in 37.9% of the patients. Main AEs were: stomatitis (11.2%), non-infectious pneumonitis - NIP (3.8%), anaemia (3.8%) and fatigue (3.2%). CONCLUSIONS: The EVA study provided new insights in the use of EVE-EVE combination in HR+ ABC pts many years after the publication of the pivotal trial. The combination is safe and the best response could be obtained in patients receiving the full dose of EVE and/or after hormone-therapy as Fulvestrant in ABC.


Subject(s)
Androstadienes/administration & dosage , Breast Neoplasms/drug therapy , Breast Neoplasms/metabolism , Everolimus/administration & dosage , Receptor, ErbB-2/metabolism , Adult , Aged , Aged, 80 and over , Breast Neoplasms/pathology , Female , Follow-Up Studies , Humans , Middle Aged , Neoplasm Metastasis , Neoplasm Staging
12.
Leukemia ; 5 Suppl 1: 95-101, 1991.
Article in English | MEDLINE | ID: mdl-1716340

ABSTRACT

One hundred seventy-nine patients with intermediate or high-grade non-Hodgkin's lymphoma were randomized to receive either ProMACE-CytaBOM (P-C) or MACOP-B (M-B). At last follow-up 71 patients in the P-C arm and 78 in the M-B arm were assessable for response. Forty-one patients treated with P-C (58%) and 49 patients treated with M-B (63%) achieved a CR. Moreover 18 and 22 patients achieved PR with P-C and M-B, respectively. Twenty-five patients relapsed, 12 in the P-C arm and 13 in the M-B arm. Thirty-nine patients died, 32 from disease progression, 5 from treatment related causes, and 2 from other causes. No differences between the two treatment groups were observed as regard to relapse or death-rate. At 27 months the survival rate was of 71.9% for patients treated with P-C and 70.7% for those treated with M-B. At 2 years the RFD rate was 64% and 60% for patients in P-C and M-B arm, respectively. Patients treated with M-B experienced an high rate of methotrexate-related toxicity. ProMACE-CytaBOM and M-B seem provided with similar activity. However P-C seem less toxic and more manageable in an outpatient setting.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Lymphoma, Non-Hodgkin/drug therapy , Adolescent , Adult , Aged , Bleomycin/administration & dosage , Bleomycin/therapeutic use , Cyclophosphamide/administration & dosage , Cyclophosphamide/therapeutic use , Cytarabine/administration & dosage , Dose-Response Relationship, Drug , Doxorubicin/administration & dosage , Doxorubicin/therapeutic use , Etoposide/administration & dosage , Female , Hematopoiesis/drug effects , Humans , Inflammation/chemically induced , Male , Methotrexate/administration & dosage , Methotrexate/therapeutic use , Middle Aged , Mucous Membrane , Prednisolone/therapeutic use , Prednisone/administration & dosage , Prognosis , Prospective Studies , Survival Analysis , Vincristine/administration & dosage , Vincristine/therapeutic use
13.
J Invest Dermatol ; 71(6): 361-2, 1978 Dec.
Article in English | MEDLINE | ID: mdl-722111

ABSTRACT

In basal cell epitheliomas the testosterone metabolism pattern differs from that of the normal surrounding skin. There is a significant reduction in 5 alpha-reductase activity with a consequent decrease in production of dihydrotestosterone and androstanediols. By contrast the 17 beta-hydroxysteroid dehydrogenase activity shows no consistent change.


Subject(s)
Carcinoma, Basal Cell/metabolism , Skin Neoplasms/metabolism , Skin/metabolism , Testosterone/metabolism , Aged , Androstane-3,17-diol/metabolism , Androstenediols/metabolism , Female , Humans , Male , Middle Aged , Oxidoreductases/metabolism
14.
Eur J Cancer ; 34(12): 1974-6, 1998 Nov.
Article in English | MEDLINE | ID: mdl-10023325

