Sie sind bereits registriert?
Loggen Sie sich mit Ihrem Universimed-Benutzerkonto ein:
Sie sind noch nicht registriert?
Registrieren Sie sich jetzt kostenlos auf universimed.com und erhalten Sie Zugang zu allen Artikeln, bewerten Sie Inhalte und speichern Sie interessante Beiträge in Ihrem persönlichen Bereich zum späteren Lesen. Ihre Registrierung ist für alle Unversimed-Portale gültig. (inkl. allgemeineplus.at & med-Diplom.at)
Tislelizumab Superior to Second-Line Chemotherapy in Esophageal Squamous Cancer
Immune checkpoint inhibitors have advanced in the treatment of metastatic squamous cancer of the esophagus, with regulatory approval for nivolumab and pembrolizumab in second-line treatment and recent approval for the addition of pembrolizumab to chemotherapy in first-line treatment. There is ongoing debate about the benefit of these agents in patients with low combined positive scores.
Investigators now report results of the RATIONALE-302 trial, a multinational, industry-sponsored, open-label, phase 3 trial comparing the anti–PD-1 antibody tislelizumab to chemotherapy in the second-line treatment of metastatic squamous cancer of the esophagus. Of 512 patients randomized to tislelizumab or investigator's choice of docetaxel, paclitaxel, or irinotecan, 80% were treated in Asia, 50% had PDL-1 tumor area positive (TAP) scores <10%, 65% had received prior radiotherapy, and 38% had prior surgery.
The primary endpoint of overall survival was significantly improved with tislelizumab compared with chemotherapy (median, 8.6 vs. 6.3 months; hazard ratio, 0.70; P=0.0001). Twelve-month survival was also higher in the tislelizumab arm (37.4% vs. 23.7%). Survival benefits were seen both in patients with TAP >10% (HR, 0.54) and in those with TAP <10% (HR, 0.82). Tislelizumab compared with chemotherapy improved both progression-free survival (HR, 0.83) and response rate (20.3% vs. 9.8%). There were no new safety signals.
Tislelizumab is another anti–PD-1 agent that is superior to second-line chemotherapy in metastatic esophageal squamous cancer. As found in other trials, the survival benefit for checkpoint inhibitor therapy is dependent on PDL-1 positivity, with a diminished survival benefit in patients with TAP scores <10%. The tumor-only TAP score likely overestimates the number of PDL-1–low or PDL-1–negative patients, as it does not consider macrophages and lymphocytes; a significant proportion of TAP-low patients are likely to be PDL-1 positive.
Shen L et al.
Title: Tislelizumab versus chemotherapy as second-line treatment for advanced or metastatic esophageal squamous cell carcinoma (RATIONALE-302): A randomized phase III study.
Source: J Clin Oncol 2022 Apr 20; [e-pub]. (Abstract/FREE Full Text)