Produção Nacional
Revisado por pares
VP4-2021: EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9: Interim analysis of phase III trial of cemiplimab vs. investigator's choice (IC) chemotherapy (chemo) in recurrent/metastatic (R/M) cervical carcinoma
2021; Elsevier BV; Volume: 32; Issue: 7 Linguagem: Inglês
10.1016/j.annonc.2021.04.009
ISSN1569-8041
AutoresKrishnansu S. Tewari, Bradley J. Monk, Ignace Vergote, Austin Miller, Andréia Cristina de Melo, H.S. Kim, Y.M. Kim, Alla Lisyanskaya, Vanessa Samouëlian, Domenica Lorusso, Fernanda Damian, Chang Cl, E.A. Gotovkin, Shunji Takahashi, Daniella Ramone, Joanna Pikiel, J. Li, Melissa Mathias, Matthew G. Fury, Ana Oaknin,
Tópico(s)Cancer Mechanisms and Therapy
ResumoSalvage chemo is ineffective for patients (pts) with R/M cervical cancer following progression on first-line (1L) platinum-based chemo ± bevacizumab. EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 is an open-label, randomised (1:1), multi-centre, phase III trial of anti-programmed cell death (PD)-1 cemiplimab vs. IC single agent chemo in R/M cervical cancer that has progressed after 1L platinum-based treatment (tx). Pts were enrolled regardless of PD-L1 expression; received cemiplimab 350 mg IV every 3 wks or IC chemo (pemetrexed, vinorelbine, gemcitabine, irinotecan or topotecan), up to 96 wks; and were stratified by histology (squamous cell carcinoma [SCC] / adenocarcinoma or adenosquamous [AC]). Primary endpoint was overall survival (OS), analysed hierarchically in pts with SCC followed by total population (SCC + AC). Additional endpoints included progression-free survival (PFS), objective response rate (ORR), quality of life (QoL) and safety. Interim analysis was scheduled when 85% events occurred among SCC pts. 608 pts were randomised: median age, 51 years [range, 22‒87]; 477 SCC, 131 AC; ECOG performance score: 0 [46.5%], 1 [53.5%]. Median cemiplimab exposure was 15 wks (range, 1.4‒100.7). At interim analysis, OS (Table), PFS, ORR in overall and SCC populations, and mean change from baseline QoL in SCC, favoured cemiplimab. Most common tx emergent adverse events (AEs) of any grade for cemiplimab vs. IC chemo were anaemia (25% vs. 45%), nausea (18% vs. 33%) and vomiting (16% vs. 23%). Discontinuation due to AEs occurred in 8% (cemiplimab) and 5% (IC chemo). Cemiplimab significantly improves OS over single agent chemo for pts with R/M cervical cancer after 1L platinum-based tx regardless of PD-L1 status or histology. No new safety signals were observed.TableCemiplimab median OS months (n)IC chemo median OS months (n)Hazard ratio for death (95% confidence interval)P valueTotal population12.0 (n = 304)8.5 (n = 304)0.69 (0.56‒0.84)P < 0.001SCC population11.1 (n = 239)8.8 (n = 238)0.73 (0.58‒0.91)P = 0.003AC population13.3 (n = 65)7.0 (n = 66)0.56 (0.36‒0.85)P < 0.005 (nominal P value, not adjusted for multiplicity) Open table in a new tab
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