Search PubMed⌕ Search

Biomedical subjects

M Paesmans

Publications and source records attributed to M Paesmans.

At least 91 records · Page 5Linked to original sources
PubMed1999

A randomised phase III trial comparing consolidation treatment with further chemotherapy to chest irradiation in patients with initially unresectable locoregional non-small-cell lung cancer responding to induction chemotherapy. European Lung Cancer Working Party.

PURPOSE: A phase III randomised trial was conducted in patients with non-metastatic unresectable non-small-cell lung cancer in order to compare, in responders to induction chemotherapy, consolidation treatment by further chemotherapy to chest irradiation. PATIENTS AND METHODS: A total of 462 untreated NSCLC patients were eligible for three courses of induction chemotherapy (MIP) consisting of cisplatin (50 mg/m2), ifosfamide (3 g/m2) and mitomycin C (6 mg/m2). It was proposed that objective responders be randomised to either three further courses of MIP or to chest irradiation (60 Gy; 2 Gy per fraction given over six weeks). RESULTS: An objective response rate of 35% was achieved; 115 patients (including 52% with initial stage IIIA and 44% with initial stage IIIB) were randomised to consolidation treatment, 60 of them to further chemotherapy and 55 to chest radiotherapy. There was no significant difference in survival between the two arms, with a respective median and two-year survival of 42 weeks (95% confidence intervals (95% CI: 35-51) and 18% (95% CI: 8-28) for chemotherapy and 54 weeks (95% CI: 43-73) and 22% (95% CI: 11-33) for irradiation. There was also no statistical difference for response duration between the two arms but chest irradiation was associated with a significantly greater duration of local control than chemotherapy (median duration times: 158 vs. 31 weeks, P = 0.0007). CONCLUSIONS: For non-metastatic unresectable NSCLC treated by an induction chemotherapy regimen containing cisplatin and ifosfamide, if an objective response is obtained, consolidation treatments by further chemotherapy or by chest irradiation result in non-statistically different survival distributions, although a better local control duration is observed with radiotherapy.

Adult↗
PubMed1998

Statistical considerations in clinical trials testing empiric antibiotic regimens in patients with febrile neutropenia.

The Chalmers scoring system for assessing the quality of randomized controlled trials was applied to 19 papers (published in 1976-1984) reporting the results of trials of antibiotics in febrile neutropenic patients, it was found at the time of this survey (publication 1986) that statistical issues were inadequately addressed in the papers and that the scoring system was a measure of the quality of reporting in the papers rather than the quality of the actual trials. Some new items have been added to the system to improve the validity of results, and 15 more recent papers have been reviewed with reference to the updated scoring procedure, to find whether the quality of trials and of their reporting has improved since 1986. Further discussion of statistical issues in clinical trials is recommended.

Anti-Bacterial Agents↗
PubMed1998

Maintenance chemotherapy for small cell lung cancer: a critical review of the literature.

Maintenance chemotherapy after induction therapy is a controversial topic in small cell lung cancer. We carried out a critical review of the literature on this topic. Since 1980, 13 randomized trials have been published. One shows a statistically significant difference in survival in favor of maintenance, five obtain some survival advantages in subgroups of patients, one shows a significantly shorter survival with maintenance and in six studies, there is no difference between both arms. A quantitative overview or meta-analysis was unpracticable because of the lack of data for calculation of the odds ratio in the publications and because of the heterogeneity of the studies' designs. A qualitative overview was carried out using two scales: the Chalmers scores and the European Lung Cancer Working Party (ELCWP) score. Correlation between both scores was excellent. There was no significant difference in quality scores with both methods between negative trials and those who showed some survival advantage for survival. The overall quality of the publications was not good, with important methodological aspects missing, such as a clear definition of the primary objective or an a priori estimate of the sample size necessary to conduct the trial. We concluded that maintenance chemotherapy could have some indications and that good quality trials, as reflected by very high quality scores, need to be carried out in the future.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1998

Evaluation of the TN sub-staging in patients with initially unresectable stage III non-small cell lung cancer treated by induction chemotherapy. The European Lung Cancer Working Party.

