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C Com-Nougué

Publications and source records attributed to C Com-Nougué.

9 recordsLinked to original sources
PubMed2002

Less frequent catheter dressing changes decrease local cutaneous toxicity of high-dose chemotherapy in children, without increasing the rate of catheter-related infections: results of a randomised trial.

Cutaneous lesions caused by catheter dressing changes can be serious and generate local pain in children undergoing high-dose chemotherapy followed by bone marrow transplantation. One hundred and thirteen children entered a randomised trial to compare two catheter dressing change frequencies (15 days vs 4 days). Skin toxicity was classified according to the following scale: grade 0: healthy skin, to grade 4: severe skin toxicity. A qualitative culture of the skin at the catheter entry site was taken whenever the dressing was changed. Of the 112 evaluable children (56 in each group) 32 developed grade > or = 2 local skin toxicity (eight in the 15-day group and 24 in the 4-day group; P = 0.001). Although higher in the 4-day group, the proportions of children experiencing pain during and between dressing changes were not statistically different between the two groups. The proportion of patients with one or more positive skin culture(s) at the catheter entry site during hospitalisation were similar in the two groups (27% in the 15-day group and 23% in the 4-day group) as were the proportions of documented nosocomial bloodstream infections (11% and 13%; NS). Whereas the planned frequency was maintained in the 4-day group (mean = 4 days, s.d. = 1), it was usually shortened in the 15-day group (mean = 8 days, s.d. = 4), mainly because dressings had loosened. Decreasing the catheter dressing change frequency proved efficient in reducing cutaneous toxicity without increasing the risk of local and systemic infection. In our unit, catheter dressings are changed every 8 days since this analysis.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2001

Optimal duration of preoperative therapy in unilateral and nonmetastatic Wilms' tumor in children older than 6 months: results of the Ninth International Society of Pediatric Oncology Wilms' Tumor Trial and Study.

PURPOSE: To determine the optimal duration of preoperative chemotherapy to further increase the proportion of stage I tumors by comparison of two regimens in the treatment of patients older than 6 months who have unilateral Wilms' tumor. PATIENTS AND METHODS: Eligible patients (n = 382) initially received four weekly doses of vincristine (VCR) and two courses of actinomycin D (AMD) and were randomized either to be operated on (4-week group [n = 193]) or to receive 4 more weeks of the same chemotherapy regimen (8-week group [n = 189]). The assessment criterion was the observed percentage of stage I tumors. After surgery, patients were assigned according to tumor stage and histology to four different treatment groups: stage I and favorable histology (n = 5) were to have no further treatment (NFT); stage I and standard histology or anaplasia (n = 244), VCR and AMD for 17 weeks (AV); stages II and III and favorable or standard histology, VCR, AMD, and an anthracycline for 27 weeks (AVE) with no abdominal radiotherapy for stage II N0 disease (n = 75) or with a 15-Gy dose of abdominal irradiation (RTH) in case of stages IIN1 and III (n = 56). Anaplastic tumors staged higher than I or clear-cell sarcoma of the kidney (14), AMD, VCR, an anthracycline, and ifosfamide for 36 weeks (DEVI). RESULTS: No advantage was found in favor of prolonged preoperative treatment. The percentages obtained for the 4-week and the 8-week groups, respectively, were as follows: stage I, 64% versus 62%; intraoperative tumor rupture rate, 1% versus 3%; 2-year EFS, 84% versus 83%; and 5-year OS, 92% versus 87%. Two-year EFS and 5-year OS rates, respectively, of the different treatment groups were as follows: NFT, 100% for both EFS and OS; AV, 88% and 93%; AVE, 84% and 88%; AVE RTH, 71% and 85%; and DEVI, 71% and 71%. The rate of abdominal recurrences in stage II N0 nonirradiated patients was 6.6%. CONCLUSION: The 4-week schedule pre-nephrectomy chemotherapy regimen should be considered the standard treatment. Clinical trials should continue to improve the cure rate of high-risk patients and the quality of life of children with a more favorable prognosis.

Adolescent↗
PubMed1999

[Assessment of risks associated with multiple events].

