Primary IgA nephropathy: prognostic factors.
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Adolescent↗
Biomedical subjects
A Kramar
Publications and source records attributed to A Kramar.
[Comparison of a cohort mortality with the mortality of a reference population. Principle, necessary number of expected deaths and the given power of the test].
This note derives the power of the test comparing the mortality of a cohort to the mortality of a reference population. The principle of the comparison is recalled i.e. computation of the standardised mortality radio (SMR) and test of the null hypothesis: SMR = 1. It is shown how one can compute the power of the test. A numerical example is given.
Adult↗
[Randomized comparative trial of a new anti-emetic: nabilone, in cancer patients treated with cisplatin].
A randomized, double-blind controlled trial of nabilone versus chlorpromazine was performed in 20 patients with advanced gynaecological cancer who received chemotherapy including cis-platinum. Each patient served as his own control. Nabilone was administered at a dose of 3 mg given orally three times a day, starting the day before cis-platinum and ending the day after. Chlorpromazine was administered at a dose of 12.5 mg given IM, 15 minutes before the start of cis-platinum. Nabilone, in comparison with chlorpromazine did not significantly reduce the number of vomiting. Ten patients preferred nabilone, 5 preferred chlorpromazine and 3 were undecided. Predominant side effects noted by patients were similar for both agents and included somnolence, dry mouth and orthostatic hypotension. No other intervention besides reassurance of the patient was necessary to treat these adverse reactions.
Adolescent↗
Cure rate estimation and long-term prognosis of uterine cervix carcinoma.
This paper reports the prognosis results of a retrospective study of over 2000 cases of uterine cervix carcinoma totally treated at Institut Gustave-Roussy from 1950 to 1963. From the study of their long-term survival, an overall cure rate was estimated at 49% seven years after the start of primary treatment. A study of several covariables revealed stage and histologic type to be the only significant factors correlated with prognosis. Relative death rates were then estimated at each level of the two interacting variables with increasing risks for increasing stage and greater risk for adenocarcinoma.
Adenocarcinoma↗
[End results of uterine cervix carcinoma (author's transl)].
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Female↗
A method of analysis taking into account competing events: application to the study of digestive complications following irradiation for cervical cancer.
Over the past 20 years, mortality rates from uterine cervix carcinoma have been decreasing owing to earlier diagnosis and improved treatment. The incidence of secondary effects from radiation therapy has spurred some interest and injuries resulting from 'over'-treatment have been of some concern. The present study concerns the evaluation of bowel complications following treatment for the 272 stage IIb and III patients treated in our centre between 1967 and 1973. Competing risk methodology is applied and the influence of radiotherapy parameters is evaluated by a log-linear model of the event-specific failure rates. A single parameter (NSD) which summarized total dose, total number of sessions and total treatment time is found to be related to the occurrence of complications.
Clinical Trials as Topic↗
Value of serial carcinoembryonic antigen levels in evaluating the response to chemotherapy in patients with advanced digestive cancers.
The main objective of this study was to evaluate the correlation between the carcinoembryonic antigen (CEA) and clinical response to chemotherapy. Sixty-five patients with gastrointestinal cancers treated by chemotherapy were studied. All patients had serial measurements of CEA and an evaluation of tumour response by CT scan. Responses based on CEA were defined in the same way as WHO clinical response based on CT scan. The sensitivity and specificity of CEA was respectively 85% and 90% for objective response, 52% and 76% for stable disease, 71% and 80% for progression. Among 19 patients in stable disease with stable or progressive evolution of their CEA level, 14 (74%) were in progression at a second evaluation, after 2 or 3 more courses of the same chemotherapy. The monitoring of chemotherapy by CEA in patients with metastatic gastrointestinal cancers could be helpful for patients stable at the first evaluation by CT scan or patients with non-measurable disease and having an elevated baseline level of CEA.
Adult↗
Individual 5FU-dose adaptation schedule using bimonthly pharmacokinetically modulated LV5FU2 regimen: a feasibility study in patients with advanced colorectal cancer.
AIM OF THE STUDY: SFU-dose adaptation optimal schedule using bimonthly LV5FU2 regimen was modulated by previously validated individual pharmacokinetic parameters, in 38 patients with advanced colorectal cancer. METHODS: At the 1st cure, 5F-U pharmacokinetic parameters (particularly the area under curve (AUC) in mg.h/l.m2) were calculated in all patients. In 19 patients (A), 5FU infusion doses were progressively increased from 25 to 50% (at every cycle), according to AUC levels from 2nd to 6th; in 19 consecutive patients (B), 5FU infusion doses were increased, at the same time, at the 2nd cure, according to a protocol taking in account AUC at the 1st cure: increase of 150% it AUC < 5, of 100% if 5 < AUC < 10, of 50% if 10 < AUC < 15, of 25% if 15 < AUC < 20 in case of toxicity < grade 3. RESULTS: a) AUC in all patients, at the beginning of the treatment averaged 9.05 +/- 3.115 (range from 3.9 to 16.41). Large interindividual variability was observed. b) FU infusion doses at the 2nd cure, increased 40% in group A and 82% in group B. Corresponding AUC increased respectively of 42% and 96%. 3-WHO toxicity 23 (per cycle) occurred not very frequently (8% haematological, 6% digestive and 2% cutaneous toxicity) and remained acceptable. CONCLUSION: This feasibility study established a 5FU-dose intensification optimal strategy within the bimonthly LV5FU2 schedule with a control for the risk of toxicity. This study constitutes the basis for a multicentre phase II trial to evaluate the importance of this approach in terms of efficacy and survival.
Antineoplastic Combined Chemotherapy Protocols↗
Efficacy of prophylactic anti-diarrhoeal treatment in patients receiving Campto for advanced colorectal cancer.
This study assessed the efficacy of combined prophylactic and curative anti-diarrhoeal medication in advanced colorectal patients treated by irinotecan. Thirty-four pre-treated eligible patients were evaluated. There were 44% women, the median age was 65 and 38% of the patients had a 0 performance status. The patients received sucralfate(4g/d) and nifuroxazide(600 mg/d) prophylactic treatment on days 0-7. In the case of severe diarrhoea, preventive treatment was replaced by loperamide(12 mg/d) and diosmectite (9 g/d). Grade 3 delayed diarrhoea occurred in 18% of patients (90% CI: [9.5-28.9]) and 4.6% of cycles. No grade 4 delayed diarrhoea was observed. Twenty-nine patients (85%) received the preventive treatment at cycle 1, while 14% (90% CI: [6.2-25.7]) experienced grade 3 delayed diarrhoea in 3.7% of cycles for a median 4.5 days. The objective response rate was 8% (90% CI [1.4-23.1]) among the 25 assessable patients. Preventive combined treatment is effective in reducing the incidence of severe delayed diarrhoea, and it should be proposed to patients treated with mono-therapy Campto(r) and evaluated in poly-chemotherapy protocols.
Adenocarcinoma↗
[Analysis of results of a trial using the subject as its own control with a criterion of binary response].
The two-period cross-over design is often used in clinical trials in which subjects serve as their own controls. This procedure may produce a more powerful test, but also may produce bias due to carry-over effects. Three tests have been proposed for the analysis of two-period binary response cross-over trials (McNemar, Gart and Prescott). These tests and a simple test for the carry-over effect are presented in this paper. The contrasts used are similar for the three tests, but McNemar's test does not allow an order effect, contrary to the other methods. The Prescott's test is more powerful, but calculations are heavy and need computer assistance. Therefore, McNemar's test can be used as a first approximation.
Clinical Trials as Topic↗