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Biomedical subjects

M Paesmans

Publications and source records attributed to M Paesmans.

At least 109 records · Page 6Linked to original sources
PubMed1996

Cancer patients psychological adjustment and perception of illness: cultural differences between Belgium and Turkey.

Little is known about cultural differences in psychological adjustment and perception of illness (PI) during medical procedures in general and radiotherapy in particular. This study compares a Turkish (TP) and a French speaking Belgian (BP) population. A group of 296 consecutive patients attending the radiotherapy clinic of Institut Jules Bordet, Brussels, (n = 172) and Oncology Institute, Capa-Istanbul, (n = 124) were interviewed and assessed by a symptom checklist, the SCL-90-R, at the beginning and at the end of the radiotherapy. PI, derived from a semi-structured interview, was assessed at the beginning of radiotherapy by a five-point observer-rating scale derived from the Omega Vulnerability Rating Scale. Differences in SCL-90-R scores, taking into account country, age, gender, level of education and PI as potential explanatory variables, have been tested by a multivariate analysis of variance with a design of repeated measures using the SCL-90-R scores as dependent variables. Mainly a time effect and a country effect have been found. Some interactions between both effects have also been found. Globally, all the SCL-90-R scores decrease between the beginning and the end of the radiotherapy. The effect of country is noticeable for most of the SCL-90-R components, with higher scores in the BP, except for the positive symptom total score where the TP showed higher scores. The interaction between country and time is not significant, the scores of both the BP and TP decreasing over time, except for somatization scores (P < 0.001) where the scores of the BP were stable over time while the scores of the TP decreased considerably, and for paranoid ideation scores (P = 0.001) where the scores of the BP decreased while the scores of the TP increased. Results showed a higher rate of correct perception in the BP compared to the TP (P = 0.0001). A PI effect has been found for somatization (P = 0.02), anxiety (P = 0.01) and Global Severity Index scores (P = 0.05), with higher mean scores for the "correct perception" category. No interaction with time was found. A significant interaction effect between country and PI has been found for anxiety scores with higher scores in the correct perception category in the BP and in the "denial of implications" category in the TP (P < 0.001). Results highlight cultural differences in psychological adjustment and/or in the responses to self-report questionnaires: greater weight was given to items by the BP, more numerous items were scored by the TP, and greater weight was given to the somatization subscale compared to the psychological subscales by the TP. This study suggests that psychosocial distress is expressed differently in Belgium and Turkey, where patients express mostly somatic complaints. Finally PI, a culture-dependent factor, appears to influence psychological adjustment very differently, a correct perception of illness leading to more anxiety in the BP compared to the TP.

Adaptation, Psychological↗
PubMed1996

Effect of bone density evaluation on hormone replacement therapy prescription.

OBJECTIVES: This study evaluates whether Bone Mineral Density (BMD) results influence HRT prescription. METHODS: Successive charts of 29 postmenopausal women were summarised. For each chart, 3 'simulated cases' were created by modifying the BMD result (based on the Z-score) in order to have 4 groups with the same clinical story but a wide range of BMD values (Group I = Z-score > 0, Group II = Z-score between 0 and -1, Group III = Z-score between -1 and -2 and Group IV = Z-score < -2). The obtained cases were presented to 10 gynaecologists who were asked whether HRT should be prescribed. The gynaecologists were not aware of the above-mentioned manipulation. RESULTS: The overall treatment rate was 74.2%, ranging from 65% for women with the highest BMD (Group I), 73% for Group II, 79% for Group III and 80% for Group IV, i.e. women with the lowest BMD (Friedman analysis of variance; chi-square 17.2; P < 0.001). In approximately a third of the patients (11/29), there was agreement for initiation of therapy, regardless of the BMD. Most of these women presented other indications and no contra-indications for therapy. The prescription frequency of the 10 gynaecologists varied between 63% and 87%; Cochran Q Statistic 39.2; P < 0.0001). For some physicians, a trend to increase prescription was observed in relation to the BMD result, but a statistical difference could only be reached for one physician (P < 0.05). Furthermore, for some physicians no modification whatsoever could be observed. CONCLUSIONS: BMD appears to be a determinant factor for HRT prescription in only a limited proportion of the patients and a small number of the physicians. From an epidemiological point of view, BMD measurements may be useful in order to help deciding women to start HRT, especially those who are reluctant or to those who present relative contra-indications, provided that their physicians are aware of the usefulness of these investigations.

