Dynamic Change of Fatigue of Pemetrexed Maintenance Treatment in the JMEN Trial
A partir des données portant sur des patients atteints d'un cancer du poumon non à petites cellules non épidermoïde de stade avancé et inclus dans un essai randomisé évaluant l'efficacité du pémétrexed en traitement d'entretien, cette étude analyse l'évolution de la fatigue induite par le traitement et son effet sur la qualité de vie
Objectives : In the JMEN trial, patients with advanced non-squamous non-small cell lung cancer (NSCLC) without progression after platinum-based first-line therapy derived extended survival, delayed disease progression, and maintained overall quality of life (QoL) from pemetrexed maintenance therapy. However, fatigue was the most common physician-reported non-hematological toxicity in the pemetrexed group. This post hoc analysis investigated dynamic change of fatigue. Materials and methods : Analysis of the overall safety population with squamous and non-squamous NSCLC subgroups included Common Terminology Criteria for Adverse Events to summarize adverse event (AE) rates by cycle and AE investigator-reported severity. Worsening of fatigue, defined as +15 mm or more from baseline on a 100 mm scale, evaluated QoL using the patient-reported Lung Cancer Symptom Scale. Patients with worsening fatigue and time-to-worsening of fatigue symptoms were also analyzed. Results : Drug-related fatigue occurred more frequently with pemetrexed than placebo. The drug-related grade 3/4 fatigue was also higher in the overall population on pemetrexed than with placebo. Fatigue incidence during pemetrexed maintenance after induction was not altered with cumulative exposure. Percentage of patients who experienced worsening of fatigue based on patient-reported LCSS scores was comparable between the two arms in cycles 1–10. The time-to-worsening of fatigue was similar between the pemetrexed arm and the placebo arm in the overall population; however, the East Asian subpopulation patients taking pemetrexed experienced a longer median time-to-worsening of fatigue than patients taking placebo. Conclusion : Analyses suggest that despite higher incidence of any grade drug-related fatigue compared with placebo in patients with advanced NSCLC, pemetrexed maintenance does not impair patient-reported QoL.
Lung Cancer 2017