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Biomedical subjects

S Pampallona

Publications and source records attributed to S Pampallona.

At least 37 records · Page 2Linked to original sources
PubMed1999

Extrapyramidal syndromes in neuroleptic-treated patients: prevalence, risk factors, and association with tardive dyskinesia.

Prevalence and risk factors for extrapyramidal syndromes (EPS) were investigated in a sample of 1,559 patients. The overall prevalence of EPS was 29.4% (N = 458). Among the EPS-diagnosed patients, parkinsonism as assessed by the presence of core parkinsonian symptoms (rigidity, tremor, bradykinesia) was present in 65.9% of patients (N = 302), akathisia in 31.8% (N = 145), and acute dystonia in 2.1% (N = 10). Old age and long-term neuroleptic drug (NL) treatment were significantly associated with EPS in both the univariate and the multivariate analyses, whereas no relationship was observed with average NL daily doses and current NL treatment. EPS was diagnosed in 50.2% of 285 patients with persistent tardive dyskinesia (TD). Distribution of EPS in patients with TD showed that tremor and akathisia were more frequent in peripheral TD cases than in orofacial TD cases. Furthermore, there was a stronger association of NL-induced parkinsonism with peripheral TD than with orofacial TD. This study suggests that the association between EPS and TD may be limited to specific subtypes of TD. Peripheral TD showed a higher association with parkinsonism and with akathisia, suggesting that these symptoms may share a common pathophysiology.

Adolescent↗
PubMed1999

Effectiveness of antidepressants. Meta-analysis of dose-effect relationships in randomised clinical trials.

BACKGROUND: Antidepressant drugs are usually prescribed at low doses, possibly to avoid adverse reactions. No comprehensive review has addressed the issue of dose, clinical response and tolerability in a quantitative way. AIMS: To determine whether high doses of antidepressants are more effective than low doses, and how safety is affected by dose. METHOD: Trials comparing two or more doses of the same antidepressant were located, and all antidepressants administered were converted to the equivalent dose of imipramine. Generalised estimating equations were used to analyse percentage improvement and adverse event rate according to dose level. RESULTS: Thirty-three studies were identified. The dose level 100-200 mg imipramine equivalents showed an average improvement of 53% by 'intention-to-treat'. Higher doses were not accompanied by increased efficacy, while lower doses showed reduction in efficacy. Adverse events significantly increased with dose. CONCLUSIONS: With a low dose of antidepressants, clinicians trade off a slightly reduced chance of improvement for a higher chance of avoiding adverse reactions.

Age Factors↗
PubMed1999

Multiple courses of high-dose ifosfamide, carboplatin, and etoposide with peripheral-blood progenitor cells and filgrastim for small-cell lung cancer: A feasibility study by the European Group for Blood and Marrow Transplantation.

PURPOSE: To determine the feasibility and safety of multiple sequential courses of high-dose chemotherapy and peripheral-blood progenitor cells (PBPCs) administered in a multicenter setting to patients with small-cell lung cancer. PATIENTS AND METHODS: Sixty-nine patients (limited disease, n = 30; extensive disease, n = 39) treated at 15 European centers were scheduled to receive three courses of high-dose chemotherapy with ifosfamide 10 g/m(2), carboplatin 1200 mg/m(2), and etoposide 1200 mg/m(2) (ICE) divided over 4 days at 28-day intervals. PBPCs were harvested before treatment and mobilized with epirubicin 150 mg/m(2) administered via an intravenous bolus divided over 2 days and filgrastim 5 microg/kg/d administered subcutaneously. RESULTS: The performed leukaphereses (one to five per patient) yielded a median of 16.6 x 10(6)/kg (range, 1.0 to 96.6 x 10(6)/kg) CD34(+) cells, which was sufficient for three reinfusions. Fifty patients (72%) completed the treatment according to schedule. Nine patients completed two courses, and six patients completed one course of treatment. The increase in dose-intensity was 290% that of a standard ICE regimen. The median duration of myelosuppression was similar between courses, namely 4 days (range, 1 to 12 days) for leukocytes less than 0.5 x 10(9)/L and 4 days (range, 0 to 22 days) for thrombocytes less than 20 x 10(9)/L. Febrile neutropenia developed in 66% of courses, severe diarrhea in 14%, mucositis in 10%, and nausea and vomiting in 21% of courses. There were six cases of toxic death (9%), most of which occurred in the first year of accrual and thus were attributable to the learning curve. The antitumor effect of the regimen was reflected in an 86% remission rate (95% confidence interval [CI], 74% to 93%), with 51% of patients achieving a complete response (95% CI, 38% to 63%). Median overall survival was 18 months for patients with limited disease and 11 months for patients with extensive disease. CONCLUSION: This multiple sequential high-dose ICE regimen could be safely administered on a multicenter basis to patients with small-cell lung cancer. The dose-intensity could be increased to 290% that of standard ICE regimen. The benefit of this approach is currently being tested in a randomized trial that aims to double the long-term rate of survival for patients with small-cell lung cancer.