Adult↗
PubMed1996

Prognostic factors for response to chemotherapy containing platinum derivatives in patients with unresectable non-small cell lung cancer. (NSCLC).

PURPOSE: To identify pretreatment variables predicting response to platinum derivatives containing chemotherapy in patients with unresectable non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: Eligible patients included in one of the 7 consecutive clinical trials conducted by the European Lung Cancer Working Party between December 1980 and August 1991. All patients received a cisplatin or carboplatin containing chemotherapy. We analyzed 22 potential prognostic factors including sex, age, histology, performance status, weight loss, type of lesions, extent of disease, main metastatic sites and several biological parameters, namely white blood cell count (WBC), neutrophil count, platelet count, hemoglobinemia, creatininemia, serum alkaline phosphatases and LDH. RESULTS: On 1052 eligible patients. 107 were not assessable for response. The objective response rate was 26% (95% C.I.: 23, 29%). Univariate analysis identified as statistically significantly associated with a higher objective antitumoral response rate the following characteristics: a normal platelet count, the absence of skin metastasis, the absence of adrenal metastasis, a higher creatininemia, a normal hemoglobinemia, an older age and a normal WBC count. On a restricted set of variables including data from 777 patients, a multivariate logistic regression model disclosed age and platelet count as significantly and independently related to response rate. CONCLUSION: Clinical and demographic characteristics of patients with unresectable NSCLC, as well as routine laboratory parameters, could not accurately predict response to chemotherapy in a population of patients selected for a clinical trial. Future studies on this subject should include more sophisticated variables as new biomolecular makers.

Adult↗
PubMed1996

Monotherapy with meropenem versus combination therapy with ceftazidime plus amikacin as empiric therapy for fever in granulocytopenic patients with cancer. The International Antimicrobial Therapy Cooperative Group of the European Organization for Research and Treatment of Cancer and the Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto Infection Program.

Combinations of beta-lactams plus aminoglycosides have been standard therapy for suspected infections in granulocytopenic cancer patients, especially those with profound long-lasting granulocytopenia. With the advent of new broad-spectrum bactericidal antibiotics such as extended-spectrum cephalosporins or carbapenems, the need to combine beta-lactams with aminoglycosides became more controversial. The objective of this prospective randomized multicenter study was to compare the efficacy, safety, and tolerance of meropenem monotherapy with those of the combination of ceftazidime plus amikacin for the empirical treatment of fever in granulocytopenic cancer patients. Of 1,034 randomized patients, 958 were assessable in the intent-to-treat analysis for response to antibacterial therapy, including 483 in the meropenem group and 475 in the ceftazidime-plus-amikacin group. The median durations of neutropenia were 16 and 17 days, respectively. A successful outcome was reported in 270 of 483 (56%) patients treated with monotherapy compared with 245 of 475 (52%) patients treated with the combination group (P = 0.20). The success rates in the monotherapy group and the combination group were similar by type of infection (single gram-negative bacteremia, single gram-positive bacteremia, clinically documented infection, and possible infection). The occurrence of further infections assessed in patients for whom the allocated regimen was not modified did not differ between the two groups (12% in both groups). Mortality due to the presenting infection or further infection was relatively low (8 patients treated with the monotherapy compared with 13 patients treated with the combination). A total of 1,027 patients were evaluable for adverse events; the proportion of those who developed adverse effects was similar between the two groups (29% in both groups), and only 19 (4%) patients in the monotherapy group and 31 (6%) in the combination group experienced an adverse event related or probably related to the study drug. Allergic reactions were the only reason for stopping the protocol antibiotic(s) (3 and 5 patients, respectively). This study confirms that monotherapy with meropenem is as effective as the combination of ceftazidime plus amikacin for the empiric treatment of fever in persistently granulocytopenic cancer patients, and both regimens were well tolerated.

