Nivolumab plus ipilimumab versus nivolumab in individuals with treatment-naive programmed death-ligand 1 positive metastatic soft tissue sarcomas: a multicentre retrospective study
Menée à partir de données portant sur des patients atteints d'un sarcome des tissus mous de stade métastatique et surexprimant PD-L1, cette étude rétrospective évalue l'efficacité, du point de vue de la survie globale et de la survie sans progression, de l'ajout de l'ipilimumab au nivolumab en traitement de première ligne
Background : Currently, the choice of treatment for individuals with metastatic soft tissue sarcomas (MSTS) presents a significant challenge to clinicians. The aim of this retrospective study was to assess the efficacy and safety of nivolumab plus ipilimumab (NPI) versus nivolumab alone (NIV) in individuals with treatment-naive programmed death-ligand 1 (PD-L1) positive MSTS. Methods : Prospectively maintained databases were reviewed from 2013 to 2018 to assess individuals with treatment-naive PD-L1 MSTS who received NPI (nivolumab 3 mg/kg and ipilimumab 1 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks) or NIV (3 mg/kg every 2 weeks) until disease progression, withdrawal, unendurable [AEs], or death. The co-primary endpoints were overall survival (OS) and progression-free survival (PFS). Results : The median follow-up was 16.0 months (IQR 14.4–18.5) after targeted intervention. The median OS was 12.2 months (95% confidence interval [CI], 6.1–13.7) and 9.2 months (95% CI, 4.2–11.5) for the NPI and NIV groups, respectively (hazard ratio [HR] 0.49, 95% CI, 0.33–0.73; p=0.0002); the median PFS was 4.1 months (95% CI, 3.2–4.5) and 2.2 months (95% CI, 1.1–3.4) for the NPI and NIV groups, respectively (HR 0.51, 95% CI, 0.36–0.71; p< 0.0001). Key grade 3–5 AEs occurred more frequently in the NPI group than in the NIV group (94 [72.9%] for NPI vs. 35 [27.1%], p< 0.001). Conclusions : For treatment-naive PD-L1 positive MSTS, NPI seems to be less tolerated but has a greater survival advantage than NIV as the primary therapy.
BMC Cancer 2021