Adult↗
PubMed1998

Palliative care of cancer patients: audit of current hospital procedures.

The palliative care of cancer patients admitted for tumour-related symptoms to three different departments (medical oncology, radiotherapy, internal medicine) of a general hospital was prospectively audited. The physicians directly responsible for the patients provided prospective data by reporting both the diagnostic and therapeutic interventions performed and the degree of control achieved for each symptom. A patient form for evaluation of the control achieved in the case of each symptom by means of linear analogue scales was also provided. The appropriateness of all procedures was evaluated by two external auditors. Over 6 months, 125 such admissions were recorded: 24 patients entered the study and the management of 56 symptoms, the most common of which were pain and dyspnoea, was reviewed. A total of 72 diagnostic procedures were performed, deemed necessary for only 50% of symptoms, optional for 15%, and performed as part of a logical sequence for 38%. A total of 130 therapeutic interventions were undertaken, deemed necessary for 55% of symptoms, optional for 15% and carried out as part of a logical sequence for 44%. Re-evaluations of symptoms and physician and patient evaluations of the degree of control achieved could not be assessed because of lack of information. The audit could not be repeated owing to the low accrual of patients and incompleteness of the data collection. Reasons for failure of the study and proposals for feasible methods of auditing the management of symptoms in cancer patients are discussed.

Adult↗
PubMed1998

In vitro schedule-dependency of myelotoxicity and cytotoxicity of Ecteinascidin 743 (ET-743).

BACKGROUND: Ecteinascidin (ET-743) is a marine derived compound with an interesting preclinical profile currently completing phase I clinical trials. The present study was undertaken to compare the toxicity of different schedules of ET-743 against human hemopoietic progenitors and tumour cell lines. MATERIALS AND METHODS: Human hemopoietic progenitors and solid tumour cell lines were incubated with ET-743 for one hour, 24 hours and one hour daily for five consecutive days to define by comparison an 'in vitro therapeutic index'. Additional experiments were set up to assess whether incubation for 24 hours or five days could change either the sensitivity of cells or the activity of ET-743. RESULTS: Prolonged or repeated exposures were more toxic than a single one hour exposure (P < 0.001), but due to the higher sensitivity to prolonged exposure of several tumor cell lines, prolonged treatment yielded a more favorable in vitro therapeutic index. After incubation for 24 hours, ET-743 showed a significantly (P < 0.01) lower inhibiting capacity. Incubation before treatment rendered progenitors more resistant, but incubation after treatment increased their sensitivity, so that overall the toxicity of ET-743 on hemopoietic cells appears to be close to AUC dependency. CONCLUSIONS: Despite the possible effect of some experimental artefacts, prolonged exposure could represent the best schedule of administration of ET-743.

Antineoplastic Agents, Alkylating↗
PubMed1998

Extensive phenotypic analysis of CD34 subsets in successive collections of mobilized peripheral blood progenitors.

