Abstract:
:This study was designed as a multicenter, randomized, double-blind, placebo-controlled trial. Patients were randomized by center to placebo (16 patients, 31%), oral bexarotene 300 mg/m2/day (21 patients, 40%), or oral bexarotene 600 mg/m2/day (15 patients, 29%) following demonstration of stable or responsive disease after first-line chemotherapy. The study was prematurely terminated because of slow accrual after 54 patients enrolled. Median time to progression (TTP) from the beginning of study drug treatment was 56 days for placebo, 82 days for moderate-dose bexarotene (300 mg/m2/day), and 128 days for high-dose bexarotene (600 mg/m2/day) (P = 0.56, log-rank test). For prior chemotherapy responders only, median TTP from the beginning of study drug treatment was 56 days for placebo, 146 days for moderate-dose bexarotene, and 177 days for high-dose bexarotene. Of note, there were more chemotherapy responders randomized to the placebo group (63%) than the bexarotene treatment arms (48% and 47%), further supporting a bexarotene-related improvement in TTP. Bexarotene-related toxicity was manageable and consisted primarily of elevated serum triglycerides and asthenia, skin toxicity (dryness, peeling, flaking), thyroid dysfunction, and headache. Because this study was closed prematurely, it does not have the statistical power to detect differences among the treatment groups. This study shows that patients can tolerate bexarotene at initial doses up to 600 mg/m2/day after platinum-based chemotherapy and that bexarotene may have the potential to delay disease progression in patients with advanced non-small-cell lung cancer with previously stable or responsive disease following platinum-based chemotherapy.
journal_name
Clin Lung Cancerjournal_title
Clinical lung cancerauthors
Rizvi N,Hawkins MJ,Eisenberg PD,Yocum RC,Reich SD,Ligand L1069-20 Working Group.doi
10.3816/clc.2001.n.005keywords:
subject
Has Abstractpub_date
2001-02-01 00:00:00pages
210-5issue
3eissn
1525-7304issn
1938-0690pii
S1525-7304(11)70724-0journal_volume
2pub_type
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journal_title:Clinical lung cancer
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journal_title:Clinical lung cancer
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pub_type: 杂志文章,评审
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journal_title:Clinical lung cancer
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journal_title:Clinical lung cancer
pub_type: 杂志文章
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pub_type: 杂志文章
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journal_title:Clinical lung cancer
pub_type: 杂志文章,评审
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journal_title:Clinical lung cancer
pub_type: 杂志文章,随机对照试验
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journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2014.09.010
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journal_title:Clinical lung cancer
pub_type: 杂志文章
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journal_title:Clinical lung cancer
pub_type: 杂志文章
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pub_type: 杂志文章
doi:10.1016/j.cllc.2020.03.010
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pub_type: 杂志文章,评审
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journal_title:Clinical lung cancer
pub_type: 杂志文章
doi:10.1016/j.cllc.2016.12.015
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pub_type: 杂志文章
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pub_type: 杂志文章
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journal_title:Clinical lung cancer
pub_type: 杂志文章,评审
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pub_type: 杂志文章
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