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J Thorac Oncol. 2014 Jan;9(1):126-31. doi: 10.1097/JTO.0000000000000037.

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.

Author information

1
*Department of Medical Oncology, Dana-Farber Cancer Institute and Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts; †IBIS (Virgen del Rocio Hospital, Seville University & CSIC), Seville, Spain; ‡Cancer Care Center of Frederick, Frederick, Maryland; §Asklepios Klinik Harburg, Hamburg, Germany; ‖Royal Victoria Hospital, Division of Medical Oncology, Montreal, Canada; ¶Eli Lilly and Company, Indianapolis, Indiana; and #Asklepios Klinikum Gauting, Munich, Germany.

Abstract

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.

PMID:
24346102
DOI:
10.1097/JTO.0000000000000037
[Indexed for MEDLINE]
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