ABSTRACT

The aim of this randomised trial was to compare the efficacy of bolus versus continuous infusion cisplatin combined with mitomycin C and vindesine (MVP) for chemotherapy-naive patients with stage IIIB-IV non-small cell lung cancer (NSCLC). 97 patients (49 given bolus cisplatin-arm A and 48 given continuous infusion cisplatin--arm B) were evaluable for response. In arm A, 2 patients achieved a complete response (CR), 21 achieved a partial response (PR), whilst in arm B, 14 patients achieved a PR (29%) (P = 0.07). Median survival was 8 months in both arms. Myelosuppression was the most frequent and severe toxicity, with a higher incidence of grade 3-4 leucopenia in arm A when compared with arm B (44% versus 25%). In conclusion, there is no advantage for a cisplatin 5 day infusion in the MVP regimen.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Non-Small-Cell Lung/drug therapy , Lung Neoplasms/drug therapy , Adult , Aged , Cisplatin/administration & dosage , Female , Humans , Infusions, Intravenous , Male , Middle Aged , Mitomycins/administration & dosage , Prospective Studies , Vindesine/administration & dosage
15.
Neuropharmacology ; 34(4): 427-31, 1995 Apr.
Article in English | MEDLINE | ID: mdl-7566474

ABSTRACT

Anticonvulsant drugs, such as carbamazepine, may exert some of their effects through peripheral benzodiazepine receptors (PBR), which are present in glial cells and regulate the synthesis of neurosteroids. PBR have also been demonstrated in human lymphocytes, where they might be used as peripheral markers of anticonvulsant drug effects. In the present paper we investigated the interaction of various antiepileptic drugs with PBR of human lymphocytes and evaluated possible effects of acute and chronic treatment with these drugs. At normal therapeutic concentrations, diazepam, carbamazepine and phenobarbital occupy respectively 70, 30 and 10% of PBR sites in human lymphocytes. Although no change of receptor density or affinity was observed after acute in vitro treatment, in epileptic patients chronically treated with carbamazepine, phenobarbital and valproic acid, PBR Bmax was increased with respect to controls and untreated epileptics. Since PBR of human lymphocytes may be affected by anticonvulsant drug treatment, we suggest that they might be involved in the immunological alterations reported in these patients and might be used as peripheral markers of drug effects on the central nervous system.


Subject(s)
Anticonvulsants/pharmacology , Lymphocytes/drug effects , Receptors, GABA-A/drug effects , Adolescent , Cells, Cultured , Child , Evaluation Studies as Topic , Female , Humans , Male
16.
Int J Oncol ; 10(2): 395-400, 1997 Feb.
Article in English | MEDLINE | ID: mdl-21533390

ABSTRACT

The aim was to compare the efficacy of ondansetron and a combination of ondansetron plus dexamethasone in the prophylaxis of cisplatin-induced delayed emesis over three consecutive courses of chemotherapy. Cancer patients scheduled to receive for the first time cisplatin (>50 mg/m(2)) in combination with other cytotoxic agents, were recruited in a multicentre, randomised, double-blind study and treated with ondansetron 8 mg i.v. and dexamethasone 20 mg i.v. Twenty-four hours after the start of chemotherapy, patients were randomised to treatment either with oral ondansetron 8 mg bd plus placebo on days 2-5 (group A) or with oral ondansetron 8 mg bd plus oral dexamethasone 8 mg bd on days 2-3, and 4 mg bd on days 4 and 5 (group B). Two hundred and thirty-six cancer patients were recruited into the study. Complete protection from delayed vomiting/nausea in group A and group B was Obtained in 50/39% and in 63/42% of patients, respectively in the first course; in 55/34% and in 64/40% in the second and in 49/31% and 60/37% in the third. Logistic regression analysis reveals a statistically significant difference in incidence of emesis between the combination of ondansetron plus dexamethasone and ondansetron alone (P<0.05). The same model, however, shows no difference in incidence of nausea between the two treatment regimens. Ondansetron plus dexamethasone reduces the risk of delayed emesis following cisplatin chemotherapy as compared to ondansetron alone.

17.
J Clin Pathol ; 50(3): 259-60, 1997 Mar.
Article in English | MEDLINE | ID: mdl-9155682

ABSTRACT

Clostridium sordellii is an infrequent human pathogen. It has been demonstrated to be occasionally responsible for myonecrosis or gas gangrene. Interestingly, in the obstetric literature, some cases of postpartum maternal deaths have been associated with C sordellii infection causing a rapidly lethal toxin mediated syndrome. This is the first reported case of postpartum death in a 29 year old woman, in which a toxigenic C sordellii was isolated from the patient's blood antemortem during the fatal toxic shock, strongly indicating its role in this rare syndrome.


