Effect of nivolumab (NIVO) in combination with ipilimumab (IPI) versus IPI alone on quality of life (QoL) in patients (pts) with treatment-naïve advanced melanoma (MEL): Results of a phase II study (CheckMate 069).
2015; Lippincott Williams & Wilkins; Volume: 33; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2015.33.15_suppl.9029
ISSN1527-7755
AutoresAmy Pickar Abernethy, Michael A. Postow, Jason Chesney, Kenneth F. Grossmann, Fiona Taylor, Cheryl D. Coon, I. Gilloteau, Homa Dastani, Paul Gagnier, Caroline Robert,
Tópico(s)Cutaneous Melanoma Detection and Management
Resumo9029 Background: New therapies in advanced MEL improve survival, but QoL preservation is uncertain. NIVO (a PD-1 immune checkpoint inhibitor) and IPI are each approved as monotherapy for advanced MEL. In a phase II, randomized, double-blind study, NIVO (1 mg/kg every 3 weeks [wks; Q3W]; 4 doses) combined with IPI (3 mg/kg Q3W; 4 doses) followed by NIVO (3 mg/kg Q2W) significantly improved response rate and progression-free survival (PFS) versus IPI (3 mg/kg Q3W; 4 doses), with a manageable safety profile, in treatment-naïve pts with advanced MEL. Methods: In this study, QoL measured by EORTC QLQ-C30 and EQ-5D was evaluated at baseline (BL) and Q6W treatment cycles for the first 6 months. Mean changes and non-parametric comparisons are reported. Further analyses are planned to examine longitudinal QoL and the relationship between clinical and pt outcomes. Results: Pts received NIVO + IPI (n = 95) or IPI (n = 47). Adjusted completion rates at BL for EQ-5D utilities and EORTC QLQ-C30, respectively, were 64% and 65% with NIVO + IPI and 77% and 79% with IPI; rates remained stable throughout the study except a notable reduction at wk 13 in NIVO + IPI (48%). While completion rates remained similar to BL in the 2 arms after wk 13, pt numbers for IPI were substantially reduced after wk 13 (n ≤ 14) due to disease progression (median PFS: 3.7 months) or toxicity. NIVO + IPI and IPI had similar mean EORTC QLQ-C30 global health scores at BL (76.9 vs 80.9), wk 7 (69.2 vs 74.5) and wk 13 (78.5 vs 72.2), and similar mean EQ-5D utility index scores at BL (0.861 vs 0.847), wk 7 (0.788 vs 0.789) and wk 13 (0.894 vs 0.834). A transient deterioration in EQ-5D utilities was noted at wk 7 for NIVO + IPI (−0.071; n = 53; P= 0.023) and IPI (−0.055; n = 35; P= 0.140), but scores returned to BL levels at wk 13 and were maintained with NIVO + IPI beyond wk 13 after the switch to NIVO alone. Similar results were noted with EORTC QLQ-C30 scales. Conclusions: NIVO + IPI and IPI alone maintained QoL to a similar level in treatment-naïve pts with advanced MEL, with NIVO + IPI providing superior tumor response and PFS. Studies with increased follow up and pt numbers are needed to confirm these results. Clinical trial information: NCT01927419.
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