PURPOSE: This study attempted to investigate, in a cohort of patients with clinical stage III initially unresectable non-small cell lung cancer (NSCLC) treated by the same induction chemotherapy regimen, the prognostic value of clinical T and N sub-groupings in order to validate the current International Staging System (ISS). PATIENTS AND METHODS: All the eligible patients with stage III NSCLC (428 patients) registered in a clinical trial were included in the study investigating, after three courses of induction chemotherapy, the role, in responders, of chest irradiation in comparison to further chemotherapy. The chemotherapy regimen consisted of mitomycin C, ifosfamide and cisplatin. RESULTS: Patients with ISS 1986 stage IIIA had a significantly better survival than those with stage IIIB (median survival 47 vs 36 weeks; P = 0.01). A RECPAM analysis showed that patients with T1-T2 N3 and T4 N0-1-2 stage had a more similar prognosis to those with stage IIIA. That result leads to define two new sub-groups: stage IIIlalpha (T3-T4 N0-N1; any T N2; T1-T2 N3) and IIIbeta (T3-T4 N3), with a highly significant difference in survival between them (median survival: 45 vs 29 weeks; P < 0.0001). The superiority of that new classification on the ISS documented in our series of stage III patients for discriminating survival and tumour response has to be confirmed on another series in a multivariate context. CONCLUSION: For unresectable NSCLC treated by induction chemotherapy, stage III sub-classification by moving T4 N0-1 and T1-2 N3 tumours from stage IIIB to stage IIIA appeared to better correlate with prognosis. The usefulness of this new sub-division has to be tested in validation studies.

Adult↗
PubMed1998

Imipenem versus targeted therapy in cancer patients.

In many instances, broad-spectrum antibiotics are initiated empirically in febrile cancer patients and continued for the whole duration of therapy. An alternative is to narrow the spectrum whenever the offending pathogen is identified. This study is aimed at comparing these two options. Non-neutropenic cancer patients with severe infections received empiric imipenem. After 72 h, those with microbiologically documented infection were randomized either to continue imipenem or to receive a targeted therapy. After 72 h of imipenem 76.1% were improved. After randomization, a higher efficacy was observed with imipenem (88.5 vs. 72.1%: P = 0.025). Bacterial and fungal superinfections were comparable. Costs were lower for targeted therapy in gram-positive infection and higher in gram-negative infection.

Anti-Bacterial Agents↗
PubMed1998

Phase III randomized trial comparing cisplatin and carboplatin with or without ifosfamide in patients with advanced non-small-cell lung cancer. European Lung Cancer Working Party.

PURPOSE: A phase III randomized trial in patients with advanced non-small-cell lung cancer (NSCLC) was performed to determine if the addition of ifosfamide to moderate-dose cisplatin and carboplatin improved response rate (primary end point) and survival. PATIENTS AND METHODS: A total of 529 patients were randomized to receive a combination of moderate-dose carboplatin (200 mg/m2 intravenously [i.v.] on day 1) and cisplatin (30 mg/m2 i.v. on days 2 and 3) with (CCI arm) or without (CC arm) ifosfamide (1.5 g/m2 i.v. on days 1 to 3). There were 248 eligible patients on the CC arm and 257 on the CCI arm, with 220 and 238 patients assessable for response, respectively. All but 23 had stage IV disease with pleural effusion. RESULTS: There was a 16% objective response (OR) rate to CC and a 31% OR rate to CCI. That observed difference was highly statistically significant (P < 0.001). Duration of response and survival were not statistically different between arms. The CCI regimen was associated with significantly more acute toxicities: emesis, alopecia, leukopenia, and thrombocytopenia. The frequency of chronic renal, auditive, and peripheral neurologic toxicity was low in both arms (4.6% and 6.6%, respectively, after six courses of chemotherapy). The relative dose-intensity (RDI) of the CCI arm was significantly lower than that of the CC arm. CONCLUSION: The addition of ifosfamide to moderate-dose cisplatin and carboplatin significantly improves the antitumoral response rate, but has no apparent effect an survival in advanced NSCLC.

Adult↗
PubMed1998

[Prognostic factors].

Thanks to the knowledge of pretherapeutic factors able to explain the evolution of a disease, the clinician gets guidelines for the choice of a treatment for an individual patient and, on a population level, he receives important information for the design and interpretation of clinical studies. Our purpose, here, is to review the "classical" prognostic factors, defined as factors usable in a daily clinical practice, for survival in a population of patients with a stage III and small cell lung cancer. The first variable to be taken into account is the operability status, highly correlated to the TNM substage IIIA or IIIB. For patients who will go to surgery, relying on the literature, we don't have any definite prognostic factor. Some data suggest that histology other than squamous cell or adenocarcinoma, male sex, age greater than 65 years, low performance status or N2 disease are unfavorable characteristics. For patients who will not benefit from surgery, a good performance index is a definitely recognized favorable feature. Prediction of the prognosis could be improved by the inclusion in a model of the TNM substage, the sex, the weight loss, the LDH level in the serum. Other biological factors like hemoglobinemia or albuminemia have to be confirmed. Generally, we need prospective studies designed to validate, on large series of patients, prognostic variables or indexes on a multivariate basis.

