Randomized, double-blind, phase II trial comparing gemcitabine-cisplatin plus the LTB4 antagonist LY293111 versus gemcitabine-cisplatin plus placebo in first-line non-small-cell lung cancer

Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer
Pasi A JänneJoachim Von Pawel

Abstract

In this phase II study, patients with stage IIIB/IV non-small-cell lung cancer were randomly assigned (1:1:1) to receive LY293111 (200 mg twice daily [200 LY293111] or 600 mg twice daily [600 LY293111]) or placebo for 7 days, followed by concurrent cisplatin (75 mg/m2; day 1) and gemcitabine (1250 mg/m2; days 1 and 8), every 21 days.The primary endpoint was progression-free survival, (PFS), with 75% power to detect 33% improvement compared with placebo (5 months). Of 200 randomized patients, 195 were treated. Demographics were well balanced across treatment arms: 65% of the patients were men; median age was 62 years; 85% had stage IV disease; and patients had an Eastern Cooperative Oncology Group performance status of 0 (36%) or 1 (64%). The most frequent study drug-related toxicities were nausea, vomiting, and fatigue. Response rates were similar across treatment arms (200 LY293111: 20%; 600 LY293111: 25%; placebo: 31%). Median PFS (95% confidence interval) was not significantly different across treatment arms (200 LY293111: 4.6 months [3.2-5.0]; 600 LY293111: 5.6 months [4.1-6.8]; placebo: 6.0 months [5.2-7.5]). LY293111 combined with gemcitabine-cisplatin did not increase median PFS compared with placebo plus gemcitabine-cis...Continue Reading

References

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Citations

Aug 26, 2016·Immunological Reviews·Louise W TreffersHanke L Matlung
Jan 25, 2019·Journal of Leukocyte Biology·Anne-Sophie ArchambaultNicolas Flamand
Dec 15, 2015·The Journal of Immunology : Official Journal of the American Association of Immunologists·Joanna M PoczobuttRaphael A Nemenoff
Sep 26, 2020·Frontiers in Pharmacology·Wen TianStanley G Rockson
Dec 29, 2020·Frontiers in Pharmacology·Amber M JohnsonRaphael A Nemenoff
Jul 23, 2021·Progress in Lipid Research·Rahul MallickAsim K Duttaroy
Feb 3, 2021·British Journal of Pharmacology·Lou Saier, Olivier Peyruchaud

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