Adolescent↗
PubMed1996

Randomized trial comparing induction chemotherapy versus induction chemotherapy followed by maintenance chemotherapy in small-cell lung cancer. European Lung Cancer Working Party.

PURPOSE AND METHODS: The European Lung Cancer Working Party (ELCWP) performed a randomized trial with the primary end point to determine if maintenance chemotherapy with 12 courses of etoposide (120 mg/m2 on days 1 and 3) and vindesine (3 mg/m2 on day 3) could improve progression-free survival in small-cell lung cancer (SCLC) patients who responded to six courses of induction chemotherapy with ifosfamide, etoposide, and an anthracycline (doxorubicin or epirubicin). RESULTS: Among 235 eligible patients initially registered, 91 were randomized to receive maintenance therapy, including seven patients who were no longer responding. Among 84 randomized responders, progression-free survival was significantly improved (P = .003) by maintenance therapy, with median durations (maintenance v follow-up) of 25 versus 12 weeks after the second randomization, but survival was not significantly increased (P = .10), with median durations of 48 and 38 weeks. However, in a multi-variate analysis that took into account disease extent, maintenance therapy, Karnofsky performance status (PS), and absolute dose-intensity (ADI) of anthracycline given during induction, limited disease (LD) and maintenance were found to be independent positive predictors of survival. CONCLUSION: We conclude that maintenance chemotherapy in responding patients is beneficial in SCLC.

Adult↗
PubMed1996

[Continuity of utilization of a levonorgestrel releasing contraceptive implant: prospective study in Belgium].

Since 1988 we inserted 760 sets of a subcutaneous hormonal contraceptive releasing levonorgestrel active for 5 years. The aim of the study was to investigate the continuation rates. We considered our first 612 insertions. The 5-year cumulative pregnancy rate was 3.7%. The continuation rates were high (50% of the implants remained in situ after 3 1/2 years). These rates increased with age, and were better with European than with non-European subjects (mainly Moroccan and Turkish women). Parity didn't influence. The rates increased over time, because more unhappy women soon came back compared to satisfied users. Removals were related to pregnancy wish, irregular blood loss, end of action, and various side effects. In a few cases untrained physicians removed the implants.

Adult↗
PubMed1995

Piperacillin-tazobactam plus amikacin versus ceftazidime plus amikacin as empiric therapy for fever in granulocytopenic patients with cancer. The International Antimicrobial Therapy Cooperative Group of the European Organization for Research and Treatment of Cancer.

Gram-positive bacteria have become the predominant infecting organisms in granulocytopenic cancer patients. Empiric antibiotic regimens used in febrile neutropenic patients often include an extended-spectrum cephalosporin, but the response to therapy in gram-positive coccal bacteremia has been unsatisfactory. Thus, new antibiotics with better activity against gram-positive bacteria should be tested. The objective of this prospective randomized controlled study was to evaluate and compare the efficacy and tolerance of piperacillintazobactam plus amikacin with that of ceftazidime plus amikacin, the standard regimen of the International Antimicrobial Therapy Cooperative Group of the European Organization for Research and Treatment of Cancer, in the empiric treatment of febrile granulocytopenic cancer patients. A total of 858 episodes were eligible for this study, and 706 episodes were assessable for efficacy. The antibiotic treatment was successful in 210 (61%) of 342 episodes in the piperacillin-tazobactam-amikacin group compared with 196 (54%) of 364 episodes treated with ceftazidime plus amikacin (P = 0.05). The time to defervescence was significantly shorter (P = 0.01) and the time to failure was significantly longer (P = 0.02) in the piperacillin-tazobactam-amikacin group. A significant difference in response to bacteremic infections between the two patient groups was found: piperacillin-tazobactam plus amikacin was successful in 40 of 80 episodes (50%), and ceftazidime plus amikacin was successful in 35 of 101 episodes (35%) (P = 0.05). A multivariate analysis showed that the probability of failure was significantly greater with ceftazidime plus amikacin than with piperacillin-tazobactam plus amikacin (P = 0.02). This trial suggests that piperacillin-tazobactam plus amikacin is more effective than ceftazidime plus amikacin for the empiric treatment of fever and bacteremia in granulocytopenic cancer patients. Although cutaneous reaction was more frequently associated with piperacillin-tazobactam plus amikacin than with ceftazidime-amikacin, this unwanted effect was relatively mild and its incidence was comparable to that of other penicillin compounds.