The transplantation of mobilized progenitor cells after high-dose chemotherapy shortens haemopoietic engraftment. CD34 cell subsets were examined in 20 consecutive mobilized progenitor cell collections obtained from patients with solid tumours that had not been previously treated. The analysis of CD34 cells was based on the expression of intracellular antigens, surface antigens including CD38, and cell size using multi-dimensional flow cytometry. We also correlated the numbers of stem cell subsets reinfused to haemopoietic recovery. The majority of CD34+ cells expressed CD13 and CD33. A significant proportion was cytoplasmic myeloperoxidase (cMPO) positive. CD34+ MPO+ cells increased significantly in late collections. MPO expression was related to cell size. Cells expressing CD13 also increased in late collections in parallel to CFU-GM count. Small subpopulations of CD34+ CD38+ were committed to B cells, T cells and erythroid cell lineages. A small population expressing the megakaryocytic antigen had a small size and were predominantly CD38-. A minor subpopulation expressed stem cells antigens. These were significantly higher in late collections (CD34+ Thy-1+ and CD34+ CD33-). After mobilization, patients received three cycles of intensive chemotherapy followed by reinfusion of mobilized progenitors (5.45 x 10(6)/kg CD34+ cells, range 3.4-11.88). The numbers of reinfused CD34 cells or the individual subsets did not influence recovery of leucocytes (9 d) or platelets (9 d). In conclusion, the numbers of stem cells and their subsets differed between collections and, in unpretreated patients receiving intensive chemotherapy, there was no delayed engraftment when sufficient numbers of stem cells were reinfused. The recovery period was short and not correlated to any stem cell subsets.

Adult↗
PubMed1997

Systemic release of soluble TNF receptors after high-dose TNF in isolated limb perfusion.

Isolated limb perfusion (ILP) with high dose tumour necrosis factor (TNF), interferon gamma and melphalan (TIM) is an efficient treatment for patients with regionally advanced melanoma and sarcoma. In 44 patients, we determined the kinetics of soluble TNF receptors (sTNF-RI and RII) plasma concentrations, and correlated them with systemic TNF and interleukin 6 (IL-6) levels and shock. Seven patients treated conventionally by ILP without cytokine served as controls. Elevated levels of both sTNF-Rs were observed within 30 min after beginning of the TIM-ILP. A first peak of sTNF-Rs levels was observed 3 h after ILP and was followed by a rapid decrease reaching a nadir at 12-14 h post ILP. This first peak was followed by a second, long-lasting elevation of both sTNF-Rs levels persisting for 4 to 5 days after TIM-ILP. Patients treated by ILP without TNF/interferon gamma (IFN-gamma) had no detectable increase in either sTNF-Rs or in circulating TNF, demonstrating that the release of TNF-Rs was dependent upon the administration of TNF/IFN-gamma. High plasma levels of TNF and IL-6 were observed in patients that had more than 5% leakage during the TIM-ILP, but no significant correlation between TNF levels and the peak values of both sTNF-Rs was observed. The levels of TNF and IL-6 were, however, significantly related to each other. TNF systemic levels, but not sTNF-Rs concentrations, correlated significantly with the severity of the shock observed after TIM-ILP. Patients in which sTNF-RII concentration was in excess over circulating TNF, had no shock or grade I shock only, suggesting that sTNF-RII may play a protective, although limited, role in inhibiting activity of circulating TNF.

Chemotherapy, Cancer, Regional Perfusion↗
PubMed1997

Radiation therapy duration influences overall survival in patients with cervical carcinoma.

