Skip Navigation LinksHome > January 2014 - Volume 9 - Issue 1 > Randomized, Double-Blind, Phase II Trial Comparing Gemcitabi...
Journal of Thoracic Oncology:
doi: 10.1097/JTO.0000000000000037
Brief Reports

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

Jänne, Pasi A. MD, PhD*; Paz-Ares, Luis MD, PhD; Oh, Yun MD; Eschbach, Corinna MD§; Hirsh, Vera MD; Enas, Nathan MS; Brail, Leslie PhD; von Pawel, Joachim MD#

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Introduction: 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).

Methods: 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%).

Results: 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%).

Conclusions: 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-cisplatin in patients with non–small-cell lung cancer.

Copyright © 2014 by the European Lung Cancer Conference and the International Association for the Study of Lung Cancer.


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