Adolescent↗
PubMed1995

History of brain and epidural metastases from breast cancer in relation with the disease evolution outside the central nervous system.

We reviewed 89 breast cancer patients with brain or epidural metastases in order to see whether a parallelism could be found between disease evolution inside and outside the central nervous system. One-fifth of the patients with brain metastases did not have any other site of relapse before neurological complication. Among the 38 patients who developed brain metastases and had a prior history of relapse outside the brain, 12 had control of constant extracranial sites while disease was progressing at these sites in 26 of them. In the epidural metastases group, all patients but 4 had progressive disease elsewhere when neurological complication appeared.

Adult↗
PubMed1995

Prognostic factors for survival in advanced non-small-cell lung cancer: univariate and multivariate analyses including recursive partitioning and amalgamation algorithms in 1,052 patients. The European Lung Cancer Working Party.

PURPOSE: This study attempted to determine the prognostic value for survival of various pretreatment characteristics in patients with nonresectable non-small-cell lung cancer in the context of more than 10 years of experience of a European Cooperative Group. PATIENTS AND METHODS: We included in the analysis all eligible patients (N = 1,052) with advanced non-small-cell lung cancer registered onto one of seven trials conducted by the European Lung Cancer Working Party (ELCWP) during one decade. The patients were treated by chemotherapy regimens based on platinum derivatives. We prospectively collected 23 variables and analyzed them by univariate and multivariate methods. RESULTS: The global estimated median survival time was 29 weeks, with a 95% confidence interval of 27 to 30 weeks. After univariate analysis, we applied two multivariate statistical techniques. In a Cox regression model, the selected explanatory variables were disease extent, Karnofsky performance status, WBC and neutrophil counts, metastatic involvement of skin, serum calcium level, age, and sex. These results were confirmed by application of recursive partitioning and amalgamation algorithms (RECPAM), which led to classification of the patients into four homogeneous subgroups. CONCLUSION: We confirmed by our analysis the role of well-known independent prognostic factors for survival, but also identified the effect of the neutrophil count, rarely studied, with the use of two methods: a classical Cox regression model and a RECPAM analysis. The classification of patients into the four subgroups we obtained needs to be validated in other series.

Algorithms↗
PubMed1994

Long-term survival after chemotherapy containing platinum derivatives in patients with advanced unresectable non-small cell lung cancer. European Lung Cancer Working Party.

The study set out to determine the rate of long-term survivors (LTS) in patients treated with platinum-containing chemotherapy for advanced non-small cell lung cancer (NSCLC), to identify prognostic factors predicting long-term survival (> or = 2 years) and to report the LTS natural history. Eligible patients with advanced NSCLC treated by chemotherapy in one of seven trials conducted by the European Lung Cancer Working Party from December 1980 to August 1991 were included. All patients received cisplatin and/or carboplatin. Of these, 1052 patients were eligible and 24 variables were analysed as potential prognostic factors. Actuarial 2-year and 5-year survival rates were, respectively, 7.4 and 1.8%. All patients surviving for > or = 5 years had limited disease and were treated by complementary chest irradiation and/or surgery. Univariate prognostic factor analysis for LTS identified as significant no major weight loss, limited disease, no liver metastases, normal white blood cells and neutrophils and normal lactic dehydrogenase levels. By multivariate analysis, the only significant factor was limited disease. Objective response to chemotherapy was also found to be, as disease extent, a highly significant predictor for LTS. Thus, the two best prognostic factors for LTS were non-metastatic disease and response to chemotherapy.

Aged↗
PubMed1994

Value of antifungal prophylaxis with antifungal drugs against oropharyngeal candidiasis in cancer patients.

