Impact of prior chemoradiotherapy-related variables on outcomes with durvalumab in unresectable Stage III NSCLC (PACIFIC)
•Trial enrollment was not stratified for variables related to mandatory prior CRT.•Clinical outcomes were assessed in subgroups defined by CRT-related variables.•As in the ITT population, PFS, OS and TTDM favored durvalumab use in all subgroups.•Durvalumab had a manageable safety profile irrespectiv...
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Veröffentlicht in: | Lung cancer (Amsterdam, Netherlands) Netherlands), 2021-01, Vol.151, p.30-38 |
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Format: | Artikel |
Sprache: | eng |
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Zusammenfassung: | •Trial enrollment was not stratified for variables related to mandatory prior CRT.•Clinical outcomes were assessed in subgroups defined by CRT-related variables.•As in the ITT population, PFS, OS and TTDM favored durvalumab use in all subgroups.•Durvalumab had a manageable safety profile irrespective of CRT-related variables.•Imbalances in baseline factors and subgroup sizes prevent robust conclusions.
The PACIFIC trial demonstrated that durvalumab significantly improved progression-free and overall survival (PFS/OS), versus placebo, in patients with Stage III NSCLC and stable or responding disease following concurrent, platinum-based chemoradiotherapy (CRT). A range of CT and RT regimens were permitted, and used, in the trial. We report post-hoc, exploratory analyses of clinical outcomes from PACIFIC according to CRT-related variables.
Patients were randomized 2:1 (1–42 days post-CRT) to up to 12 months durvalumab (10 mg/kg intravenously every 2 weeks) or placebo. Efficacy and safety were analyzed in patient subgroups defined by the following baseline variables: platinum-based CT (cisplatin/carboplatin); vinorelbine, etoposide, or taxane-based CT (all yes/no); total RT dose (66 Gy); time from last RT dose to randomization ( |
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ISSN: | 0169-5002 1872-8332 |
DOI: | 10.1016/j.lungcan.2020.11.024 |