Abstract
BACKGROUND: Consolidation durvalumab is standard of care treatment for patients with unresectable, stage III non-small-cell lung cancer without progression after chemoradiotherapy. Additional study is warranted to investigate the long-term efficacy of this regimen in real-world settings. METHODS: PACIFIC-R (NCT03798535) was an international, observational, cohort study of patients who started durvalumab 10 mg/kg intravenously every 2 weeks within an AstraZeneca-initiated early access program between September 2017 and December 2018. Data were extracted retrospectively from medical records to describe the real-world effectiveness of consolidation durvalumab in patients with unresectable non-small-cell lung cancer without progression after chemoradiotherapy. The primary endpoints were real-world progression-free survival (rwPFS) and overall survival (OS). RESULTS: Median age was 65.0 years (range 26-88 years); most patients [747/1153 (64.8%)] were male and current [300/1153 (26.0%)] or former [750/1153 (65.0%)] smokers. Among patients with reported data, most had Eastern Cooperative Oncology Group performance status <2 [743/755 (98.4%)], stage IIIB/C disease [584/1090 (53.6%)], non-squamous histology [746/1137 (65.6%)], and programmed death-ligand 1 expression on ≥1% of tumor cells [572/791 (72.3%)]. Median follow-up (censored patients) was 63.5 months for rwPFS and 67.5 months for OS. Median rwPFS was 24.3 months [95% confidence interval (CI) 20.3-28.4 months]; 5-year rwPFS was 35.2% (95% CI 32.4% to 38.1%). Median OS was 59.0 months (95% CI 52.7-64.3 months); 5-year OS was 49.2% (95% CI 46.2% to 52.2%). Encouraging results were observed across subgroups, including among patients who received durvalumab after either concurrent or sequential chemoradiotherapy [median rwPFS (95% CI): 25.8 months (20.9-31.8 months) versus 23.2 months (16.9-29.5 months); median OS: 63.1 months (57.3-73.5 months) versus 47.1 months (35.3-58.1 months)], and irrespective of programmed death-ligand 1 expression [on ≥1% versus <1% of tumor cells; median rwPFS (95% CI): 25.5 months (19.1-32.8 months) versus 16.3 months (10.9-27.5 months); median OS: 62.4 months (55.0 months-not estimable) versus 43.3 months (31.6-60.7) months]. CONCLUSIONS: PACIFIC-R provides mature data on OS and rwPFS from a large, real-world cohort, supporting consolidation durvalumab as a standard of care in this setting.