Age Factors↗
PubMed1998

[Maintenance chemotherapy in the treatment of small cell lung cancer: the advocate's view].

The role of maintenance chemotherapy in the treatment of small cell lung cancer remains controversial. We have collected the arguments in favor of that approach by performing a quantitative and qualitative overview of the studies published on this topic in the French and English literatures since 1980. On the thirteen prospective randomized trials reported, six demonstrated a significant survival advantage in favor of maintenance, no difference was observed in 6 and 1 study had a significant survival advantage for no maintenance. Due to the heterogeneity of the study designs and to the lack of published data, no meta-analysis could be performed. A qualitative overview of the different trials showed that the quality scores of the positive trials was similar to the negative ones, allowing us to conclude that they could be considered at the same level. No negative trial with a similar design can be opposed to each particular positive trial that is thus not conterbalanced. Moreover the trials not in favor of maintenance could be falsely negative by a lack of power, the publications mentioning no statistical consideration. There are thus a series of arguments in favor of maintenance chemotherapy for small-cell lung cancer, which require to be confirmed by randomised trials of adequate quality.

Antineoplastic Agents↗
PubMed1998

[Critical review of the randomized trials assessing the role of adjuvant thoracic irradiation and chemotherapy in the treatment of limited-stage small cell lung cancer].

The role of chest irradiation in the treatment of small cell lung cancer remains controversial. Two meta-analyses have shown a significant improvement of survival when this therapy is associated to chemotherapy but the controlled studies individually lead to contradictory conclusions. We have performed qualitative and quantitative evaluation of the literature on this topic in order to try to clarify this problem. On 15 published trials, 8 only give sufficient data allowing a meta-analysis. This does not show that chest irradiation improves statistically significantly survival in comparison to chemotherapy alone (odds ratio = 0.82; 95% CI: 0.63-1.07). The qualitative evaluation has been performed with the Chalmers and ELCWP scales. The scores obtained by both methods are highly correlated. There is no significant difference between the scores obtained by studies showing a survival improvement with irradiation or by negative studies. Very few trials report important criteria like definition of the primary end-point or the a priori estimate of the population size, attesting important methodological deficiencies. In conclusion, the quantitative aggregation of studies seems difficult to interpret because of the non optimal quality of the studies.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1997

Improving cancer prevention at the worksite: how are Belgian companies dealing with smoking regulations?

Little is known about the impact of smoking policy on companies' policies related to smoking in Belgium. The study was designed in order to compare the companies' policies related to smoking (CPRS) in 1990 and in 1993. During this 3 year period, numerous information and regulation inputs (media, brochures) were aimed at companies to regulate smoking behavior in the workplace, so as to reduce the risks of passive smoking. A short questionnaire was mailed to 3543 Belgian companies in October 1990 and in June 1993 to assess: designation of smoke free areas (SFA); willingness to offer a worksite information program (WIP); willingness to offer a worksite smoking cessation program (WSCP); willingness to subsidize a WSCP; willingness to offer a WSCP during working hours; willingness to offer a meeting room for a WSCP and actual organization of a WSCP. In 1990, 773 companies (22%) and in 1993, 890 companies (25%) responded to the questionnaire. The results showed that small companies and companies with a high blue/white collar ratio were less able to implement health policy recommendations. A total of 325 (9%) companies responded to the 1990 and 1993 questionnaires. Comparison of 1990 and 1993 dataset showed that during this 3 year period, no major changes occurred for a majority of companies. Amongst the small positive changes, only the designation of smoke free areas and the organization of a small number of WSCP was observed. The conclusion is that despite inputs, little impact on smoking policies is noticeable. Strategies designed to intensify inputs and to promote implementation of regulation of WSCP should therefore further be studied.

Belgium↗
PubMed1997

Continuation rates with a levonorgestrel-releasing contraceptive implant (Norplant). A prospective study in Belgium.