Subject(s)
Cesarean Section , Clostridium Infections/microbiology , Postoperative Complications/microbiology , Shock, Septic/microbiology , Adult , Animals , Bacterial Toxins/toxicity , Clostridium/classification , Clostridium/isolation & purification , Fatal Outcome , Female , Humans , Mice , Mice, Inbred BALB C , Pregnancy
18.
Clin Neurophysiol ; 110(5): 876-86, 1999 May.
Article in English | MEDLINE | ID: mdl-10400201

ABSTRACT

OBJECTIVE: To detect early losses of contrast sensitivity (CS) in patients with pituitary adenomas, before the occurrence of visual acuity and visual field defects. METHODS: CS has been evaluated in both hemifields of 28 patients with different kinds of pituitary adenoma (mainly intrasellar) and normal visual acuity and visual field, as well as in 15 age-matched controls. Two different stimuli were used: a coarse (0.3 c/deg) dynamic (10 Hz) grating and a finer (2 c/deg) static grating. RESULTS: On average, CS and/or hemifield asymmetry were reduced in patients, whereas perimetric sensitivity was normal. CS losses were more frequent for 2 c/deg static-, as compared with 0.3 c/deg, 10 Hz stimuli. However selective losses for either stimuli were also found. CS losses did not correlate with anatomical measurements (size, chiasm involvement) of tumors as established by MRI scans. CONCLUSIONS: CS evaluation may provide a simple and effective tool for early detection and monitoring of visual dysfunction in patients with pituitary adenoma. The lack of correlation between CS losses and chiasm involvement suggests causes different from chiasmal compression for visual dysfunction.


Subject(s)
Adenoma/physiopathology , Contrast Sensitivity/physiology , Pituitary Neoplasms/physiopathology , Visual Acuity/physiology , Visual Fields/physiology , Adult , Aged , Female , Functional Laterality/physiology , Humans , Male , Middle Aged , Photic Stimulation
20.
Diabetes Res Clin Pract ; 39(2): 101-6, 1998 Feb.
Article in English | MEDLINE | ID: mdl-9597379

ABSTRACT

With the aim to assess the prevalence and the main clinical correlations of skin lesions in diabetes mellitus, 457 diabetic subjects consecutively attending an outpatient clinic underwent a dermatological examination. Neurovascular foot lesions were excluded. Thirty-five of 64 IDDM patients (54%) had skin alterations mainly consisting of vitiligo (9% of all patients), psoriasis (9%) and eczema (8%). The most frequent skin lesions observed in 240/393 NIDDM subjects (61%) were represented by infections (20% of all patients) and diabetic dermopathy (12.5%), while other lesions were not common. NIDDM patients with skin infections had a worse metabolic control, and those with diabetic dermopathy had a greater prevalence of neuropathy and large vessel disease than patients without skin lesions. These data show that the prevalence of skin diseases in a large, unselected diabetic population is higher than expected and indicate that, in most cases, a careful dermatological examination and a better metabolic control are needed in order to improve quality of life in these patients.


Subject(s)
Diabetes Mellitus, Type 1/complications , Diabetes Mellitus, Type 2/complications , Skin Diseases/complications , Adolescent , Adult , Aged , Candidiasis/complications , Candidiasis/drug therapy , Dermatomycoses/complications , Dermatomycoses/drug therapy , Diabetes Mellitus, Type 1/metabolism , Diabetes Mellitus, Type 2/metabolism , Diabetic Angiopathies/complications , Diabetic Angiopathies/epidemiology , Diabetic Angiopathies/metabolism , Diabetic Neuropathies/complications , Diabetic Neuropathies/epidemiology , Diabetic Neuropathies/metabolism , Female , Humans , Hypersensitivity, Delayed/chemically induced , Hypoglycemic Agents/adverse effects , Hypoglycemic Agents/therapeutic use , Insulin/adverse effects , Insulin/therapeutic use , Italy/epidemiology , Male , Middle Aged , Prevalence , Skin/drug effects , Skin/microbiology , Skin/pathology , Skin Diseases/epidemiology , Skin Diseases/microbiology
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