Oncologie

, Volume 19, Issue 1–2, pp 16–20 | Cite as

Étude QUALIOR : faisabilité et efficacité d’un programme d’activité physique adaptée standardisée et encadrée à domicile chez des patients bénéficiant d’une thérapie ciblée orale pour un cancer métastatique

Essai de phases II–III randomisé de l’intergroupe Unicancer–AFSOS soins de support
Mise au Point / Update

Résumé

L’effet secondaire le plus souvent rapporté par les patients traités par thérapies ciblées orales pour un cancer avancé est la survenue d’une fatigue qui peut être un facteur limitant pour la tolérance au long cours de ces traitements. L’activité physique adaptée (APA) a démontré son bénéfice en améliorant l’état de fatigue de patients traités pour un cancer localisé et dans certaines situations une amélioration de la survie. La majorité des études ont été réalisées pendant la période de l’après-cancer ou lors de la phase de traitement par chimiothérapie et/ou radiothérapie. Très peu d’études ont été conduites auprès de patients avec un traitement par thérapies ciblées orales. Les programmes d’APA sont de qualité inégale dans leurs objectifs et les modalités de réalisation et d’évaluation. Notamment chez des patients fatigués ayant une maladie avancée, il est important d’évaluer des programmes d’APA à domicile supervisée. L’étude QUALIOR, promue par Unicancer, est une étude randomisée de phases II–III qui a pour but d’évaluer de façon rigoureuse la mise en place d’un programme d’APA à domicile de trois mois chez plus de 300 patients traités par thérapie ciblée pour un cancer avancé (incluant le cancer du sein, du rein, du poumon, plus une cohorte divers) sur l’amélioration de la fatigue et de la qualité de la vie, ainsi que l’observance à long terme du traitement. Un objectif secondaire est d’évaluer la survie sans rechute. Ce programme est également évalué sur sa pertinence médicoéconomique. La faisabilité du programme d’APA qui a été conçu avec des paliers d’intensité est évaluée lors de la phase II qui sera ensuite poursuivie par une phase III pour mesurer son efficacité. L’objectif final est de permettre d’avoir accès à des séances d’APA encadrée à l’attention des patients traités par ces nouvelles thérapies ciblées dans le cadre de l’activité de soins de support.

Mots clés

Activité physique adaptée Thérapie ciblée orale Cancer avancé Fatigue Qualité de vie Étude randomisée 

QUALIOR study: the feasibility and efficacy of a home based standardised adapted physical activity programme of patients receiving oral targeted therapy for metastatic cancer

Randomised, phases II–III Unicancer–AFSOS supportive care intergroup study

Abstract

The adverse effect most commonly reported by patients treated with oral targeted therapies for advanced cancer is the onset of fatigue, which may be a limiting factor in long-term tolerance of these treatments. Adapted physical activity (APA) has a demonstrated its beneficial effect on the level of fatigue experienced by patients treated for localised cancer and, under certain circumstances, has shown an improvement in survival. The majority of studies were conducted in the post-cancer period or during the treatment phase, with chemotherapy and/or radiotherapy. Very few studies have been carried out on patients treated with oral targeted therapies. APA programmes vary in quality in terms of their objectives and the ways in which they are carried out and assessed. Particularly for patients with fatigue who have an advanced illness, it is important to assess supervised, home-based APA programmes. The QUALIOR study, sponsored by Unicancer, is a phase II–III randomised study, with the aim of thoroughly assessing the implementation of a 3-month home-based APA programme for more than 300 patients treated with targeted therapy for an advanced cancer (including breast, kidney and lung cancer plus a diverse cohort) in improving fatigue and quality of life, as well as full-term treatment compliance. A secondary objective is to evaluate progression-free survival. This programme is also assessed for its medico-economic relevance. The feasibility of the APA programme, which has been designed with various intensity levels, is assessed during the phase II study, which will then be continued with a phase III study to measure the programme’s efficacy. The final objective is to provide access to supervised APA sessions, specifically aimed at patients treated with these new targeted therapies, within the framework of a supportive care activity.

Keywords

Adapted physical activity Oral targeted therapy Advanced cancer Fatigue Quality of life Randomised study 

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Copyright information

© Lavoisier 2017

Authors and Affiliations

  1. 1.Centre François-BaclesseCaenFrance
  2. 2.Groupe GERICO - Groupe Soins de Support R&D UNICANCERParis cedex 13France
  3. 3.CHU de BesançonBesançonFrance

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