Contraceptive protection offered by a method depends on its duration of use, which reflects costs, side effects, and relatives' opinions. This study investigated in Norplant implants users the continuation rates, some of their determinants, and the motives for removals. Since 1988, 612 Norplant implants sets, designed to protect for 5 years, have been inserted. Observing 13,907 months of use, we determined over time the continuation rates and how age, parity, circumstances at insertion (postpartum, postabortum, others), and patronymic origins (surrogate for sociocultural factors) influenced them. Statistics included Kaplan-Meier's method and log rank tests, and uni- and multivariate Cox models. Continuation increased with age and depended on sociocultural factors. Parity exerted influence only in younger women. Median duration of use was 3 years 11 months. Removals before 5 years related almost equally to irregular bleeding, other side effects, and pregnancy wish. The cumulative 5-year failure rate was 1.5%. Unsatisfied users returned earlier, distorting the first results. A literature search showed that implants yield, in the mean, slightly better continuation figures than do intrauterine devices, and clearly higher than those obtained with pills and injectables. To optimize costs and counseling, warnings about the risk of short duration of use in young nullipara, especially if negative sociocultural influences prevail, are recommended. In no category are the implants absolutely to be avoided. Individual and programmatic contraceptive choice should take into account the expected continuation of use.

Adolescent↗
PubMed1997

Factors influencing the prescription of hormone replacement therapy.

OBJECTIVE: To assess the effects of age, bone mineral density, risk of cardiovascular disease, and of breast cancer on the prevalence of hormone replacement therapy (HRT) prescriptions. METHODS: Seventeen charts of postmenopausal women were summarized. For each chart, we constructed 36 different cases by modifying the age (two levels), the bone mineral density (three levels), the cardiovascular risk (three levels), and the breast cancer risk (two levels). Twelve cases of these 612 files were sent to each Belgian gynecologist (n = 1010). RESULTS: Overall, HRT was prescribed in 67% of the cases. It was prescribed in 54.6% of women who had a normal bone mass, 67.9% of women with a low bone mass, and 79.0% of those with osteoporosis (P < .001). The prescription rate was higher in younger women (mean +/- standard deviation 55 +/- 4 years) than in their peers who were 10 years older (79.3% versus 55.2%; p < .001). No significant variation was observed in relation to the cardiovascular risk profile or to breast cancer risk. CONCLUSION: Osteoporosis is associated with an increased rate and older age with a decreased rate of HRT prescription, whereas no difference is observed in association with cardiovascular or breast cancer risk.

Age Factors↗
PubMed1997

Response to chemotherapy has predictive value for further survival of patients with advanced non-small cell lung cancer: 10 years experience of the European Lung Cancer Working Party.

The aim of this study was the assessment of the predictive value for survival of an antitumoral response to three courses of chemotherapy in association with various pretreatment characteristics in patients with non-resectable non-small cell lung cancer treated by cisplatin- (or carboplatin)-based combination regimens. Patients considered for this study were eligible patients with advanced non-small cell lung cancer registered in one of the seven trials conducted by the European Lung Cancer Working Party from December 1980 to August 1991. All these trials tested chemotherapy regimens with platinum derivatives (cisplatin and/or carboplatin). In this population of 1052 eligible patients, 752 were assessed in this analysis. Data were prospectively collected on 23 pretherapeutic variables and objective response after three chemotherapy cycles. The predictive value of response to chemotherapy on survival (measured from the time of response assessment i.e. 12 weeks after registration in the trial) was studied by univariate analysis as well as by multivariate methods (adjustment of the impact of several covariates simultaneously on the dependent variable) with adjustment for the pretreatment prognostic variables. After three cycles of chemotherapy, the global estimated median survival time was 24 weeks with a 95% confidence interval of 22-25 weeks. By univariate analysis, we identified an objective response to chemotherapy as a highly significant discriminant marker (P < 0.0001) for further survival with estimated median survival times of 41 weeks (95% CI: 38-46) and 19 weeks (95% CI: 17-20), respectively, for the responding and non-responding patients. In a Cox regression model fitted to the data using a forward stepwise procedure, this variable was the first selected explanatory variable. Its effect was adjusted by the introduction in the model of initial disease extent, Karnofsky performance status, serum calcium level and white blood cell count. These results were consistent with those obtained by application of recursive partitioning and amalgamation algorithms (RECPAM) which led to a classification of the patients into three homogeneous subgroups. Our results, using a classical Cox regression model consistent with those highlighted by application of a RECPAM analysis, found an objective response to chemotherapy to be a predominant predictive factor for further survival, although it did not allow any conclusion about a causal relationship. The RECPAM results led to a classification of the patients into three subgroups which needs to be validated in other series.

Adult↗
PubMed1997

A comparison of outcome from febrile neutropenic episodes in children compared with adults: results from four EORTC studies. International Antimicrobial Therapy Cooperative Group (IATCG) of the European Organization for Research and Treatment of Cancer (EORTC).