OBJECTIVE: This article analyses the influence of treatment duration on survival in patients with invasive carcinoma of the cervix treated by radical radiation therapy. METHOD: Three hundred and sixty patients with FIGO stage IB-IIIB carcinoma of the cervix were treated in Lausanne (Switzerland) with external radiation and brachytherapy as first line therapy. Median therapy duration was 45 days. Patients were classified according to the duration of the therapies, taking 60 days (the 75th percentile) as an arbitrary cut-off. RESULTS: The 5-year survival was 61% (S.E. = 3%) for the therapy duration group of less than 60 days and 53% (S.E. = 7%) for the group of more than 60 days. In terms of univariate hazard ratio (HR), the relative difference between the two groups corresponds to a 50% increase of deaths (HR = 1.53, 95% CI = 1.03-2.28) for the longer therapy duration group (P = 0.044). In a multivariate analysis, the magnitude of estimated relative hazards for the longer therapies are confirmed though significance was reduced (HR = 1.52, 95% CI = 0.94-2.45, P = 0.084). CONCLUSION: These findings suggest that short treatment duration is a factor associated with longer survival in carcinoma of the cervix.

Adenocarcinoma↗
PubMed1997

Treatment of ocular melanoma metastatic to the liver by hepatic arterial chemotherapy.

PURPOSE: Ocular melanoma is characterized by a high rate of liver metastases and is associated with a median survival time less than 5 months. There is no standard treatment available. Treatment strategies have, without success, relied on the experience with metastatic cutaneous melanoma. The only effective treatment is chemoembolization using cisplatin and polyvinyl sponge, which has never become accepted on a large scale. The objective of the study was to establish prospectively the efficacy and toxicity of hepatic intraarterial fotemustine, a third-generation nitrosourea, in patients with liver metastases from ocular melanoma. PATIENTS AND METHODS: Thirty-one patients were subjected to laparotomy to place a totally implantable catheter into the hepatic artery and received fotemustine 100 mg/m2 as a 4-hour infusion, first once a week for four times and then, after a 5-week rest period, every 3 weeks until progression or toxicity. Cox regression models were used to assess the prognostic role of patient survival characteristics. RESULTS: Objective responses were observed in 12 of 30 assessable patients (40%; 95% confidence interval, 22% to 59%). The median duration of response was 11 months and the median overall survival time, 14 months. Lactate dehydrogenase (LDH) appeared to be the strongest prognostic factor for survival. Toxicity was minimal and treatment could be administered on an outpatient basis. CONCLUSION: The results of hepatic arterial chemotherapy with fotemustine produced a high response rate and survival similar to chemoembolization therapy. It involves no major toxicity and preserves the quality of life. To assess further its effectiveness, a randomized study to compare hepatic intraarterial versus intravenous chemotherapy is being planned.

Adult↗
PubMed1996

Effect of total treatment of time on event-free survival in carcinoma of the cervix.

The objective of this study was to analyze the effect of radiation therapy duration on event-free survival in patients with invasive carcinoma. Three hundred and sixty patients with FIGO stage IB-IIIB carcinoma of the cervix were treated with external radiation and brachytherapy as first line therapy. Median therapy duration was 45 days. Patients were classified according to whether they had rather long therapies, taking 60 days (the 75th percentile) as an arbitrary cutoff. Cumulative incidences of local recurrence, metastasis, and death were estimated. The 5-year event-free survival rate was 59 +/- 3% for the less than 60 days group and 42 +/- 7% for the more than 60 days group (P = 0.003). In terms of univariate hazard ratio (HR), the relative difference between the two groups corresponds to an increase in hazard of any of the three events considered more than the double (HR = 1.756, P = 0.003) for the longer therapy duration group. A multivariate analysis, which included selected prognostic factors, confirmed these results (HR = 1.76, P = 0.017). A short radiation therapy duration is a highly significant prognostic factor associated with longer event-free survival in carcinoma of the cervix.

Adult↗
PubMed1996

The last 3 months of life of cancer patients: medical aspects and role of home-care services in southern Switzerland.

