Implications cliniques

Un fait intéressant, résultant de la sous-analyse par période de temps, est la tendance pour mie meilleure survie dans les années 2000 pour les femmes qui participaient à un EC Entre 2000 et 2008, les résultats ajustés ont été statistiquement significatifs autant pour la survie de toutes causes (RH = 0,66; p = 0,02) que pour la survie spécifique au cancer du sein (RH = 0,60; p = 0,02) en faveur des patientes sous EC. Malgré qu'il y ait peu de temps de recul pour évaluer la survie, beaucoup de femmes ont été diagnostiquées dans cette période de temps. Ces résultats s'avèrent prometteurs pour les années à venir, car ils suggèrent que les efforts déployés jusqu'à maintenant pour améliorer le recrutement doivent être maintenus. De plus, une étude conduite en 2008 par Chan et al. (8) ont évalué les critères des EC de phase II pouvant prédire la réussite des EC de phase III subséquents. De façon statistiquement significative, la proportion des EC de phases II qui ont généré des EC positifs de phase III était passée de 56,0%, entre 1996-2000 et à 76,8%) dans la période 2001-2005. La progression positive de ces résultats à travers les années propose un avenir prometteur pour améliorer la survie des patientes qui participent aux E C Dans quelques années d'ici, il serait intéressant de reconduire la présente étude pour vérifier si le simple

58 fait de participer à un EC peut, à lui seul, expliquer la baisse de la mortalité par cancer du sein.

Les résultats de notre étude n'ont pas démontrés d'association statistiquement significative, entre les EC et la survie des patientes atteintes d'un cancer du sein. Toutefois, les résultats n'ont pas montré non plus que les EC étaient néfastes pour les patientes atteintes d'un cancer du sein. En l'absence d'un effet de participation aux EC, il reste que les patientes ont la possibilité de recevoir un traitement possiblement supérieur avant les patientes traitées hors EC. De plus, pour certaines d'entre elles, le suivi régulier et le contact plus étroit avec les infirmières de recherche peut être rassurant. Pour ces raisons, les EC pourraient venir en aide au prolongement de la survie des femmes atteintes d'un cancer du sein et représenter des options de traitements supplémentaires pour les médecins.

Les initiatives pour promouvoir la participation à l'essai de nouveaux médicaments ou de nouvelles interventions doivent être maintenues auprès des patientes. Le développement de nouvelles procédures pour optimiser et améliorer le recrutement doit rester en vigueur afin que les médecins puissent faire profiter les patientes des nouvelles interventions. Le CMS doit poursuivre sa contribution à la mise au point d'agents anticancéreux pour les femmes avec un cancer du sein afin que le Canada puisse améliorer et poursuivre son rayonnement à l'échelle mondiale en matière d'EC (47).

7. CONCLUSION

En somme, la participation à un EC n'améliore pas la survie des patientes ayant un cancer du sein. Les résultats, qui tiennent compte de l'ensemble des variables d'ajustement, n'ont pas démontré une différence de survie statistiquement significative entre le groupe de patientes sous EC versus celui non sous EC. Cela sous-entend que l'évolution du cancer du sein d'une patiente qui se trouve sous EC est la même qu'une patiente qui est traitée hors EC. Toutefois, les mesures d'association ajustées, étant près de la valeur nulle, permettent d'affirmer que les EC n'ont pas d'effet délétère sur les participantes. De plus, une patiente qui participe à un EC, peu importe si elle est assignée dans le bras standard, expérimental ou inconnu, est assurée d'avoir au minimum un traitement standard qui respecte les guides de pratique en vigueur. Les femmes qui participent à des EC présentent des caractéristiques distinctives de celles qui n'y participent pas. Dans d'éventuelles études du même contexte, pour augmenter la précision des résultats, il serait intéressant d'obtenir l'information sur les patientes approchées pour faire partie des EC

Les initiatives déployées jusqu'à maintenant sont prometteuses pour améliorer le recrutement et la conduite des EC dans le futur. Elles sont d'autant plus utiles pour approfondir l'étude de la relation entre la participation aux EC et leurs effets sur différentes issues de santé d'un patient atteint de cancer. La promotion des EC, autant chez les professionnels de la santé que chez les patients, doit donc être maintenue pour favoriser et soutenir un contexte propice à la recherche dans ce domaine. Ainsi, les professionnels de la santé seront plus enclins à proposer différents EC aux patients et, ces derniers, seront plus confiants d'y participer.

60

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