Abstract
BackgroundCurrently, 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.MethodsProspectively 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).ResultsThe 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).ConclusionsFor treatment-naive PD-L1 positive MSTS, NPI seems to be less tolerated but has a greater survival advantage than NIV as the primary therapy.
Highlights
The choice of treatment for individuals with metastatic soft tissue sarcomas (MSTS) presents a significant challenge to clinicians
The cohort consisted of 214 individuals with histologically confirmed, unresectable, treatment-naive MSTS who were treated with nivolumab plus ipilimumab (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 nivolumab alone (NIV: nivolumab 3 mg/kg every 2 weeks) until disease progression, withdrawal, unendurable Adverse events (AEs), or death [7]
Comparison of baseline data A total of 214 patients with treatment-naive programmed death-ligand 1 (PD-L1) positive MSTS were reviewed, 64 of whom were deemed to be ineligible according to our criteria, leaving 150 patients (NPI: n=74, median age 35 years [21.2–51.8] and NIV: n=76, median age 34 years [23.8–57.3]) who were included for eligibility (Fig. 1)
Summary
The choice of treatment for individuals with metastatic soft tissue sarcomas (MSTS) presents a significant challenge to clinicians. For individuals with treatment-naive metastatic STS (MSTS), several approved chemotherapy regimens (i.e., doxorubicin, either alone or in combination) seem to have similar effects, with a low response rate, progression-free survival (PFS) of nearly 0.5 years and overall survival (OS) of 1–1.5 years [7, 8]. For MSTS, the median PFS tends to be approximately 4 months, and OS from a diagnosis of MSTS is less than 14 months [7, 11] Management of such individuals is still a challenge, and a poor prognosis seems to be inevitable [5]
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