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dc.contributor.authorCarril-Ajuria, Lucía
dc.contributor.authorRomero Ferreiro, Carmen
dc.contributor.authorAlbiges, Laurence
dc.date.accessioned2023-01-27T12:18:53Z
dc.date.available2023-01-27T12:18:53Z
dc.date.issued2022
dc.identifier.issn0959-8049spa
dc.identifier.urihttps://hdl.handle.net/10641/3232
dc.description.abstractBackground Immune checkpoint inhibitor-based combination therapy (ICI-based combination) is a new standard of care for metastatic clear cell renal cell carcinoma (mRCC) in the frontline setting. Patients with poor performance status (PS) (≥2) were excluded from pivotal trials. Hence, the activity and safety of ICI-based combination therapy in this group of patients is still unknown. Methods We performed a multicentre retrospective study of PS ≥2 mRCC patients who received frontline ICI-based combination, either nivolumab-ipilimumab (NI) or pembrolizumab-axitinib (AP). Patients' characteristics, clinical outcomes, and toxicity were collected. We analysed overall response rate (ORR), median progression-free survival (mPFS), median overall survival (mOS) and grade ≥3 adverse events (G ≥ 3AEs). The association between the predictive biomarker IPI (immune prognostic index) and ORR/PFS/OS was also evaluated. Results We identified 70 mRCC patients with PS ≥2 treated with ICI-based combination across 14 institutions between October 2017 and December 2021, including 45 and 25 patients were treated with NI and AP, respectively. Median age at diagnosis was 63 years, 51 (73%) were male, only 17 (24%) had prior nephrectomy, 50 (71%) had synchronous metastatic disease at diagnosis, and 16 (23%) had brain metastases. Sixty-one (87%) and 9 (13%) patients had ECOG (Eastern Cooperative Oncology Group) PS 2 and 3, respectively, and 25 (36%) and 45 (64%) patients were intermediate and poor International Metastatic RCC Database Consortium (IMDC) risk, respectively. Among all, 91% were clear cell RCC, 7 patients had sarcomatoid features. At the time of the analysis (median follow-up 11.1 months), 41% patients were dead. Median PFS and mOS in the entire cohort were 5.4 months and 16.0 months, respectively; ORR was 31%. No significant differences in ORR, PFS, OS, or G ≥3AEs were seen between NI and AP. The intermediate and poor IPI groups were significantly associated with reduced ORR and shorter PFS. Conclusion We report the first cohort of PS ≥2 mRCC patients treated with frontline ICI-based combination therapy. The survival outcomes in our cohort were inferior to that reported in pivotal trials. No significant differences in ORR, PFS, OS or toxicity were seen between NI and AP. Prospective real-world studies are needed to confirm these results.spa
dc.language.isoengspa
dc.publisherEuropean Journal of Cancerspa
dc.rightsAtribución-NoComercial-SinDerivadas 3.0 España*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/es/*
dc.subjectRenal cell carcinomaspa
dc.subjectPoor performance statusspa
dc.subjectCombination therapyspa
dc.subjectImmune checkpoint inhibitorsspa
dc.subjectImmunotherapyspa
dc.subjectKidney cancerspa
dc.titleFrontline immune checkpoint inhibitor-based combination therapy in metastatic renal cell carcinoma patients with poor performance status.spa
dc.typejournal articlespa
dc.type.hasVersionSMURspa
dc.rights.accessRightsopen accessspa
dc.description.extent728 KBspa
dc.identifier.doi10.1016/j.ejca.2022.11.013spa
dc.relation.publisherversionhttps://www.sciencedirect.com/science/article/abs/pii/S0959804922017580spa


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Except where otherwise noted, this item's license is described as Atribución-NoComercial-SinDerivadas 3.0 España