The object of this study was to determine whether there were any differences between the 'typical' child with fever and neutropenia and their adult counterpart with regard to infection type and outcome, by analysis of 3080 patients, including 759 children < 18 years of age and 2321 adults. These represented patients randomized in previous trials, between 1986 and 1994, which compared empirical antibiotic regimens for fever in neutropenic patients. There were fewer childhood acute myeloid leukaemia patients than adults but more acute lymphoblastic leukaemia cases and more with solid tumours undergoing intensive myelosuppressive therapy. The children were less likely to be undergoing first induction therapy but the relative incidence of patients receiving relapse schedules or maintenance therapies were not significantly different in the two age groups. Children less frequently had a defined site of infection than adults and where they had a defined site there were more upper respiratory tract but fewer lung infections. There was a similar low incidence of shock at presentation in the two groups but the children's median neutrophil count was lower, and their median duration of granulocytopenia before the trial was shorter. The incidence of bacteraemia was similar, but clinically documented infection was less frequent and fever of unknown origin consequently more common in children. Children developed more streptococcal bacteraemias and fewer staphylococcal bacteraemias than adults (P=0.003) but the relative incidence of various gram-negative species was similar (P=0.57). In general, the children had a better overall success rate and lower mortality than adults. Death from infection was only 1% in children versus 4% in adults (P=0.001), and time to defervescence was shorter in children. In the younger age group, univariate logistic regression models showed high temperature, prolonged neutropenia before the trial and shock as prognostic indicators for the presence of bacteraemia. Solid tumour patients were significantly less likely to have a bacteraemia. Multivariate analysis confirmed the independent prognostic value of these indicators. Using the logistic equation of the selected model, the overall discriminant ability was poor. However, it was possible to identify a small subgroup without shock or high fever and with a short prior duration of neutropenia which carries a particularly low risk of bacteraemia, who could be considered for early discharge, monotherapy and shortened courses of antibodies, in prospective trials.

Acute Disease↗
PubMed1997

[Belgian registry of thyroid cancer. Preliminary epidemiological characteristics revealed by a retrospective study (1988-1995). Belgian Thyroid Cancer Study Group].

The aim of a cancer registry is to study the incidence of cancer in a well-determined population and to allow epidemiological research to the setting up of diagnosis and therapeutic strategies. The Belgian Thyroid Cancer Study Group (BTCSG) was founded in 1990. In the present study we report data collected from 1988 to 1995 in 397 patients with a differentiated (papillary and follicular) thyroid carcinoma living in the french-speaking area of Belgium. The sex ratio female/male is 3.5 and the median ages at the diagnosis, is similar (45 yrs, 12-82) in both sexes. Seven cases of thyroid cancer were registered in young patients less than 18 yrs old. Thyroid carcinoma were associated with multinodular goiter in more than 50% cases. Cancer was bilateral in 17%. Papillary histological type accounts for 84% in our series while its diagnosis was established in 45% at early clinical stages (TO-T1). These observations could probably be related with 1) broader indications and more aggressive options for the surgical removal of diffuse multinodular goiter, 2) more sophisticated pathologic examinations that might have led to the detection of a greater incidence of occult carcinomas, incidentally discovered. Lymph nodes metastases were present at the time of diagnosis in 20%, especially in young patients. The risk for local and/or lateral recurrence or distant metastases is significantly related to the size of the tumor, histologically verified lymph node metastases and the values of the EORTC prognostic index (> or = 50) that additionally takes into account the differentiation of the tumor. Considering our short median follow-up time of 25 months, it is currently too early to define if the controversial attitude about the extent of surgery (total thyroidectomy plus I131 or individualized surgery) can also negatively influence the risk for recurrence. In our series, eight patients died of thyroid cancer.

Adolescent↗
PubMed1997

[Prognostic factors in advanced stage non-small cell bronchial cancer: experiences of the European Lung Cancer Working Party].

The European Lung Cancer Working Party has investigated prognostic factors for response, overall survival, long term survival in a population with advanced non small cell lung cancer registered in a clinical trial evaluating platinum derivatives-containing chemotherapy regimens. Various factors have been identified in multivariate analyses and were classified using RECPAM methodology. In addition to the clinical factors such as disease extent and performance status were shown, as significant predictors, rarely studied biological factors like pretherapeutic leucocyte and polynuclear levels. The obtention of an objective response to chemotherapy appeared to be a major prognostic factor for further survival.

Age Factors↗