The clinical data on terminal cancer patients who have died since the establishment of a program of collaboration between community services and the cancer center of Canton of Ticino, southern Switzerland, were retrospectively analyzed to describe the characteristics of patients seen and the effect on them of a home-care program coordinated by the cancer center. The home-care program is based on five geographically grouped community-based domiciliary services, with the addition of one nurse responsible for coordination and one physician from the oncology center. Selection criteria for participation in the home-care program are defined. The main outcome measures were: number of hospitalizations and median hospital stay during the last 3 months of life; reasons for and median length of last hospitalization; place of death of patients who had home care and those who did not. In the group of 993 patients analyzed, the median contact time with the cancer center was 9.5 months (10th percentile: 1 month, 90th percentile: 71 months); the most frequent neoplasm was lung cancer (22%) with the briefest contact time (7.5 months; 10th percentile: 1 month; 90th percentile: 21 months); 13.5% of patients were never hospitalized; half of the patients had a total hospital stay of 24 days or longer and 23% died at home. The sociodemographic and medical characteristics of home-care users were similar to those of the home-care non-users and to those of the overall group. In the group of home-care users (32% of the total) 22% were never hospitalized, half of the patients had a total hospital stay of 17 days or longer, and 43.5% of them died at home. These values were significantly different (P > 0.001) from those reported in the group of home-care non-users. Palliative care, provided at home through community-based domiciliary services, is associated with less frequent and shorter hospitalizations in the last 3 months of life. Medical oncology and palliative treatments should be mutually complementary to improve patients care. Cancer centers should be involved in the planning and coordination of supportive-care domiciliary services.

Aged↗
PubMed1996

Younger age as a bad prognostic factor in patients with carcinoma of the cervix.

OBJECTIVE: To verify the influence of age on the prognosis of cervix carcinoma. STUDY DESIGN: Five hundred and sixty eight patients treated for a FIGO stage IB-IVA with radical irradiation in the Centre Hospitalier Universitaire Vaudois of Lausanne were subdivided according to the following age categories: < or = 45, 46-60, 61-69 and >70 years. Taking the 46-60 years age group as the reference, the hazard ratios (HR) of death and corresponding 95% confidence intervals (95% CI) were estimated by means of a Cox multivariate analysis. RESULTS: The 5-year survival rates were, respectively, 57%, 67%, 60% and 45%. For the youngest women the risk of death was significantly increased (HR = 2.00, 95% CI [1.32-3.00]) and was even more accentuated in advanced stages. CONCLUSION: Age under 45 years is a bad prognostic factor in carcinoma of the cervix.

Adult↗
PubMed1995

A model to control data flow in multicenter clinical trials.

A model for the data management procedures of multicenter clinical trials is proposed. Focus will be restricted to those trials in which data are collected over time depending on therapy and follow-up schedules. The requirements for the model are structured data collection forms and a theoretical data flow governing the submission of materials by the participating institutions. The existence of a coordinating center is assumed, but the model presented here can be applied irrespective of the organizational set up of the research environment. It is suggested that each data collection form (or any other piece of documentation) is seen as an independent information holder, irrespective of the actual data it contains. The status of each form, from when it is expected by the coordinating center to when it is accepted for statistical analysis, can be summarized by a single variable, maintained by the data manager. Depending on its value, certain activities can be initiated, such as requesting missing forms or corrections. The implementation of the described model within a database system as well as its relation to the requirements for reliable statistical evaluation of the study are discussed with reference to a real example.

Clinical Trials as Topic↗
PubMed1995

Prevalence of tuberculosis in Vietnamese migrants: the experience of the Orderly Departure Program.