This report focuses on the value of antifungal prophylaxis with antifungal drugs in preventing oropharyngeal candidiasis. Randomised trials comparing non-AIDS immunocompromised patients receiving or not an oral antifungal agent were reviewed. Colonisation of the throat with Candida albicans is a risk factor, principally when cultures for this species of yeasts remain positive after initiation of the prophylaxis. The results of the trials were meta-analysed and we obtained a combined odds ratio for developing oropharyngeal candidiasis of 0.15 when under antifungal prophylaxis (confidence interval at 95%:0.10-0.22, chi 2 statistic of 90.77, P < 0.0001). We conclude that there is a strong beneficial effect of antifungal prophylaxis against the occurrence of oropharyngeal candidiasis. However, up to now, no study has correctly assessed the value of nystatin as a prophylactic agent against oropharyngeal candidiasis.

Antifungal Agents↗
PubMed1994

[How to assess the size of a clinical trial?].

The interpretation of the results of a clinical trial, an experimental method now recognised as the agreed technique for studying new therapeutic modes of treatment in man, is based on a statistical study of data collected on a sample of patients enrolled in the study and treated till its fulfillment. This interpretation is often made using statistical inference techniques based on the construction of a decision rule associated with a statistical hypothesis test; this hypothesis test serves to formalize a research question in a precise manner, and allows the null hypothesis H0 to be tested against an alternative hypothesis H1. The decision rule will be constructed using a probability distribution, which assumes control against type I error, and consists of falsely rejecting the null hypothesis. However, the control of the risk of type II error, made error where one mistakenly takes a decision not to reject the null hypothesis, can only be achieved using a sufficiently large sample. The correct evaluation of the sample size is thus paramount if one does not wish to be doomed to the failure of a study, by including an insufficient number of patients to achieve the aimed objective. The aim of this report is to review how this evaluation can be due, in a practical manner without proof, in the context of simple situations which are used when Phase II or III clinical trials are put into action.

Clinical Trials as Topic↗
PubMed1994

[Small cell bronchial cancer. Comparison of results of weekly polychemotherapy using multiple drugs with standard chemotherapy. European Lung Cancer Working Party].

The administration of multiple cytostatic drugs on a weekly basis has been proposed as a new intensive chemotherapy modality for small-cell lung cancer. The European Lung Cancer Working Party has conducted a randomized trial comparing to a standard regimen (cyclophosphamide + adriamycin + etoposide given at the cycle beginning) a weekly chemotherapy with 7 active drugs (cyclophosphamide + adriamycin + etoposide on day 1; cisplatin + vindesine on day 8; methotrexate + vincristine on day 15). A total of 215 eligible patients have been registered. There has been no significant difference between the 2 arms for response and for survival. The total relative dose-intensity has been lower in the weekly chemotherapy arm. This approach has failed to improve current results.

Adult↗
PubMed1993

The effects of a 24-h psychological training program on attitudes, communication skills and occupational stress in oncology: a randomised study.

The usefulness of psychological training programs (P.T.P.) in health care settings devoted to cancer care is beginning to be recognised but their content, form and effectiveness need further investigation. Seventy-two oncology nurses were randomly assigned to a 24-h P.T.P. or to a waiting list period. Attitudes were assessed by a semantic differential questionnaire, occupational stress was assessed by the Nursing Stress Scale and communication skills were assessed by standardised videotaped role-playing exercises. These were used to compare trained (T.S.) and control subjects (C.S.). The results show a significant training effect on attitudes (P = 0.05), especially on those related to self concept (P = 0.004), and on the level of occupational stress related to inadequate preparation (P = 0.02). Limited changes were found regarding post-training communication skills. T.S. were significantly more in control of the interview than C.S. (P = 0.02). The results indicate that 24-h P.T.P. assessed here are effective. The data also demonstrate the need to consolidate the skills acquired by regular post-training sessions.

Adult↗
PubMed1993

Multiple-drug weekly chemotherapy versus standard combination regimen in small-cell lung cancer: a phase III randomized study conducted by the European Lung Cancer Working Party.

