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Biomedical subjects

C Rodary

Publications and source records attributed to C Rodary.

52 records · Page 3Linked to original sources

[Problems raised by interim analysis in therapeutic trials].

Interim analyses are analyses performed before complete collection of information on all patients in the study is obtained. The precocity and the repetiveness of these analyses considerably increase the risk of false conclusions of a significant difference. For instance, if ten statistical tests are carried out during the course of a trial at the alpha = 5 per cent nominal level, the overall significance level increases to 19 per cent. Statistical methods allowing repeated analyses are described here: Classical Sequential Analysis (Armitage) and Group Sequential Analysis (Pocok).

Clinical Trials as Topic↗

[The treatment of Wilm's tumor, improvements and new trends. A study of 724 cases treated at the Gustave-Roussy Institute. 1952-1980 (author's transl)].

Study of 724 cases of Wilm's tumor treated between 1952 and 1980 at the Gustave-Roussy Institute, according to 5 successive therapeutic protocols with or without chemotherapy (Actinomycin alone or Actinomycin and Vincristine). Recovery rates change from 44 to over 90% during this period. Improvement of survival was first obtained by the efficient treatment of metastases, then by preventing their development with systematic chemotherapy with Actinomycin and Vincristine. Rate of survival without relapse changed from 38 to 71 and 86%. Thus, the decrease in the number of patent metastases subjected to heavy treatments responsible for severe respiratory and orthopedic sequelae improved the quality of survival of these children.

Adolescent↗

[Optic glioma in children. A retrospective study of 57 cases treated by irradiation (author's transl)].

57 children presenting with optic glioma, 30 of which with neurofibromatosis, were treated from 1956 to 1978 at the Institute Gustave-Roussy. In 3, the tumor was confined to a single optic nerve; 18 had a chiasm-infiltrating tumor and 36 a large tumor invading adjacent structures. At the time of diagnosis, all but 2 had visual deficit, 5 had endocrine dysfunction and 27 had symptoms of increased intracranial pressure. X-ray examinations showed an enlargement of the sella turcica in 28 out of 37 patients and enlarged optic canals in 39 out of 41 investigated cases. 25 patients were operated on (most often exploratory operation only) and all received a 50 to 60 grays irradiation. 42 patients are alive but 20 are blind and 26 present with important mental retardation.

Adolescent↗

[Results of treatment of 178 pediatric non Hodgkin's malignant lymphomas between 1973 and 1978 (author's transl)].

178 children presenting with non Hodgkin's lymphomas (NHL) were treated using the same protocol from 1973 to 1978 at the Institut Gustave-Roussy. They were classified according to stages (13 stage I, 21 stage II, 80 stage III, 50 stage IV, 6 undetermined stage), according to initial site of involvement (abdomen: 68, mediastineum 55, ORL: 32, lymph glands: 13, "others": 10) and according to histology. They were given combination chemotherapy (Vincristinee-adriamycin-cyclophosphamide-prednisone), preventive CNS therapy by cranial irradiation and intrathecal methotrexate (except in stage I patients) and maintenance therapy by cyclic multiple agents regimens including vincristin-adriamycin, vincristin-cyclophosphamide and cytarabine-asparaginase. Radiation therapy was carried out up to 1977 in stage I and II patients only. Combination chemotherapy improved global survival of pediatric NHL (40% at 4 years, all staged added); however improvements remain to be done in patients with widespread disease.

Adolescent↗

[Double blind randomized trial of metopimazine: for postoperative nausea and vomiting after cholecystectomy].

Eighty-four patients submitted to cholecystectomy were randomly assigned in a double-blind study either to an intravenous dose of 10 mg of metopimazine, three times D-1, for two days or to an identically administered placebo. A definite superiority of metopimazine as an anti-emetic drug was demonstrated. General acceptance was excellent, but arterial pressure might be looked over closely when metopimazine was administered intravenously immediately after a general anesthesia.

Adult↗

[Estimation of survival rates: technics used (author's transl)].

The direct method and life-table methods (actuarial and Kaplan-Meier) for estimating survival rates are described here. The difference between direct method and lifetable method is the use of information about the patients who are still alive. Practical examples of calculation are given with recommandations for graphical displays.

Actuarial Analysis↗

Treatment of nausea and vomiting related to anti-cancerous multiple combination chemotherapy: results of two controlled studies.

Two controlled double-blind studies were carried out successively on a cancerous out-patient population receiving multiple combination chemotherapy at successive treatment courses to show the anti-emetic efficiency of metopimazine compared to a placebo. The patient was taken as his own control and the treatment order was randomly selected. The first trial--consisting of sixty-seven patients, showed a weak statistically significant difference (0.05 less than p less than 0.10) between metopimazine at doses of 30 mg/day or 15 mg/day and a placebo. The second trial--comparing a higher dose of metopimazine (45 mg/day) among one hundred and sixteen patients, showed a highly statistically significant therapeutic advantage over a placebo (0.001 less than p less than 0.01).

Antineoplastic Agents↗

[Treatment of non hodgkinian malignant lymphomas in children].

Non Hodgkin Lymphomas are in children nostly diffuse and non or poorly differentiated. The exact frontiers with ALL are difficult to assess. With old classical treatments, the chances of cure were limited to localized tumors (stage I). The present indications of combined intensive chemotherapies, of neuromeningeal prophylaxis, and radiotherpy are analyzed. Preliminary results in 51 children treated first in 1973-1974 are presented. The rate of complete remission is 82%. Actuarial survival rate is 57% at 30 months. The aim and the limitations of treatment protocol are discussed.

Child↗