[Method for evaluating long term complications. A study from a phase III trial comparing two low dose rates in gynecologic brachytherapy].
When treatment complications are the main criteria of a study, the simplest way for estimating the complication rate over time is to use the Kaplan-Meier method. The failure is the onset of the first complication. A new way is proposed here which takes into account the time to an eventual second, and third complication, and their duration as well. Results from a phase III randomized trial comparing two preoperative brachytherapy low dose rates in localized stage cervix carcinoma patients are used to illustrate both methods. The new method showed a greater long term complication rate in the higher dose rate group.
Lancar
R
R
Biostatistiques, institut Gustave-Roussy, Villejuif, France.
Kramar
A
A
Haie-Meder
C
C
Lambin
P
P
Bouzy
J
J
Scalliet
P
P
Gerbaulet
A
A
D001918:Brachytherapy / Q000009:adverse effects*; D003430:Cross-Sectional Studies; D004307:Dose-Response Relationship, Radiation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D009367:Neoplasm Staging; D011832:Radiation Injuries / Q000209:etiology*; D011879:Radiotherapy Dosage; D012307:Risk Factors; D016019:Survival Analysis; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery
Méthode d'évaluation des complications tardives. Etude basée sur un essai de phase III comparant deux faibles débits de dose en curiethérapie gynécologique.