Localized high grade endometrial stromal sarcoma and localized undifferentiated uterine sarcoma: a retrospective series of the French Sarcoma Group.

Objective: High grade endometrial stromal sarcoma and undifferentiated uterine sarcomas are associated with a very poor prognosis. Although large surgical resection is the standard of care, the optimal adjuvant strategy remains unclear.

Methods: A retrospective analysis of patients with localized high grade endometrial stromal sarcoma and undifferentiated uterine sarcomas (stages I-III) treated in 10 French Sarcoma Group centers was conducted.

[Good practices of publication of clinical cases of pharmacovigilance: comments, Groupe de Travail sur les Bonnes Pratiques de Publication de Cliniques en Pharmacovigilance: commentary].

This paper introduces some comments on the complete text of Good Pharmacovigilance Publishing Practices, which forms appendix number 2 of the Good Pharmacovigilance Practices now published by the French Drug Agency, as was Good Clinical Practices. Each good practice is printed in italic and presented in a frame; the following comments are designed to facilitate its application. The technical terms that are used in this text are presented according to the glossary in Good Pharmacovigilance Practices.

[Drugs and patient information. Writing of instructions].

The main accusation against package inserts is that they are not understood by the patients: the vocabulary used is uncommon and the information is not always relevant. A recent European directive on package inserts for drugs concerning human use specifies the items that must be mentioned. Following this directive and regarding patient interest, a presentation for notices is proposed in which the subject headings are presented as questions and the text is a guide to drug practical use to provide the elements of surveillance.

Does proof of casualty ever exist in pharmacovigilance?

Identifying the adverse effects of drugs, thus transforming adverse events into adverse drug reactions, is a useful and necessary but complicated task. Objective proof of a causal relationship between a drug and a specific event is quite exceptional. In most cases, this relationship remains subjective and is no more than inner conviction.

[Problems of the number of cases in drug surveillance].

The purpose of drug surveillance studies is to ascribe the adverse event observed to a pharmacological cause and to try to evaluate its frequency in order to draw reliable conclusions. The present study shows that epidemiological investigations of the cohort or case-control type not only are of poor warning value but also require so many patients that the information required is obtained very slowly and at a very high cost. Despite its imperfections, spontaneous reporting seems to be the most effective method of post-marketing drug surveillance.