This study aimed to describe the Internal Organization for Migration (IOM) tuberculosis screening and treatment program in Ho-Chi-Minh City (Vietnam); and to review the prevalence of tuberculosis and treatment outcome in a cohort of Vietnamese migrants and refugees prior to their departure. From 1 November 1992 to 1 June 1993, prospective migrants and refugees bound to the United States, Australia, and Canada underwent medical examination by IOM in Ho-Chi-Minh City. Screening for tuberculosis was based on chest x-rays, and the diagnosis was confirmed by smear examination. Smear-positive patients received short-course chemotherapy, directly supervised, with isoniazid, rifampicin, ethambutol, and pyrazinamide. Out of 39,581 persons screened, 322 were smear-positive (641 per 100,000), and started treatment. Follow-up varied from a minimum of 12 months to a maximum of 18 months. At that time, 265 (82%) were cured, while the remaining either continued treatment with first-line drugs (24), started second-line treatment (17), or failed to be cured for various reasons (16). This report confirms the efficacy of short course chemotherapy and directly observed treatment for tuberculosis, in the context of one of the largest screening programs for prospective migrants. Follow-up in receiving countries would help clarify risk factors for both new infection and relapse of tuberculosis.

Adult↗
PubMed1994

Antipsychotic drugs: is more worse? A meta-analysis of the published randomized control trials.

Effectiveness and side-effects of high- versus low-dose neuroleptic treatment of chronic psychosis have been assessed through a meta-analysis of 22 published randomized control trials comparing different neuroleptic doses. No incremental clinical improvement was found at doses above 375 mg equivalent of chlorpromazine, while a significant increase in adverse reactions was observed.

Antipsychotic Agents↗
PubMed1994

Chemotherapy vs supportive care in advanced non-small-cell lung cancer. Results of a meta-analysis of the literature.

STUDY OBJECTIVE: To contribute to the current debate about the relative merits of meta-analysis of the literature (MAL) and of individual patients data (MAP). DESIGN: Identification of published randomized trials and extraction of essential results directly from the published reports. SETTING: Chemotherapy vs supportive care in advanced non-small-cell lung cancer. MEASUREMENTS AND RESULTS: Survival probability at 6 months after randomization, as estimated from the published survival curves, has been considered as the end-point of interest. Quality scoring of the studies has also been performed. Specific methodologic issues concerning the estimation of relevant quantities necessary for the MAL have been addressed. The estimated pooled odds ratio of death was 0.44, with 95 percent confidence interval of 0.32 to 0.59, thus significantly favoring chemotherapy, and it corresponds to an estimated increase in median survival from 3.9 months for best supportive care to 6.7 for chemotherapy. CONCLUSIONS: The results of our MAL, favoring chemotherapy, are in line with those of a MAP recently published. However, they have to be considered in the light of their actual clinical relevance and of the balance between quality of life, toxicity, and costs of chemotherapy and best supportive care.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1994

Treatment and prognosis of centrocytic (mantle cell) lymphoma: a retrospective analysis of twenty-six patients treated in one institution.

We retrospectively attempted to analyse prognostic factors in a group of 26 patients with centrocytic lymphomas (CCL) treated from 1979 to 1991 (representing 7% of all cases of NHL diagnosed in our institution during that period). Ten of the patients were females and 16 males, and their median age at diagnosis was 69 years (range 38-85). The majority of patients (77%) had advanced disease (Ann Arbor stage III-IV) at presentation. Twenty-two patients (85%) had good performance status (0-1 ECOG). B-symptoms were present in 10 cases. Most patients (87%) presented with generalized adenopathies. Bone marrow involvement was observed in 12 patients (46%) and Waldeyer's ring involvement in 5 (4 of them with stage I-II). In 5 cases the liver was involved and 3 pts had gastrointestinal localizations; 15 patients had more than 2 sites of disease: LDH elevation was observed in 8/24 pts. Fourteen patients (54%) received single-agent chlorambucil (3 pts) or CVP (11 pts). Eleven patients were treated with ADM-containing regimens (7 with CHOP or M-ACOD and 4 with 3rd generation regimens). One patient had radiotherapy alone. The complete response (CR) rate was 50% (13/26); 8 patients relapsed with a median time to progression of 19 months, and only 3 responded to salvage treatment. The median overall survival was 33 months, with fewer than 40% of patients surviving longer than 3 years. At univariate analysis the use of ADM-containing regimens seems significantly correlated with the CR rate (p = 0.047), the failure-free survival (p = 0.023), and the overall survival (p = 0.004).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