Our aim, when evaluating many events, is to assess overall survival S(t) but also event free survival EFS(t). In addition, we often wish to estimate the respective contribution of each event involved in event free survival and to describe the distribution of the time of occurrence of each event by breaking down EFS into its different components. However, these different events are often dependent and/or exclusive. Appropriate statistic tools, named competing risk analyses are then required. The aim of this article is to define situations necessitating competing risk analyses as opposed to more simple alternatives which, although often used, are not always appropriate. First two examples are presented to illustrate the problems we face when studying many events. Statistical methods used to compute competing risks are then developed, as is the type of interpretation that can be given to these results.

Adult↗
PubMed1995

[Problems which arise when testing the equivalence of 2 survival distributions].

Clinicians' interest in equivalence trials has been increasing for many years. In cancer research we are more often concerned with survival or event free survival (EFS). The usual logrank test has to be modified to test whether the true value r of the relative risk is at least equal to a limit value rL. An equivalence trial of post-operative therapy was carried out in children with stage II nephroblastomas without lymph node involvement, and serves as an illustration of some problems, discussed here, which arise in such design: ethical questions when defining the equivalence region, the choice of a one sided or a two sided formulation, the required number of patients or the power of the comparison. A formula is given in order to allow calculation for the required number of patients to ensure a given power when the treatment effects are the same. Other problems are also encountered when analyzing the observed results as the number of events which is evidently low in a de-escalation trial, may be reduced due to a stopping rule. We also discuss about the possibility to use event free survival as a surrogate of overall survival, and about the difficulties encountered when interpreting the results in terms of significance level.

Disease-Free Survival↗
PubMed1993

Results of the Sixth International Society of Pediatric Oncology Wilms' Tumor Trial and Study: a risk-adapted therapeutic approach in Wilms' tumor.

PURPOSE: The Sixth International Society of Pediatric Oncology study (SIOP6) concerned Wilms' tumor with favorable histology, preoperatively treated to obtain a high rate of stage I patients, and sought to reduce treatment for patients with stage I and stage II negative nodes (IIN0) tumors and to find better therapy to prevent relapses in stage II positive nodes (IIN1) and stage III patients. PATIENTS AND METHODS: Eligible patients (N = 509) had received four weekly doses of vincristine (VCR) and two courses of dactinomycin (AMD) preoperatively and were assigned after surgery, according to stage and lymph node involvement, to three different prognostic groups, which were to be randomized. Stage I patients (n = 303) received VCR and AMD either for 17 weeks (S) or 38 weeks (L). Stage IIN0 patients (n = 123) received either 20 Gy irradiation (R+) or no irradiation (R-) and received VCR and AMD for 38 weeks. Stage IIN1 and III patients (n = 83) received intensified VCR and AMD (INTVCR) versus VCR, AMD, and Adriamycin (ADRIA; Doxorubicin Farmitalia Carbo Erba, Rueil, Malmaison, France; doxorubicin). Assessment criteria were 2-year disease-free survival (DFS) and 5-year survival (SURV) percentages. A stopping rule was added that took into account abdominal recurrences for the stage IIN0 trial. RESULT: A 52% rate of stage I tumors was obtained, with a low rate of ruptures (7%). The 2-year DFS and 5-year SURV rates according to the different therapeutic groups were stage I, 92% versus 88% (equivalent) and 95% versus 92% for S and L, respectively; stage IIN0, 72% versus 78% (stage equivalent) and 88% versus 85% for R+ and R-, respectively; and stage IIN1 and stage III, 49% versus 74% (P < .029) and 77% versus 80% for INTVCR and ADRIA, respectively, which results in an 82% DFS and 89% SURV rate for the entire trial population. However, six abdominal metastases observed during the first year of follow-up (FU) in the R- group versus none in the R+ group resulted in discontinuation of the stage IIN0 trial. CONCLUSION: Risk-adapted therapy to limit risk of sequelae is possible. More intensive chemotherapy is necessary to prevent abdominal recurrences in nonirradiated stage IIN0 patients treated preoperatively. A three-drug protocol is necessary in stage IIN1 and stage III patients.

Adolescent↗
PubMedDate not supplied

[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↗