Adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma: Health-related quality of life from the randomized phase 3 KEYNOTE-716 study
Mené à partir de données portant sur 969 patients atteints d'un mélanome de stade III à haut risque de récidive et ayant été réséqué, cet essai de phase III évalue l'intérêt, du point de vue de la qualité de vie, du pembrolizumab en traitement adjuvant
Résumé en anglais
Background : Adjuvant pembrolizumab significantly improved recurrence-free survival (RFS) versus placebo in resected stage IIB and IIC melanoma in the phase 3 KEYNOTE-716 study. Health-related quality of life (HRQoL) results are reported.
Methods : Patients were randomly assigned 1:1 to pembrolizumab 200 mg (2 mg/kg, patients ≥12to <18 years) Q3W or placebo for ≤17 cycles or until disease recurrence, unacceptable toxicity, or withdrawal. Change from baseline in EORTC QLQ-C30 global health status(GHS)/quality of life (QoL) was a prespecified exploratory end point. Change in EORTCQLQ-C30 functioning, symptom, and single-item scales, and EQ-5D-5L visual analog scale(VAS) were also summarized. Primary analyses were performed at week 48 to ensure adequate completion/compliance. The HRQoL population comprised patients who received ≥1 doseof treatment and completed ≥1 assessment.
Results : The HRQoL population included 969 patients (pembrolizumab, n = 483; placebo, n = 486). Compliance at week 48 was ≥80% for both instruments. EORTC QLQ-C30 GHS/QoL,physical functioning, role functioning, and EQ-5D-5L VAS scores were stable from baselineto week 48 in both arms, with no clinically meaningful decline observed. Scores didnot differ significantly between pembrolizumab and placebo. EORTC QLQ-C30 GHS/QoL,physical functioning, role functioning, and EQ-5D-5L VAS scores remained stable throughweek 96 in both arms.
Conclusions : HRQoL was stable with adjuvant pembrolizumab, with no clinically meaningful declineobserved. Change from baseline in HRQoL was similar between arms. These results, inconjunction with the improved RFS and manageable safety previously reported, supportthe use of adjuvant pembrolizumab for high-risk stage II melanoma.