PURPOSE: A randomized trial was conducted in patients with small-cell lung cancer (SCLC) to determine if survival can be improved by a weekly chemotherapy regimen combining various drugs. PATIENTS AND METHODS: Two hundred twenty-three patients were randomized to receive either six courses of a multiple-drug combination (MDC) regimen (Adriamycin [ADR; doxorubicin; Farmitalia Carlo Erba, Milan, Italy] 25 mg/m2 intravenously [i.v.] on day 1; etoposide [VP16] 120 mg/m2 i.v. on day 1; cyclophosphamide [CPA] 500 mg/m2 i.v. on day 1; cisplatin 60 mg/m2 i.v. on day 8; vindesine [VDS] 3 mg/m2 i.v. on day 8; vincristine [VCR] 2 mg i.v. on day 15; methotrexate [MTX] 100 mg/m2 i.v. on day 15), or a standard chemotherapy (SC) regimen (ADR 50 mg/m2 i.v. on day 1; CPA 1 g/m2 i.v. on day 1; VP16 80 mg/m2 i.v. on days 1 to 3). RESULTS: In 98 MDC-treated and 101 SC-treated assessable patients, we observed 69% and 62% objective responses rates, respectively. There was no significant difference in survival, with median durations and 2-year overall survival rates of 49 and 43 weeks and 8.5% and 7.9%, respectively. There was a significant increase in response rate in favor of MDC patients with limited disease (84% v 62%). Toxicity was tolerable, although SC was more hematotoxic, with 76% (v 59%) experiencing leukopenia and 17% (v 7%) experiencing thrombocytopenia (grades III and IV). If the cumulative doses received were nearly equal to the scheduled cumulative doses in both arms, the total relative dose-intensity (RDI) was significantly higher in the SC arm. The difference was due to increased treatment delays in the MDC arm. CONCLUSION: Weekly MDC failed to improve survival rates in patients with SCLC.

Adult↗
PubMed1992

Screening for psychiatric disorders in a lymphoma out-patient population.

The Hospital Anxiety and Depression Scale (HADS), a four-point, 14-item self-assessment questionnaire, was tested as a screening method for psychiatric disorders in a sample of 117 Hodgkin's lymphoma and non-Hodgkin lymphoma consecutive out-patients. A receiver operating characteristic (ROC) analysis was performed, giving the relationship between the true positive rate (sensitivity) and the false positive rate (1--specificity). This makes it possible to choose an optimal cut-off score that takes into account the costs and benefits of treatment of psychiatric disorders (mainly adjustment, depressive and anxiety disorders) in a lymphoma out-patient population. A cut-off point of 10 gave 84% sensitivity and 66% specificity. HADS appears in this study to be a well accepted, simple, sensitive and specific tool.

Adjustment Disorders↗
PubMed1992

Monoclonal immunoradiometric assay and polyclonal radioimmunoassay compared for measuring neuron-specific enolase in patients with lung cancer.

Neuron-specific enolase (NSE) is the most sensitive and specific tumor marker for small-cell lung cancer (SCLC). We evaluated a new monoclonal IRMA (Sangtec) for NSE and compared it with a polyclonal RIA (Pharmacia) in patients with SCLC or other lung cancers (NSCLC). We measured NSE concentrations in 100 healthy subjects (NI group), 100 patients with benign pulmonary diseases (BPD group), and 194 patients with advanced lung cancer (97 SCLC and 97 NSCLC). Intra- and interassay CVs were less than 7% for both assays, and dose-dilution curves paralleled their respective standard curves. Values measured by both assays were highly correlated in all groups. NSE concentrations were significantly (P less than 0.001) lower by IRMA than by RIA in NI and BPD groups. The upper 95th percentile values for NSE in the NI group were 11.7 micrograms/L in the RIA and 9.2 micrograms/L in the IRMA. In NSCLC, the values were significantly (P less than 0.05) lower by IRMA but the percentage of subjects with increased values was higher (vs the NI group, 31% for RIA and 44% for IRMA, P less than 0.005). Diagnostic sensitivity for SCLC was improved with IRMA: 83% of values with RIA and 93% with IRMA were increased above the NI group values (P less than 0.005); the corresponding values for SCLC vs BPD were 81% and 89% (P less than 0.05). NSE values measured in 39 patients with SCLC after chemotherapy were more often increased and were significantly higher with the IRMA than with the RIA (P less than 0.005).

Adolescent↗